Enhancing Engagement by Integrating Goals and Concerns That Matter to Patients
NCT ID: NCT06898593
Last Updated: 2025-08-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
2448 participants
INTERVENTIONAL
2025-04-02
2027-06-30
Brief Summary
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* 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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Clinical Decision Support System
Collaborative care model, with a clinical decision support system (CDSS) which includes an enhanced pre-visit questionnaire and dashboard to visualize patient-reported information and clinical information.
Collaborative care model with clinical decision support system
A new patient-level clinical decision support system (CDSS) will include enhancing the existing pre-visit questionnaire to capture patient-reported goals and concerns, and displaying pre-visit questionnaire responses and clinical information within a patient-level dashboard in the electronic health record (EHR) for use by clinicians and patients.
Collaborative care model (usual care)
Standard collaborative care model of integrated behavioral health.
Collaborative care model
Collaborative care model of integrated behavioral health and primary care.
Interventions
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Collaborative care model with clinical decision support system
A new patient-level clinical decision support system (CDSS) will include enhancing the existing pre-visit questionnaire to capture patient-reported goals and concerns, and displaying pre-visit questionnaire responses and clinical information within a patient-level dashboard in the electronic health record (EHR) for use by clinicians and patients.
Collaborative care model
Collaborative care model of integrated behavioral health and primary care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
100 Years
ALL
No
Sponsors
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National Center for Advancing Translational Sciences (NCATS)
NIH
Dartmouth College
OTHER
Dartmouth-Hitchcock Medical Center
OTHER
Responsible Party
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Anna Tosteson
Principal Investigator
Principal Investigators
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Anna Tosteson, ScD
Role: PRINCIPAL_INVESTIGATOR
Dartmouth College
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2014 Jan 3;16(1):e2. doi: 10.2196/jmir.3085.
Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812.
Basch E, Barbera L, Kerrigan CL, Velikova G. Implementation of Patient-Reported Outcomes in Routine Medical Care. Am Soc Clin Oncol Educ Book. 2018 May 23;38:122-134. doi: 10.1200/EDBK_200383.
Oliver BJ, Nelson EC, Kerrigan CL. Turning Feed-forward and Feedback Processes on Patient-reported Data into Intelligent Action and Informed Decision-making: Case Studies and Principles. Med Care. 2019 May;57 Suppl 5 Suppl 1:S31-S37. doi: 10.1097/MLR.0000000000001088.
Tse CS, Van Citters AD, Ricci B, Freundlich NZ, Lee M, Shah SA, Melmed GY, Siegel CA, van Deen WK; IBD Qorus. Identifying and Predicting the Goals and Concerns Prioritised by Individuals with Inflammatory Bowel Disease. J Crohns Colitis. 2022 Mar 14;16(3):379-388. doi: 10.1093/ecco-jcc/jjab142.
Van Citters AD, Holthoff MM, Kennedy AM, Melmed GY, Oberai R, Siegel CA, Weaver A, Nelson EC. Point-of-care dashboards promote coproduction of healthcare services for patients with inflammatory bowel disease. Int J Qual Health Care. 2021 Nov 29;33(Supplement_2):ii40-ii47. doi: 10.1093/intqhc/mzab067.
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.
Related Links
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Patient Health Questionnaire-9 instrument
General Anxiety Disorder-7 instrument
Other Identifiers
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STUDY00033019 | STUDY02002511
Identifier Type: -
Identifier Source: org_study_id
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