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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDIC-HF | Experimental | Group clinic or shared medical appointment of Education & Intervention in Heart Failure |
|
| Usual Care | No Intervention | Usual care in heart failure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix VA Health Care System, Phoenix, AZ | Phoenix | Arizona | 85012 | United States | ||
| Louis Stokes VA Medical Center, Cleveland, OH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29276763 | Background | 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. | |
| 29940335 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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'. | 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. | Posted | Mean | Standard Deviation | score on a scale | 180 days |
|
6 months from time of randomization
We collected hospitalizations (SAE) and Emergency room visits (AE) through monthly contact of either phone or in-person visits, in addition to chart reviews
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MEDIC-HF | Multidisciplinary Education & Intervention Class in Heart Failure 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Hospitalizations | Cardiac disorders | Systematic Assessment | Number of subjects that had at least 1 hospitalization during the study period. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any Emergency room visits | Cardiac disorders | Systematic Assessment | Number of subjects that had at least 1 Emergency Room visit during the study period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Wen-Chih Wu | Providence VA Medical Center | 401-273-7100 | 16237 | wen-chih.wu@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 17, 2018 | Apr 20, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Participants are assigned to either usual care group or the MEDIC-HF group in parallel for the duration of the study.
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|
|
| Cleveland |
| Ohio |
| 44106 |
| United States |
| Providence VA Medical Center, Providence, RI | Providence | Rhode Island | 02908 | United States |
| 35130320 | Result | 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. |
| 33724390 | 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. |
| 39082405 | Derived | 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. |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Left ventricular ejection fraction (LVEF) by Echocardiogram | Left Ventricular Ejection Fraction (LVEF) is measured by echocardiogram, where a higher number is better. | Count of Participants | Participants |
|
| OG001 | Usual Care | Usual in-person clinic visits in heart failure |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | 180 days |
|
|
|
| 10 |
| 117 |
| 57 |
| 117 |
| 42 |
| 117 |
| EG001 | Usual Care | Usual heart failure care | 10 | 125 | 61 | 125 | 55 | 125 |
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| 6 months |
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