Community Paramedic Hospitalization Reduction and Mitigation Program: Pragmatic Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Mayo Clinic
- Enrollment
- 250
- Locations
- 2
- Primary Endpoint
- Number of days spent outside the hospital and ED
Study Overview
Brief Summary
The purpose of this research is to compare the effectiveness of the Care Anywhere with Community Paramedics program with usual care in a pragmatic randomized controlled trial. The goal of the Care Anywhere with Community Paramedics program is to prevent or shorten hospitalizations among patients who are being treated in the clinic/ambulatory setting ("prehospital setting"), emergency department, or hospital and are clinically appropriate to be cared for at home with community paramedic services.
Detailed Description
This pragmatic randomized controlled trial will randomize, with 1:1 allocation, 240 adults being treated in the pre-hospital setting, emergency department or hospital to either availability of the Care Anywhere with Community Paramedics (CACP) program or to no availability of the CACP program (i.e. usual care). Patients randomized to the CACP program will be able to receive in-home medical care - as ordered by their treating clinicians - from the Mayo Clinic Ambulance Community Paramedic Service. Primary outcome is going to be days alive spent at home without hospitalization (excluding planned admissions), emergency department visits, or skilled nursing facility care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult (age ≥ 18 years) patients currently admitted to the ED, hospital or are in a pre-hospital setting but being considered for referral to the ED or hospital in Mayo Clinic Rochester, MN and Barron, WI but do not require hospital-level monitoring or care other than services that could be delivered by CPs in the ambulatory setting.
- •Must reside within approximately a 40-mile radius of Rochester, MN or within the service radius of Barron, WI.
- •Participants who require assistance with activities of daily living, or who are at increased risk for falls, need to have a caregiver available at home
Exclusion Criteria
- •Referring clinician and the community paramedic service do not believe the patient to be clinically appropriate for outpatient care with the CACP program.
- •Inability or unwillingness of individual or legal guardian/representative to give written informed consent.
- •Clinical, behavioral, or cognitive instability, determined by the referring clinician or the CACP service.
- •Living conditions unsafe for CPs to enter (patient refuses to secure weapons or animals prior to CP's arrival).
- •Enrolled in the trial during an earlier hospitalization or ED visit.
Arms & Interventions
Care Anywhere with Community Paramedics program
Subjects will be discharged from a pre-hospital setting, Emergency Department or the hospital with community paramedic services ordered and overseen by the treating clinical team per current standard of care.
Intervention: Care Anywhere with Community Paramedics program (Other)
Standard of Care
Subjects will receive continued usual care
Outcomes
Primary Outcomes
Number of days spent outside the hospital and ED
Time Frame: 30 days
The number of days spent outside the hospital and ED during the 30 days following enrollment to the trial. (not in the hospital, ED, or nursing home; not counting planned admissions)
Secondary Outcomes
- CACP Program patient satisfaction(30 days)
- Community Paramedic satisfaction with the CACP program(30 days)
- Health related quality of life(30 days)
- Referring clinician satisfaction with the CACP program(30 days)
- Treatment burden(30 days)
- Patients with an ED visit hospitalization or death(30 days)
Investigators
Rozalina G. McCoy
Principal Investigator
Mayo Clinic