Heart FailureMEDIC-HFNCT02481921
Group Medical Visits in Heart Failure
A study testing Group medical visits in people with Heart Failure, run by VA Office of Research and Development at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Group medical visits
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 May 2015to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106
Phoenix VA Health Care System, Phoenix, AZ
Phoenix, Arizona, 85012
Providence VA Medical Center, Providence, RI
Providence, Rhode Island, 02908
About this study
Official title: Group Medical Visits in Heart Failure for Post-Hospitalization Follow-Up
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.
Read the 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:
- Experience better cardiac health status measured by Kansas City Cardiomyopathy Questionnaire and overall health status measured by EQ5D;
- Have fewer hospitalization or death and
- 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.
- Conditions
- Heart Failure
- Being tested
- Group medical visits
- Keywords
- heart failure, self-management, group intervention
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group medical visitsBehavioural
Also called SMA
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.
| Study group | Role | What they receive |
|---|---|---|
| MEDIC-HF | Experimental | Group clinic or shared medical appointment of Education \& Intervention in Heart Failure Receives: Behavioral: Group medical visits |
| Usual Care | No intervention | Usual care in heart failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 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.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study start1 May 2015
- Primary completion1 Oct 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Wen-Chih Hank Wu, MD, Principal investigator, Providence VA Medical Center, Providence, RISherry Ball, PhD, Principal investigator, Cleveland VA Health Care System, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481921
- Sponsor's protocol ID
- IIR 14-293
- Acronym
- MEDIC-HF
- Status last verified
- Jul 2024
- First submitted
- 23 Jun 2015
- Last updated
- 24 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29276763Wu 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.
PubMed 29940335Marshall 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.
PubMed 35130320Madrigal 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.
PubMed 33724390Taveira 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.
PubMed 39082405
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Medical Visits in Heart Failure for Post-Hospitalization Follow-Up
- ClinicalTrials.gov ID
- NCT02481921
- Acronym / sponsor ID
- MEDIC-HF / IIR 14-293
- Conditions
- Heart Failure
- Keywords
- heart failure, self-management, group intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 May 2015 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Posted 8 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Experience better cardiac health status measured by Kansas City Cardiomyopathy Questionnaire and overall health status measured by EQ5D;
- Have fewer hospitalization or death and
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to either usual care group or the MEDIC-HF group in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| MEDIC-HF | Experimental | Behavioral: Group medical visitsGroup clinic or shared medical appointment of Education \& Intervention in Heart Failure |
| Usual Care | No intervention | –Usual care in heart failure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group medical visitsAlso: SMAGroup 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. | Behavioural | MEDIC-HF |
Primary outcome
EQ Visual Analog Scale (EQVAS)
Time frame: 180 days
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'.
Kansas City Cardiomyopathy Questionnaire (KCCQ), Overall Summary Score
Time frame: 180 days
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29276763Cohen 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.
- Background: PubMed 29940335Wu 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 publication: PubMed 35130320Marshall 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.
- Results publication: PubMed 33724390Madrigal 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.
- Derived from this study: PubMed 39082405Taveira 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen-Chih Hank Wu, MD principal investigator
Providence VA Medical Center, Providence, RI
Sherry Ball, PhD principal investigator
Cleveland VA Health Care System, Cleveland, OH
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group medical visits in people with Heart Failure, run by VA Office of Research and Development at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EQ Visual Analog Scale (EQVAS) (time frame: 180 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02481921, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.