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Group Medical Visits in Heart Failure (MEDIC-HF)

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group medical visits
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring heart failure, self-management, group intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phoenix VA Health Care System, Phoenix, AZ
  • Louis Stokes VA Medical Center, Cleveland, OH
  • Providence VA Medical Center, Providence, RI

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MEDIC-HF

Usual Care

Arm Description

Multidisciplinary Education & Intervention Class in Heart Failure

Usual heart failure care

Outcomes

Primary Outcome Measures

Kansas City Cardiomyopathy Questionnaire
cardiac health status

Secondary Outcome Measures

hospitalization or death
Time to hospitalization or death since enrollment

Full Information

First Posted
June 23, 2015
Last Updated
April 6, 2021
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT02481921
Brief Title
Group Medical Visits in Heart Failure
Acronym
MEDIC-HF
Official Title
Group Medical Visits in Heart Failure for Post-Hospitalization Follow-Up
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2015 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 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.
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: Experience better cardiac health status measured by Kansas City Cardiomyopathy Questionnaire (primary outcome), and overall health status (EQ5D, secondary outcome); Have fewer hospitalization or death and 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 250 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, self-management, group intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MEDIC-HF
Arm Type
Experimental
Arm Description
Multidisciplinary Education & Intervention Class in Heart Failure
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual heart failure care
Intervention Type
Behavioral
Intervention Name(s)
Group medical visits
Other Intervention Name(s)
SMA
Intervention Description
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.
Primary Outcome Measure Information:
Title
Kansas City Cardiomyopathy Questionnaire
Description
cardiac health status
Time Frame
180 days
Secondary Outcome Measure Information:
Title
hospitalization or death
Description
Time to hospitalization or death since enrollment
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen-Chih Hank Wu, MD
Organizational Affiliation
Providence VA Medical Center, Providence, RI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandesh Dev, MD
Organizational Affiliation
Phoenix VA Health Care System, Phoenix, AZ
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix VA Health Care System, Phoenix, AZ
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Louis Stokes VA Medical Center, Cleveland, OH
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Providence VA Medical Center, Providence, RI
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29276763
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.
Results Reference
result
PubMed Identifier
29940335
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.
Results Reference
result

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Group Medical Visits in Heart Failure

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