A Study of Paramedic HF Management

NCT06874556 | Recruiting

• 1 other identifier: 24-009568
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to see if having community paramedic (CP) visit patients at home to manage their heart failure help them stay out of the hospital and improve their overall health compared to standard care. The investigators want to find out if their approach is better for patients in terms of their quality of life, hospital stays, emergency visits, and cost. The investigators are also looking to see how happy patients and doctors are with this method and if it's a practical and sustainable option for the future.

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (6)

• Number of Days without Hospitalization

  Number of Days without Hospitalization will be measured by the number of days a patient is not admitted to the hospital.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months

• Number of Days in the Hospital

  Number of Days in the Hospital will be determined by a patient's length of hospital stay.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months

• Number of Emergency Department (ED) Visits

  Number of Emergency Department (ED) Visits will be determined by the number of ED visits per patient

  From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months

• Number of Hospitalizations

  Number of Hospitalizations will be determined by the number of patients that are hospitalized.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months

• Minnesota Living with Heart Failure Questionnaire (MLHFQ)

  Minnesota Living with Heart Failure Questionnaire (MLHFQ) is a 21-question quality of life questionnaire. The scores can range from 0-105, with a higher score reflecting a worse quality of life

  Baseline, 31 Days

• Number of patients to comply with the guideline-directed medical therapy (GDMT)

  Number of patients to comply with the guideline-directed medical therapy (GDMT) will be measured through medical record reviews to determine changes in adherence rates to prescribed HF medications and therapies.

  From date of randomization until the date of first documented progression or date of death from any cause, whichever comes first, assessed up to 12 months

Secondary Outcomes (4)

• Patient Satisfaction

  up to 1 year

• Clinician Satisfaction

  up to 1 year

• Stakeholder-Perceived Sustainability

  up to 1 year

• Cost-effectiveness of Community Paramedic Program

  up to 1 year

Study Arms (2)

Community Paramedic Heart Failure Management (CP-HF) program

Behavioral: CP-HF Management

Standard of Care (SOC)

Interventions

CP-HF Management BEHAVIORAL

Community Paramedics will visit patients up to twice daily. Visits will include patient care discussion with Heart Failure APP, IV placement, lab phlebotomy, heart failure education, and IV medication administration. Community Paramedics will administer up to 120 mg IV furosemide twice daily.

Community Paramedic Heart Failure Management (CP-HF) program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients will be identified by the inpatient cardiology services along with outpatient cardiology and/or primary care offices.

You may qualify if:

• One of the following criteria:
• Adults admitted to the hospital with decompensated HF eligible for early discharge with CP support and monitoring.
• Acutely decompensated HF patients at home or being evaluated in the ambulatory clinic who require large volume diuresis but do not require hospital-level monitoring.
• Stage D advanced HF patients who require frequent (\>weekly) diuretic adjustments (either inpatient or outpatients).

You may not qualify if:

• Hospital-level monitoring or care is clinically indicated.
• Failed safety assessment, active substance abuse, or behavioral health diagnosis which could impact participation.
• Enrolled in hospice.
• Patient is a resident in a skilled nursing facility.
• Patient does not have a primary care physician or cardiologist at Mayo Clinic.
• Patient participants with communication barriers due to medical illness or cognitive impairment.
• Pregnant

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Sara Severson, APRN, C.N.P.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Biorn

CONTACT

507-266-2328; Biorn.Sara@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2025
• First Posted: March 13, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)