Reducing Emergency Diabetes Care for Older African Americans

This Phase-III RCT will compare the efficacy of Preventing and Reducing Emergency Visits in
Diabetes through Education and Trust (PREVENT) vs. intensive home-based DM education to
reduce the number of DM-related ED visits and/or hospitalizations over 12 months (primary
outcome), in 230 AAs with DM, 40 years and older, who are recruited from the ED after an ED
visit. PREVENT is a culturally relevant intervention that extends from the ED to the
community, and aims to improve access to care and DM self-care (secondary outcomes). A
mediation analysis will determine whether changes in access to care and/or DM self-care
explain PREVENT's efficacy. 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 will begin soon after the participant's index ED visit, when many patients remain
uncertain how to manage DM or how to access follow-up care. 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. The control treatment, EUC, is
intensive home-based DM education. EUC matches PREVENT in treatment intensity (i.e., 6
in-home sessions over 4 months, and 3 booster sessions over the next 8 months) and delivery
of culturally relevant DM education, but does not include DM-specific Behavioral Activation
or telehealth visits. The treatment comparison will identify PREVENT's specific efficacy over
and above EUC.

This RCT is significant as the population ages and becomes more racially diverse, and as ED
use and costs increase. This RCT is innovative because it: 1) tests the first ED-to-community
intervention designed to reduce the need for ED care in AAs with DM; 2) assesses both
subjective and objective indicators of access to care; and 3) defines the specific
characteristics of COPDE that confer its cultural relevance. If successful, PREVENT will meet
Healthy People 2020's twin goals of reducing the personal and societal costs of DM and
achieving health equity for all Americans. The Specific Aims of this RCT are:

Primary Specific Aim: Test the efficacy of PREVENT to reduce the number of incident
DM-related ED visits and/or hospitalizations over 12 months (primary outcome) in AAs with DM.
Hypothesis: PREVENT will halve the number of incident DM-related ED visits and/or
hospitalizations relative to EUC over 12 months.

The Secondary Aims are to:

1. Test the efficacy of PREVENT to increase perceived access to care over 12 months
(secondary outcome). Hypothesis: PREVENT will increase Patient Satisfaction
Questionnaire-18 scores to a greater extent than EUC over 12 months.

2. Test the efficacy of PREVENT to increase realized access to care over 12 months
(secondary outcome). Hypothesis: PREVENT will increase the number of received Diabetes
Quality Metrics (e.g., hemoglobin A1c testing, urine screening) to a greater extent than
EUC over 12 months.

3. Test the efficacy of PREVENT to improve DM self-care over 12 months (secondary outcome).
Hypothesis: PREVENT will increase Diabetes Self-Care Inventory scores to a greater
extent than EUC over 12 months.

4. Determine if increasing subjective and/or objective indicators of access to care and/or
DM self-care mediates PREVENT's reduction of DM-related ED visits and/or
hospitalizations. Hypothesis: PREVENT will reduce DM-related ED visits and/or
hospitalizations to the extent that it increases subjective and/or objective indicators
of access to care and/or improves DM self-care.

The Exploratory Aims are to: 1) determine whether PREVENT reduces "all cause" ED
visits/hospitalizations relative to EUC.; 2) determine whether Community Need Index scores,
literacy, age, and/or sex moderate treatment effects; 3) determine if PREVENT improves
glycemic control (i.e., lowers hemoglobin A1c levels), impacts DM-related health beliefs,
reduces depression, and/or improves quality-of-life; 4) identify PREVENT's treatment features
that confer its cultural relevance; and 5) estimate PREVENT's costs and net financial benefit
to the healthcare system.

Inclusion Criteria:

1. African American race (self-identified)

2. Age ≥ 50 years

3. Type 1 or 2 DM

4. A DM-related cause for the ED visit in the opinion of the ED physician

5. Has a Jefferson PCP (participants receiving COPDE will have a telehealth visit with
their Jefferson PCP).

Exclusion Criteria:

1. Medical or psychiatric morbidity (e.g., acute stroke, schizophrenia) that would
preclude study participation in the opinion of the ED physician

2. Clinically significant cognitive impairment

3. Pregnancy