Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this study, we will determine the feasibility of an innovative care model for young adults with diabetes and compare the primary and secondary outcomes in the innovative model to those in the usual care model for adult diabetes management at Massachusetts General Hospital (MGH) Diabetes Center.
This study is a quasi-randomized mixed methods evaluation of the implementation of an innovative collaborative care model to assess whether it is feasible and improves indicators of diabetes and mental health, while exploring themes that will inform redesign of the care model to improve healthcare delivery to young adults with diabetes transitioning to the adult care setting. We will compare primary and secondary outcomes in this model to those in the usual care model for adult diabetes management at MGH Diabetes Center. Those who agree to the research study will be asked to complete a series of three survey questionnaires over the timeframe of the study. The electronic health records (EHRs) of these patients who agree to the research study will also be examined. All patients who successfully complete all 3 survey questionnaires will be eligible for a structured interview portion of the study to explore themes that will inform care model redesign.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care Model | Active Comparator | Patients enrolled in this arm will receive diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center. |
|
| Diabetes Collaborative Care Model for Young Adults | Active Comparator | Patients enrolled in this arm will receive diabetes care per the diabetes collaborative care model for young adults. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Collaborative Care Model for Young Adults | Other | We designed a diabetes collaborative care model for young adults that incorporates a mental health provider alongside a diabetes care provider during joint office visits to facilitate screening and treatment of psychosocial determinants of diabetes management. The Massachusetts General Hospital (MGH) Diabetes Center will be piloting this model with a multi-disciplinary team of diabetologists, nurse practitioners, diabetes nurse educators, and mental health provider. Patients scheduled to be seen in the diabetes collaborative care model will continue to follow in the diabetes collaborative care model, with follow up visits every 3-4 months. All patients will receive routine diabetes care with lab testing, medical interventions, therapies and referrals performed at the discretion of the patients' providers. |
| Measure | Description | Time Frame |
|---|---|---|
| Visit completion rate in patients seen in the collaborative care and usual care models | Mean number of completed visits compared to scheduled visits (visit completion rate) in patients seen in the collaborative care and usual care models | 12 months |
| Change in diabetes-related distress, measured by Problem Areas in Diabetes (PAID) | Problems Areas in Diabetes (PAID) is a validated screening tool for diabetes-related distress. Will measure change in PAID scores for both arms. The minimum score is 0 and maximum score is 80. The higher the score, the more severe diabetes-related distress. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | Change in hemoglobin A1c | 12 months |
| Change in mood, measured by Patient Health Questionnaire-8 (PHQ-8) | Patient Health Questionnaire-8 (PHQ-8) is a validated screening tool for depression. The minimum score is 0 and maximum score is 24. The higher the score, the more severe depression. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Deborah J Wexler, MD, MSc | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
Not provided
| Label | URL |
|---|---|
| Diabetes Collaborative Care for Young Adults: A Formative, Mixed Methods Study of a Pragmatic, Multidisciplinary Care Model for Young Adults With Diabetes in an Adult Center | View source |
Not provided
Pilot and Feasibility study, no plan to share IPD
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 23, 2021 | Apr 21, 2026 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Usual Care Model | Other | Patients enrolled in this arm will receive routine diabetes care per usual care at the Massachusetts General Hospital (MGH) Diabetes Center, with lab testing, medical interventions, therapies and referrals performed at the discretion of the patients' providers. In the usual care model, behavioral/mental health and social work services are available on a referral basis and are not integrated into a patients' routine appointment. Screening and treatment of psychosocial determinants of diabetes management are at done at the discretion of the patients' provider. Frequency of follow up visits is at the discretion of the patients' provider. |
|
| 12 months |
| Change in anxiety, measured by Generalized Anxiety Disorder Scale-7(GAD-7) | Generalized Anxiety Disorder Scale-7(GAD-7) is a validated screening tool for anxiety. The minimum score is 0 and maximum score is 21. The higher the score, the more severe anxiety. | 12 months |
| Change in Problem Areas in Diabetes (PAID) scores among those with score of 40 or higher at baseline, indicating moderate distress | Problems Areas in Diabetes (PAID) is a validated screening tool for diabetes-related distress. Will measure change in PAID scores for both arms. The minimum score is 0 and maximum score is 80. The higher the score, the more severe diabetes-related distress. | 12 months |
| Change in disordered eating behavior, measured by Diabetes Eating Problem Survey- Revised (DEPS-R) | Diabetes Eating Problem Survey- Revised (DEPS-R) is a validated screening tool for disordered eating behavior for patients with diabetes on insulin therapy. The minimum score is 0 and maximum score is 75. The higher the score, the most severe disordered eating behavior. | 12 months |
| Change in alcohol use, measured by Alcohol Use Disorders Identification Test Consumption (AUDIT-C) | Alcohol Use Disorders Identification Test Consumption (AUDIT-C) is a three-item self-administered screening test for alcohol misuse, validated in adults 18 years and older. | 12 months |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided