Community-Informed Interventions for Equitable Congestive Heart Failure Management in Primary Care
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
The purpose of this study is to expand subject matter expertise and sustained capacity for equity-oriented care within the Advanced Care Ecosystem (ACE) by engaging patients, caregivers, community health workers (CHW), and care-team stakeholders in development work focused on adults living with congestive heart failure (CHF) and adverse social determinants of health (SDoH).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Under age 18 years.
Unable or unwilling to provide informed consent.
Trial population
The study population will include adults with congestive heart failure (CHF) who receive primary care at Mayo Clinic in Rochester and have evidence of adverse social determinants of health, elevated health care utilization, or other medical or social complexity relevant to CHF self-care and transitions-of-care support. Eligible patients may nominate adult caregivers or family members to participate when their perspective is relevant to the patient's CHF care experience. The study will also include adult Community Health Workers, chronic disease nurse care coordinators, education specialists, clinicians, and other clinical or operational stakeholders with roles relevant to CHF care, transitions of care, social needs, patient education, or CHW workflows.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Interviews and group discussion for patients and caregivers
Other interventionParticipants will be asked to complete an individual interview or participate in a group discussion lasting approximately 60 to 120 minutes, conducted in person, by telephone, or by Mayo-approved video platform. Interview and discussion guides will include discussion of barriers, facilitators, preferences, priorities, and care gaps related to congestive heart failure self-care, access, transitions of care, community health worker support, caregiver support, social needs, health literacy, language access, trust, and culturally responsive care.
Interviews and group discussion for community health worker and care-team stakeholders
Other interventionParticipants will be asked to complete an individual interview or participate in a group discussion lasting approximately 60 to 120 minutes. Interview and discussion guides will focus on development of a community health worker competency-based training module and development of workflows for community health workers to support congestive heart failure patients' self-management and care transitions. Participants will provide feedback on implementation barriers and facilitators, including training burden, role clarity, sustainability, cultural responsiveness, and integration with clinical care teams.
Treatment groups
75 Participants
are divided into 3 treatment groupsGroup A: Adults living with congestive heart failure (CHF)1 intervention
Group B: Caregivers or family members of eligible congestive heart failure (CHF) patients1 intervention
Group C: Community health workers and care-team stakeholders1 intervention
Trial outcomes
Primary outcomes
1
Identification of prioritized barriers to self-care
Total number of prioritized barriers to equitable congestive heart failure self-care and transitions-of-care support identified through participant interviews and group discussions.
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov