Care Anywhere With Community Paramedics Program to Reduce Hospitalization

Study Overview
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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.

Official Title
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Community Paramedic Hospitalization Reduction and Mitigation Program: Pragmatic Clinical Trial

Conditions
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Acute Illness

Intervention / Treatment
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* Other: Care Anywhere with Community Paramedics program


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Care Anywhere with Community Paramedics program<br>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<br>* Outpatient management with supportive services provided by the community paramedic team.<br>|
| No Intervention: Standard of Care<br>Subjects will receive continued usual care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Community Paramedicine, Acute care, Home care