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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Community Paramedic Heart Failure Management (CP-HF) program |
| ||
| Standard of Care (SOC) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 | 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. | 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 | Baseline, 31 Days |
| Number of patients to comply with the guideline-directed medical therapy (GDMT) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
One of the following criteria:
Exclusion Criteria:
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Patients will be identified by the inpatient cardiology services along with outpatient cardiology and/or primary care offices.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sara Biorn | Contact | 507-266-2328 | Biorn.Sara@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Sara Severson, APRN, C.N.P. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Rochester | Minnesota | 55905 | United States |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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. |
| 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 |
| 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. | 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. | 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) | up to 1 year |