ABSTRACT
Background: A major part of the HEALing Communities Study (HCS), launched in 2019 to address the growing opioid epidemic, is evaluating the study's intervention implementation process through an implementation science (IS) approach. One component of the IS approach involves teams with more than 20 researchers collaborating across four research sites to conduct in-depth qualitative interviews with over 300 participants at four time points. After completion of the first two rounds of data collection, we reflect upon our qualitative data collection and analysis approach. We aim to share our lessons learned about designing and applying qualitative methods within an implementation science framework. Methods: The HCS evaluation is based on the RE-AIM/PRISM framework and incorporates interviews at four timepoints. At each timepoint, the core qualitative team of the Intervention Work Group drafts an interview guide based on the framework and insights from previous round(s) of data collection. Researchers then conduct interviews with key informants and coalition members within their respective states. Data analysis involves drafting, iteratively refining, and finalizing a codebook in a cross-site and within-site consensus processes. Interview transcripts are then individually coded by researchers within their respective states. Results: Successes in the evaluation process includes having structured procedures for communication, data collection, and analysis, all of which are critical for ensuring consistent data collection and for achieving consensus during data analysis. Challenges include recognizing and accommodating the diversity of training and knowledge between researchers, and establishing reliable ways to securely store, manage, and share the large volumes of data. Conclusion: Qualitative methods using a team science approach have been limited in their application in large, multi-site randomized controlled trials of health interventions. Our experience provides practical guidance for future studies with large, experientially and disciplinarily diverse teams, and teams seeking to incorporate qualitative or mixed-methods components for their evaluations.
ABSTRACT
INTRODUCTION: Opioid overdoses are a major public health emergency in the United States. Despite effective treatments that can save lives, access to and utilization of such treatments are limited. Community context plays an important role in addressing treatment barriers and increasing access. The HEALing Communities Study (HCS) is a multisite community-level cluster-randomized trial that will study implementation and outcomes of a community coalition-based intervention (Communities that HEAL [CTH]) that implements evidence-based practices (EBPs) to reduce opioid overdose deaths in four states. To examine contextual factors critical to understanding implementation, we assessed the perspectives of community members about their communities, current substance use-related services, and other important issues that could impact intervention implementation. METHODS: Researchers conducted 382 semi-structured qualitative interviews in the HCS communities. Interviews were audio-recorded and transcribed; researchers subsequently analyzed data using directed content analysis based on the constructs of the RE-AIM/PRISM implementation science framework to identify key themes within the external community context. RESULTS: Despite the diversity in states and communities, four similar themes related to the external community context emerged across communities: These themes included the importance of understanding: 1) community risk perceptions, 2) levels of stigma, 3) the health services environment and the availability of substance use services, and 4) funding for substance use services. CONCLUSION: Understanding and addressing the external community context in which the CTH intervention and EBPs are implemented are crucial for successful health services-related and community engaged interventions. While implementing EBPs is a challenging undertaking, doing so will help us to understand if and how a community-based intervention can successfully reduce opioid overdose deaths and influence both community beliefs and the community treatment landscape.
