Background
Depression stands as a prevalent mental health disorder affecting millions of adults across the United States. It’s not merely a transient feeling of sadness; depression is a significant health concern with far-reaching consequences. Statistics reveal that a substantial percentage of U.S. adults experience at least one major depressive episode, underscoring the urgency for effective and widespread intervention strategies. The impact of depression extends beyond emotional distress, contributing to substantial economic burdens, estimated at billions of dollars annually due to healthcare costs and lost productivity. Untreated depression can severely impair an individual’s quality of life, affecting work, relationships, and overall well-being, while also increasing the risk of co-occurring physical health conditions.
Recognizing the profound impact of depression, healthcare guidelines strongly advocate for routine depression screening within primary care settings. Early identification and intervention are critical to mitigating the detrimental effects of this disorder. The U.S. Preventive Services Task Force (USPSTF) explicitly recommends depression screening for all adults aged 18 and older in primary care, emphasizing the integration of screening with robust support systems and evidence-based treatment protocols. Leading medical organizations, including the American Academy of Family Physicians, endorse these recommendations, highlighting the consensus on the importance of proactive depression screening in primary care. Furthermore, value-based payment models from Centers for Medicare & Medicaid Services (CMS) are increasingly aligning with USPSTF guidelines, incentivizing healthcare providers to prioritize depression screening and subsequent care.
The landmark Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, a comprehensive study on depression treatment, has provided compelling evidence supporting the effectiveness of depression screening and treatment within primary care. This large-scale trial demonstrated that primary care settings can achieve treatment outcomes comparable to those in specialty mental health care for depression. Despite the growing body of research and national guidelines advocating for increased depression screening and treatment, a significant gap persists in practice. Alarmingly, over half of individuals with depression in primary care remain undiagnosed and, consequently, undertreated. National data reveals consistently low rates of depression screening in primary care visits, highlighting a critical need for improved implementation of screening practices.
To bridge this gap and enhance depression care in primary settings, increasing the utilization of effective Depression Screening Tools Primary Care Screener For Affective Disorder is paramount. Tools like the Patient Health Questionnaire (PHQ)-2 and PHQ-9 have emerged as the most widely used and clinically validated instruments for adult depression screening. These tools offer primary care physicians practical and accurate methods for identifying individuals who may be struggling with depression. The PHQ-2 serves as an efficient initial screening tool, designed to be followed by the more detailed PHQ-9 when a positive screen is indicated. Understanding the utility and appropriate application of these depression screening tools is crucial for improving the early detection and management of affective disorders in the primary care environment.
This image depicts a healthcare professional utilizing a tablet device to engage with a patient in a clinic setting, possibly illustrating the use of technology in patient screening or education.
Purpose and Innovation: VitalSign6 for Enhanced Depression Care
This quality improvement project focused on implementing VitalSign6, an evidence-based measurement-based care (MBC) program, with the primary goal of improving the identification and management of depression among adult patients in a primary care setting. The project was conducted at the Department of Family and Community Medicine at the University of Texas Southwestern Medical Center (UTSW). The core objectives of this project were multifaceted, aiming to systematically enhance depression care delivery:
- Increase Depression Screening Rates: To screen a substantial majority (at least 75%) of unique patients for depression using the PHQ-2.
- Maximize Follow-up Screening: To ensure that a high percentage (85%) of patients who screen positive on the PHQ-2 are subsequently screened using the more comprehensive PHQ-9.
- Implement Measurement-Based Care: To administer MBC to a significant proportion (75%) of patients diagnosed with depression and schedule timely follow-up appointments within 4 to 6 weeks.
- Utilize MBC for Monitoring and Treatment: To effectively monitor patient responses, treatment effects, and remission progress using the VitalSign6 MBC system.
- Evaluate User Satisfaction: To assess the satisfaction levels of both physicians and clinic staff with the VitalSign6 system and its integration with the electronic health record (EHR).
These specific aims were adapted from the VitalSign6 Primary Care First Model, a framework designed to optimize depression screening and MBC implementation in primary care settings. The project leveraged the innovative VitalSign6 program to address the critical need for improved depression screening tools and systematic management of affective disorders in primary care.
The innovation at the heart of this project is the VitalSign6 MBC program. MBC represents a comprehensive approach to mental health care, integrating validated depression screening tools, standardized symptom measurements, monitoring of treatment effects and patient adherence, and evidence-based decision support tools. This framework empowers primary care physicians to effectively manage depression, guiding them through diagnosis, treatment selection, follow-up strategies, and referral decisions. VitalSign6, developed by the University of Texas Southwestern Medical Center for Depression Research and Clinical Care (CDRCC), is a web-based application specifically designed to facilitate MBC in primary care.
