Clinical Trials

Inclusion Criteria:

• Aim 1

  • Patients living with CHF:

    • Age 18 years or older.

    • Diagnosis or clinical documentation of CHF or heart failure in the Mayo Clinic medical record.

    • Empaneled in Mayo Clinic, Rochester, primary care

    • Evidence in the EHR of one or more adverse SDoH, elevated utilization, medical/social complexity.

    • Able to provide informed consent.

    • Able to participate in study procedures.

  • Caregivers:

    • Age 18 years or older.

    • Caregiver with relevant lived, caregiving, or community experience related to CHF, and nominated by the patient.

    • Able to provide informed consent

    • Able to participate in study procedures.

• Aim 2

  • CHW and care-team stakeholders:

    • Age 18 years or older.

    • Current or recent role relevant to CHF care, transitions of care, SDoH, patient education, or CHW workflows.

    • Able to provide informed consent

    • Able to participate in study procedures.

• Aim 3

  • Patients receiving Aim 3 intervention:

    • Age 18 years or older.

    • Diagnosis or clinical documentation of CHF or heart failure in the Mayo Clinic medical record.

    • Empaneled in Mayo Clinic, Rochester, primary care.

    • Within 30 days of an emergency department visit, hospital dismissal, or skilled nursing facility dismissal at the time of enrollment.

    • Elevated risk of poor clinical outcomes or suboptimal utilization based on the AI-ML Elder Risk Assessment Index-2 and elevated risk of unmet social needs based on the AI-NLP tool, with eligibility confirmed by trained study staff.

    • Resides within the approved CHW home-visit service area.

    • Able to provide written or electronic informed consent and HIPAA Authorization.

    • Able to participate in 3 to 4 home visits over 4 to 6 weeks and a post-intervention survey, with interpreter or other reasonable accommodations when needed.

  • CHW and care-team implementation participants:

    • Age 18 years or older.

    • Current or recent role in delivery, supervision, referral, care coordination, data support, or clinical integration of the Aim 3 intervention.

    • Able to provide informed consent and participate in an individual interview or group discussion.

Exclusion Criteria:

• Under age 18 years.

• Unable or unwilling to provide informed consent.

• For Aim 3 only, outside the approved CHW home-visit service area or unable to participate safely in home visits after reasonable accommodations.

• Patients who are clinically unstable at outreach will be referred to appropriate clinical care and may be re-approached if they become stable within the recruitment window.

   

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 09/21/2026. Questions regarding updates should be directed to the study team contact.