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Recruiting

NCT Number: NCT06874556

A Study of Paramedic HF Management

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.

Recruiting

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Location contact

Sara Severson, APRN, C.N.P.

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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).

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Number of Days without Hospitalization

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

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

  3. Number of Emergency Department (ED) Visits

    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 will be determined by the number of ED visits per patient

  4. Number of Hospitalizations

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

  5. Minnesota Living with Heart Failure Questionnaire (MLHFQ)

    Time frame: 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

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

    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 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 outcomes

  1. Patient Satisfaction

    Time frame: 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.

  2. Clinician Satisfaction

    Time frame: 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.

  3. Stakeholder-Perceived Sustainability

    Time frame: 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.

  4. Cost-effectiveness of Community Paramedic Program

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Sara Biorn

CONTACT

[email protected]

507-266-2328

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Community Paramedic Heart Failure Management (CP-HF) Program

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 13, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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