A key feature of VitalSign6 is its seamless integration with existing clinical workflows. The system utilizes a user-friendly web-based interface accessible on tablets, supporting both English and Spanish languages. Patients can complete self-reported depression questionnaires, including primary care screener for affective disorder like PHQ-2 and PHQ-9, during their check-in process. The results are instantly available to providers in real-time, enabling them to promptly document diagnoses and initiate tailored treatment plans with clinical decision support. For patients screening negative, VitalSign6 automatically schedules rescreening reminders for annual follow-up, ensuring continuous monitoring.
To overcome a significant barrier to technology adoption in healthcare – interoperability with EHR systems – the UTSW technology team developed a sophisticated application programming interface. Utilizing Fast Healthcare Interoperability Resources (FHIR) and Substitutable Medical Apps Reusable Technology (SMART), they achieved real-time integration of VitalSign6 directly into the Epic EHR database. This integration allows physicians to launch VitalSign6 contextually within the Epic Hyperspace environment, review patient data, access clinical decision support, and seamlessly transfer treatment plans from VitalSign6 back into the patient’s EHR chart. This EHR integration is a critical factor in streamlining workflow and enhancing the usability of depression screening tools in busy primary care settings.
Methods: Implementing VitalSign6 in Primary Care
To evaluate the impact of VitalSign6 implementation, a pre-post intervention design was employed. This approach allowed for a direct comparison of screening rates, clinical outcomes, and satisfaction levels before and after the introduction of the VitalSign6 program. The study setting was the UTSW Department of Family and Community Medicine, a clinic characterized by its residency program, diverse patient population, and substantial monthly patient volume. The project commenced in February 2019, with initial screening activities continuing through May. Patients diagnosed with depression and initiated on MBC were followed for a 14-week period to assess treatment response and outcomes. The Institutional Review Board of UTSW Medical Center approved the study, granting a waiver for individual patient informed consent due to the quality improvement nature of the project.
Prior to the clinic-wide rollout, comprehensive training and stakeholder engagement were prioritized. The project team engaged with departmental leadership and clinical staff to thoroughly assess existing workflows and identify optimal integration strategies to minimize disruptions. Two-hour in-person training sessions were conducted for physicians, residents, and clinic staff. These sessions covered essential topics including depression education, effective depression screening tools (PHQ-2 and PHQ-9), standardized symptom measurement techniques, diagnostic criteria, evidence-based treatment practices, medication management, dosing guidelines, and referral protocols. To provide ongoing support and facilitate smooth implementation, VitalSign6 expert trainers remained on-site at the clinic for the initial two weeks of the project.
The implementation procedure was carefully structured, starting with initial screening. Patients were provided with a Patient Acknowledgement Form prior to screening. Upon arrival for their appointments, patients used the Epic Welcome tablet to complete the PHQ-2. The PHQ-2 scores were automatically transferred into the patient’s EHR. Patients scoring 2 or less on the PHQ-2, with no prior history of depression documented in their EHR, proceeded with standard clinic procedures.
For patients who screened positive on the PHQ-2 (score >2), or those who screened negative but had a documented history of depression or antidepressant medication in their EHR, a Best Practice Advisor (BPA) alert was triggered within the EHR. This BPA prompted the nursing staff to administer the PHQ-9 using the VitalSign6 iPad application. The PHQ-9, a more detailed primary care screener for affective disorder, assessed the severity of depressive symptoms. Patient-reported scores were instantly integrated into the EHR. This self-reporting approach is known to reduce stigma associated with mental health screening and encourage more honest symptom reporting.
The EHR presentation of self-reported depression measures allowed physicians to readily review scores, update patient conditions, procedures, and medications. VitalSign6 incorporated a diagnostic checklist and decision support tools to assist providers in developing personalized treatment plans. Treatment options included pharmacological interventions guided by MBC principles, behavioral therapies (such as psychotherapy offered by on-site behavioral health providers), exercise recommendations, symptom monitoring, specialist referrals, or, in some cases, no further immediate follow-up. The system also facilitated scheduling follow-up appointments within the recommended 4 to 6 week timeframe to monitor patient progress.
Follow-up visits were equally structured. During check-in for follow-up appointments, patients again completed the PHQ-9 and other relevant standard measures via VitalSign6. Based on these self-reported measures and the physician’s clinical assessment, decision support tools within VitalSign6 provided guidance for treatment continuation, modification, referral decisions, or scheduling subsequent follow-up. The MBC program equipped physicians with a systematic framework for managing, treating, and referring patients based on their individual symptom responses and progress.
