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Phase 3 N=156 Randomized Double-blind Health Services Research

Reducing Emergency Diabetes Care for Older African Americans

Diabetes Mellitus

Enrolled (actual)
156
Serious AEs
48.1%
Results posted
May 2024
Primary outcome: Primary: Number of Incident Diabetes-related ED Visits and/or Hospitalizations — .88; 1.29 Incidence rate ratio — p=.12

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
PREVENT (Behavioral); EUC (Enhanced Usual Care) (Behavioral)
Age
Adult, Older Adult · 40+ yrs
Sex
All
Sponsor
Thomas Jefferson University
Primary completion
Aug 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Incident Diabetes-related ED Visits and/or Hospitalizations
.88; 1.29 .12
SECONDARY
Perceived Access to Health Care
.22; .11; .13; .29; .2; .17 .502
SECONDARY
Actual Access to Care
3.69; 3.42 .23
SECONDARY
Change From Baseline to 12 Months on Diabetes Self-Care Inventory Scores
8.02; 3.57 .094

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.

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03466866). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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