Implementing a Clinical Pathway for Mental Health Screenings in a Specialty Practice Clinic: A Process Improvement Initiative

Mental health disorders, including anxiety and depression, are prevalent among individuals with Phenylketonuria (PKU). These conditions can significantly impact quality of life, treatment adherence, and overall health outcomes. Despite the known psychological burden and risk of these conditions, routine mental health screening is not widely implemented in specialty metabolic clinics. Without a standardized approach to screening, many patients remain undiagnosed and untreated. Systematic screening using validated tools facilitates early identification and intervention, ultimately improving patient well-being and supporting a holistic care model. A local academic medicine clinic in Salt Lake City, Utah, provides specialized care for individuals with PKU. Historically, there has not been a standardized approach to mental health screening in this population. Discussions about mental health were inconsistent, and there was no clear clinical pathway for managing positive screening results. The absence of a structured process highlighted the need for a quality improvement initiative to integrate mental health screening into routine metabolic care. This quality improvement initiative followed the Johns Hopkins Evidence-Based Practice model to implement and evaluate a mental health screening process. Pre-surveys were distributed to a multi-disciplinary clinic team to assess knowledge and confidence in accessing, administering, and interpreting mental health screening tools. Open-ended questions aided the creation and education of a clinician toolkit. A post-survey was distributed 11 weeks after implementation to reassess participants' knowledge and confidence with mental health screening tools. Post-survey open-ended questions assessed satisfaction, usability, and feasibility. Pre- and post-surveys were paired, and the Wilcoxon signed-rank test was utilized for comparative analyses (α=0.05). A clinical toolkit was created to guide targeted training on the importance of mental health screening, administration of the tools, interpretation of results, integration of results in the electronic medical record (EMR), and the designated clinical pathway for individuals who screen positive. Two education sessions and a mid-implementation check-in were held to counsel participants and obtain feedback on the process. During implementation, the EMR was assessed weekly to note the number of screens and mental health PKU clinic referrals completed for eligible patients. The pre- and post-surveys were completed by 19 participants who primarily identified as white, non-Hispanic, females, ages 25-34, and were employed full-time with about 1 to 3 years of experience. The inferential analysis comparing pre- and post-survey results suggested several statistically significant improvements, with medium to high effect sizes, in accessing, administering, and interpreting mental health screening tools. EMR data showed 86.8% of eligible patients were screened, 36.5% screened positive for depression and/or anxiety, and among positive screens, 33.3% received a referral to the mental health PKU clinic. Implementation of a systematic mental health screening process in a specialty metabolic clinic is both feasible and beneficial. The project improved clinician confidence in regularly utilizing mental health screening tools for patients with PKU, aged 13 years and above. Post-project comments suggested participant satisfaction, usability, and feasibility of the initiative. Future efforts should focus on expanding diagnoses and integrating the tools with the EMR.

1 Implementing a Clinical Pathway for Mental Health Screenings in a Specialty Practice Clinic: A Process Improvement Initiative Ashley L. Andrews, Kate M. McMinimee, Edly Mendez, Brian J. Shayota & Scott Christensen College of Nursing: The University of Utah NURS 7703: DNP Scholarly Project III 28 April 2025 2 Abstract Background: Mental health disorders, including anxiety and depression, are prevalent among individuals with Phenylketonuria (PKU). These conditions can significantly impact quality of life, treatment adherence, and overall health outcomes. Despite the known psychological burden and risk of these conditions, routine mental health screening is not widely implemented in specialty metabolic clinics. Without a standardized approach to screening, many patients remain undiagnosed and untreated. Systematic screening using validated tools facilitates early identification and intervention, ultimately improving patient well-being and supporting a holistic care model. Local Problem: A local academic medicine clinic in Salt Lake City, Utah, provides specialized care for individuals with PKU. Historically, there has not been a standardized approach to mental health screening in this population. Discussions about mental health were inconsistent, and there was no clear clinical pathway for managing positive screening results. The absence of a structured process highlighted the need for a quality improvement initiative to integrate mental health screening into routine metabolic care. Methods: This quality improvement initiative followed the Johns Hopkins Evidence-Based Practice model to implement and evaluate a mental health screening process. Pre-surveys were distributed to a multi-disciplinary clinic team to assess knowledge and confidence in accessing, administering, and interpreting mental health screening tools. Open-ended questions aided the creation and education of a clinician toolkit. A post-survey was distributed 11 weeks after implementation to reassess participants’ knowledge and confidence with mental health screening tools. Post-survey open-ended questions assessed satisfaction, usability, and feasibility. Pre- and 3 post-surveys were paired, and the Wilcoxon signed-rank test was utilized for comparative analyses (α=0.05). Interventions: A clinical toolkit was created to guide targeted training on the importance of mental health screening, administration of the tools, interpretation of results, integration of results in the electronic medical record (EMR), and the designated clinical pathway for individuals who screen positive. Two education sessions and a mid-implementation check-in were held to counsel participants and obtain feedback on the process. During implementation, the EMR was assessed weekly to note the number of screens and mental health PKU clinic referrals completed for eligible patients. Results: The pre- and post-surveys were completed by 19 participants who primarily identified as white, non-Hispanic, females, ages 25-34, and were employed full-time with about 1 to 3 years of experience. The inferential analysis comparing pre- and post-survey results suggested several statistically significant improvements, with medium to high effect sizes, in accessing, administering, and interpreting mental health screening tools. EMR data showed 86.8% of eligible patients were screened, 36.5% screened positive for depression and/or anxiety, and among positive screens, 33.3% received a referral to the mental health PKU clinic. Conclusion: Implementation of a systematic mental health screening process in a specialty metabolic clinic is both feasible and beneficial. The project improved clinician confidence in regularly utilizing mental health screening tools for patients with PKU, aged 13 years and above. Post-project comments suggested participant satisfaction, usability, and feasibility of the initiative. Future efforts should focus on expanding diagnoses and integrating the tools with the EMR. Keywords: phenylketonuria, mental health, anxiety, depression, quality-improvement 4 Implementing a Clinical Pathway for Mental Health Screenings in a Specialty Practice Clinic: A Process Improvement Initiative Problem Description Phenylketonuria (PKU) or phenylalanine hydroxylase (PAH) deficiency is an inborn error of metabolism with an estimated frequency of 1 in 13,500 to 19,000 live births in Northern America (NORD, 2024). Variants in the PAH gene, inherited in an autosomal recessive pattern, cause PAH deficiency (Regier & Greene, 2010). PAH deficiency results in the incomplete metabolism of the amino acid phenylalanine into tyrosine. Treatment of PKU has historically been focused on a diet low in natural protein from foods and supplementation of phenylalaninefree medical formulas. Dietary compliance is notoriously difficult, especially in adolescence and adulthood, and while other targeted therapeutic interventions exist, not all are well tolerated or have a sufficient response to currently available therapies (Bilder et al., 2016; Reiger & Green, 2010, Rocha et al., 2023). Regardless of the therapies utilized, it is recommended to maintain phenylalanine levels below 360µM for life (Vockley et al., 2014). Excess phenylalanine and low tyrosine levels have several significant impacts, particularly relating to the downstream neurotransmitters that are derived from these amino acids, often resulting in decreased dopamine, norepinephrine, and serotonin production (Ashe et al., 2019; Reiger & Green, 2010). Due to these changes in neurochemistry, individuals with PKU are at increased risk of depression and anxiety, when compared to the general population and other chronic conditions such as diabetes (Ashe et al., 2019; Kenneson & Singh, 2021). Mental health concerns are highly associated with poor metabolic control, though they can be mitigated with improved disease management (Ashe et al., 2019; Kenneson & Singh, 2021; Rocha et al., 2023). While formal studies are lacking, it is 5 theorized that, due to the neurochemistry of this condition, individuals with PKU may have a greater response to anxiety and depression medications, specifically serotonin reuptake inhibitors (SSRIs), compared to the general population (Ashe et al., 2019; Risoleo et al., 2022). Despite the known risks of undiagnosed mental health concerns, and the availability of effective therapies, regular screenings for mental illness in outpatient metabolic clinics are uncommon (Angelino et al., 2012; Burton et al., 2013). By integrating these screenings into the care of individuals with PKU, metabolic clinics can reduce barriers such as stigma, lack of awareness, and financial constraints for this vulnerable population. However, most metabolic clinics do not have embedded support from behavioral health specialists and/or social workers to administer screenings (Angelino et al., 2012; Burton et al., 2013). Additionally, many providers note a lack of resources, time constraints, and uncertain reimbursement for screening (Burton et al., 2013; Sapra et al., 2020). Only 28% of the United States population lives in an area with enough mental health support to meet the population's needs (Modi, Orgera & Grover, 2022). As such, providers also highlight the importance of a designated clinical pathway for individuals who screen positive for these assessments (Burton et al., 2013). These barriers all contribute to a lack of systematic screening for anxiety and depression in this high-risk population which decreases the potential for treatment and improved outcomes overall. By bringing mental health screenings, and treatment options, into an already utilized service, bolstered with trusted relationships, individuals with PKU may experience improved health outcomes, better medical management of their condition, and enhanced overall quality of life. Available Knowledge Anxiety and depression are two exceedingly common self-reported symptoms in children and adults with PKU (Angelino et al., 2012; Ashe et al., 2019; Charrière et al., 2023; Kenneson 6 & Singh, 2021; Risoleo et al., 2022; Rocha et al., 2023). In a feasibility study for the use of psychiatric distress screenings in three separate metabolic clinics in North America, Burton et al. (2013) found the vast majority of patients accepted the screenings and 32% screened positive for psychiatric concerns. These findings were substantiated by a 2017 retrospective cohort study including 3,715 individuals with PKU (Bilder et al., 2017). In this cohort, 19.5% of people with PKU had depression, which is significantly higher than the rates in the general population of 11.8% (Bilder et al., 2017). Additionally, 15.6% of individuals with PKU had anxiety compared to 9.2% estimated for the general population. A major contributor to these mood disorders is the impact of high phenylalanine levels on the brain (Ashe et al., 2019; Bilder et al., 2017). However, the extremely restrictive dietary treatment may also play a role (Manti et al., 2016). In a study of early-treated PKU patients compared to healthy age-matched controls, Manti et al. (2016) did not find biochemical differences that would explain the higher rates of anxiety amongst those with PKU. Instead, they theorized the burden of the disease and internalization of stressors related to the strict dietary treatment contributed to the increased rates of anxiety (Manti et al., 2016). Clinical practice experience with this disorder suggests that likely both neurochemical and disease-related influences play a role in mental health concerns. While the risks of anxiety and depression in PKU are well-known, only 15% of metabolic clinics reported consistently screening for mental health issues (Burton et al., 2013). Additionally, 56% of surveyed metabolic clinics felt that cognitive issues, including mental health disorders, affected patient’s ability to maintain regular care (Angelino et al., 2012). Although respondents agreed that individuals who screen positive for mental health concerns would benefit from treatment, few were receiving mental healthcare. In a PKU patient perspective survey, 88% of adult respondents reported at least one mental, behavioral, or 7 neurocognitive diagnosis. However, less than 50% reported they have had an assessment of their mental health concerns (Ilgaz et al., 2023). An additional online survey combining PKU patients from three European centers reported that 50% of respondents desired psychological assessments as part of their regular disease management (Van Wegberg et al., 2021). In 2013, the ADAPT (A Diversified Approach to PKU Treatment) project sought to initiate regular screenings for mental health concerns in three North American metabolic clinics. Challenges noted in previous publications and the ADAPT program were the availability of affordable and/or insurance-covered mental health professionals, scheduling conflicts, and the stigma associated with receiving mental healthcare (Angelino et al., 2012; Burton et al., 2013). However, mental health diagnoses may help patients demonstrate the need for public insurance or services, allowing for a greater pool of mental health resources (Angelino et al., 2012). Rationale The Johns Hopkins Evidence-Based Practice (JHEBP) model, a systematic framework for translating evidence into practice, was instrumental in directing this project (Johns Hopkins Medicine, 2024). The model has three phases: Practice Question, Evidence, and Translation. Each phase, comprised of several steps, guided evidence-based interventions toward implementation and evaluation. A critical first step was to define the problem or clinical question the project aimed to address. A clear population, intervention, comparison, and outcome (PICO) question narrowed the project's scope, making it manageable and specific. For this project, we evaluated the impact of regular mental health screenings among patients with PKU. This problem was identified through discussions with providers in the metabolic clinic, along with personal clinical experience. 8 The next phase, evidence, involved the gathering, appraisal, and synthesis of evidence for the project, which included gathering sources related to mental health diagnoses in the PKU population, to identify trends and best practices. Published literature can be scarce for rare diseases, so several techniques were utilized for the review, using keyword searches and “SCOPUS.” This approach ensured the project was grounded in the best available evidence and ready for translation into practice. Finally, the translation phase facilitated the implementation of the evidence-based intervention. In addition to planning for the implementation of mental health screenings for PKU patients, sustainability with a roadmap for treatment for positive screens could not be overlooked. Monitoring progress and making necessary adjustments based on feedback and outcomes was also important. After the initiative began, regular data check-ins along with motivation meetings with the team enabled the project’s success. The dissemination of results was an additional goal given the scarcity of published resources in this population. By following the JHEBP model, the project benefited from a defined template to facilitate the successful integration of evidence-based practice into the clinical setting. Specific Aims The purpose of this Doctor of Nursing Practice (DNP) evidence-based quality improvement initiative was to promote patient well-being within a local academic medicine clinic by implementing systematic screening for anxiety and depression among patients, 13 years and older, with phenylketonuria. A secondary measure was to refer positively screened individuals for mental health services, with screening practices and referrals tracked as a measure of feasibility. Methods 9 Context This DNP scholarly initiative was conducted within a pediatric outpatient clinic housed in an academic medical center located in Salt Lake City, Utah. The clinic provides lifelong care for individuals diagnosed with inborn errors of metabolism, including PKU. It serves a broad geographic region encompassing Utah, Nevada, Southeast Idaho, Southwest Wyoming, and Alaska. Approximately 250 individuals with PKU are actively followed in the clinic, the majority of whom reside in Utah and Nevada. These patients represent diverse residential settings, including urban, suburban and rural communities. Although patients were not direct participants in this initiative, their demographic and geographical characteristics informed the development of an inclusive and accessible screening process. To promote equitable access, screening tools were made available in English and Spanish, with interpretation services offered for additional languages as needed. Furthermore, screenings were administered during both in-person and virtual clinic visits to reduce potential barriers related to geography. This multi-disciplinary metabolic clinic included three biochemical geneticists, two nurse practitioners (NPs), four metabolic dietitians (RDs), one genetic counselor (GC), one registered nurse (RN), two clinical coordinators, one division manager, two clinic managers, and five medical assistants (MAs). The medical assistants served multiple clinic teams and were not solely utilized in the metabolic clinic. One physician was the director of metabolic services with a nurse practitioner as associate director and immediate supervisor to metabolic RDs, the second NP, and one clinic coordinator. Several other clinical enterprises supported the clinic team including scheduling, health information management, preauthorization, triage, referrals, and social work. A central social work team was available to support all patients seen at the 10 children’s hospital, regardless of specialty. Recently, the social work team started screening for social determinants of health in all clinics. Should the patient screen positive, a social worker was contacted for an in-clinic consult. This process enhanced the clinic’s capacity to respond to mental health needs, as social workers were available to assist with emergent mental health concerns identified during routine screening. Interventions Before implementation of the DNP scholarly initiative, pre-surveys were distributed to the clinic team, as described above. Convenience sampling was used with the goal being to engage all members of the metabolic clinic team. The pre-survey included demographic information of gender identification, race and ethnicity, age, highest level of education completed, role in the clinic, time in current role, and employment status (part-time, full-time, per diem). The pre-survey also assessed participants’ knowledge and confidence in accessing, administering, and interpreting the Patient Health Questionaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) tools. These multiple-choice Likert-Scale questions were organized from strongly disagree to strongly agree. Two open-ended questions were included in the presurvey to assess how mental health concerns are currently addressed in patients with PKU and what support or resources would make the participant feel confident in using mental health screening tools. Paper surveys were collected from participants over one week. Answers were reviewed and open-ended questions were assessed for common themes. A clinician toolkit was then created to advance a clinical pathway for mental health screenings among PKU populations. The toolkit included an informational handout on the importance of mental health screenings in PKU (see Appendix A), annotated PHQ-9 and GAD-7 tools, a step-by-step guide (see Appendix B) for the use of the tools, flow diagrams for in-person 11 and virtual visit tool implementation (see Appendix C), and the American Academy of Pediatrics Guidelines for Adolescent Depression (GLAD) clinic assessment flowchart. The project content expert reviewed each toolkit component and provided feedback for improvement. The project sponsor reviewed the clinic flows and aided in scheduling the MA education sessions. Training on the toolkit utilization was provided in two sessions, one with clinic MAs and the other with remaining metabolic clinic team members. Each document outlining PKU mental health screening clinic pathways was reviewed with all participants, allowing time for feedback and questions. In weekly pre-clinic meetings, patients appropriate for screening were identified by the metabolic team. Virtual patients had screens emailed to them the week before clinic as part of a standard visit reminder. The emails, sent by the clinic coordinator, contained standardized language informing the patients of the screenings with directions to complete and then return via email. The patients receiving screenings were identified on the clinic board for in-person clinic days. Printed English and Spanish screenings were easily accessible in the clinic space. During the implementation of the screenings, the electronic medical record (EMR) of eligible patients was assessed weekly. Information gleaned from the EMR included uploaded completed screens, documentation of screens, results, and plans in provider clinic notes, a referral message to the scheduling team, and an appointment scheduled in the mental health PKU clinic. Feedback was then incorporated into the process for the remaining weeks. Finally, post-surveys were collected after 11 weeks of patient screenings. Post-surveys included the same demographic and knowledge/confidence questions as the pre-survey. Additionally, the post-survey included three Likert-scale questions and three open-ended questions to address the usability, satisfaction, and feasibility of the project. 12 Study of the Interventions Quantitative analysis of paired pre-survey and post-survey knowledge and confidence change was one method to assess the intervention’s impact. In addition to the Likert-scale questions, the open-ended questions ensured the clinical toolkit addressed any gaps in knowledge and perceived barriers to screening. Likewise, the post-survey open-ended question elicited feedback on how the program can continue to improve. Change in participants’ knowledge and confidence also reflect the effectiveness of the clinical toolkit and associated education. A midinitiative check-in with clinicians and MAs was completed for feedback on the screening process. As these screens were not regularly done before this project, pre-implementation charts were not reviewed. Instead, the EMRs of patients seen during implementation were evaluated as described above. In this way, the number of eligible patients seen during implementation was compared to the number of screenings documented. Additionally, the number of flagged positive screens was compared to the number of referrals to the mental health PKU clinic. The regular review of these metrics provided feedback on how the practice change was being incorporated into the clinic. An expected outcome of this initiative was that more mental health screening would be performed, leading to referrals for mental health services. Measures For this scholarly initiative, several measures were employed to evaluate the intervention's impact and effectiveness. Pre- and post-surveys were utilized to assess the clinic team's knowledge, confidence, and satisfaction with the implementation of mental health screenings for PKU patients. These surveys collected demographic information and evaluated baseline knowledge and confidence in administering and interpreting the PHQ-9 and GAD-7 13 tools. The pre-survey (see Appendix D) included 20 items, divided into two main sections: demographic questions (gender identification, race, ethnicity, age, education level, role, time in current role, and employment status) and knowledge and confidence (assessed using a 5-point Likert scale from "strongly disagree" to "strongly agree"). Two open-ended questions and one select all that apply were also included. These open-ended questions explored how mental health concerns were addressed in the PKU population and identified the resources needed to support clinicians in screening for mental health issues. The select all that apply question investigated perceived barriers to mental health assessments, including lack of time, uncertainty in interpretation of results, limited resources, patient resistance, or other factors with a prompt to specify. The post-survey (see Appendix E), administered after the project, was similar to the presurvey but included additional questions on usability and satisfaction with the new screening process. No questions were reverse-scored on either survey. To assess patient mental health, the PHQ-9 and GAD-7 screening tools were employed. The PHQ-9 (see Appendix F) consists of nine items that assess depressive symptoms, with each item scored on a 4-point Likert scale ranging from 0 ("not at all") to 3 ("nearly every day"), leading to total scores between 0 and 27. Compared to the standard of mental health interviewing, a PHQ-9 of 10 or greater has a sensitivity and specificity of 88% (Kroenke et al., 2001). Similarly, the GAD-7 (see Appendix G) contains seven items measuring anxiety, scored on the same 4-point Likert scale, with total scores ranging from 0 to 21. A systemic review of GAD-7 also showed appropriate sensitivity and specificity to identify generalized anxiety disorder; sensitivity was 83% and specificity was 0.84% (Plummer et al., 2016). These tools provided critical data for tracking mental health symptoms and were collected during both inperson and virtual visits. 14 Feasibility, usability, and satisfaction of the project were also key measures of success. Feasibility was assessed through feedback on whether the project provided sufficient value to address the mental health needs of patients with PKU, whether it could be sustained with available resources, and whether clinic staff intended to continue using the screening tools after the project concluded. Clinician input was gathered through mid-project feedback sessions and the post-survey to gauge whether the intervention was valuable and likely to succeed long-term. Usability was evaluated by identifying facilitators and barriers encountered during the implementation. Medical assistants and clinicians provided feedback on how easily the screening process fit into the clinic's workflow and whether any adjustments were needed. Completion rates for both in-person and virtual screenings were tracked to assess how well the screening tools were integrated into routine care. The post-survey asked clinicians about their satisfaction with the intervention, whether they would continue to use the screening tools, and if any further changes were needed. This feedback helped to gauge overall satisfaction with the intervention and identify areas for further improvement. Through these comprehensive measures, the project's effectiveness and potential for continued success were thoroughly evaluated. Analysis The analysis included descriptive statistics, such as rates and percentages, related to demographic features, barriers to implementation, PHQ-9 and GAD-7 utilization, and rates of documentation and referrals. A paired comparative analysis of pre-and post-survey findings utilized the Wilcoxon signed-rank test (p < 0.05) to identify statistically significant changes and Pearson's r as a measure of effect size. Finally, the analysis included a summary of open-ended comments. Ethical Considerations 15 Ethical considerations in the implementation and study of the mental health screening intervention for PKU patients extended to both the clinic staff, who were the participants in the project, and the patients themselves. The project was deemed a healthcare improvement process and therefore did not require full Institutional Review Board (IRB) approval. Clinic staff members, as key participants, were asked to voluntarily engage in pre- and post-surveys to assess their knowledge and confidence in using the PHQ-9 and GAD-7 screening tools. Training sessions emphasized the ethical handling of patient information and the need to maintain confidentiality when using screening tools and safeguarding patients' mental health data in the EMRs. Screenings were available to both English and Spanish-speaking patients, as well as those attending in-person or virtual appointments. This helped to minimize disparities in mental health care access including language and geographical barriers. Results Participants Twenty pre-surveys were distributed and 19 were completed (95% response rate). Postsurveys were distributed to all who completed the pre-survey with 100% returned. The pre-and post-survey samples were paired, allowing for a comparative analysis of dependent samples using the Wilcoxon Signed-Rank Test. Demographics We collected demographic information on age, gender, race/ethnicity, education, clinic roles, years in current role, and employment status (see Table 1). The majority of participants were females (84.2%), ages 25-34 (47.7%), white (52.6%), non-Hispanic (73.7%), and all were employed full-time. Participants were more likely to have completed higher education (68%). Clinical roles were diverse, with medical assistants (26.3%) and registered dietitians (21.1%) 16 comprising the most common roles. Finally, most participants had 1 to 3 years of experience in their role (68.4%). Pre-and Post-Survey Comparative Analysis The inferential analysis comparing pre-to post-survey results suggested several statistically significant improvements between the groups, with medium to high effect sizes, as shown in Figure 1 and Table 2. Participants strongly agreed on the importance of screening for mental health conditions in both the pre- and post-surveys, with medians of five in both groups and no difference between the samples (p=0.68, r=0.09). However, the current use of screening tools was infrequent at baseline, with a reported significant increase in screening postimplementation (p < 0.01, r=0.82). Confidence in assessing, administering, and interpreting the PHQ-9 and GAD-7 screening tools also showed significant gains across multiple survey questions. Understanding the appropriate steps to take with a positive screen also improved postimplementation from a median score of two to four (p < 0.01, r=0.75). Two open-ended questions were included in the pre-survey to understand the current practice of addressing mental health in patients with PKU and the necessary resources to feel more confident in utilizing the mental health screen tools. See Appendix H for the complete list of pre-survey responses; responses were organized into common categories (see Table 3). Answers regarding the current practices of addressing mental health in patients were varied with the top response being that they are not currently addressed (4 responses). For example, one participant said, “I don't, but if concerned I refer to (a) specialist.” The next two responses, equal in frequency (3 responses each), were to recommend patients follow up with their primary care provider (PCP) while working to optimize metabolic control and discussing mental health with providers in the clinic. One participant said, “Suggest a referral to outpatient therapy. Try to 17 address issues I can help with (diet, formula, labs) to decrease stress/anxiety around them.” The majority of participants (14 responses) agreed that education or training on tools and the clinic flow for incorporation would be needed to feel more confident in utilizing the screenings. The post-survey included three open-ended questions that served to help understand the usability, feasibility, and satisfaction of the initiative (see Appendix I for the complete list of post-survey responses). Responses were organized into common categories (see Table 4). Participants responded that they didn’t need additional support or training to feel more confident using mental health screens (11 responses) or that more practices would be helpful (five responses). One participant noted, “I don't think I need any more training/support. I'm confident in using the screening tools.” No suggested improvements were made by the majority of participants (11 responses). However, four respondents noted that electronic screening tools that could be completed before the clinic visit or integrated into the EMR would be helpful. Expanding mental health screenings to additional diagnoses was also suggested (two responses). For example, one participant said, “PKU is a great start for screenings and I would love to see the screenings take place with other genetic disorders (if applicable).” Thirteen participants either did not answer or indicated that they did not have suggestions to improve the usability and effectiveness of the mental health screenings with one participant commenting, “None, it's great.” The remaining responses were scattered and included having a dedicated social worker (one response), enhancing relationships with talk therapists for referrals (one response), and expanding to other areas served (one response). Screening Barriers In addition to improved familiarity and confidence in using screening tools regularly, barriers decreased significantly from a median score of 4 (2, 5) to 2 (1, 3) (p < 0.01, r = 0.61). A 18 select all-that-apply question further illuminated participants’ pre- and post-survey barriers to screening. As seen in Table 5, the most frequently chosen barrier before implantation was uncertainty in interpreting results, selected by 42.1% of participants. Post-implementation, this option was chosen by 5.3% of participants. Post-survey, patient resistance became the most frequently chosen barrier, increasing 47.4% from the pre-survey. Overall barriers decreased 25.9% from the pre-survey to the post-survey. Post-Project Feasibility Three questions in the post-survey focused on the project’s feasibility (see Table 6). The majority of participants (94.7%) responded they were either “very likely” or “likely” to continue using the screening tools in clinical practice. Participants rated the efficiency of the workflow as “efficient” (68.4%) or “very efficient” (31.6%). Finally, participants appraised the ease of scheduling screen-positive patients into the mental health PKU clinic as “easy” (42.1%) or “very easy” (42.1%). EMR Data During implementation, staff completed mental health screenings on 33 of 38 (86.8%) eligible clinic patients (see Table 7). Of those screened, 36.5% (n = 12) had positive results for depression and/or anxiety. Mental health referrals were completed for four of these patients (33.3%) with three patients able to be scheduled for a visit (75%). Clinic documentation highlighted reasons that patients who screened positive were not referred to the mental health clinic. Most commonly, patients were either not interested or already established with behavioral health and/or prescribed anti-depressants. Discussion 19 Summary This evidence-based quality improvement initiative aimed to promote patient well-being within a local academic medicine clinic by implementing systematic screenings for anxiety and depression among patients, 13 years and older, with PKU. A comparison of pre-post participant surveys indicated several statistically significant increases, with medium to high effect sizes, in the knowledge and confidence regarding accessing, administering, and interpreting the screening tools. These results may demonstrate the effectiveness of the clinician toolkit and training interventions. Additionally, participant results suggested an increased understanding regarding the appropriate next steps with a positive screen. Barriers to screenings significantly decreased from pre-project implementation. Interestingly, the perceived barriers also shifted from uncertainty in interpreting results to patient resistance. Open-ended questions showed that participants agreed screening is important but often not addressed, with referrals to specialists or primary care providers being the most common actions taken. Participants noted a need for training to feel more comfortable incorporating screening into their practice. According to the post-survey open-ended questions, the workflow incorporating screenings into practice was highly successful. The screening workflow was rated to be efficient and the referral process to the mental health PKU clinic was noted to be easy. The majority of participants felt like they did not need additional support to use the screening tools. However, some suggested integrating electronic screening tools into the EMR and expanding screenings to other diagnoses and regions. Participant responses to post-project questions related to feasibility suggested a strong likelihood that they will continue to use the screening tools in their practice. 