Care Anywhere With Community Paramedics Program to Reduce Hospitalization

Community Paramedic Hospitalization Reduction and Mitigation Program: Pragmatic Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Acute Illness
• Intervention / Treatment: Other: Care Anywhere with Community Paramedics program

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 Type: Interventional
• Enrollment (Actual): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wendy Sundt, BS; Phone Number: 507-293-4234; Email: Sundt.Wendy@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester
  • Wisconsin
    • Barron, Wisconsin, United States, 54812
      • Mayo Clinic Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Care Anywhere with Community Paramedics program; Outpatient management with supportive services provided by the community paramedic team.
No Intervention: Standard of Care; Subjects will receive continued usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of days spent outside the hospital and ED	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)	30 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Rozalina McCoy, MD, MS, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2022
• Primary Completion (Actual): March 31, 2023
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Home care; Acute care; Community Paramedicine
• Other Study ID Numbers: 21-010816

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No