NCT05232799

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 21, 2022

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

October 5, 2023

Status Verified

October 1, 2023

Enrollment Period

1.2 years

First QC Date

January 27, 2022

Last Update Submit

October 4, 2023

Conditions

Keywords

Community ParamedicineAcute careHome care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Patients with an ED visit hospitalization or death

    30 days

  • CACP Program patient satisfaction

    30 days

  • Health related quality of life

    30 days

  • Treatment burden

    30 days

  • Community Paramedic satisfaction with the CACP program

    30 days

  • +1 more secondary outcomes

Study Arms (2)

Care Anywhere with Community Paramedics program

EXPERIMENTAL

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

Standard of Care

NO INTERVENTION

Subjects will receive continued usual care

Interventions

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

Care Anywhere with Community Paramedics program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Mayo Clinic Health System

Barron, Wisconsin, 54812, United States

Location

Related Publications (2)

  • 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.

  • 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.

Related Links

Study Officials

  • Rozalina McCoy, MD, MS

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 10, 2022

Study Start

January 21, 2022

Primary Completion

March 31, 2023

Study Completion

March 31, 2023

Last Updated

October 5, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations