Discussion
prediabetes, diabetes
RECRUITMENT, PREDIABETES, DIABETES
In the CHORD study, we hypothesized that trained CHWs, through individualized goal setting, educational coaching, and facilitated referrals, would support positive lifestyle changes and prevent the onset of diabetes among patients with prediabetes. However, an intervention may not affect lifestyle change if it deviates from its protocol during implementation. In this concurrent process evaluation of the CHORD intervention, we examined implementation fidelity and fidelity moderators. Our analysis demonstrated moderate to high (depending on intervention component) rates of implementation fidelity of CHORD, and moderation by implementation site. The level of implementation fidelity achieved in this intervention is likely to be sufficient to justify inferences drawn about the impact of the intervention on the outcomes. However, with less than 100% adherence and the variability observed in these components, as is likely common in complex behavioral interventions, the analysis of CHORD outcomes will provide an opportunity to explore the relative importance and impact of each of these components, accounting for their degree of implementation fidelity. Our use of quantitative methods for fidelity assessment will allow us to use these measures in outcome data analyses to determine the role of fidelity in observed outcomes [We found that CHWs completed an intake with nearly 80% of the patients enrolled in the intervention arm, and three of the four core components (goal setting, education and PC visits) were delivered to nearly 80% of the patients. Even though coverage and content adherence were moderate to high, there was high variability in the dosage. While the fourth core component in our intervention, referrals for social determinants of health and promoting access to healthy lifestyle choices, was delivered to only 45% of the patients, a quarter received 3 or more referrals. As referrals were designed to be tailored to each patient’s circumstance, the dosage of referrals cannot be directly associated with outcomes as more referrals are not necessarily better. Further, we do not know if the remaining 55% patients who did not receive a referral needed one.. We strived to deliver all core components for each patient, but we had not established, a priori, thresholds for adherence for core components among study participants. Our analysis explores the extent to which we attained implementation success as measured by percent of patients for which the core components were delivered. An implementation fidelity analyses of a randomized trial delivering a complex care continuum intervention for frail elderly people in Sweden also reported high variability in the adherence to intervention components. On a 4-point scale (never, seldom, sometimes, often, always), while most components were reported to be ‘always’ delivered, several were only ‘seldom’ delivered [We assessed the role of patient motivation in our study by examining moderation of fidelity measures by PAM score. Null findings on moderation by PAM score was unexpected because patient activation measured by PAM scores has been found to be positively associated with engaging in healthy lifestyle behaviors and exhibiting readiness to change [The pragmatic nature of the CHORD trial permitted and promoted continuous adaptations. While this improved the meaningfulness of our intervention, it resulted in deviations from the original intervention protocol, decreasing fidelity. We adapted implementation in response to ongoing developments and situations. For example, the recruitment and follow-up process changed significantly after BH adopted a new EHR system in the second year of the CHORD trial. Provider communication and follow-up was adapted to align with their work schedule. In five cases, CHWs delivered education sessions before establishing goals as an engagement strategy to demonstrate how the intervention could be useful and encourage patients to set goals. In addition, the number of patients with a successful encounter was less than the number of patients who completed at least one goal or the number of patients who received coaching on at least one education topic. This occurred because for some patients, CHWs completed intake, established goals and provided some education in the same intake visit, but were unable to follow-up with the patient after repeated attempts, resulting in patients with goals and education but few successful encounters. The median number of successful encounters was 5 and about 10% patients had 12 or more successful encounters. As the CHORD protocol planned at least monthly contacts between a CHW and patient, these findings suggest that CHWs divided their time between meeting motivated patients less frequently and checking-in more frequently with patients who perhaps had more complex social needs. All these adaptations could have impacted our fidelity. Future analysis will focus on sharing these adaptations or natural deviations in implementation of a pragmatic trial.Our finding of moderation by the implementation site underscores the need to account for site-based differences in patient characteristics such as their social risk profiles, when implementing evidence-based interventions. Although BH and VA are both safety-net settings, they differ in terms of their patient populations.BH is the flagship of New York City’s large, municipal hospital system, and serves a diverse, multicultural and multilingual population with high numbers of poor and racial/ethnic minorities, many of whom are uninsured or on Medicaid. VA NY Harbor is smaller, and provides care to veterans (mostly older, White, male, and English speakers) and is funded federally. Variation in the complexity of patient populations have historically necessitated innovation, and the differences in fidelity at the two sites could be reflecting such adaptations by CHWs to meet the needs of their patient populations. Earlier studies have found different implementation fidelity across different organizations [These differences in patient populations at the two sites could also explain the different participation rates at the two sites. Utilizing CHWs as a healthcare workforce is an equity-oriented approach to improving healthcare access and health outcomes among underserved populations [