Care Anywhere With Community Paramedics Program to Reduce Hospitalization

NCT ID: NCT05232799

Last Updated: 2023-10-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-21

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Acute Illness

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Care Anywhere with Community Paramedics program

Intervention Type OTHER

Outpatient management with supportive services provided by the community paramedic team.

Standard of Care

Subjects will receive continued usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Care Anywhere with Community Paramedics program

Outpatient management with supportive services provided by the community paramedic team.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Rozalina G. McCoy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rozalina McCoy, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Mayo Clinic Health System

Barron, Wisconsin, United States

Site Status

Countries

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United States

References

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Ridgeway JL, Sundt WJS, Krpata TS, Glasgow A, Smith OA, Lampman MA, Smith-Stellflug JL, Menser TL, Juntunen MB, Liedl CP, Hentz JG, McCoy JJ, McCoy RG. Evaluating adoption and reach in a pragmatic randomized trial of community paramedicine for intermediate acuity patient care. J Clin Transl Sci. 2024 Oct 17;8(1):e199. doi: 10.1017/cts.2024.646. eCollection 2024.

Reference Type DERIVED
PMID: 39655042 (View on PubMed)

Ridgeway JL, Gerdes EOW, Dodge A, Liedl CP, Juntunen MB, Sundt WJS, Glasgow A, Lampman MA, Fink AL, Severson SB, Lin G, Sampson RR, Peterson RP, Murley BM, Klassen AB, Luke A, Friedman PA, Buechler TE, Newman JS, McCoy RG. Community paramedic hospital reduction and mitigation program: study protocol for a randomized pragmatic clinical trial. Trials. 2023 Feb 20;24(1):122. doi: 10.1186/s13063-022-07034-w.

Reference Type DERIVED
PMID: 36805692 (View on PubMed)

Related Links

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Other Identifiers

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21-010816

Identifier Type: -

Identifier Source: org_study_id

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