A Study of Paramedic HF Management

Официальное название

Community Paramedic Heart Failure Management (CP-HF) Program

Обзор

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Number of Days without Hospitalization [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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) [Срок оценки: Baseline, 31 Days]
• Number of patients to comply with the guideline-directed medical therapy (GDMT) [Срок оценки: 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]

Вторичные конечные точки (4)

• Patient Satisfaction [Срок оценки: up to 1 year]
• Clinician Satisfaction [Срок оценки: up to 1 year]
• Stakeholder-Perceived Sustainability [Срок оценки: up to 1 year]
• Cost-effectiveness of Community Paramedic Program [Срок оценки: up to 1 year]

Критерии участия

Критерии включения

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).

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Mayo Clinic — Rochester

Идентификаторы

NCT: NCT06874556 · 24-009568

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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