Abstract
BackgroundType 2 diabetes mellitus (DM) affects 9.4% of US adults and children, while another 33.9% of Americans are at risk of DM. Health care institutions face many barriers to systematically delivering the preventive care needed to decrease DM incidence. Community health workers (CHWs) may, as frontline public health workers bridging clinic and community, help overcome these challenges. This paper presents the protocol for a pragmatic, cluster-randomized trial integrating CHWs into two primary care clinics to support DM prevention for at-risk patients.MethodsThe trial will randomize 15 care teams, stratified by practice site (Bellevue Hospital and Manhattan VA), totaling 56 primary care physicians. The study cohort will consist of ~ 2000 patients who are 18–75 years of age, actively enrolled in a primary care team, able to speak English or Spanish, and have at least one glycosylated hemoglobin (HbA1c) result in the prediabetic range (5.7–6.4%) since 2012. Those with a current DM diagnosis or DM medication prescription (other than metformin) are ineligible. The intervention consists of four core activities – setting health goals, health education, activation for doctor’s appointments, and referrals to DM prevention programs – adjustable according to the patient’s needs and readiness. The primary outcome is DM incidence. Secondary outcomes include weight loss, HbA1C, and self-reported health behaviors. Clinical variables and health behaviors will be obtained through electronic medical records and surveys, respectively. Implementation outcomes, namely implementation fidelity and physicians’ perspectives about CHW integration into the clinic, will be assessed using interviews and CHW activity logs and analyzed for the influence of moderating organizational factors.DiscussionThis is the first rigorous, pragmatic trial to test the effectiveness of integrating CHWs into primary care for DM prevention reaching a population-based sample. Our study’s limitations include language-based eligibility and the use of HbA1c as a measure of DM risk. It will measure both clinical and implementation outcomes and potentially broaden the evidence base for CHWs and patient-centered medical home implementation. Further, the intervention’s unique features, notably patient-level personalization and referral to existing programs, may offer a scalable model to benefit patients at-risk of DM.Trial Registration.Clinicaltrials.gov NCT03006666 (Received 12/27/2016).
Highlights
diabetes mellitus (DM) incidence can be reduced [2,3,4,5,6,7,8], even in the long term [9, 10], by identifying patients with prediabetes, half of whom may develop DM over the decade [9], and by offering them proven behavior change interventions focusing on weight loss and physical activity
Several studies have discussed the limitations of using HbA1c as a measure of diabetes risk, noting the measure likely under-estimates risk for diabetes [40,41,42,43,44,45]
Our trial is the first to use a rigorous, pragmatic trial design to test the effectiveness of integrating Community Health Workers (CHW) into primary care teams for DM prevention
Summary
Type 2 diabetes mellitus (DM) affects 9.4% of US adults and children, while another 33.9% of Americans are at risk of DM. Health care institutions face many barriers to systematically delivering the preventive care needed to decrease DM incidence. Type 2 diabetes mellitus (DM) is a preventable chronic disease that affects 9.4% of US adults and children. Despite the potential for reduced morbidity and cost savings, primary care systems face several barriers to systematically deliver proven, preventive strategies to patients at highest risk of DM, as existing evidence has demonstrated that primary care teams have low levels of awareness and referral to evidence-based prevention programs [11]. In the traditional structure of visit-based encounters, barriers include a lack of time for clinical staff to conduct and maintain behavior change counseling, unclear delegation of non-visit based outreach tasks, and insufficient skills and tools for performing motivational and behavioral counseling interventions with populations of patients to optimize prevention of DM [12]
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