Rapid Qualitative Methods to Inform Implementation of a Community Paramedicine Multi-site Pragmatic Randomized Clinical Trial

JENNIFER RIDGEWAY, PhD, MPP
Mayo Clinic

Practice-embedded pragmatic trials aim to generate timely evidence for translation. While balancing rigor and speed, researchers must also ensure that interventions and trial procedures are feasible, minimize practice burden, and maintain real-world conditions as much as possible. The reported qualitative research was conducted in the pre-implementation period of a trial assessing effectiveness and implementation of a community paramedic (CP) program to shorten and prevent hospitalization in adults being treated in, or referred to, the hospital or emergency department. The aim was to identify facilitators and barriers to implementation and to refine workflows, ensuring feasible program and study conduct.

Care team members and administrative and clinical stakeholders affiliated with an academic medical center in a small metropolitan area and a rural community in the Midwest U.S.

The study team identified individuals in roles likely to be involved in or impacted by the trial and invited them to complete an interview. A snowball sampling approach was used to gather additional contacts. Interviews were audio recorded and reviewed by two team members. Notes were summarized in Rapid Assessment Procedure sheets organized by constructs related to implementation determinants. The study team also presented trial information to key stakeholder groups to increase awareness and solicit questions and concerns, which were summarized in field notes. The study team met biweekly to debrief key findings and identify necessary actions, including trial adaptations to increase feasibility, acceptability, and adoption.

Interviews were conducted with 26 participants between December 2021 and March 2022. The mean duration was 30 minutes (range 19, 59). The study team also presented the study to 17 institutional committees and clinical departments. Barriers to implementation included low awareness of the program and CP scope of practice, ambiguous program boundaries, and logistics around program referral and use. Major concerns included CP shortages and lack of clear financial reimbursement models, need for bi-directional communication, potential for program misuse, general safety concerns with in-home care, and trial randomization procedures. Recommended changes to workflow were primarily related to trial enrollment and referral, resource management, and electronic health record utilization. Participant questions informed further study outreach, including education related to key determinants like attitudes toward CP scope of practice and perceived clinical setting constraints.

In the three months before trial deployment, the team was able to identify and resolve several areas of concern. While resource intensive, rapid methods of engagement, data collection, and analysis provide timely feedback and allow for real-time changes to be made to bolster feasibility and build relationships.