20 Tracking EMR screening documentation allows for additional understanding of how the screening tools are being utilized. The tools were well utilized among eligible patients; however, two areas of improvement were noted. First, provider buy-in is important to reach all eligible patients. Second, technology issues impeded screenings during virtual visits, which again underscores the potential of screening tools integrated into EMRs. Interpretation Before project implementation, the mental health of individuals with PKU was not being routinely addressed by participants. This aligns with previous investigations noted by Burton et al. (2013), who found that only 15% of metabolic clinics screened for mental health concerns. This finding is in contrast to the perceived importance of screening as seen in this project and a previous study, which surveyed metabolic clinics and noted that mental health concerns were linked with patients’ ability to manage their care (Angelino et al., 2012). This DNP initiative illuminated the discomfort of participants in accessing, administering, and interpreting depression and anxiety screening tools. Post-surveys showed statistically significant improvements, with medium to high effect sizes, in all knowledge and confidence questions, showing the benefit of the clinical toolkit and targeted education sessions. Post-project feasibility questions further demonstrated the potential efficiency and ease of the screening workflow, allowing for a sustainable impact in this patient group. Despite their critical importance, barriers limit the widespread implementation of screening. Barriers identified in the project were similar to those previously described, including time constraints, lack of resources, and the need for a clinical pathway for individuals who screen positive (Burton et al., 2013; Sapra et al., 2020). While concern for patient refusal had not noted in prior research, one previous study found that 50% of surveyed European patients 21 desired psychological assessments as part of their regular metabolic care (Van Wedberg et al., 2021). Likewise, in this project, patient refusal emerged as a barrier to screening. While zero patients refused screening, several patients who screened positive for depression and/or anxiety declined a referral to the mental health PKU clinic. Technology concerns had not been detailed in previous studies as a barrier to screening, though this may be a new consideration given the increase in virtual visits post-COVID-19 pandemic (Chaver, 2022). With this DNP initiative, technology concerns were the culprit in 40% of patients not being screened during implementation. In fact, 21% of participants suggested EMR integration as a future improvement to the screening workflow, which would help mitigate some technology concerns of screening during virtual visits. It is important to continue making improvements to allow screenings for patients seen virtually, helping to limit geographic barriers. Several previous studies highlight the need for mental health screenings in patients with PKU due to the increased risk of depression and anxiety in this population (Bilder et al., 2017; Burton et al., 2013; Manti et al., 2016). This project found similar rates of depression and anxiety in patients screened. One-third of these patients were referred to the mental health clinic where medication therapy can be discussed. As noted in the post-survey open-ended questions, establishing relationships with therapists for talk therapy would contribute additional benefits. Limitations The metabolic clinic employs a relatively small team, allowing a small sample size of 20 potential participants. However, the response rate was high at 95%, and all who participated in the pre-survey received implementation training and completed the post-survey, allowing for a paired comparative analysis and the use of the Wilcoxon Signed-Rank Test. The project was 22 limited to a single specialty clinic, which limits the generalizability and understanding of how mental health screening tools could be implemented more widely in inborn errors of metabolism. Clinician adoption also impacted the number of patients screened during implementation. Additionally, in this clinic, most patients with PKU are followed by nurse practitioners so the physicians who participated had limited opportunities to use the screening tools, if any, during the short implementation time. However, the physician participants were able to attend the training and provided valuable feedback on the screening process. Patient engagement and technology issues also emerged as potential limitations. While no one rebuffed screening, several positively screened patients declined an appointment with the mental health PKU clinic. Regardless, they were offered the resource for the future. Virtual appointments added further complexity to screening. Screens were often not returned before the visit, as requested, leading to verbally reviewing the questionnaires during the visit. In addition to adding time to the visits, internet interruptions or other technology issues limited the ability to screen in some cases. Email follow-ups were attempted for these patients but were not returned. Future projects can explore ways to enhance patient participation and improve clinician buy-in. Conclusion This initiative demonstrated the feasibility and value of integrating systematic mental health screenings into a specialty clinic for patients with PKU. Initially, mental health concerns were inconsistently addressed but targeted training and workflow adaptations empowered clinicians to incorporate screening tools with confidence. While post-implementation feedback was largely positive, opportunities for improvement, such as EMR integration and expansion to other genetic disorders and clinic regions, highlight the potential for broader impact. 23 This initiative may serve as a roadmap for other metabolic clinics wishing to incorporate mental health screenings. Further studies should include more on patient and disease-related outcomes such as the relationship of metabolic control with changes in depression and/or anxiety scores. Moving forward, sustaining and refining these efforts will be key to ensuring that mental health care becomes a standard component of comprehensive metabolic management, ultimately enhancing patient well-being and clinical outcomes. 24 Acknowledgments I sincerely thank the Metabolic Clinic Team at the University of Utah for their support, constant encouragement, and involvement in this initiative. There would not be an initiative without the experience and support of Dr. Kate McMinimee, thank you. I extend my unwavering gratitude to the metabolic dietitians, the constant stars of our show. Thank you to Dr. Lorenzo Botto for his years of mentorship and support of this project. As the context expert, metabolic clinic director, and consistent supporter Dr. Brian Shayota was essential to this initiative. Finally, my deepest gratitude to my project chair, Scott Christensen, for his insight, skills, guidance, and encouragement in this initiative’s design, data analysis, and manuscript production. 25 References Angelino, A. F., Bone, A., & Kuehl, A. K. (2012). A neuropsychiatric perspective of phenylketonuria II: Needs assessment for a psychiatric presence. Psychosomatics, 53(6), 541–549. https://doi.org/10.1016/j.psym.2012.04.011 Ashe, K., Kelso, W., Farrand, S., Panetta, J., Fazio, T., De Jong, G., & Walterfang, M. (2019). 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Nutrients, 15(18), 3940. https://doi.org/10.3390/nu15183940 Sapra, A., Bhandari, P., Sharma, S., Chanpura, T., & Lopp, L. (2020). Using generalized anxiety disorder-2 (GAD-2) and GAD-7 in a primary care setting. Cureus. https://doi.org/10.7759/cureus.8224 Shaver J. (2022). The state of telehealth before and after the COVID-19 pandemic. Primary Care, 49(4), 517–530. https://doi.org/10.1016/j.pop.2022.04.002 Southeast Regional Genetics Network. (2022). PKU nutrition guidelines: Biochemical pathway and nutrition treatment rationale (Version 2.5). Nutrition Management Guidelines. https://managementguidelines.net/guidelines.php/136/bpntr/0/0/PKU%20Nutrition%20G uidelines/Version%202.5/Biochemical%20Pathway%20and%20Nutrition%20Treatment %20Rationale 28 Van Wegberg, A. M. J., MacDonald, A., Abeln, D., Hagedorn, T. S., Lange, E., Trefz, F., Van Vliet, D., & Van Spronsen, F. J. (2021). Patient’s thoughts and expectations about centres of expertise for PKU. Orphanet Journal of Rare Diseases, 16(1), 2. https://doi.org/10.1186/s13023-020-01647-7 Vockley, J., Andersson, H. C., Antshel, K. M., Braverman, N. E., Burton, B. K., Frazier, D. M., Mitchell, J., Smith, W. E., Thompson, B. H., & Berry, S. A. (2014). Phenylalanine hydroxylase deficiency: Diagnosis and management guideline. Genetics in Medicine, 16(2), 188–200. https://doi.org/10.1038/gim.2013.157 29 Tables and Figures Table 1 Pre-and Post-survey Demographics Characteristic N (%) Age Range 18-24 25-34 35-44 46-54 55-64 Gender Identity Female Male Race Asian White Multiple Races Other Ethnicity Hispanic, Latino, or Spanish origin Non-Hispanic Education High school diploma or equivalent Some college, no degree Associate's degree (e.g., AA, AS) Bachelor's degree (e.g., BA, BS) Master's degree (e.g., MS, MSN, MBA) Doctoral degree (e.g., PhD, DNP, MD, PharmD, etc.) Role in Clinic Medical Assistant Clinic Coordinator Clinic Coordinator/ Medical Assistant Registered Nurse Genetic Counselor Registered Dietitian Manager Advanced Practice Clinician/Provider Physician Years in Role <1 1–3 4–6 > 10 Employment Status Fulltime 6 (31.6) 9 (47.7) 2 (10.5) 1 (5.3) 1 (5.3) 16 (84.2) 3 (15.8) 5 (26.3) 10 (52.6) 1 (5.3) 3 (15.8) 5 (26.3) 14 (73.7) 3 (15.8) 2 (10.5) 1 (5.3) 5 (26.3) 5 (26.3) 3 (15.8) 5 (26.3) 1 (5.3) 1 (5.3) 1 (5.3) 1 (5.3) 4 (21.1) 3 (15.8) 1 (5.3) 2 (10.5) 1 (5.3) 13 (68.4) 4 (21.1) 1 (5.3) 19 (100) 30 Table 2 Comparative Analysis of Pre-and Post-Survey Items Q# 1 2 3 4 5 6 7 8 9 10 11 Question (Scale Used) I routinely screen patients with PKU for depression and anxiety. I feel it is important to screen patients with PKU for anxiety and depression. I am familiar with the GAD-7 and PHQ-9 screening tools. I am confident in my ability to access GAD-7 and PHQ-9 screening tools while in clinic. I am confident in my ability to administer the GAD-7 screening tool for anxiety. I know how to interpret results of the GAD-7 screening tool. I am confident in my ability to administer the PHQ-9 screening tool for depression. I know how to interpret results of the PHQ-9 screening tool. I know the appropriate steps to take when receiving positive GAD-7 and PHQ-9 screening results. *How often do you currently use the GAD-7 and PHQ-9 tools in clinical practice to assess for anxiety and depression in PKU? Barriers limit me from using the GAD-7 and PHQ-9 tools in my practice. Pretest n = 19 Posttest n = 19 Z Score Median (Q1, Q3) 4 (2, 5) Wilcoxon signedrank P value (α 0.05) < 0.01* Median (Q1, Q3) 1 (1, 3) Effect Size -3.12 0.72 5 (5, 5) 5 (5, 5) 0.68 -0.41 0.09 3 (2, 5) 5 (4, 5) 0.01* -2.58 0.59 3 (2, 4) 5 (4, 5) < 0.01* -3.24 0.75 3 (1, 4) 5 (4, 5) < 0.01* -3.25 0.74 2 (1, 3) 4 (3, 5) < 0.01* -3.40 0.78 3 (1, 4) 5 (4, 5) < 0.01* -2.76 0.63 2 (1, 4) 4 (3, 5) < 0.01* -3.17 0.73 2 (1, 4) 4 (4, 5) < 0.01* -3.25 0.75 1 (1, 1) 4 (3, 4) < 0.01* -3.56 0.82 4 (2, 5) 2 (1, 3) < 0.01* -2.68 0.61 r * signifies signifiance 5-Point Likert Agreement Scale: • 1 = Strongly Disagree; 2 = Disagree; 3 = Neither Agree or Disagree; 4 = Agree; 5 = Strongly Agree *Q10 used a 5-point Frequency Scale: • 1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Often; 5 = Always 31 Table 3 Open Ended Questions- Pre-survey 1. How do you currently address mental health concerns in your patients with phenylketonuria? Comment Categories Count Currently not addressing 4 Recommend mental health provider or 3 discussing with primary care provider (PCP) but also work on metabolic control to help reduce issues Conversation with clinic provider about 3 concerns Not answered 3 Refer to mental health provider 2 Recommend discussing with PCP 1 Provide PHQ-9 and GAD-7 1 Address disordered eating or body image 1 Unsure 1 2. What support or resources would help you feel more confident using mental health screening tools? Comment Categories Count Education or training on tools and clinic 14 process Not answered 3 Standardized protocol on how to use tools 2 32 Table 4 Open Ended Questions- Post-survey 1. What additional support or training do you need to feel more confident using mental health screening tools? Comment Categories Count None or N/A 11 More practice 5 Question of dietitians administering screens 2 Regular review of use 1 2. What improvements, if any, would you suggest for integrating GAD-7 and PHQ-9 into routine care? Comment Categories Count None or N/A 11 Electronic screening tools that can be 4 completed ahead of visit or integrated into electronic medical record Expand to additional diagnosis 2 Flow of administration with dietitians in visit 1 No suggestions due to no experience 1 3. What suggestions do you have for improving the usability and effectiveness of the mental health PKU clinic? Comment Categories Count None/NA 13 Dedicated clinic social worker 1 Establishing relationships with therapists to 1 refer patients Clinic check ins to review data/how it is 1 going Expand to other clinics (Alaska) 1 More communication on which patients need 1 screening No suggestions due to no experience 1 33 Table 5 Select All That Apply Pre-and Post-survey Questions Barriers Lack of Time Uncertainty in interpreting results Limited resources for mental health follow-up Patient resistance Other Pre-Survey count 6 8 Pre-survey % of Participants 31.6% 42.1% Post-Survey count 6 1 Post-survey % of Participants 31.6% 5.3% 4 21.1% 3 15.8% 5 4 26.3% 21.1% 9 1 47.4% 5.3% 34 Table 6 Post-Project Feasibility Questions Question How likely are you to continue using the GAD-7 and PHQ-9 tools in your clinical practice? Very Unlikely Unlikely Neutral Likely Very likely N (%) 1 (5.3) 6 (31.6) 12 (63.2) How would you rate the efficiency of the clinic’s workflow for coordinating mental health and PKU care? Very inefficient Inefficient Neutral Efficient 13 (68.4) Very Efficient 6 (31.6) How would you rate the overall ease of scheduling patients in the mental health PKU clinic? Very difficult Difficult Neutral 2 (2.8) Easy 8 (42.1) Very easy 8 (42.1) [value missing] 1 (5.3) 35 Table 7 Electronic Medical Record Data EMR Metric Patients Seen Patients Screened Positive Screens Average PHQ-9 Score (0-27) Average GAD-7 Score (0-21) Referred to Mental Health Clinic Scheduled in Mental Health Clinic Total/Average 38 33 (86.8%) 12 (36.4%) 5.73 6.55 4 (33.3%) 3 (74%) 36 Figure 1 Comparative Analysis of Selected Pre-/Post Implementation Survey Items 37 Appendix A Informational Handout 38 Appendix B Step-by-Step Implementation Guide Step-by-Step Pre-clinic 1) At staffing meetings: the patient is identified as needing screening a. Inclusion criteria: >13 years, PKU diagnosis, Utah address b. Exclusion criteria: significant developmental delay or ID, does not have PKU diagnosis, <13 years old, address outside of Utah 2) If virtual appointment a. The clinic coordinator is to send two screens and an explanation along with preclinic emails b. Ask for screens to be emailed back before the appointment c. Once received, the clinic coordinator will email screens to health information management (HIM) to be uploaded into the electronic medical record (EMR) d. Template email: “Our clinic has recently started regular screenings for depression and anxiety for patients 13 years and older with a diagnosis of PKU. Please complete the attached screenings and email them back to me. You can complete them on your computer or complete them by hand and send a picture. They will be discussed during your clinic visit.” 3) If in-person appointment: printed screenings will be available in the clinic During clinic 1) Patients to be screened are marked on the whiteboard displaying the patient schedule 2) Screenings are given to MAs to include in intake paperwork 3) Patients complete screenings while waiting for the provider 4) Results are reviewed by the provider and discussed in the clinic 5) Decision-making if the patient would benefit from referral to Mental Health/PKU clinic a. PHQ9 https://www.hiv.uw.edu/page/mental-health-screening/phq-9 39 b. GAD7 score https://www.parinc.com/docs/default-source/product-resources/checkit_series_gad7_tech_supp_paper_v4_092920.pdf c. How to explain Mental Health PKU clinic: We have seen a need for clinic time to work on medication therapies for anxiety and depression for people with PKU. Given your scores and the anxiety and depression screening, I recommend we make you an appointment for our mental health PKU clinic. During the visit, you will only meet Kate McMinimee and discuss possible medications. The focus will be only on mental health medications and not on your PKU treatment plan. There will not be a dietitian at the visit. d. Emergency action plan: if the patient expresses suicidal ideation, self-harm, or other emergent/immediate concerns have a medical assistant “vocera” social worker for urgent consult 6) Screenings are placed in the MA upload folder to be added to EMR by HIM Post clinic 1) Provider completes clinic documentation and includes screening score and plan of referral (if applicable) a. Add PHQ9 and GAD7 score in the medical record under interim history PHQ9 score: Interpretation of Total Score 1-4: minimal depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression GAD7 score: Interpretation of Total Score 0–4: minimal anxiety 5–9: mild anxiety 10–14: moderate anxiety 15–21: severe anxiety b. Under assessment: note that scores are/are not concerning for depression and/or anxiety 40 i. Example: The patient had a PHQ9 score of 11, indicative of moderate depression. c. Under Plan: note if the patient is referred to the mental health PKU clinic 2) Referral to mental health/PKU template: send a message or ask MA to send a message inside the patient chart to the “yellow scheduling” team and ask the patient to be scheduled with Kate McMinimee in the Mental Health PKU template a. Example: Please call the patient to schedule with Kate McMinimee in a virtual mental health PKU visit, the provider only (no RD), Frequently Asked Questions Q: What patients should have screening done? A: Utah and Nevada patients 13 years and older with a diagnosis of PKU. Q: Are there any patients that should not be screened? A: We are not screening patients who have significant cognitive impairment, are less than 18 years old, and who live outside of Utah or Nevada. Q: Are there screenings available in other languages? A: PHQ9 and GAD7 screenings are available in English and Spanish. For additional languages, they should be reviewed with the patient during the visit, with the aid of the interpreter. Q: What if patients decline screening? A: Please notify the provider to discuss this further during the clinic visit. Q: What happens if a telehealth patient does not email back their screens? A: The provider can ask for it in the clinic. If they cannot, the provider can note the answers to the questions/final score and record this in their clinic note. Q: Is the mental health PKU clinic in person or virtual? A: This clinic is only offered virtually at this time. Q: How often should screenings be completed? A: With each clinic visit. They should be kept in the medical record and clinic note documentation to compare for changes. 41 Appendix C Screening Flow Diagrams 42 Appendix D Pre Survey Demographics: 1) Do you think of yourself as a. Male b. Female c. Non-binary/third gender d. Prefer not to say 2) Are you of Hispanic, Latino, or Spanish origin? a. Yes b. No c. Unknown d. Prefer not to say 3) How would you describe yourself? a. American Indian or Alaska Native b. Asian c. Black or African American d. Native Hawaiian or Other Pacific Islander e. White f. Other Race g. Unknown h. Prefer not to say 4) Age a. <18 years b. 18–24 years c. 25–34 years d. 35–44 years e. 45–54 years f. 55–64 years 5) What is your highest level of education completed?" a. High school diploma or equivalent (e.g., GED) b. Some college, no degree c. Associate's degree (e.g., AA, AS) d. Bachelor's degree (e.g., BA, BS) e. Master's degree (e.g., MS, MSN, MBA) f. Doctoral degree (e.g., PhD, DNP, MD, PharmD, etc) 6) What is your role with the metabolic clinic? a. Advanced Practice Clinician/Provider b. Clinic Coordinator 43 c. Genetic Counselor d. Manager e. Medical Assistant f. Physician g. Registered Dietitian h. Registered Nurse 7) How long have you been in your role a. <1 year b. 1-3 years c. 4-6 years d. 7-9 years e. >10 years 8) What is your employment status at the clinic? a. Full-time employee (scheduled to work more than 35 hours per week) b. Part-time employee (scheduled to work less than 35 hours per week) c. Per diem/As-needed (works on an as-needed basis, without a regular schedule) d. Other (please specify): ________ Pre-Survey knowledge and confidence 1) I routinely screen patients with PKU for depression and anxiety. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 2) I feel it is important to screen patients with PKU for anxiety and depression. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 3) How do you currently address mental health concerns in your patients with phenylketonuria? Provide Answer Here: 4) I am familiar with both the GAD-7 and PHQ-9 screening tools. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 44 5) I am confident in my ability to access GAD-7 and PHQ-9 screening tools while in the clinic. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 6) I am confident in my ability to administer the GAD-7 screening tool for anxiety. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 7) I know how to interpret the results of the GAD-7 screening tool. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 8) I am confident in my ability to administer the PHQ-9 screening tool for depression. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 9) I know how to interpret the results of the PHQ-9 screening tool. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 10) I know the appropriate steps to take when receiving positive GAD-7 and PHQ-9 screening results. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 11) How often do you currently use the GAD-7 and PHQ-9 tools in your clinical practice to assess for anxiety and depression in PKU? a. Never 45 b. Rarely c. Sometimes d. Often e. Always 12) Barriers limit me from using the GAD-7 and PHQ-9 tools in my practice. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 13) Select all that apply: What barriers, if any, do you anticipate when using the GAD-7 and PHQ-9 tools in your practice? a. Lack of time b. Uncertainty about how to interpret results c. Limited resources for mental health follow-up d. Patient resistance e. Other (please specify): ________ 14) What support or resources would help you feel more confident using mental health screening tools? Provide Answer Here: 46 Appendix E Post-Survey Demographics: 1) Do you think of yourself as a. Male b. Female c. Non-binary/third gender d. Prefer not to say 2) Are you of Hispanic, Latino, or Spanish origin? a. Yes b. No c. Unknown d. Prefer not to say 3) How would you describe yourself? a. American Indian or Alaska Native b. Asian c. Black or African American d. Native Hawaiian or Other Pacific Islander e. White f. Other Race g. Unknown h. Prefer not to say 4) Age a. <18 years b. 18–24 years c. 25–34 years d. 35–44 years e. 45–54 years f. 55–64 years 5) What is your highest level of education completed?” a. High school diploma or equivalent (e.g., GED) b. Some college, no degree c. Associate’s degree (e.g., AA, AS) d. Bachelor'’ degree (e.g., BA, BS) e. Master’s degree (e.g., MA, MS, MSN, MBA) f. Doctoral degree (e.g., PhD, DNP, MD, PharmD, etc) 6) What is your role with the metabolic clinic? a. Advanced Practice Clinician b. Clinic Coordinator 47 c. Genetic Counselor d. Manager e. Medical Assistant f. Physician g. Registered Dietitian h. Registered Nurse 7) How long have you been in your role a. <1 year b. 1-3 years c. 4-6 years d. 7-9 years e. >10 years 8) What is your employment status at the clinic? a. Full-time employee (scheduled to work more than 35 hours per week) b. Part-time employee (scheduled to work less than 35 hours per week) c. Per diem/As-needed (works on an as-needed basis, without a regular schedule) d. Other (please specify): ________ Post-Survey Knowledge and Confidence 1) I routinely screen patients with PKU for depression and anxiety. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 2) I feel it is important to screen patients with PKU for anxiety and depression. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 3) I am familiar with both the GAD-7 and PHQ-9 screening tools. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 4) I am confident in my ability to access GAD-7 and PHQ-9 screening tools while in the clinic. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree 48 d. Somewhat agree e. Strongly agree 5) I am confident in my ability to administer the GAD-7 screening tool for anxiety. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 6) I know how to interpret the results of the GAD-7 screening tool. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 7) I am confident in my ability to administer the PHQ-9 screening tool for depression. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 8) I know how to interpret the results of the PHQ-9 screening tool. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 9) I know the appropriate steps to take when receiving positive GAD-7 and PHQ-9 screening results. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 10) How often do you currently use the GAD-7 and PHQ-9 tools in your clinical practice to assess for anxiety and depression in PKU? a. Never b. Rarely c. Sometimes d. Often e. Always 49 11) Barriers limit me from using the GAD-7 and PHQ-9 tools in my practice. a. Strongly disagree b. Somewhat disagree c. Neither agree nor disagree d. Somewhat agree e. Strongly agree 13) Select all that apply: What barriers, if any, do you anticipate when using the GAD-7 and PHQ-9 tools in your practice? a. Lack of time b. Uncertainty about how to interpret results c. Limited resources for mental health follow-up d. Patient resistance e. Other (please specify): ________ 14) How likely are you to continue using the GAD-7 and PHQ-9 tools in your clinical practice? a. Very unlikely b. Unlikely c. Neutral d. Likely e. Very likely 15) How would you rate the efficiency of the clinic’s workflow for coordinating mental health and PKU care? a. Very inefficient b. Inefficient c. Neutral d. Efficient e. Very efficient 16) How would you rate the overall ease of scheduling patients in the mental health PKU clinic? a. Very difficult b. Difficult c. Neutral d. Easy e. Very easy 17) What additional support or training do you need to feel more confident using mental health screening tools? Provide Answer Here: 18) What improvements, if any, would you suggest for integrating GAD-7 and PHQ-9 into routine care? Provide Answer Here: 19) What suggestions do you have for improving the usability and effectiveness of the mental health PKU clinic? Provide Answer Here: 50 Appendix F PHQ-9 51 Appendix G 52 Appendix G GAD-7 Appendix H 53 Appendix H Pre-Survey Open Ended Question Responses 1. How do you currently address mental health concerns in your patients with phenylketonuria? • Suggest a referral to outpatient therapy. Try to address issues I can help with (diet, formula, labs) to decrease stress/anxiety around them. • Refer to PCP, behavioral health or counseling and help lower phe levels when able. • Open discussion with patients, recommend/refer to mental health services, refer to PCP, teach about PKU and mood disorders. • I try to look for disordered eating or body image concerns through MI (motivational interviewing). • I rarely see patients with PKU. • Refer to mental healthcare provider. • I don't, but if concerned I refer to specialist. • Discussion during clinic visits, recommendations to continue seeing PCP for management or establishing care for further support. • Not answered • Ask general questions regarding their current mental health status and current mental health support they are receiving. • What I would do is assess the mental health concerns during each visit and make sure there is a set plan in place to help the patient cope with things. • Not answered • In my role I don't see patients but our clinic team will hand out GAD7 and PHQ9 forms when asked by the provider. • If patient expresses mental health concerns, I make sure to communicate that with provider. • I currently don't do anything to address mental health. • Unsure • Currently not addressing • Currently not addressing • Not answered 2. What support or resources would help you feel more confident using mental health screening tools? • A course or handout to better understand how to administer the tools and steps to take based on results. • Training on using and interpreting GAD7 and PHQ-9. • I thought the screening tools give you a score and then categorize the score for you… maybe I have more to learn. Also, I don't think it's legally in an RDs scope to do this. • Probably more training, also feels like it is probably more of the responsibility of the provider than the RD. 54 • • • • • • • • • • • • • • • Brief training on interpretation and next steps. More training and education on tools. Training, hands on with examples Not answered Not answered A standardized protocol for screening and follow up recommendations for those that screen positive. Learning from my providers Show me where the screens are and how to get it to patients. An in-service or review about these forms, how and why they are used would be very beneficial in helping our team explain it to our patients and families with more confidence. Having a training and brief discussion of this tool, what is expected of us to complete. A set specific question I could incorporate into our intake. Being taught and practicing what to do with our patients. This is a great idea. Knowing steps to positive results. Getting familiar with the screening. Not answered 55 Appendix I Post-Survey Open Ended Question Responses 1. What additional support or training do you need to feel more confident using mental health screening tools? • I think being able to shadow it's use and outcomes will be beneficial for familiarity. • More practice interpreting results and discussing options with patients. • I think the providers who have been administering the screens have done an excellent job so as a clinic, nothing. As an RD though, I haven't actually administered the screens. • Should RDs be helping with screening? • Just more practice and possibly check ins with those providing them. • N/A • Regular review at scheduled intervals. Update/review 2-3 times per year. • None • N/A • None • N/A • Any trainings available are always helpful for clinic staff MAs to understand how to help patients fill these out. • N/A • N/A • N/A • I don't think I need any more training/support. I'm confident in using the screening tools. • Understand more on why we do these screenings. • None, everything is straight forward. 2. What improvements, if any, would you suggest for integrating GAD-7 and PHQ-9 into routine care? • None, I think it fits well into routine care. • Having an e-version to administer during telemed appointments. • A smoother transition for RD to exit the visit (would discuss as a group). • Including other diagnosis in screening. • Not sure patients would do it, but as a pre-clinic checklist they complete before they attend the visit. • Can't say, no experience • A better EMR (with integration). • N/A • None • N/A • N/A 56 • • • • • • • It would be great if we could send this to patients ahead of time/before their appointment so they didn't feel rushed in filling it out during their appointment. N/A N/A PKU is a great start for screenings and I would love to see the screenings take place with other genetic disorders (if applicable). N/A No feedback. the routine flow works perfect with our clinic. Everything is straight forward. 3. What suggestions do you have for improving the usability and effectiveness of the mental health PKU clinic? • None at this time. • Establishing relationships with talk therapists to refer patients to use in conjunction with mental health PKU clinic. • None, it's great. • None right now. • Check-ins with the clinic of data points or review of how it is going. • N/A • No experience • Clinic social worker • N/A • Make it possible for me to send Alaska patients to the mental health PKU clinic • N/A • N/A • Nothing I can think of! • N/A • N/A • More heads up on which patients receive the screening for the day • I think it’s going great and no improvements are needed. • None • Everything is straight forward. 57 Appendix J Executive Summary Implementing a clinical pathway for mental health screenings in a specialty practice clinic: A Process Improvement Initiative Introduction: This Doctor of Nursing evidence-based quality improvement initiative was to promote patient well-being within a local academic medicine clinic by implementing systematic screening for anxiety and depression among patients, 13 years and older, with phenylketonuria (PKU). Background: PKU is a rare, genetic, chronic condition with an increased risk of anxiety and depression due to disease pathology and the burden of disease management. Untreated anxiety and depression lead to worsening disease-related outcomes and significant impacts on quality of life. Despite the known risks of undiagnosed mental health concerns and the potential for effective therapies, regular screenings for mental health illness in outpatient metabolic clinics are uncommon, in part due to a lack of dedicated and trained staff and unclear clinical pathways for those who screen positive. Deliverables: To address the lack of systematic screenings for mental health concerns in patients with PKU, a clinician toolkit was created to guide targeted training on the importance of mental health screening, administration of the tools, interpretation of results, integration of results in the electronic medical record (EMR), and the designated clinical pathway for individuals who screen positive. Pre-andpost surveys were conducted to assess changes in the multi-disciplinary clinic team’s knowledge and attitude. EMR tracking was utilized to monitor screening completion rates and follow-up actions. The direct implementation costs are minimal, with only printing expenses amounting to approximately $23.40 annually. Indirect costs primarily involve clinician and administration time, totaling an estimated $1,475.20 per year. However, the projected benefits outweigh these costs, with improved patient outcomes, enhanced adherence to care, and an estimated additional $23,040 in annual revenue from increased visits in a newly formed mental health PKU clinic. Results: The pre-and-post surveys were completed by 19 participants who were most likely to identify as white, non-Hispanic, females, ages 25-34, and were employed full-time with about 1 to 3 years’ experience. The inferential analysis comparing pre-to post-survey results suggested several statistically significant differences, with medium to high effect sizes, in accessing, administering, and interpreting mental health screening tools. EMR data showed 86.8% of eligible patients were screened, and 36.5% screened positive for depression and/or anxiety. Recommendations: This QI evidence-based initiative aimed to improve patient well-being within a local academic medicine clinic by implementing systematic screening for anxiety and depression among patients, 13 years and older, with phenylketonuria (PKU). This project seemed to improve clinician confidence to regularly utilize mental health screenings. Post-project comments suggested participant satisfaction, usability, and feasibility of the initiative. Additionally, with a net revenue gain of approximately $21,541.40, this initiative presents a strong return on investment, supporting patient wellbeing while optimizing clinic resources. Future efforts should focus on expanding the diagnoses screened, integrating the tools with the EMR, and strengthening collaboration with mental health professionals to ensure comprehensive patient support.