To assess provider and staff perceptions, a Likert-type scale survey, developed by the CDRCC, was administered both before and after the project implementation. The survey explored knowledge of depression, comfort levels in discussing depression with patients, opinions on the optimal setting for depression care, and perceptions of VitalSign6’s strengths and weaknesses. Mann-Whitney U tests were used to analyze paired Likert-type scale items. Post-survey, open-ended questions were included to gather qualitative feedback on the most challenging and valuable aspects of using VitalSign6. Thematic analysis was used to identify recurring themes in these written responses.
Outcome measures were carefully defined using the Specific, Measurable, Achievable, Relevant, and Time-Bound (SMART) framework. Program fidelity was assessed by tracking screening rates, positive screen rates, and the proportion of patients receiving MBC and scheduled follow-up. Clinical outcomes were measured by changes in patient’s self-reported PHQ-9 scores from baseline to follow-up, analyzed using a paired t-test. Process outcomes focused on physician and staff beliefs and satisfaction with VitalSign6, using Mann-Whitney U tests for Likert-type scale items. Data were collected from the EHR and UTSW’s REDCap survey database. Statistical analyses were performed using IBM SPSS v.25, with an alpha level of .05.
This CONSORT flow diagram visually summarizes the patient journey throughout the VitalSign6 project, from initial screening to follow-up and treatment outcomes.
Results: Improved Screening and Patient Outcomes
Screening Rates and Sample Demographics
During the project period, a total of 1200 unique adult patients were seen at the clinic. The demographic breakdown was 44.5% male and 55.5% female, with a broad age range from 18 to 94 years and an average age of 46.7 years. Impressively, 95.4% of these patients (n=1145) were screened for depression using the PHQ-2, demonstrating high fidelity to the screening protocol. Of those screened, 18.2% (n=208) screened positive based on the PHQ-2 criteria (score >2). Among patients with positive PHQ-2 screens, a substantial majority, 89.4% (n=186), proceeded to PHQ-9 screening. Technical issues impacted data recording for a small percentage (10.5%) of patients with positive PHQ-2 screens.
Notably, 18.6% (n=214) of patients initially screened negative on the PHQ-2 but had a pre-existing history of depression or antidepressant medication documented in their EHR. This triggered the BPA, prompting nurses to proceed with PHQ-9 screening for these individuals as well. Furthermore, at physician discretion, an additional 7.1% (n=81) of patients with negative PHQ-2 scores and no prior depression history were also screened with the PHQ-9.
In total, 481 patients underwent PHQ-9 screening. A significant proportion, 62.8% (n=302), screened positive on the PHQ-9 (score >4). Of these positive PHQ-9 screens, 89.4% (n=270) received a diagnosis of depressive disorder. Among those diagnosed, the majority (87.4%, n=236) initiated MBC with personalized treatment plans, while 10% (n=27) were referred to specialty mental health care, and a small percentage (2.6%, n=7) declined treatment.
Depression Follow-up and Score Changes
Patients diagnosed with depressive disorder and started on personalized treatment plans were scheduled for follow-up visits within 4 to 6 weeks. Among the 236 patients who initiated MBC, the treatment modalities were diverse: 59.7% received pharmacological treatment, 8.1% received non-pharmacological treatment, 31.3% were recommended for symptom monitoring and rescreening, and 2 patients had no follow-up indicated. These patients were followed for a total of 14 weeks to assess treatment progress.
Analysis of self-reported PHQ-9 scores revealed significant improvements. A paired t-test conducted on 65 patients with complete baseline and follow-up data showed a statistically significant decrease in mean PHQ-9 scores, from 14.89 at baseline to 9.58 at follow-up (p<0.05). This indicates a notable reduction in self-reported depression symptom severity following the implementation of VitalSign6 and MBC. Furthermore, 23.1% (n=15/65) of these patients achieved remission, defined as a PHQ-9 score of less than 5, at the 14-week follow-up.
This graph visually compares the average PHQ-9 scores at the beginning of treatment (baseline) and at follow-up, highlighting the reduction in depression scores achieved through the VitalSign6 intervention.
Physician and Staff Satisfaction
Physician surveys indicated mixed results. While there was no statistically significant change in physicians’ self-reported frequency of treating depression, understanding of depression, or comfort in discussing mental health with patients, a surprising finding was a statistically significant decrease in their perceived importance of depression screening and MBC post-implementation (p=.002). Physician responses regarding the ease of use and usefulness of VitalSign6 software were moderately positive, with median scores ranging from 2.5 to 3.5 on a 5-point scale. However, open-ended responses revealed concerns about workflow disruption and technical interoperability issues.
Staff surveys showed a significant positive change in staff comfort levels when talking to patients about their mental health (p=.044). Similar to physician feedback, staff open-ended responses highlighted workflow slowdown as a major challenge associated with VitalSign6 implementation. However, both physicians and staff identified EHR integration and improved depression screening and awareness as valuable aspects of the VitalSign6 program.
Discussion: VitalSign6 Effectiveness and Implementation Challenges
The observed patient remission rate of 23.1% in this quality improvement project represents a significant improvement compared to the baseline of 0% remission prior to VitalSign6 implementation. This finding underscores the potential of integrating depression screening tools and MBC principles into primary care to enhance patient outcomes. The combination of systematic screening, diagnosis, and measurement-based treatment, facilitated by VitalSign6 and EHR integration, appears to be a key factor in driving these positive results. The project findings align with evidence suggesting that EHR systems equipped with clinical decision support tools can effectively increase depression screening and remission rates in primary care settings.
Both physicians and staff acknowledged the positive impact of VitalSign6 on raising mental health awareness and improving depression screening within the clinic. The two-step screening process, utilizing PHQ-2 as an initial screen followed by PHQ-9 for positive cases, coupled with real-time EHR integration, proved effective in increasing screening rates to over 95%. The high rate of diagnosis among patients with positive PHQ-9 screens further suggests the effectiveness of these depression screening tools in identifying individuals with depressive disorders. The clinic’s prior participation in the Delivery System Reform Incentive Payment (DSRIP) program, which emphasized depression screening, may have also contributed to the already high baseline screening rates observed before the project.
The project findings support the concept of approaching depression care as a triage issue within primary care, rather than solely a mental health access issue. VitalSign6 empowered primary care providers to manage the vast majority (87.4%) of diagnosed depression cases using personalized treatment plans and MBC, with only a small proportion requiring specialist referrals. This approach, integrating pharmacological and non-pharmacological treatments, aligns with collaborative care models that have demonstrated effectiveness in treating depression in primary care and reducing the need for specialty mental health referrals.
The unexpected decrease in physicians’ perceived importance of depression screening and MBC post-implementation, as indicated by survey results, likely reflects the workflow disruptions and technical challenges encountered during the project. Workflow integration and EHR interoperability issues emerged as the most significant concerns in both physician and staff feedback. The simultaneous implementation of Epic Welcome tablets and VitalSign6, coupled with technical glitches and data transfer challenges, likely contributed to physician frustration and a perception of increased workload. Upcoming EHR system upgrades are expected to address some of these interoperability issues and further streamline VitalSign6 integration.
The significant improvement in staff comfort levels in discussing mental health with patients is a notable positive outcome. This improvement can be attributed to the depression and MBC training sessions provided to all clinic staff and the on-site support offered during the project implementation phase. Investing in staff education and support is crucial for successful implementation of mental health initiatives in primary care.
Limitations and Future Directions
This quality improvement project, conducted at a single academic clinic site with a residency program, has limitations in terms of generalizability to other primary care settings. The project’s focus on PHQ-2 and PHQ-9 screening also means that other valuable measures available within VitalSign6, such as anxiety screening, treatment side effect monitoring, and adherence assessments, were not analyzed. Furthermore, the high patient attrition rate (70.2% not returning for follow-up) represents a significant limitation. Future research should investigate factors contributing to patient attrition and explore strategies to improve retention, such as care coordination, patient navigation, and teletherapy interventions. Evidence suggests that these approaches can reduce barriers to care and improve follow-up rates.
Conclusion: Advancing Depression Care in Primary Settings
This project demonstrates the successful implementation of VitalSign6 as an effective adjunct for enhancing depression identification and management in primary care. By providing primary care physicians with evidence-based practice tools and integrating them into the EHR workflow, VitalSign6 facilitates improved depression screening tools utilization, treatment initiation, and referral management. Addressing workflow challenges and technical interoperability issues remains critical for optimizing the adoption and sustainability of such programs. Future efforts should focus on developing integrated, multidisciplinary care team models, streamlining clinical workflows, and establishing robust reporting and sustainment policies to further enhance depression care in primary care settings. The results of this project contribute to the growing body of evidence supporting the effectiveness of VitalSign6 and similar MBC programs in improving the quality of depression care within primary care.
Footnotes
Declaration of Conflicting Interests: The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
Funding: The author(s) received no financial support for the research, authorship, and/or publication of this article.
ORCID iD: Kimberly A. Siniscalchi https://orcid.org/0000-0002-7129-0821
