Group Medical Visits in Heart Failure



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:June 1, 2015
End Date:June 30, 2019
Contact:Wen-Chih H Wu, MD
Email:wen-chih.wu@va.gov
Phone:(401) 273-7100

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Group Medical Visits in Heart Failure for Post-Hospitalization Follow-Up

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 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 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.

The primary goal of this research project is to improve the health status and decrease
hospitalization and death for patients discharged with heart failure (HF) via education to
patients, disease monitoring and medication titration through shared medical appointments
(SMAs). Studies have found patient self-care behaviors in HF (e.g. medication/dietary
non-compliance) and health system factors (e.g. care discoordination, limited access, lack of
education to patients and caregivers) played an important role in patient's health status and
hospitalization risk to the extent that 50% of the readmissions were judged to be
possibly/probably preventable. To address patient and system factors based on the Chronic
Care Model, redesign of care delivery, via SMA's, can be a good solution to provide patient
self-management support while also performing disease monitoring and medication management in
an environment of peer support. The investigators propose a randomized controlled trial to
enroll patients within 12 weeks of discharge from a HF hospitalization and randomized them to
receive either SMA intervention every other one-two weeks for 4 sessions versus usual care
for HF. The investigators will determine, at 180 days from randomization, whether HF patients
who participate in HF-SMA, as compared to patients who receive usual care:

1. Experience better cardiac health status measured by Kansas City Cardiomyopathy
Questionnaire (primary outcome), and overall health status (EQ5D, secondary outcome);

2. Have fewer hospitalization or death and

3. Experience improvement in intermediate outcomes: a) increase in HF Self-Care behavior,
and b) decrease in plasma BNP levels.

For patients who underwent HF-SMA, the investigators will also determine perceived benefits,
areas in need of improvement, potential obstacles of implementation, and fidelity of the
intervention across sites, by conducting (a) face-to-face interviews with patients and (b)
telephone interviews with stakeholders (physicians of the patients and administrators).

The sites will be Providence VA, Cleveland VA and Phoenix VA hospitals to enroll a total of
375 patients. The study duration will be 180 days for all patients from the time of
randomization. The investigators will use stratified (enrollment in other programs for HF
care, <2 hospitalizations last 6 months, left ventricular ejection fraction <40%), block
randomization with block sizes of 4 in each site to ensure balance of the stratified
variables. The team will consist of a nutritionist, nurse, health psychologist, a clinical
pharmacist and/or nurse practitioner, without the presence of a physician (cardiologist will
be available on call). The session will contain an assessment of patient needs, theme-based
disease self-management education, patient-initiated disease management discussion, and
break-out sessions of individualized medication case management.

The study findings will be used in health care management and system redesign to provide
better quality and patient centered care for Veterans with HF. The long-term goal is to use a
multi-disciplinary team approach in a group setting to manage HF support regular physician
visits, in a peer support environment, all of which, are necessary to provide
patient-centered care and improve outcomes.

Inclusion Criteria:

- All subjects >18 years old,

- within 12 weeks of discharge from a hospitalization with a principal diagnosis of
heart failure

- 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 since the setting and
goals of disease management will be very different compared to the general HF patients
after discharge, who are the target of the investigators' intervention. -

- 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.
We found this trial at
3
sites
Cleveland, Ohio 44106
Phone: 216-791-2300
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Cleveland, OH
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Phoenix, Arizona 85012
Phone: 602-277-5551
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Phoenix, AZ
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Providence, Rhode Island 02908
Principal Investigator: Wen-Chih Hank Wu, MD
Phone: (401) 273-7100
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Providence, RI
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