Reducing Emergency Diabetes Care for Older African Americans

NCT03466866 | Completed Phase 3 Results DMC

• 1 other identifier: R01DK114033-01A1
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

This RCT will compare the efficacy of Preventing and Reducing Emergency Visits in Diabetes through Education and Trust (PREVENT) vs. intensive home-based diabetes (DM) education \[i.e., Enhanced Usual Care (EUC)\] to reduce DM-related emergency department (ED) visits and/or hospitalizations over 12 months (primary outcome) in 230 blacks with diabetes, 50 years and older, after an ED visit. A moderation analysis will determine whether participants who reside in low- vs. high-need communities \[defined by Community Need Index scores (i.e., an indicator of the built environment)\] respond differently to treatment. PREVENT is a collaborative intervention of Primary Care Physicians, (PCPs), a DM nurse educator, and Community Health Workers (CHWs) that extends from the ED into the community. The CHWs will: 1) deliver in-home DM education to increase participants' knowledge and skills to manage DM; 2) use DM-specific Behavioral Activation to reinforce DM self-care; and 3) facilitate telehealth visits with PCPs and a DM nurse educator to increase access to care. The control treatment, EUC, is home-based intensive DM education. EUC matches PREVENT in treatment intensity (i.e., number and duration of in-home visits) and delivery of DM self-care education, but does not include PREVENTS's other active elements (i.e., Behavioral Activation and telehealth). The treatment comparison will identify PREVENTS's specific efficacy over and above EUC. We hypothesize that PREVENT will halve the rate of incident DM-related ED visits and/or hospitalizations relative to EUC. The three secondary outcomes are: 1) subjective perceptions of access to care; 2) receipt of DM Quality Metrics (i.e., objective indicators of realized access to care); and 3) DM self-care.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Number of Incident Diabetes-related ED Visits and/or Hospitalizations

  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)

• Perceived Access to Health Care

  12 months

• Actual Access to Care

  12 months

• Change From Baseline to 12 Months on Diabetes Self-Care Inventory Scores

  12 months

Study Arms (2)

PREVENT (Preventing and Reducing Emergency Visits in Diabetes through Education and Telehealth)

EXPERIMENTAL

Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care.

Behavioral: PREVENT

EUC (Enhanced Usual Care)

ACTIVE COMPARATOR

In-home diabetes education with no goal setting or telehealth visits

Behavioral: EUC (Enhanced Usual Care)

Interventions

PREVENT BEHAVIORAL

Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care.

Also known as: COPDE (former name)

PREVENT (Preventing and Reducing Emergency Visits in Diabetes through Education and Telehealth)

EUC (Enhanced Usual Care) BEHAVIORAL

In-home diabetes education with no goal setting or telehealth visits

EUC (Enhanced Usual Care)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• African American race (self-identified)
• Age ≥ 40 years
• Type 1 or 2 DM
• A DM-related cause for the ED visit in the opinion of the ED physician
• Has a Jefferson PCP (participants receiving PREVENT will have a telehealth visit with their Jefferson PCP).

You may not qualify if:

• Medical or psychiatric morbidity (e.g., acute stroke, schizophrenia) that would preclude study participation in the opinion of the ED physician
• Clinically significant cognitive impairment
• Pregnancy

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Barry Rovner,MD
• Organization: Thomas Jefferson University

Barry.Rovner@Jefferson.edu

215-503-1243

Study Officials

• Barry W Rovner

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Model Details: Single blind, randomized controlled trial

Study Record Dates

• First Submitted: March 9, 2018
• First Posted: March 15, 2018
• Study Start: January 10, 2019
• Primary Completion: August 31, 2023
• Study Completion: September 30, 2023
• Last Updated: May 14, 2024
• Results First Posted: May 14, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)