Collaborative Care Model for Depression

Recruiting at 5 trial locations

Overseen By Irina Perreard, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Not in CoCM, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3-4 months

2448 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is the Collaborative Care Model for Depression safe for humans?

The Collaborative Care Model, especially when combined with a Clinical Decision Support System (CDSS), has been shown to reduce medication errors and adverse drug events, which are important for patient safety. Studies indicate that these systems can help prevent harmful drug interactions and improve prescribing practices, suggesting a positive safety profile. ^{1 2 3 4 5}

How is the collaborative care model for depression unique compared to other treatments?

The collaborative care model for depression is unique because it involves a team-based approach where case managers connect primary care providers, patients, and mental health specialists to improve depression management. This model enhances routine screening, diagnosis, and treatment by using evidence-based protocols and supports patient engagement in their care. ^{6 7 8 9 10}

What data supports the effectiveness of the Collaborative Care Model for Depression treatment?

Research shows that the Collaborative Care Model (CCM) is effective in managing depression by improving routine screening, diagnosis, and treatment through a team approach involving primary care providers and mental health specialists. Studies have found that this model leads to better depression outcomes compared to usual care. ^{7 8 11 12 13}

Who Is on the Research Team?

Anna Tosteson, ScD

Principal Investigator

Dartmouth College

Are You a Good Fit for This Trial?

This trial is for adult patients with anxiety or depression who are currently receiving collaborative care. It's not specified who can't join, but typically those unable to complete questionnaires or follow the study protocol might be excluded.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in the Collaborative Care Model (CoCM) with enhanced pre-visit questionnaires and a clinical decision support system to improve engagement and satisfaction.

3-4 months

Regular visits as per CoCM protocol

Follow-up

Participants are monitored for engagement and satisfaction, with assessments of communication and treatment response.

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Collaborative care model
• Collaborative care model with clinical decision support system

Trial Overview The study tests if adding a clinical decision support system, which uses an enhanced questionnaire and dashboard, to collaborative care improves patient engagement and satisfaction compared to traditional collaborative care.

How Is the Trial Designed?

Group I: Clinical Decision Support System Experimental Treatment 1 Intervention

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.

Group II: Collaborative care model (usual care) Active Control 1 Intervention

Standard collaborative care model of integrated behavioral health.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Trustees of Dartmouth College

Lead Sponsor

Trials

32

Recruited

14,500+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

Published Research Related to This Trial

The study is evaluating the effectiveness and implementation of the Collaborative Behavioral Health Program (CBHP) in 11 primary care practices over a 30-month period, aiming to improve access to mental health services for depression.

It will provide insights into the barriers and facilitators of implementing the Collaborative Care Model (CoCM) and conduct economic analyses to assess the cost-effectiveness of the program, potentially benefiting both mental health outcomes and chronic health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative care for depression management in primary care: A randomized roll-out trial using a type 2 hybrid effectiveness-implementation design. Smith, JD., Fu, E., Rado, J., et al.[2022]

In a study of 5,439 patients using the collaborative care model (CCM), having a follow-up contact with a care manager within four weeks significantly increased the likelihood of improvement in depression symptoms (odds ratio of 1.63).

Receiving a psychiatric consultation between weeks 8 and 12 also improved the chances of symptom improvement (odds ratio of 1.44), highlighting the importance of these care tasks in enhancing patient outcomes in depression treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unpacking Collaborative Care for Depression: Examining Two Essential Tasks for Implementation. Bao, Y., Druss, BG., Jung, HY., et al.[2023]

Collaborative care models significantly improve depression management, showing a standardized mean difference of 0.34 in depression symptoms and enhancing treatment adherence and response rates in various populations.

The systematic review of 69 studies indicates that these models not only improve clinical outcomes like remission and recovery from symptoms but also enhance patient satisfaction and quality of life, demonstrating their effectiveness across different healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative care to improve the management of depressive disorders: a community guide systematic review and meta-analysis. Thota, AB., Sipe, TA., Byard, GJ., et al.[2022]

In a study analyzing 1009 ICU days, 230 adverse drug events were identified in 79 patients, with the most frequent issues being hypoglycemia, prolonged activated partial thromboplastin time, and hypokalemia.

The occurrence of adverse drug events was significantly linked to higher severity of illness and increased nursing workload, indicating that patient condition and staff demands may influence the safety of drug administration in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse drug events in intensive care units: a cross-sectional study of prevalence and risk factors. Seynaeve, S., Verbrugghe, W., Claes, B., et al.[2013]

Citations

1. Netherlands pubmed.ncbi.nlm.nih.gov

Collaborative care for depression management in primary care: A randomized roll-out trial using a type 2 hybrid effectiveness-implementation design. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Unpacking Collaborative Care for Depression: Examining Two Essential Tasks for Implementation. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Clinical effectiveness of collaborative care for depression in UK primary care (CADET): cluster randomised controlled trial. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Collaborative care to improve the management of depressive disorders: a community guide systematic review and meta-analysis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Collaborative depression care: history, evolution and ways to enhance dissemination and sustainability. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Systematic review of computerized prescriber order entry and clinical decision support. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

[ Preventing adverse drug events using clinical decision support systems]. [2015]

8. Canada pubmed.ncbi.nlm.nih.gov

Inappropriate prescribing practices: the challenge and opportunity for patient safety. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Improving patient safety by modifying provider ordering behavior using alerts (CDSS) in CPOE system. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Adverse drug events in intensive care units: a cross-sectional study of prevalence and risk factors. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Understanding collaborative care implementation in the Department of Veterans Affairs: core functions and implementation challenges. [2018]

12. England pubmed.ncbi.nlm.nih.gov

Costs of implementing and sustaining enhanced collaborative care programs involving community partners. [2020]

13. England pubmed.ncbi.nlm.nih.gov

Clinical effectiveness and cost-effectiveness of collaborative care for depression in UK primary care (CADET): a cluster randomised controlled trial. [2022]