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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a collaborative care model (CoCM) to help adults with type 1 diabetes manage their health more effectively. The study examines whether discussions with a behavioral health consultant can improve health outcomes and overall well-being. Participants will complete online surveys about their health and management habits every six months over 18 months. Adults with type 1 diabetes who speak English and have phone access are suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance diabetes care for many.

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 prior data suggests that this collaborative care model is safe for adults with type 1 diabetes?

Research has shown that the collaborative care model (CoCM) is generally safe and well-tolerated. Studies have found that this approach can improve health outcomes, such as better blood sugar control and reduced depression symptoms, without causing major side effects. In this model, healthcare professionals collaborate to support both physical and mental health, which is particularly beneficial for managing long-term conditions like type 1 diabetes.

The collaborative care model has been successfully used in primary care to help patients manage various health issues. Reports of negative effects from this model have been minimal. Instead, it focuses on enhancing overall care through teamwork and regular check-ins with healthcare providers, proving both effective and safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Collaborative Care Model (CoCM) for Type 1 Diabetes because it integrates behavioral health support into diabetes management. Unlike standard treatments that primarily focus on insulin therapy and routine medical care, this model offers personalized consultations with a behavioral health specialist. This approach aims to address mental health challenges, such as depression, that often accompany diabetes, potentially improving overall patient outcomes. By facilitating comprehensive care through phone or Zoom consultations, CoCM provides accessible mental health support, which is a unique addition to traditional diabetes care.

What evidence suggests that the collaborative care model is effective for type 1 diabetes?

This trial will compare the Collaborative Care Model (CoCM) with usual care for managing Type 1 Diabetes. Studies have shown that CoCM effectively manages both diabetes and depression. Research indicates that this approach improves blood sugar control by lowering HbA1c levels, an important measure of long-term blood sugar management. For people with diabetes and depression, CoCM has also improved depression symptoms. Additionally, a pharmacist-led collaborative care program has been linked to better overall blood sugar control, helping to keep blood sugar levels stable. This model involves teamwork among different healthcare providers to better support patients' mental and physical health needs. ^{1 6 7 8 9}

Who Is on the Research Team?

Leslie Johnson, PhD, MPH

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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 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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06448429

NCT06448429 | Testing an Integrated Care Model 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).

2. diabetesjournals.org diabetesjournals.org/care/article/47/12/2291/157516/Effects-of-Integrated-Care-Approaches-to-Address

Effects of Integrated Care Approaches to Address Co ... In our study we summarize the effects of IC approaches to address depression and diabetes and examine moderating effects of IC approaches (e.g., ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9438466/

Effectiveness of Collaborative Care for Depression and ... This study aimed to investigate whether CC could improve depression outcomes and HbA1c in patients with depressive symptoms and diabetes, and assess its effects ...

4. nature.com nature.com/articles/s41467-025-58120-x

Cost-effectiveness of community-based integrated care ... We find that the CIC-PDD model demonstrates cost-effectiveness within primary health care settings, but further studies are needed to assess its long-term ...

5. jmcp.org jmcp.org/doi/10.18553/jmcp.2015.21.6.452

The Effect of a Diabetes Collaborative Care Management ... A pharmacist-led, diabetes collaborative care management program in a patient-centered primary care setting is associated with improved glycemic control over ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10723617/

The Impact of a Collaborative Care Model on Health ... We conducted a post-hoc analysis of the INDEPENDENT trial to investigate the role of differential engagement of participants on health outcomes over 3 years.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2215016125004728

Effects of Integrated Care on Health Outcomes in Patients ... This protocol for a systematic review and meta-analysis aims to evaluate the effects of integrated care on clinical and health outcomes in ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9803502/

Collaborative mental health care: A narrative review - PMC The Collaborative Care model is a systematic strategy for treating behavioral health conditions in primary care through the integration of care managers and ...

9. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2776302

Assessment of Interprofessional Collaborative Practices ... Primary care ICP was associated with reductions in HbA1c regardless of baseline levels, but the greatest reductions were found with HbA1c levels ...