Community paramedic hospital reduction and mitigation program: study protocol for a randomized pragmatic clinical trial

Background: New patient-centered models of care are needed to individualize care and reduce high-cost care, including emergency department (ED) visits and hospitalizations for low- and intermediate-acuity conditions that could be managed outside the hospital setting. Community paramedics (CPs) have advanced training in low- and high-acuity care and are equipped to manage a wide range of health conditions, deliver patient education, and address social determinants of health in the home setting. The objective of this trial is to evaluate the effectiveness and implementation of the Care Anywhere with Community Paramedics (CACP) program with respect to shortening and preventing acute care utilization. Methods: This is a pragmatic, hybrid type 1, two-group, parallel-arm, 1:1 randomized clinical trial of CACP versus usual care that includes formative evaluation methods and assessment of implementation outcomes. It is being conducted in two sites in the US Midwest, which include small metropolitan areas and rural areas. Eligible patients are ≥ 18 years old; referred from an outpatient, ED, or hospital setting; clinically appropriate for ambulatory care with CP support; and residing within CP service areas of the referral sites. Aim 1 uses formative data collection with key clinical stakeholders and rapid qualitative analysis to identify potential facilitators/barriers to implementation and refine workflows in the 3-month period before trial enrollment commences (i.e., pre-implementation). Aim 2 uses mixed methods to evaluate CACP effectiveness, compared to usual care, by the number of days spent alive outside of the ED or hospital during the first 30 days following randomization (primary outcome), as well as self-reported quality of life and treatment burden, emergency medical services use, ED visits, hospitalizations, skilled nursing facility utilization, and adverse events (secondary outcomes). Implementation outcomes will be measured using the RE-AIM framework and include an assessment of perceived sustainability and metrics on equity in implementation. Aim 3 uses qualitative methods to understand patient, CP, and health care team perceptions of the intervention and recommendations for further refinement. In an effort to conduct a rigorous evaluation but also speed translation to practice, the planned duration of the trial is 15 months from the study launch to the end of enrollment. Discussion: This study will provide robust and timely evidence for the effectiveness of the CACP program, which may pave the way for large-scale implementation. Implementation outcomes will inform any needed refinements and best practices for scale-up and sustainability. Trial registration: ClinicalTrials.gov NCT05232799. Registered on 10 February 2022.