NCT06874556 · Mayo Clinic
A Study of Paramedic HF Management
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
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.
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.
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
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.
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
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Rochester, Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 16, 2026 · Source of record for eligibility and locations