Diabetes Interprofessional Team to Enhance Adherence to Medical Care

NCT03393338 | Completed DMC

• 1 other identifier: 4100077081
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this randomized controlled trial is to test the efficacy of DM I-TEAM (Diabetes Interprofessional Team to Enhance Adherence to Medical Care) to reduce emergency department (ED) visits and hospitalizations over 12 months in older African Americans (AAs) with diabetes mellitus (DM). DM I-TEAM is a multidisciplinary behavioral intervention that comprises a community health worker (CHW), the participant's primary care physician (PCP), a diabetes nurse educator, and a clinical geriatric pharmacist. In DM I-TEAM, the CHW conducts in-home sessions to: (1) provide diabetes education, (2) facilitate adherence to diabetes self-management behaviors (e.g., medication adherence glucose monitoring, diet, exercise); and (3) build trust between patients and their primary care team. This is accomplished by: (1) using culturally relevant diabetes educational materials; (2) facilitating telehealth visits with the participant's PCP and the diabetes nurse educator via JeffConnect; and (3) having the study pharmacist review participants' medication regimens to identify potentially inappropriate medications, simplify medication regimens if possible, and to reduce medication side effects.

Conditions

Diabetes

Keywords

Diabetes; African American; Emergency Department visits

Outcome Measures

Primary Outcomes (1)

• Number of emergency room visits and hospitalizations over 12 months

  The primary efficacy analysis will consider the number of incident diabetes-related ED visits and/or hospitalizations (i.e., an "event") over 12 months after the index ED visit. Each ED visit or hospitalization is counted as a single event (although an ED visit that leads to a hospitalization is counted once). ED visits and hospitalization will be ascertained through chart reviews and subject self-report.

  12 months

Secondary Outcomes (3)

• hemoglobin A1c

  12 months

• Potentially Inappropriate Medications (PIMS)

  12 months

• Physician Trust

  12 months

Study Arms (2)

DM I-TEAM

EXPERIMENTAL

DM I-TEAM is a home-based behavioral intervention that involve 9 treatment visits with a community health worker (CHW) over 12 months. During the treatment visits, the CHW provides culturally-relevant diabetes education, and facilitates telehealth visits with a diabetes nurse educator and participants' primary care physicians (PCPs). In addition, a clinical pharmacist reviews participants' medication regimens to identify potentially inappropriate medications (PIMS), and to simply regimens when indicated to facilitate medication adherence.

Behavioral: DM I-TEAM

Usual Medical Care

NO INTERVENTION

Usual medical care

Interventions

DM I-TEAM BEHAVIORAL

DM I-TEAM is a home-based behavioral intervention that involve 9 treatment visits with a community health worker (CHW) over 12 months. During the treatment visits, the CHW provides culturally-relevant diabetes education, and facilitates telehealth visits with a diabetes nurse educator and participants' primary care physicians (PCPs). In addition, a clinical pharmacist reviews participants' medication regimens to identify potentially inappropriate medications (PIMS), and to simply regimens when indicated to facilitate medication adherence.

DM I-TEAM

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American race
• Age ≥ 35 years; When first proposed the age criterion was 60 or older; it was later modified to 35 and older
• Type 1 or 2 DM
• A DM-related cause for the ED visit (i.e., hyperglycemia/hypoglycemia, diabetic ketoacidosis, chest pain, skin or soft tissue infection, diabetic neuropathy, retinopathy, urinary tract infection/pyelonephritis/acute renal injury, requesting DM medication refill) OR an hemoglobin A1c of 7.0% or greater within the past 30 days

You may not qualify if:

• Evidence of cognitive and functional decline suggestive of dementia.
• Anti-dementia medication use
• Life expectancy less than one year (in the opinion of the evaluating ED physician)
• DSM-V psychiatric disorders other than anxiety or depression (as per EMR)
• Intoxicated
• Suicidal
• In police custody or currently incarcerated
• Undergoing medical clearance for a detox center or any involuntary court or magistrate order
• Lives in assisted living, currently in a rehabilitation facility (other than Jefferson), lives in a nursing home or skilled nursing facility
• Pregnant

Sponsors & Collaborators

• Thomas Jefferson University: lead
• University of the Sciences in Philadelphia: collaborator

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (6)

• Rovner BW, Casten R, Chang AM, Hollander JE, Leiby BE, Nightingale G, Pizzi L, Herres J, White N, Kelley M, Rising K. Interprofessional Intervention to Reduce Emergency Department Visits in Black Individuals with Diabetes. Popul Health Manag. 2023 Feb;26(1):46-52. doi: 10.1089/pop.2022.0216. Epub 2023 Feb 6.

  PMID: 36745390 DERIVED

• Rovner BW, Casten RJ, Chang AM, Hollander JE, Rising K. Mistrust, Neighborhood Deprivation, and Telehealth Use in African Americans with Diabetes. Popul Health Manag. 2021 Dec;24(6):699-700. doi: 10.1089/pop.2021.0094. Epub 2021 May 17.

  PMID: 34000211 DERIVED

• Rovner BW, Casten RJ. Medication Beliefs and Depression in African Americans With Diabetes. Am J Geriatr Psychiatry. 2021 Dec;29(12):1296-1297. doi: 10.1016/j.jagp.2021.03.011. Epub 2021 Apr 9. No abstract available.

  PMID: 33994087 DERIVED

• Rovner BW, Casten RJ. Emergency department visits in African Americans with mild cognitive impairment and diabetes. J Diabetes Complications. 2021 May;35(5):107905. doi: 10.1016/j.jdiacomp.2021.107905. Epub 2021 Mar 16.

  PMID: 33752964 DERIVED

• Rovner BW, Casten RJ. Discordant health beliefs and telehealth use in African Americans with diabetes. J Am Geriatr Soc. 2021 Jun;69(6):1684-1686. doi: 10.1111/jgs.17081. Epub 2021 Mar 5. No abstract available.

  PMID: 33675034 DERIVED

• Rovner BW, Casten RJ, Chang AM, Hollander JE, Kelley M, Rising KL. Cognitive Deficits in African Americans With Diabetes in an Emergency Department. Am J Geriatr Psychiatry. 2020 Apr;28(4):503-504. doi: 10.1016/j.jagp.2019.07.018. Epub 2019 Aug 6. No abstract available.

  PMID: 31477457 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Barry Rovner, MD

  Thomas Jefferson Uinversity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 31, 2017
• First Posted: January 8, 2018
• Study Start: January 1, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

US (1)