N/A
N=242
Group Medical Visits in Heart Failure
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT02481921 ↗Enrolled (actual)
242
Serious AEs
48.8%
Results posted
Dec 2023
Primary outcome: Primary: EQ Visual Analog Scale (EQVAS) — 64.6; 66.8; 73.8; 67.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Group medical visits (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY EQ Visual Analog Scale (EQVAS) |
64.6; 66.8; 73.8; 67.0 | — |
| PRIMARY Kansas City Cardiomyopathy Questionnaire (KCCQ), Overall Summary Score |
60.4; 58.7; 70.0; 68.4 | — |
Summary
The primary goal of this proposal is to improve the quality of care and outcomes for patients discharged with heart failure using an innovative multidisciplinary group intervention approach. Heart failure is a complex chronic illness where comprehensive patient-centered care is difficult and resource intensive. One potential solution is to use shared medical appointments (SMA), where a group of patients with the same disease process shared the same medical or clinic appointment. This can be provided by a multi-disciplinary team of providers with expertise in nutrition, nursing, behavior and medication management join to manage heart failure. The investigators will enroll patients from Providence, Cleveland and Phoenix VA Hospitals who were within 12 weeks of discharge from a heart failure hospitalization and/or an outpatient encounter (clinic, emergent or urgent care) that required IV diuretic therapy. Patients were randomized them to receive SMA intervention or usual care. Results from this project are expected to add an innovative intervention that could improve outcomes important for both the patient and the VA: health status, hospitalizations, and mortality.
Eligibility Criteria
Inclusion Criteria
- All subjects >18 years old,
- within 12 weeks of discharge from a heart failure hospitalization and/or an outpatient encounter (clinic, emergent or urgent care) that required IV diuretic therapy
- able to participate in a group setting and
- able to sign informed consent, will be eligible for enrollment
Exclusion Criteria
- Unable to attend the group sessions due to either psychiatric instability (acutely suicidal, psychotic) or organic brain injury (e.g., severe dementia, encephalopathy) that precludes self-reporting on health status
- Discharged to hospice or long-term nursing home facilities (as opposed to short-term rehab), or patients with a code status of comfort-measures-only
- Recipients of heart transplant or ventricular assist devices, patients receiving intravenous inotropic infusions for heart support, women who are pregnant, and patients with end-stage liver disease or renal disease on dialysis since these conditions would preclude them from standard HF care. All women of childbearing age will have a pregnancy test before study enrollment.
Data sourced from ClinicalTrials.gov (NCT02481921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.