NCT06898593

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,448

participants targeted

Target at P75+ for not_applicable

Timeline
28mo left

Started Apr 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Apr 2025Jul 2028

First Submitted

Initial submission to the registry

March 14, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 27, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 2, 2025

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2028

Last Updated

April 29, 2026

Status Verified

April 1, 2025

Enrollment Period

2.3 years

First QC Date

March 14, 2025

Last Update Submit

April 27, 2026

Conditions

Keywords

Collaborative Care Modelpre-visit questionnairedashboardclinical decision support systemDepressionAnxietyintegrated behavioral health and primary care

Outcome Measures

Primary Outcomes (2)

  • Engagement

    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.

    From enrollment in CoCM to discharge from CoCM, approximately 3-4 months.

  • Patient and clinician satisfaction and barriers/facilitators to implementation

    Qualitative data collected through semi-structured interviews.

    From enrollment in CoCM to discharge from CoCM, approximately 3-4 months.

Secondary Outcomes (5)

  • Practice-level communication: Shared decision-making

    Approximately 1 month following enrollment in CoCM

  • Patient experience: Communication

    Approximately 1 month following enrollment in CoCM

  • Patient experience: Goal setting

    Approximately 1 month following enrollment in CoCM

  • Treatment response: Depression

    From enrollment in CoCM to discharge from CoCM, approximately 3-4 months.

  • Treatment response: Anxiety

    From enrollment in CoCM to discharge from CoCM, approximately 3-4 months.

Study Arms (2)

Clinical Decision Support System

EXPERIMENTAL

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.

Behavioral: Collaborative care model with clinical decision support system

Collaborative care model (usual care)

ACTIVE COMPARATOR

Standard collaborative care model of integrated behavioral health.

Behavioral: Collaborative care model

Interventions

Collaborative care model of integrated behavioral health and primary care.

Collaborative care model (usual care)

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.

Also known as: dashboard, pre-visit questionnaire
Clinical Decision Support System

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Dartmouth Hitchcock Concord Family Medicine

Concord, New Hampshire, 03301, United States

RECRUITING

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

RECRUITING

Dartmouth-Hitchcock Heater Road Internal Medicine

Lebanon, New Hampshire, 03766, United States

RECRUITING

Dartmouth Hitchcock Manchester Family Practice

Manchester, New Hampshire, 03104, United States

RECRUITING

Dartmouth Hitchcock Nashua Family Practice

Nashua, New Hampshire, 03063, United States

RECRUITING

Dartmouth Hitchcock Nashua General Internal Medicine

Nashua, New Hampshire, 03063, United States

RECRUITING

Related Publications (7)

  • 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.

    PMID: 24389354BACKGROUND
  • 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.

    PMID: 22310560BACKGROUND
  • 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.

    PMID: 30231381BACKGROUND
  • 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.

    PMID: 30985594BACKGROUND
  • 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.

    PMID: 34350943BACKGROUND
  • 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.

    PMID: 34849970BACKGROUND
  • 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.

    PMID: 11918503BACKGROUND

Related Links

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

Dashboard Systems

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Database Management SystemsManagement Information SystemsOrganization and AdministrationHealth Services Administration

Study Officials

  • Anna Tosteson, ScD

    Dartmouth College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Stepped-wedge cluster-randomized controlled trial (3 steps of 2 clinics each)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 14, 2025

First Posted

March 27, 2025

Study Start

April 2, 2025

Primary Completion (Estimated)

July 31, 2027

Study Completion (Estimated)

July 31, 2028

Last Updated

April 29, 2026

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

IPD falls under patient protected health information (PHI).

Locations