A Study of Paramedic HF Management

Mayo Clinic75 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Heart Failure

Interventions

CP-HF ManagementBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: 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.

Time frame: 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

Time frame: 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.

Central Contacts

Sara Biorn

CONTACT

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

Data from ClinicalTrials.gov

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Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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)

Time frame: up to 1 year