Clinical trial NCT02481921: Group Medical Visits in Heart Failure
Official title: Group Medical Visits in Heart Failure for Post-Hospitalization Follow-Up
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
self-management
group intervention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-06-25
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to either usual care group or the MEDIC-HF group in parallel for the duration of the study.
Primary purpose: TREATMENT

Brief 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.

Detailed description: The primary goal of this research project is to improve the health status and outcomes for patients treated for heart failure (HF) via a group clinic or shared medical appointment approach where education to patients, disease monitoring and medication titration occurs. 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 with peer support, self-management education while also performing disease monitoring and medication management in a group environment. The investigators propose a randomized controlled trial to enroll patients 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, and randomized them to receive either SMA intervention either weekly or bi-weekly for 4 total 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 and overall health status measured by EQ5D;
2. Have fewer hospitalization or death and
3. Experience improvement in a) HF Self-Care behavior, or b) plasma BNP or NT-pro-BNP levels.

The sites will be Providence VA, Cleveland VA and Phoenix VA hospitals to enroll a total of 250 patients. The study duration will be 180 days for all patients from the time of randomization. The investigators will use stratified randomization with the following variables: enrollment in other programs for HF Clinic, support group or education, \<2 hospitalizations last 6 months, left ventricular ejection fraction \<40% and study site. The team will consist of a nutritionist, social worker or 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.

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.

Primary outcomes:
measure: EQ Visual Analog Scale (EQVAS)
timeFrame: 180 days
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ), Overall Summary Score
timeFrame: 180 days
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix VA Health Care System, Phoenix, AZ
state: Arizona
city: Cleveland
country: United States
facility: Louis Stokes VA Medical Center, Cleveland, OH
state: Ohio
city: Providence
country: United States
facility: Providence VA Medical Center, Providence, RI
state: Rhode Island
Study officials:
affiliation: Providence VA Medical Center, Providence, RI
name: Wen-Chih Hank Wu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cleveland VA Health Care System, Cleveland, OH
name: Sherry Ball, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen LB, Parent M, Taveira TH, Dev S, Wu WC. A Description of Patient and Provider Experience and Clinical Outcomes After Heart Failure Shared Medical Appointment. J Patient Exp. 2017 Dec;4(4):169-176. doi: 10.1177/2374373517714452. Epub 2017 Jun 20.
citation: Wu WC, Parent M, Dev S, Hearns R, Taveira TH, Cohen L, Shell-Boyd J, Jewett-Tennant J, Marshall V, Gee J, Schaub K, LaForest S, Ball S. Group medical visits after heart failure hospitalization: Study protocol for a randomized-controlled trial. Contemp Clin Trials. 2018 Aug;71:140-145. doi: 10.1016/j.cct.2018.06.015. Epub 2018 Jun 22.
citation: Marshall V, Jewett-Tennant J, Shell-Boyd J, Stevenson L, Hearns R, Gee J, Schaub K, LaForest S, Taveira TH, Cohen L, Parent M, Dev S, Barrette A, Oliver K, Wu WC, Ball SL. Healthcare providers experiences with shared medical appointments for heart failure. PLoS One. 2022 Feb 7;17(2):e0263498. doi: 10.1371/journal.pone.0263498. eCollection 2022.
citation: Madrigal C, Kim J, Jiang L, Lafo J, Bozzay M, Primack J, Correia S, Erqou S, Wu WC, Rudolph JL. Delirium and Functional Recovery in Patients Discharged to Skilled Nursing Facilities After Hospitalization for Heart Failure. JAMA Netw Open. 2021 Mar 1;4(3):e2037968. doi: 10.1001/jamanetworkopen.2020.37968.