Collaborative Care Model for Type 1 Diabetes

Overseen By Leslie Johnson, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Severe psychiatric illness, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

80 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Collaborative Care Model (CoCM) for Type 1 Diabetes?

The Collaborative Care Model (CoCM) has been shown to improve outcomes in managing depression and diabetes together, as well as enhancing insulin use and glycemic control in diabetes care. This suggests that CoCM could be effective in managing Type 1 Diabetes by integrating care and improving overall health management. ^{1 2 3 4 5}

Is the Collaborative Care Model safe for humans?

The Collaborative Care Model (CoCM) has been widely studied and used in primary care settings for managing mental health conditions like depression. It is generally considered safe and does not negatively impact patient care or clinic revenue. ^{1 3 6 7 8}

How is the Collaborative Care Model treatment for Type 1 Diabetes different from other treatments?

The Collaborative Care Model (CoCM) is unique because it integrates behavioral health care with medical care, involving a team-based approach that includes a care manager, primary care clinician, and psychiatric consultant. This model focuses on coordinated care and systematic treatment planning, which is different from traditional treatments that often address medical and mental health issues separately. ^{1 2 3 4 9}

What is the purpose of this trial?

This study aims to test the use of an adapted collaborative care model for improving the health outcomes of adults diagnosed with type 1 diabetes (T1D). The duration of the study is 18 months with 4 study survey points. Participants will fill out an online survey regarding their psychosocial health and chronic disease management behaviors once every six months over the 18 months, and individuals who are randomly assigned to the study intervention will also consult at least once with a behavioral health consultant during the first year (active intervention period).

Research Team

Leslie Johnson, PhD, MPH

Principal Investigator

Emory University

Eligibility Criteria

Adults over 18 with type 1 diabetes can join this trial. It's not for those who have severe psychiatric illness, active suicidal thoughts, or don't speak English/have phone access.

Inclusion Criteria

I am an adult diagnosed with Type 1 Diabetes.

Exclusion Criteria

Individuals with the presence of severe psychiatric illness (PHQ-9≥20) or active suicidal ideation will also be excluded and referred to specialty care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention group engage with a behavioral health consultant to establish personalized health goals and manage stress and healthy behaviors.

12 months

2-3 sessions per year via phone or Zoom

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with assessments of HbA1c and PHQ-9 scores.

6 months

Online surveys every 6 months

Treatment Details

Interventions

• Collaborative care model (CoCM)

Trial Overview The study is comparing usual care for type 1 diabetes against a collaborative care model (CoCM) that includes regular online surveys and consultations with a behavioral health consultant.

Participant Groups

Group I: Collaborative care group Experimental Treatment 2 Interventions

Enrolled participants assigned to the intervention arm will be offered free consultation services with a behavioral health specialist, who is also a licensed clinical social worker. Participants randomized into the intervention group will consult with a behavioral health consultant (BHC) one or more times over the intervention period (based on the assessment of the BHC) via phone or Zoom based on the participant's preference. The BHC will participate in systematic caseload reviews to facilitate the medical management of depression if indicated.

Group II: Usual Care Active Control 1 Intervention

Participants randomized to the usual care will continue their routine clinical care at the diabetes clinic at Grady.

Collaborative care model (CoCM) is already approved in United States, India, European Union for the following indications:

Approved in United States as Collaborative Care Model for:

• Type 1 Diabetes
• Depression
• Anxiety

Approved in India as Integrated Care Model for:

• Type 1 Diabetes
• Depression
• Anxiety

Approved in European Union as Collaborative Care Model for:

• Type 1 Diabetes
• Depression
• Anxiety

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

MQ Mental Health Research

Collaborator

Trials

1

Recruited

80+

Juvenile Diabetes Research Foundation

Collaborator

Trials

237

Recruited

142,000+

Findings from Research

The collaborative care management (CoCM) model can be successfully adapted for use in a low-barrier HIV clinic, which serves a complex patient population with high levels of mental illness and substance use, demonstrating its flexibility beyond traditional primary care settings.

Despite the need for significant adaptations to fit the unique context of the HIV clinic, the core structural elements of CoCM were preserved, indicating that effective behavioral health integration can be achieved even in nonconventional healthcare environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adaptation of the collaborative care model to integrate behavioral health care into a low-barrier HIV clinic. Dombrowski, JC., Halliday, S., Tsui, JI., et al.[2023]

The Diabetes Care Collaborative Model (DCCM) was successfully implemented in 18 primary care practices, leading to significant improvements in glycemic control, with over a 1% reduction in the proportion of patients with glycated hemoglobin levels above 9% after 2 years (P < .001).

The model's success was attributed to effective teamwork, stakeholder engagement, and alignment of institutional priorities, which facilitated better insulin use among patients with hyperglycemia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Implementation of a Collaborative Team Care Model for Effective Insulin Use in an Academic Medical Center Primary Care Network. Eisenstat, SA., Chang, Y., Porneala, BC., et al.[2022]

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]

The collaborative care model significantly improves depression scores in adults with comorbid depression and diabetes, based on a systematic review of seven randomized controlled trials involving 1895 participants.

This model also leads to a notable reduction in glycated hemoglobin (HbA1c) levels, indicating better glycaemic control, although improvements in depression did not directly predict better glycaemic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative care for comorbid depression and diabetes: a systematic review and meta-analysis. Atlantis, E., Fahey, P., Foster, J.[2022]

The collaborative care model (CoCM) effectively engaged low-income patients from racial-ethnic minority groups, with 58% of those who participated in treatment showing significant clinical improvement in depression and anxiety symptoms after 10 to 14 weeks.

Despite high screening rates (87%) and identification of patients with mental health issues, only 56% engaged in CoCM, highlighting the need to address barriers to engagement to enhance treatment outcomes and reduce health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Collaborative Care for Low-Income Patients From Racial-Ethnic Minority Groups in Primary Care: Engagement and Clinical Outcomes. Blackmore, MA., Patel, UB., Stein, D., et al.[2022]

Successful implementation of Medicare's Collaborative Care Model (CoCM) billing codes requires strong support from interdisciplinary stakeholders and careful planning, as evidenced by interviews with 25 respondents from 12 healthcare organizations.

Organizations faced challenges with workflow changes and consent processes but found creative solutions to maximize billing flexibility, demonstrating that financial sustainability through CoCM codes is achievable with the right strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Health System Experiences with Collaborative Care (CoCM) Billing Codes: a Qualitative Study of Leadership and Support Staff. Carlo, AD., Corage Baden, A., McCarty, RL., et al.[2023]

The implementation of collaborative care model (CoCM) billing codes is operationally feasible and does not negatively impact patient care or clinic revenue.

Providers find the use of CoCM billing codes acceptable, suggesting that these codes can support the management of common mental disorders in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making It to Sustainability: Evaluating Billing Strategies for Collaborative Care. Chang, D., Morrison, DJ., Bowen, DJ., et al.[2023]

A scoping review of 20 studies on digital and mobile health technologies in collaborative care models (CoCM) found that while patient and provider satisfaction was generally positive, the impact on clinical outcomes was modest or unclear, indicating a need for further research.

The most effective use of technology in CoCM occurred when it was seamlessly integrated into existing workflows, rather than relying on patients or providers to initiate its use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital and Mobile Health Technology in Collaborative Behavioral Health Care: Scoping Review. Moon, K., Sobolev, M., Kane, JM.[2022]

The collaborative care model (CCM) was successfully adapted for use in hospital outpatient clinics, focusing on integrating care for patients with both physical and mental health conditions.

A key component of the CCM is the role of the care manager, who coordinates treatment and engages with patients and primary care clinicians, highlighting the importance of teamwork in improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Collaborative Care Model for Patients With Both Mental Health and Medical Conditions Implemented in Hospital Outpatient Care Settings. Geist, R., Versloot, J., Mansfield, E., et al.[2021]

References

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

Adaptation of the collaborative care model to integrate behavioral health care into a low-barrier HIV clinic. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Development and Implementation of a Collaborative Team Care Model for Effective Insulin Use in an Academic Medical Center Primary Care Network. [2022]

3. 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]

4. England pubmed.ncbi.nlm.nih.gov

Collaborative care for comorbid depression and diabetes: a systematic review and meta-analysis. [2022]

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

Collaborative Care for Low-Income Patients From Racial-Ethnic Minority Groups in Primary Care: Engagement and Clinical Outcomes. [2022]

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

Early Health System Experiences with Collaborative Care (CoCM) Billing Codes: a Qualitative Study of Leadership and Support Staff. [2023]

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

Making It to Sustainability: Evaluating Billing Strategies for Collaborative Care. [2023]

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

Digital and Mobile Health Technology in Collaborative Behavioral Health Care: Scoping Review. [2022]

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

The Collaborative Care Model for Patients With Both Mental Health and Medical Conditions Implemented in Hospital Outpatient Care Settings. [2021]