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Anxiety DisordersNCT06898593

Enhancing Engagement by Integrating Goals and Concerns That Matter to Patients

A study testing Collaborative care model with clinical decision support system and Collaborative care model in people with Anxiety Disorders and Depression Disorders, run by Dartmouth-Hitchcock Medical Center at 6 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Anxiety Disorders, Depression Disorders
What is being tested?
Collaborative care model with clinical decision support system and Collaborative care model
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,448 participants
Where
6 sitesUnited States
Study dates
2 Apr 2025to 31 Jul 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

6 sites in 1 country

United States6 sites, 6 recruiting
  • Dartmouth Hitchcock Concord Family Medicine

    Concord, New Hampshire, 03301

    Matthew Duncan, MD, 603-650-4725, matthew.s.duncan@hitchcock.org

    Recruiting
  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

    Matthew Duncan, MD, 603-650-4725, matthew.s.duncan@hitchcock.org

    Matthew Duncan, MD

    Recruiting
  • Dartmouth-Hitchcock Heater Road Internal Medicine

    Lebanon, New Hampshire, 03766

    Matthew Duncan, MD, 603-650-4725, matthew.s.duncan@hitchcock.org

    Recruiting
  • Dartmouth Hitchcock Manchester Family Practice

    Manchester, New Hampshire, 03104

    Matthew Duncan, MD, 603-650-4725, matthew.s.duncan@hitchcock.org

    Recruiting
  • Dartmouth Hitchcock Nashua Family Practice

    Nashua, New Hampshire, 03063

    Matthew Duncan, MD, 603-650-4725, matthew.s.duncan@hitchcock.org

    Recruiting
  • Dartmouth Hitchcock Nashua General Internal Medicine

    Nashua, New Hampshire, 03063

    Matthew Duncan, MD, 603-650-4725, matthew.s.duncan@hitchcock.org

    Recruiting

Other trials in United States

About this study

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?
Read more

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.

Read the 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.

Being tested
Collaborative care model with clinical decision support system, Collaborative care model
Keywords
Collaborative Care Model, pre-visit questionnaire, dashboard, clinical decision support system, Depression, Anxiety, integrated behavioral health and primary care
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collaborative care model with clinical decision support systemBehavioural

    Also called dashboard, pre-visit questionnaire

    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 modelBehavioural

    Collaborative care model of integrated behavioral health and primary care.

Study groups in NCT06898593
Study groupRoleWhat they receive
Clinical Decision Support SystemExperimentalCollaborative 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.
Receives: Behavioral: Collaborative care model with clinical decision support system
Collaborative care model (usual care)Active comparatorStandard collaborative care model of integrated behavioral health.
Receives: Behavioral: Collaborative care model

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Patient and clinician satisfaction and barriers/facilitators to implementation

    Qualitative data collected through semi-structured interviews.

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

Secondary outcomes (5)
  1. Practice-level communication: Shared decision-making

    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.

    Measured: Approximately 1 month following enrollment in CoCM

  2. Patient experience: Communication

    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.

    Measured: Approximately 1 month following enrollment in CoCM

  3. Patient experience: Goal setting

    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.

    Measured: Approximately 1 month following enrollment in CoCM

  4. Treatment response: Depression

    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.

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

  5. Treatment response: Anxiety

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2025
  2. Study start2 Apr 2025
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
Stepped-wedge cluster-randomized controlled trial (3 steps of 2 clinics each)
Masking
None (open label)
Enrolment
2,448 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06898593
Sponsor's protocol ID
STUDY00033019 | STUDY02002511
Other IDs
1UM1TR004772-01
Status last verified
Jul 2026
First submitted
14 Mar 2025
Last updated
22 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD falls under patient protected health information (PHI).

Publications

  • 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.

    PubMed 24389354
  • 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.

    PubMed 22310560
  • 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.

    PubMed 30231381
  • 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.

    PubMed 30985594
  • 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.

    PubMed 34350943
  • 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.

    PubMed 34849970
  • 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.

    PubMed 11918503

Questions about this trial

What is this clinical trial studying?

A study testing Collaborative care model with clinical decision support system and Collaborative care model in people with Anxiety Disorders and Depression Disorders, run by Dartmouth-Hitchcock Medical Center at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Irina Perreard, PhD (603-646-5449, irina.perreard@dartmouth.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Engagement (time frame: From enrollment in CoCM to discharge from CoCM, approximately 3-4 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06898593, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.

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