Care Anywhere With Community Paramedics Program to Reduce Hospitalization

Acute Illness Clinical Trial

Official title:

Community Paramedic Hospitalization Reduction and Mitigation Program: Pragmatic Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05232799
• Other study ID #: 21-010816
• Status: Completed
• Phase: N/A
• Start date: January 21, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Illness

Intervention

Other:
• Care Anywhere with Community Paramedics program
Outpatient management with supportive services provided by the community paramedic team.

Locations

Country	Name	City	State
United States	Mayo Clinic Health System	Barron	Wisconsin
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	CACP Program patient satisfaction	Percentage of patients who are "extremely likely" or "very likely" to recommend the program	30 days
Secondary	Health related quality of life	EQ-5D survey	30 days
Secondary	Treatment burden	Relevant components of the PETS survey	30 days
Secondary	Community Paramedic satisfaction with the CACP program	CP survey	30 days
Secondary	Referring clinician satisfaction with the CACP program	Clinician Survey	30 days

External Links

•   Mayo Clinic Clinical Trials