Clinical trial NCT06898593: Enhancing Engagement by Integrating Goals and Concerns That Matter to Patients
Official title: Enhancing Engagement by Integrating Goals and Concerns That Matter to Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Depression Disorders
Keywords: Collaborative Care Model
pre-visit questionnaire
dashboard
clinical decision support system
Depression
Anxiety
integrated behavioral health and primary care
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
name: Dartmouth College
First posted: 2025-03-27
Enrollment: 2448
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Stepped-wedge cluster-randomized controlled trial (3 steps of 2 clinics each)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Engagement
timeFrame: From enrollment in CoCM to discharge from CoCM, approximately 3-4 months.
measure: Patient and clinician satisfaction and barriers/facilitators to implementation
timeFrame: From enrollment in CoCM to discharge from CoCM, approximately 3-4 months.
Secondary outcomes:
measure: Practice-level communication: Shared decision-making
timeFrame: Approximately 1 month following enrollment in CoCM
measure: Patient experience: Communication
timeFrame: Approximately 1 month following enrollment in CoCM
measure: Patient experience: Goal setting
timeFrame: Approximately 1 month following enrollment in CoCM
measure: Treatment response: Depression
timeFrame: From enrollment in CoCM to discharge from CoCM, approximately 3-4 months.
measure: Treatment response: Anxiety
timeFrame: From enrollment in CoCM to discharge from CoCM, approximately 3-4 months.
Other outcomes:
Locations:
city: Concord
country: United States
facility: Dartmouth Hitchcock Concord Family Medicine
state: New Hampshire
city: Lebanon
country: United States
facility: Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Heater Road Internal Medicine
state: New Hampshire
city: Manchester
country: United States
facility: Dartmouth Hitchcock Manchester Family Practice
state: New Hampshire
city: Nashua
country: United States
facility: Dartmouth Hitchcock Nashua Family Practice
state: New Hampshire
city: Nashua
country: United States
facility: Dartmouth Hitchcock Nashua General Internal Medicine
state: New Hampshire
Study officials:
affiliation: Dartmouth College
name: Anna Tosteson, ScD
role: PRINCIPAL_INVESTIGATOR
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citation: Boudreau DM, Capoccia KL, Sullivan SD, Blough DK, Ellsworth AJ, Clark DL, Katon WJ, Walker EA, Stevens NG. Collaborative care model to improve outcomes in major depression. Ann Pharmacother. 2002 Apr;36(4):585-91. doi: 10.1345/aph.1A259.