Embedded Primary Care MultiDisciplinary Diabetes Clinic

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Embedding and Evaluating Multidisciplinary Diabetes Management and Continuous Glucose Monitoring Into Primary Care for a Vulnerable Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06015685
• Other study ID #: STUDY00006033
• Status: Recruiting
• Phase: N/A
• Start date: October 20, 2023
• Est. completion date: November 1, 2024

Study information

• Verified date: December 2023
• Source: Emory University
• Contact: Britt A Marshall, MD
• Phone: (404) 686-4411
• Email: britt.marshall[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: November 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Other:
• Embedded Clinic
Once a week, a Primary Care clinic half-day will be dedicated to multi-disciplinary, team-based DM care. The inter-professional team will include an Internal Medicine attending physician, an Internal Medicine resident, a DM educator, a nurse trained in professional CGM, a behavioral health provider, and a social worker to assist in finding resources for housing, food, and patient assistance programs.
• Routine Care
Researchers will use a 2:1 ratio of control to intervention patients. Using the CDW, researchers will identify a control population [patients who receive routine care (i.e., referral to subspecialty care)], who will be a propensity-matched cohort of individuals with similar age, gender, race/ethnicity, zip codes, insurance type, visit dates, and co-morbidities (Charlson Comorbidity Index) as the intervention group.

Locations

Country	Name	City	State
United States	Emory Primary Clinic Care at Midtown	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	Georgia Center for Diabetes Translation Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the proportion of embedded clinic patients with an HbA1c >9%	Percentage of participants with HbA1c >9% since the embedded clinic implementation. Data will be assessed from electronic medical records (EMR)	Baseline and 6 months
Primary	Change in acceptability of intervention measure (AIM)	AIM score is a four-item measures of implementation outcomes that are often considered "leading indicators" of implementation success (likert scale 1-5 with 5 being best outcome) at the baseline and 6-month follow-up visits will be used by the team members to assess the acceptability of model implementation.	Baseline and 6 months
Primary	Change in feasibility of intervention measure (FIM) scores	FIM score is a four-item measures of implementation outcomes that are often considered "leading indicators" of implementation success likert scale 1-5 with 5 being best outcome) at the baseline and 6-month follow-up visits will be used by the team members to assess the feasibility of model implementation.	Baseline and 6 months
Secondary	Change in weight	Change in weight will be assessed from available measurements in EMR.	Baseline, 3 months, and 6 months
Secondary	Change in body mass index (BMI)	BMI will be calculated from available measurements in EMR	Baseline, 3 months, and 6 months
Secondary	Change in diabetes self-efficacy score	Participants will complete the diabetes management self-efficacy scale (DMSES). It assesses the extent to which respondents are confident they can manage their blood sugar, diet, and level of exercise. Responses are rated on a 5-point scale ranging from ''can't do at all'' to ''certain can do'' (1, 5). In this scale, higher scores indicate higher self-efficacy in performing Diabetes self-management (DSM) activities.	Baseline, 3 months, and 6 months
Secondary	Change in depression status	The 9-question Patient Health Questionnaire (PHQ9) is a diagnostic tool to screen adult patients in a primary care setting for the presence and severity of depression. Scores represent: 0-5 = mild 6-10 = moderate 11-15 = moderately severe. 16-20 = severe depression.	Baseline, 3 months, and 6 months
Secondary	Change in the patient-reported quality of life score	Participants will complete the Patient-Reported Outcomes Measurement Information System (PROMIS) survey. The possible score ranges from 0 to 20 points in each case. 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health.	Baseline, 3 months, and 6 months
Secondary	Change in anxiety score	Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and severity measuring of generalized anxiety disorder. Scores represent 0-4: Minimal Anxiety; 5-9: Mild Anxiety; 10-14: Moderate Anxiety; a score greater than 15: Severe Anxiety	Baseline, 3 months, and 6 months
Secondary	Change in food insecurity	Participants will complete the Latin American and Caribbean (ELSCA) Household Food Security Measurement Scale. This scale uses a set of 15 questions, with yes/no response categories, seven of which are for households with children. Each question asks the respondent whether he/she or any other household member has experienced a certain manifestation of food insecurity in the previous three months. Households that affirm 3 items are classified as food insecure.	Baseline, 3 months, and 6 months
Secondary	Change in Housing Insecurity	Percentage of participants of being at risk for housing insecurity by answering the 2-question housing insecurity instrument: (1) "Are you worried or concerned that in the next 2 months you may not have stable housing that you own, rent, or stay in as part of a household?" with responses of "yes" or "no," and (2) "How likely do you think it would be that you would have to use a homeless shelter in the next 6 months?" with 4 response options ranging from "very unlikely" to "very likely."	Baseline, 3 months, and 6 months
Secondary	Change in urine microalbumin	Change in urine microalbumin (mcg/mg min 0 and higher the worse the outcome) will be calculated from available laboratory assessments from EMR	Baseline, 3 months, and 6 months