Clinical trial NCT06015685: Embedded Primary Care MultiDisciplinary Diabetes Clinic
Official title: Embedding and Evaluating Multidisciplinary Diabetes Management and Continuous Glucose Monitoring Into Primary Care for a Vulnerable Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Primary Care
Continuous Glucose Monitoring (CGM)
Diabetes Management
Multidisciplinary care
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Georgia Center for Diabetes Translation Research
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: American Diabetes Association
First posted: 2023-08-29
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to improve diabetes management for patients at Midtown General Internal Medicine Clinic (Aim 1). The clinic offers dedicated diabetes care on certain days with trained providers able to offer dedicated diabetes care. The clinic will also make sure to address other aspects of life and health that may impact an individual's ability to manage their diabetes - food insecurity, housing insecurity, knowing about healthy food, finding ways to exercise, and mental health. The study will also train the medical residents to be able to participate in this dedicated diabetes care (Aim 2).

Detailed description: There is a widening quality of care gap in diabetes mellitus (DM) management that sees Black and Hispanic patients with much higher rates of DM complications and hospitalizations compared to their white counterparts. Primary Care is the frontline for DM prevention and management; however, Primary Care Clinics, including Internal Medicine resident continuity clinics, struggle to improve DM metrics. The lack of resources, such as time and personnel, is a significant limiting factor in strategies that would allow these clinics to optimize care. As a result, the current DM management model was created, in which Primary Care providers refer patients with elevated hemoglobin A1c (HbA1c) to subspecialty care. This process is inefficient, overwhelms subspecialty practices, and most importantly does not address the social determinants of health that often make it difficult for patients to get their DM under control.

This traditional model also comes with a potential institutional financial cost. There is a perception that reducing upfront costs of care can make a system more economically viable; yet this can have devastating results for a system and for its patients on the back end. For example, HbA1c is a Merit-based Incentive Payment System Clinical Quality Measure if a patient population is not supported in their efforts for DM control, this can translate to monetary loss annually for the Emory Healthcare System. In addition, there are also potential losses to the system related to long-term morbidity and mortality risks of elevated HbA1c over time.

Studies have shown that a multi-disciplinary approach including physician, dietitian, DM education, psychotherapy, and social work services functioning concurrently and cooperatively has the potential to positively change the current paradigm. Given the vital role Primary Care plays in the management of all aspects of patient care, including physical and psychosocial well-being, this care delivery model is optimally designed to have the most impact and success in the Primary Care Clinic setting. The research team proposes to embed a multi-disciplinary diabetes-focused clinic within Primary Care in the Emory Healthcare System where this approach would create a central location for all the patients' DM needs, provide efficient care that helps patients address social and economic barriers, and engage the care team through between-clinic touchpoints to motivate patients to take agency over their health. This also provides a venue to implement modern technologies for DM management, such as continuous glucose monitoring (CGM). Despite its proven efficacy in DM management, CGM remains an understudied intervention in Primary Care, especially in patient populations that would otherwise have difficulty accessing specialty care. Researchers anticipate that these changes will enable improved adherence to follow-up visits and treatment.

In addition to the benefits of streamlined patient care, this model also offers the opportunity to enhance Internal Medicine residency education. Investigators intend to develop a hybrid clinical/educational curriculum for residents that capitalizes on and models appropriate resource utilization through an integrated care model and provides early exposure to multi-disciplinary care and CGM.

Eligibility criteria: Aim 1 (Embedded diabetes clinic):

Inclusion Criteria:

* Age 18+
* Patient at Midtown Diabetes Clinic
* Able to consent
* HbA1c \>=9%

Exclusion Criteria:

* Not planning to follow up at Midtown
* Pregnancy
* Followed by Endocrinology as a specialist

Aim 2 (Embedded diabetes clinic and curriculum):

Inclusion Criteria:

- All residents in Midtown Primary Care are eligible

Primary outcomes:
measure: Change in the proportion of embedded clinic patients with an HbA1c >9%
timeFrame: Baseline and 6 months
measure: Change in acceptability of intervention measure (AIM)
timeFrame: Baseline and 6 months
measure: Change in feasibility of intervention measure (FIM) scores
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in weight
timeFrame: Baseline, 3 months, and 6 months
measure: Change in body mass index (BMI)
timeFrame: Baseline, 3 months, and 6 months
measure: Change in diabetes self-efficacy score
timeFrame: Baseline, 3 months, and 6 months
measure: Change in depression status
timeFrame: Baseline, 3 months, and 6 months
measure: Change in the patient-reported quality of life score
timeFrame: Baseline, 3 months, and 6 months
measure: Change in anxiety score
timeFrame: Baseline, 3 months, and 6 months
measure: Change in food insecurity
timeFrame: Baseline, 3 months, and 6 months
measure: Change in Housing Insecurity
timeFrame: Baseline, 3 months, and 6 months
measure: Change in urine microalbumin
timeFrame: Baseline, 3 months, and 6 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Primary Clinic Care at Midtown
state: Georgia
Study officials:
affiliation: Emory University
name: Britt A Marshall, MD
role: PRINCIPAL_INVESTIGATOR
References: