Clinical trial NCT05232799: Care Anywhere With Community Paramedics Program to Reduce Hospitalization
Official title: Community Paramedic Hospitalization Reduction and Mitigation Program: Pragmatic Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Illness
Keywords: Community Paramedicine
Acute care
Home care
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of days spent outside the hospital and ED
timeFrame: 30 days
Secondary outcomes:
measure: Patients with an ED visit hospitalization or death
timeFrame: 30 days
measure: CACP Program patient satisfaction
timeFrame: 30 days
measure: Health related quality of life
timeFrame: 30 days
measure: Treatment burden
timeFrame: 30 days
measure: Community Paramedic satisfaction with the CACP program
timeFrame: 30 days
measure: Referring clinician satisfaction with the CACP program
timeFrame: 30 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Barron
country: United States
facility: Mayo Clinic Health System
state: Wisconsin
Study officials:
affiliation: Mayo Clinic
name: Rozalina McCoy, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: