Group Medical Visits in Heart Failure

NCT02481921 | Completed Results

• 1 other identifier: IIR 14-293
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 3

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.

Conditions

Heart Failure

Keywords

heart failure; self-management; group intervention

Outcome Measures

Primary Outcomes (2)

• EQ Visual Analog Scale (EQVAS)

  A self-reported scale that reports how good or bad the respondent's health is TODAY, where higher scores mean a better health state. Minimum = 0 "worst health you can imagine"; maximum= 100 "Best health you can imagine'.

  180 days

• Kansas City Cardiomyopathy Questionnaire (KCCQ), Overall Summary Score

  KCCQ is self reported heart failure-specific health status over the prior two weeks, where higher scores mean a perceived better health status. Score ranges from 0-100 where higher score is better.

  180 days

Study Arms (2)

MEDIC-HF

EXPERIMENTAL

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

Behavioral: Group medical visits

Usual Care

NO INTERVENTION

Usual care in heart failure

Interventions

Group medical visits 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.

Also known as: SMA

MEDIC-HF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

Phoenix VA Health Care System, Phoenix, AZ

Phoenix, Arizona, 85012, United States

Location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106, United States

Location

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908, United States

Location

Related Publications (5)

• 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.

  PMID: 29276763 BACKGROUND

• 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.

  PMID: 29940335 BACKGROUND

• 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.

  PMID: 35130320 RESULT

• 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.

  PMID: 33724390 RESULT

• Taveira TH, Cohen LB, Laforest SK, Oliver K, Parent M, Hearns R, Ball SL, Dev S, Wu WC. Shared Medical Appointments in Heart Failure for Post Acute Care Follow-Up: A Randomized Controlled Trial. J Am Heart Assoc. 2024 Aug 6;13(15):e035282. doi: 10.1161/JAHA.124.035282. Epub 2024 Jul 31.

  PMID: 39082405 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Wen-Chih Wu
• Organization: Providence VA Medical Center

wen-chih.wu@va.gov

401-273-7100

Study Officials

• Wen-Chih Hank Wu, MD

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

• Sherry Ball, PhD

  Cleveland VA Health Care System, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 23, 2015
• First Posted: June 25, 2015
• Study Start: May 1, 2015
• Primary Completion: October 1, 2021
• Study Completion: December 31, 2021
• Last Updated: July 24, 2024
• Results First Posted: December 8, 2023

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)