Protocol for the CHORD project (community health outreach to reduce diabetes): a cluster-randomized community health worker trial to prevent diabetes.

BACKGROUND: 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. 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. METHODS: The 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. DISCUSSION: This 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).

Accounting for Blood Pressure Seasonality Alters Evaluation of Practice-Level Blood Pressure Control Intervention.

BACKGROUND: Despite the large body of literature evaluating interventions to improve hypertension management, few studies have addressed seasonal variation in blood pressure (BP) control. This underreported phenomenon has implications for interpreting study findings and informing clinical care. We share a methodology that accounts for BP seasonality, presented through a case study-HealthyHearts NYC, an intervention aimed at increasing adherence to the Million Hearts BP control evidence-based guidelines in primary care practices. METHODS: We used a randomized stepped-wedge design (n = 257 practices). Each intervention included 13 visits from practice facilitators trained in improving practice-level BP control over 12 months. Two models were used to assess the intervention effect-one that did not account for seasonality (model 1) and one that did (model 2). Model 2 was a re-specification of model 1 to include our proposed two fixed-effects terms to address BP seasonality. RESULTS: Model 1 showed a significant negative association between the intervention and BP control (IRR = 0.98, 95% CI = 0.96-0.99, P ≤ 0.05). In contrast, Model 2, which did address seasonality, showed no intervention effect on BP control (IRR = 0.99, 95% CI = 0.97-1.01, P = 0.19). CONCLUSIONS: These findings reveal that analyses that do not account for BP seasonality may not present an accurate picture of intervention effects. In our case study, accounting for BP seasonality turned a negative association into a null association. We recommend that when evaluating BP control, studies compare outcome measures across similar seasons and that the measurement period last long enough to account for seasonal effects. CLINICAL TRIALS REGISTRATION: Trial registration number: NCT02646488.

Cardiovascular Disease Guideline Adherence: An RCT Using Practice Facilitation.

INTRODUCTION: Practice facilitation is a promising practice transformation strategy, but further examination of its effectiveness in improving adoption of guidelines for multiple cardiovascular disease risk factors is needed. The objective of the study is to determine whether practice facilitation is effective in increasing the proportion of patients meeting the Million Hearts ABCS outcomes: (A) aspirin when indicated, (B) blood pressure control, (C) cholesterol management, and (S) smoking screening and cessation intervention. STUDY DESIGN: The study used a stepped-wedge cluster RCT design with 4 intervention waves. Data were extracted for 13 quarters between January 1, 2015 and March 31, 2018, which encompassed the control, intervention, and follow-up periods for all waves, and analyzed in 2019. SETTING/PARTICIPANTS: A total of 257 small independent primary care practices in New York City were randomized into 1 of 4 waves. INTERVENTION: The intervention consisted of practice facilitators conducting at least 13 practice visits over 1 year, focused on capacity building and implementing system and workflow changes to meet cardiovascular disease care guidelines. MAIN OUTCOME MEASURES: The main outcomes were the Million Hearts' ABCS measures. Two additional measures were created: (1) proportion of tobacco users who received a cessation intervention (smokers counseled) and (2) a composite measure that assessed the proportion of patients meeting treatment targets for A, B, and C (ABC composite). RESULTS: The S measure improved when comparing follow-up with the control period (incidence rate ratio=1.152, 95% CI=1.072, 1.238, p<0.001) and when comparing follow-up with intervention (incidence rate ratio=1.060, 95% CI=1.013, 1.109, p=0.007). Smokers counseled improved when comparing the intervention period with control (incidence rate ratio=1.121, 95% CI=1.037, 1.211, p=0.002). CONCLUSIONS: Increasing the impact of practice facilitation programs that target multiple risk factors may require a longer, more intense intervention and greater attention to external policy and practice context. TRIAL REGISTRATION: This study is registered at www.clinicaltrials.gov NCT02646488.