Enhancing Engagement by Integrating Goals and Concerns That Matter to Patients

Not Applicable

Recruiting

• Conditions: Anxiety Disorders; Depression Disorders

• Registration Number: NCT06898593
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

Brief Summary

The goal of this clinical trial is to learn if adding patients' goals and concerns to measurement-based collaborative care can tailor care and provide a more holistic view of treatment, thereby improving engagement in care among adult patients receiving collaborative care. The main questions it aims to answer are:

* Does using a clinical decision support system (which includes an enhanced pre-visit questionnaire and patient-level dashboard) improve patient engagement in the collaborative care model?

* Does using a clinical decision support system improve patient and clinician satisfaction with care?

Researchers will compare the enhanced collaborative care with traditional collaborative care.

Patient participants will complete pre-visit questionnaires before their collaborative care appointments. Responses will be viewed by the clinician and/or patient in a visual dashboard inside the electronic health record.

Detailed Description

Dartmouth Health (DH) has implemented the evidence-based Collaborative Care Model (CoCM) of integrated behavioral health in primary care.

CoCM includes (a) an initial behavioral health assessment with validated patient-reported outcomes, including the Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) scale, (b) joint care planning and treatment with pharmacotherapy and/or psychotherapy, (c) monitoring using a registry to track treatment and patient-reported outcomes, and (d) caseload review with a psychiatric consultant.

There are several limitations associated with CoCM, including loss of patients between referral and treatment, failure to complete CoCM, and a limited ability to monitor for post-treatment relapse in depressive symptoms. These limitations are associated with low motivation to engage in BH services and patient perceptions that providers cannot accommodate their needs.

The scientific premise of the project is that structured collection and use of personalized treatment goals and concerns will improve patient engagement with CoCM, extending service impact. This study will highlight patient priorities for healthcare services to the CoCM team and will overcome clinical translational science challenges associated with patients' goals and concerns being neither fully documented nor available to support care, improvement, and research.

Enhancing patient-generated data collected through CoCM (e.g., PHQ-9; GAD-7) with patients' goals and concerns will reduce barriers to engagement in BH services by overcoming patient perceptions that services are misaligned with needs. Previous studies demonstrate that agenda setting processes that elicit priorities can improve clinicians' understanding of patients' concerns, increase patients' perceptions that what matters most is heard and incorporated into care plans, and increase likelihood of patients adhering to treatment recommendations.

Clinicians and patient stakeholders will use human-centered co-design principles to (a) enhance the existing CoCM pre-visit questionnaire (PVQ) to capture patient-reported goals and concerns, and (b) build a patient-level clinical decision support system (CDSS) that visualizes PVQ responses and clinical information within the electronic health record (EHR) for in-visit use by clinicians and patients. PVQs will support the patient in defining their visit agenda and providing an opportunity to align care with their immediate psychosocial and clinical needs. PVQs will be configured in Epic's MyChart® patient portal, allowing for completion at home prior to the visit or with a tablet upon clinic check-in. PVQ responses will be directly imported via a smart phrase into a clinical note template that clinicians can edit during the visit, reducing documentation burden and complexity. The care plan will be based on joint clinician and patient input and be available to the patient in the patient portal after the visit.

Intervention rollout will involve coaching CoCM care managers to use the CDSS following an established process. This will include a quality improvement curriculum to optimize use of the CDSS within clinical workflows and to incorporate patient preferences into decision-making. Training and support will be provided to care managers via monthly sessions informed by monitoring and feedback to assess and resolve challenges.

Study Timeline

• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-20
• Study First Posted: 2025-03-27
• Status Verified: 2025-04
• Study Start: 2025-04-02
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2448

Inclusion Criteria

• Patients enrolled in the Collaborative Care Model (CoCM) at Dartmouth Health

Exclusion Criteria

• Patients not enrolled in the Collaborative Care Model (CoCM) at Dartmouth Health

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Engagement	From enrollment in CoCM to discharge from CoCM, approximately 3-4 months.	The primary outcome measure targeted is increased Collaborative Care Model (CoCM) engagement as measured by the proportion of CoCM patients with 2 or more Patient Health Questionnaire (PHQ-9)/Generalized Anxiety Disorder (GAD-7) assessments completed.
Patient and clinician satisfaction and barriers/facilitators to implementation	From enrollment in CoCM to discharge from CoCM, approximately 3-4 months.	Qualitative data collected through semi-structured interviews.

Secondary Outcome Measures

Name	Time	Method
Practice-level communication: Shared decision-making	Approximately 1 month following enrollment in CoCM	Practice-level communication will be assessed using the collaboRATE measure of shared decision making. The collaboRATE survey includes three questions, rated from 0 (no effort was made) to 4 (every effort was made). Responses will be scored using the Top Score approach which excludes cases where a response to one or more of the collaboRATE questions is missing. Each encounter is coded as either '1', if the response to all three collaboRATE items was 4, or '0' if the response to any of the three collaboRATE items was less than 4. The percentage of all encounters that were coded as '1' is the collaboRATE Score. Higher scores represent more shared decision making.
Patient experience: Communication	Approximately 1 month following enrollment in CoCM	Communication will be assessed using the "Communication with Mental Health Counselor" composite measure from the CAHPS Outpatient Mental Health Survey, which includes two questions: "In the last 6 months, how often did your main mental health counselor listen carefully to you? In the last 6 months, how often did your main mental health counselor show respect for what you had to say?" (Response options: never, sometimes, usually, always).; The score for the composite measure is equal to the mean of the proportion of responses (excluding missing data) in each response category across the items in the composite, where the numerator is the number of people responding "always" and the denominator for each question is the total number of responses. Higher scores indicate higher quality communication.
Patient experience: Goal setting	Approximately 1 month following enrollment in CoCM	Goal setting will be assessed using a single question from the CAHPS Outpatient Mental Health Survey: "In the last 6 months, how much did your main mental health counselor consider what is important to you when setting the goals for treatment?" (Response options: not at all, a little, some, a lot).; The score is equal to the proportion of responses (excluding missing data) who indicate the top answer "a lot", divided by the total number of responses. Higher proportions indicate higher goal setting.
Treatment response: Depression	From enrollment in CoCM to discharge from CoCM, approximately 3-4 months.	Change in depressive symptoms will be determined based on the scores obtained from the Patient Health Questionnaire-9 (PHQ-9). The total score can range from 0 to 27. Higher scores indicate greater severity of depression.
Treatment response: Anxiety	From enrollment in CoCM to discharge from CoCM, approximately 3-4 months.	Change in anxiety symptoms will be determined based on scores obtained from the 7-item General Anxiety Disorder (GAD-7) scale. The total score can range from 0 to 21. Higher scores indicate greater severity of anxiety.

Trial Locations

Locations (6)

Dartmouth Hitchcock Concord Family Medicine; 🇺🇸 Concord, New Hampshire, United States

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Dartmouth-Hitchcock Heater Road Internal Medicine; 🇺🇸 Lebanon, New Hampshire, United States

Dartmouth Hitchcock Manchester Family Practice; 🇺🇸 Manchester, New Hampshire, United States

Dartmouth Hitchcock Nashua Family Practice; 🇺🇸 Nashua, New Hampshire, United States

Dartmouth Hitchcock Nashua General Internal Medicine; 🇺🇸 Nashua, New Hampshire, United States