Clinical trial NCT06874556: A Study of Paramedic HF Management
Official title: Community Paramedic Heart Failure Management (CP-HF) Program
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Heart Failure
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-03-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients will be identified by the inpatient cardiology services along with outpatient cardiology and/or primary care offices.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Days without Hospitalization
timeFrame: 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
measure: Number of Days in the Hospital
timeFrame: 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
measure: Number of Emergency Department (ED) Visits
timeFrame: 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
measure: Number of Hospitalizations
timeFrame: 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
measure: Minnesota Living with Heart Failure Questionnaire (MLHFQ)
timeFrame: Baseline, 31 Days
measure: Number of patients to comply with the guideline-directed medical therapy (GDMT)
timeFrame: 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:
measure: Patient Satisfaction
timeFrame: up to 1 year
measure: Clinician Satisfaction
timeFrame: up to 1 year
measure: Stakeholder-Perceived Sustainability
timeFrame: up to 1 year
measure: Cost-effectiveness of Community Paramedic Program
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sara Severson, APRN, C.N.P.
role: PRINCIPAL_INVESTIGATOR
References: