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Completed

NCT Number: NCT05232799

Care Anywhere With Community Paramedics Program to Reduce Hospitalization

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester, Rochester, Minnesota, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Care Anywhere with Community Paramedics program

Other

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

Primary outcomes

  1. Number of days spent outside the hospital and ED

    Time frame: 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 outcomes

  1. Patients with an ED visit hospitalization or death

    Time frame: 30 days

    Proportion of patients with an ED visit, hospitalization, or death within 30-days of the day following randomization

  2. CACP Program patient satisfaction

    Time frame: 30 days

    Percentage of patients who are "extremely likely" or "very likely" to recommend the program

  3. Health related quality of life

    Time frame: 30 days

    EQ-5D survey

  4. Treatment burden

    Time frame: 30 days

    Relevant components of the PETS survey

  5. Community Paramedic satisfaction with the CACP program

    Time frame: 30 days

    CP survey

  6. Referring clinician satisfaction with the CACP program

    Time frame: 30 days

    Clinician Survey

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Community Paramedic Hospitalization Reduction and Mitigation Program: Pragmatic Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 10, 2022
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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