Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-24 @ 4:31 PM
Study NCT ID:
NCT03466866
Status:
COMPLETED
Last Update Posted:
2024-05-14
First Post:
2018-03-09
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Reducing Emergency Diabetes Care for Older African Americans
Sponsor:
Thomas Jefferson University
Organization:
Study Overview
Official Title:
Randomized Controlled Trial of Preventing and Reducing Emergency Visits in Diabetes Through Education and Telehealth vs. Diabetes Education to Reduce Emergency Visits and Hospitalizations Over 12 Months in African Americans Americans
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREVENT
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: