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Group Medical Visits in Heart Failure (MEDIC-HF)

This study is currently recruiting participants.
Verified August 2017 by VA Office of Research and Development
Sponsor:
ClinicalTrials.gov Identifier:
NCT02481921
First Posted: June 25, 2015
Last Update Posted: August 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
  Purpose
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.

Condition Intervention
Heart Failure Behavioral: Group medical visits

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are assigned to either usual care group or the MEDIC-HF group in parallel for the duration of the study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Group Medical Visits in Heart Failure for Post-Hospitalization Follow-Up

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Kansas City Cardiomyopathy Questionnaire [ Time Frame: 180 days ]
    cardiac health status


Secondary Outcome Measures:
  • hospitalization or death [ Time Frame: 180 days ]
    Time to hospitalization or death since enrollment


Estimated Enrollment: 375
Actual Study Start Date: June 1, 2015
Estimated Study Completion Date: June 30, 2019
Estimated Primary Completion Date: April 30, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MEDIC-HF
Multidisciplinary Education & Intervention Class in Heart Failure
Behavioral: Group medical visits
Or shared medical appointments where a multidisciplinary team of providers with expertise in nutrition, nursing, behavior and medication management join to manage heart failure in addition to and in support of, the patient's regular physician visits.
Other Name: SMA
No Intervention: Usual Care
Usual heart failure care

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481921


Contacts
Contact: Wen-Chih H Wu, MD (401) 273-7100 ext 2426 wen-chih.wu@va.gov
Contact: Tracey Taveira, PharmD (401) 273-7100 ext 2244 tracey.taveira@va.gov

Locations
United States, Arizona
Phoenix VA Health Care System, Phoenix, AZ Active, not recruiting
Phoenix, Arizona, United States, 85012
United States, Ohio
Louis Stokes VA Medical Center, Cleveland, OH Recruiting
Cleveland, Ohio, United States, 44106
Contact: Sherry L Ball, PhD    216-791-2300 ext 5830    sherry.ball@va.gov   
Sub-Investigator: Sherry L. Ball, PhD         
United States, Rhode Island
Providence VA Medical Center, Providence, RI Recruiting
Providence, Rhode Island, United States, 02908
Contact: Melanie Parent, BS    (401) 273-7100 ext 2445    Melanie.Parent@va.gov   
Principal Investigator: Wen-Chih Hank Wu, MD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Wen-Chih Hank Wu, MD Providence VA Medical Center, Providence, RI
Principal Investigator: Sandesh Dev, MD Phoenix VA Health Care System, Phoenix, AZ
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02481921     History of Changes
Obsolete Identifiers: NCT02454985
Other Study ID Numbers: IIR 14-293
First Submitted: June 23, 2015
First Posted: June 25, 2015
Last Update Posted: August 4, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
heart failure
self-management
group intervention

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases