Group Medical Visits in Heart Failure

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Prevention of Early Readmission in Elderly Congestive Heart Failure Patients

NCT00000475

Cardiovascular Diseases Heart Diseases Heart Failure, Congestive +1 more

COMPLETED PHASE2

Self-Management and Care of Heart Failure With Group Clinics (SMAC-HF)

NCT00439842

Heart Failure, Congestive

COMPLETED NA

Virtual Visits in Heart Failure Care Transitions

NCT03675828

Heart Failure

COMPLETED NA

Enhancing Caregiver Support for Heart Failure Patients: the CarePartner Study

NCT00555360

Heart Failure, Congestive

COMPLETED NA

Evaluating Telehealth Home Care for Elderly Veterans With Congestive Heart Failure

NCT00057200

Heart Failure Telemedicine

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to either usual care group or the MEDIC-HF group in parallel for the duration of the study.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MEDIC-HF

Group clinic or shared medical appointment of Education \& Intervention in Heart Failure

Group Type EXPERIMENTAL

Group medical visits

Intervention Type BEHAVIORAL

Group clinics or shared medical appointments where a multidisciplinary team of providers with expertise in nutrition, nursing, behavior and/or medication management join to manage heart failure in addition to and in support of, the patient's regular individual clinic visits.

Usual Care

Usual care in heart failure

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Group medical visits

Group clinics or shared medical appointments where a multidisciplinary team of providers with expertise in nutrition, nursing, behavior and/or medication management join to manage heart failure in addition to and in support of, the patient's regular individual clinic visits.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

SMA

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No