A Study of Paramedic HF Management

Not yet recruiting

• Conditions: Heart Failure

• Registration Number: NCT06874556
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-03
• Study First Submitted QC: 2025-03-07
• Study First Posted: 2025-03-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-08
• Study Start: 2025-05
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Days without Hospitalization	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 without Hospitalization will be measured by the number of days a patient is not admitted to the hospital.
Number of Days in 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 will be determined by a patient's length of hospital stay.
Number of Emergency Department (ED) Visits	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 will be determined by the number of ED visits per patient
Number of Hospitalizations	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 will be determined by the number of patients that are hospitalized.
Minnesota Living with Heart Failure Questionnaire (MLHFQ)	Baseline, 31 Days	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
Number of patients to comply with the guideline-directed medical therapy (GDMT)	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 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.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	up to 1 year	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.
Clinician Satisfaction	up to 1 year	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.
Stakeholder-Perceived Sustainability	up to 1 year	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.
Cost-effectiveness of Community Paramedic Program	up to 1 year	Cost-effectiveness will be determined by comparing the measured cost of the community Paramedic Program against the Standard of Care (SOC)

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States