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Group Medical Visits in Heart Failure

Group Medical Visits in Heart Failure for Post-Hospitalization Follow-Up

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02481921
Acronym
MEDIC-HF
Enrollment
242
Registered
2015-06-25
Start date
2015-05-01
Completion date
2021-12-31
Last updated
2024-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure

Keywords

heart failure, self-management, group intervention

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.

Interventions

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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
EQ Visual Analog Scale (EQVAS)180 daysA 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'.
Kansas City Cardiomyopathy Questionnaire (KCCQ), Overall Summary Score180 daysKCCQ 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
MEDIC-HF
Shared Medical Appointments in Heart Failure: or group clinics with 4-10 patients at a time provided by a multidisciplinary team of health care professionals with expertise in nutrition, social work or health psychologist, and pharmacist or nurse practitioner on alternate fashion to provide heart failure care in in addition to and in support of, the patient's regular individual clinic visits.
117
Usual Care
Usual heart failure care through individual clinic visits that includes but not limited to heart failure, nutrition, cardiology, and primary care, among others, available at the hospital
125
Total242

Baseline characteristics

CharacteristicMEDIC-HFUsual CareTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
88 Participants88 Participants176 Participants
Age, Categorical
Between 18 and 65 years
29 Participants37 Participants66 Participants
Age, Continuous69.8 years
STANDARD_DEVIATION 8.7
68.9 years
STANDARD_DEVIATION 9.9
69.3 years
STANDARD_DEVIATION 9.4
Left ventricular ejection fraction (LVEF) by Echocardiogram
LVEEF >=40%
72 Participants82 Participants154 Participants
Left ventricular ejection fraction (LVEF) by Echocardiogram
LVEF <40%
45 Participants43 Participants88 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
26 Participants37 Participants63 Participants
Race (NIH/OMB)
More than one race
2 Participants3 Participants5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
89 Participants84 Participants173 Participants
Region of Enrollment
United States
117 Participants125 Participants242 Participants
Sex: Female, Male
Female
5 Participants8 Participants13 Participants
Sex: Female, Male
Male
112 Participants117 Participants229 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
10 / 11710 / 125
other
Total, other adverse events
42 / 11755 / 125
serious
Total, serious adverse events
57 / 11761 / 125

Outcome results

Primary

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'.

Time frame: 180 days

Population: 8 patients in the MEDIC-HF arm and 9 patients in the Usual Care arm died prior to the final survey. Additionally, 11 patients in the MEDC-HF arm and 10 patients in the Usual Care arm were lost to follow-up or did not complete the final survey. 1 usual care patient did not complete the 6 month survey.

ArmMeasureGroupValue (MEAN)Dispersion
MEDIC-HFEQ Visual Analog Scale (EQVAS)Baseline64.6 score on a scaleStandard Deviation 18.1
MEDIC-HFEQ Visual Analog Scale (EQVAS)6 months73.8 score on a scaleStandard Deviation 17.1
Usual CareEQ Visual Analog Scale (EQVAS)Baseline66.8 score on a scaleStandard Deviation 21.7
Usual CareEQ Visual Analog Scale (EQVAS)6 months67.0 score on a scaleStandard Deviation 18.7
Primary

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.

Time frame: 180 days

Population: 1 patient in the MEDIC-HF arm did not complete KCCQ at baseline. 8 patients in the MEDIC-HF arm and 9 patients in the Usual Care arm died prior to the final survey. Additionally, 11 patients in the MEDIC-HF arm and 10 patients in the Usual Care arm were lost to follow-up or did not complete the final survey. 1 patient in the usual care arm did not complete EQ-VAS but completed KCCQ.

ArmMeasureGroupValue (MEAN)Dispersion
MEDIC-HFKansas City Cardiomyopathy Questionnaire (KCCQ), Overall Summary ScoreBaseline60.4 score on a scaleStandard Deviation 22.7
MEDIC-HFKansas City Cardiomyopathy Questionnaire (KCCQ), Overall Summary Score6 months70.0 score on a scaleStandard Deviation 21.4
Usual CareKansas City Cardiomyopathy Questionnaire (KCCQ), Overall Summary ScoreBaseline58.7 score on a scaleStandard Deviation 24.5
Usual CareKansas City Cardiomyopathy Questionnaire (KCCQ), Overall Summary Score6 months68.4 score on a scaleStandard Deviation 23

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026