Care Anywhere With Community Paramedics Program to Reduce Hospitalization

Not Applicable

Completed

• Conditions: Acute Illness
• Interventions: Other: Care Anywhere with Community Paramedics program

• Registration Number: NCT05232799
• Lead Sponsor: Mayo Clinic

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 Timeline

• Study Start: 2022-01-21
• Study First Submitted: 2022-01-27
• Study First Submitted QC: 2022-02-08
• Study First Posted: 2022-02-10
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 250

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Care Anywhere with Community Paramedics program	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.

Primary Outcome Measures

Name	Time	Method
Number of days spent outside the hospital and ED	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 Outcome Measures

Name	Time	Method
CACP Program patient satisfaction	30 days	Percentage of patients who are "extremely likely" or "very likely" to recommend the program
Community Paramedic satisfaction with the CACP program	30 days	CP survey
Health related quality of life	30 days	EQ-5D survey
Referring clinician satisfaction with the CACP program	30 days	Clinician Survey
Treatment burden	30 days	Relevant components of the PETS survey
Patients with an ED visit hospitalization or death	30 days	Proportion of patients with an ED visit, hospitalization, or death within 30-days of the day following randomization

Trial Locations

Locations (2)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic Health System; 🇺🇸 Barron, Wisconsin, United States