A Study of Paramedic HF Management

Community Paramedic Heart Failure Management (CP-HF) Program

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.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: CP-HF Management

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Sara Biorn; Phone Number: 507-266-2328; Email: Biorn.Sara@mayo.edu

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
      • Contact: Sara Severson, APRN, C.N.P.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

Inclusion Criteria:

One of the following criteria:

1. Adults admitted to the hospital with decompensated HF eligible for early discharge with CP support and monitoring.
2. 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.
3. Stage D advanced HF patients who require frequent (>weekly) diuretic adjustments (either inpatient or outpatients).

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Community Paramedic Heart Failure Management (CP-HF) program	Behavioral: CP-HF Management; 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.
Standard of Care (SOC)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction	Measured through a structured patient satisfaction survey developed for the CP-HF program. The survey assesses various aspects of patient experience, including communication, responsiveness, medication management, and overall satisfaction. Responses are rated on a 5-point Likert scale (1 = Strongly Disagree, 5 = Strongly Agree), with higher scores indicating greater satisfaction. Additional questions evaluate care coordination, interpreter service utilization, perceived safety, and willingness to recommend the program.	up to 1 year
Clinician Satisfaction	Measured through the Clinician & Stakeholder Satisfaction Survey, which assesses clinician experiences and perceptions of the CP-HF program's effectiveness. The survey includes questions on program structure, implementation, sustainability, and collaboration. Responses are rated on a 5-point Likert scale, with higher scores indicating greater satisfaction.	up to 1 year
Stakeholder-Perceived Sustainability	Stakeholder-Perceived Sustainability will be measured through interviews and surveys of key stakeholders to gauge their views on the sustainability and scalability of the CP-HF program.	up to 1 year
Cost-effectiveness of Community Paramedic Program	Cost-effectiveness will be determined by comparing the measured cost of the community Paramedic Program against the Standard of Care (SOC)	up to 1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Sara Severson, APRN, C.N.P., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: March 3, 2025
• First Submitted That Met QC Criteria: March 7, 2025
• First Posted (Actual): March 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 16, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 24-009568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No