Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Diabetes Interprofessional Team to Enhance Adherence to Medical Care (DM I-TEAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03393338
Recruitment Status : Active, not recruiting
First Posted : January 8, 2018
Last Update Posted : October 6, 2020
Sponsor:
Collaborator:
University of the Sciences in Philadelphia
Information provided by (Responsible Party):
Barry Rovner, Thomas Jefferson University

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.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: DM I-TEAM Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Diabetes Interprofessional Team to Enhance Adherence to Medical Care
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Arm Intervention/treatment
Experimental: DM I-TEAM
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
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.

No Intervention: Usual Medical Care
Usual medical care



Primary Outcome Measures :
  1. Number of emergency room visits and hospitalizations over 12 months [ Time Frame: 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.


Secondary Outcome Measures :
  1. hemoglobin A1c [ Time Frame: 12 months ]
    Subjects will have their hemoglobin A1c tested using a point of care test.

  2. Potentially Inappropriate Medications (PIMS) [ Time Frame: 12 months ]
    PIMS will be assessed via chart review by a clinical pharmacist.

  3. Physician Trust [ Time Frame: 12 months ]
    Physician trust will be assessed with the Multidimensional Trust in Health Care Systems. This 17-item scale measures trust in physicians (e.g., "I trust my doctor's judgment"); health payers (e.g., "Healthcare payers are good at what they do"); and health care institutions (e.g., "Healthcare institutions provide high quality care").



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. African American race
  2. Age ≥ 60 years
  3. Type 1 or 2 DM
  4. 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393338


Locations
Layout table for location information
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Thomas Jefferson University
University of the Sciences in Philadelphia
Investigators
Layout table for investigator information
Principal Investigator: Barry Rovner, MD Thomas Jefferson Uinversity
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Barry Rovner, Professor, Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT03393338    
Other Study ID Numbers: 4100077081
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barry Rovner, Thomas Jefferson University:
Diabetes
African American
Emergency Department visits
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases