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
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Number of Incident Diabetes-related ED Visits and/or Hospitalizations
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Number of Incident Diabetes-related ED Visits and/or Hospitalizations
时间窗: 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.
次要结局
- 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)
研究者
Barry Rovner
PI
Thomas Jefferson University