Background

Adherence to intervention training implementation strategies is at the foundation of fidelity; however, few studies have linked training adherence to trainee attitudes and leadership behaviors to identify what practically matters for the adoption and dissemination of evidence-based practices. Through the conduct of this hybrid type 3 effectiveness-implementation cluster randomized controlled trial, we collected Exploration, Preparation, Implementation, and Sustainment (EPIS) data and merged it with tailored motivational interviewing training adherence data, to elucidate the relationship between provider attitudes toward evidence-based practices, leadership behaviors, and training implementation strategy (e.g., workshop attendance and participation in one-on-one coaching) adherence.

Method

Our sample included data from providers who completed baseline (pre-intervention) surveys that captured inner and outer contexts affecting implementation and participated in tailored motivational interviewing training, producing a dataset that included training implementation strategies adherence and barriers and facilitators to implementation (N = 77). Leadership was assessed by two scales: the director leadership scale and implementation leadership scale. Attitudes were measured with the evidence-based practice attitude scale (EBPAS-50). Adherence to training implementation strategies was modeled as a continuous outcome with a Gaussian distribution. Analyses were conducted in SPSS.

Results

Of the nine general attitudes toward evidence-based practice, openness was associated with training adherence (estimate [EST] = 0.096, p < .001; 95% CI = [0.040, 0.151]). Provider general (EST = 0.054, 95% CI = [0.007, 0.102]) and motivational interviewing-specific (EST = 0.044, 95% CI = [0.002, 0.086]) leadership behaviors were positively associated with training adherence (p < .05). Of the four motivational interviewing-specific leadership domains, knowledge and perseverant were associated with training adherence (p < .05). As these leadership behaviors increased, knowledge (EST = 0.042, 95% CI = [0.001, 0.083]) and perseverant (EST = 0.039, 95% CI = [0.004, 0.075]), so did provider adherence to training implementation strategies.

Conclusions

As implementation science places more emphasis on assessing readiness prior to delivering evidence-based practices by evaluating organizational climate, funding streams, and change culture, consideration should also be given to metrics of leadership. A potential mechanism to overcome resistance is via the implementation of training strategies focused on addressing leadership prior to conducting training for the evidence-based practice of interest.

Background

Electronic health records (EHRs) are a cost-effective approach to provide the necessary foundations for clinical trial research. The ability to use EHRs in real-world clinical settings allows for pragmatic approaches to intervention studies with the emerging adult HIV population within these settings; however, the regulatory components related to the use of EHR data in multisite clinical trials poses unique challenges that researchers may find themselves unprepared to address, which may result in delays in study implementation and adversely impact study timelines, and risk noncompliance with established guidance.

Objective

As part of the larger Adolescent Trials Network (ATN) for HIV/AIDS Interventions Protocol 162b (ATN 162b) study that evaluated clinical-level outcomes of an intervention including HIV treatment and pre-exposure prophylaxis services to improve retention within the emerging adult HIV population, the objective of this study is to highlight the regulatory process and challenges in the implementation of a multisite pragmatic trial using EHRs to assist future researchers conducting similar studies in navigating the often time-consuming regulatory process and ensure compliance with adherence to study timelines and compliance with institutional and sponsor guidelines.

Methods

Eight sites were engaged in research activities, with 4 sites selected from participant recruitment venues as part of the ATN, who participated in the intervention and data extraction activities, and an additional 4 sites were engaged in data management and analysis. The ATN 162b protocol team worked with site personnel to establish the necessary regulatory infrastructure to collect EHR data to evaluate retention in care and viral suppression, as well as para-data on the intervention component to assess the feasibility and acceptability of the mobile health intervention. Methods to develop this infrastructure included site-specific training activities and the development of both institutional reliance and data use agreements.

Results

Due to variations in site-specific activities, and the associated regulatory implications, the study team used a phased approach with the data extraction sites as phase 1 and intervention sites as phase 2. This phased approach was intended to address the unique regulatory needs of all participating sites to ensure that all sites were properly onboarded and all regulatory components were in place. Across all sites, the regulatory process spanned 6 months for the 4 data extraction and intervention sites, and up to 10 months for the data management and analysis sites.

Conclusions

The process for engaging in multisite clinical trial studies using EHR data is a multistep, collaborative effort that requires proper advanced planning from the proposal stage to adequately implement the necessary training and infrastructure. Planning, training, and understanding the various regulatory aspects, including the necessity of data use agreements, reliance agreements, external institutional review board review, and engagement with clinical sites, are foremost considerations to ensure successful implementation and adherence to pragmatic trial timelines and outcomes.