Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
110 participants
INTERVENTIONAL
2022-04-21
2026-05-31
Brief Summary
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This study will include two prospective interventional cohorts and a retrospective control cohort. The first prospective interventional cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant. The second prospective interventional cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an LVAD implanted (due to transplant, death, explant, etc.), and will be matched with the prospective interventional patients. The purpose of this study is to characterize the impact of routine MDT care on health-related quality of life, caregiver burnout and functional capacity of outpatient VAD patients, and to determine if implementation of MDT care is associated with a reduction in complications and readmissions in VAD patients at one- and two-years post implant. The investigators hypothesize that the MDT clinic model in addition to standard of care VAD management will positively impact the quality of life and functional status of VAD patients.
Subjects who consent to this study will be seen by the MDT providers and complete Cardiopulmonary Exercise Tests (CPET), six-minute-walk-tests, and quality of life questionnaires. The primary caregivers of these subjects will complete a Caregiver Self-Assessment at two timepoints. We anticipate to enroll 20 newly-implanted VAD patients in the pure-MDT arm, 35 pre-existing VAD patients in hybrid-MDT/SOC arm, and 55 primary caregivers.
Detailed Description
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Prior studies have shown that MDT care in VAD patients improves survival in an in-patient setting and proves to be feasible and effective in other disease processes. Despite major improvements in survival for VAD patients however, quality of life and physical functioning measures have not seen significant improvements. Since there is a clinical need to examine post-implant treatment, this study aims to characterize the impact of routine MDT care on health-related quality of life, caregiver burnout and functional capacity of outpatient VAD patients, and to determine if implementation of MDT care is associated with a reduction in complications and readmissions in VAD patients at one- and two-years post implant.
This study will include two prospective interventional cohorts and a retrospective control cohort. The first prospective interventional cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant. The second prospective interventional cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits. The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an LVAD implanted (due to transplant, death, explant, etc.). This group will be matched with the prospective interventional patients. The investigators hypothesize that the MDT clinic model in addition to standard of care VAD management will positively impact the quality of life and functional status of VAD patients. Future work will study readmission rates, medical complications, and overall survival difference between MultiVAD clinic care and usual care VAD clinics.
Subjects who consent to this study will be seen by the MDT providers and complete Cardiopulmonary Exercise Tests (CPET), six-minute-walk-tests, and quality of life questionnaires. Newly-implanted VAD subjects will participate over a 24-month period and previously-implanted VAD subjects will participate over a 12-month period. The primary caregivers of these subjects will complete a Caregiver Self-Assessment at two timepoints. We anticipate to enroll 20 newly-implanted VAD patients in the pure-MDT arm, 35 pre-existing VAD patients in hybrid-MDT/SOC arm, and 55 primary caregivers.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Prospective interventional cohort of newly-implanted patients
This cohort will consist of patients who recently underwent LVAD implantation at Massachusetts General Hospital, and their caregivers. These patients will receive only multidisciplinary team care from the time of their implant.
Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires)
Subject will receive care from a multidisciplinary team (physical therapy, occupational therapy, palliative care, social work) in addition to their standard of care VAD clinic visits. Subject will also perform a CPET, six-minute-walk-test, MoCA, and be administered quality of life questionnaires.
Prospective interventional cohort of previously-implanted patients
This cohort will consist of patients who have previously undergone LVAD implantation at Massachusetts General Hospital who are being followed-up with standard-of-care VAD clinic visits, and their caregivers. These patients will receive a hybrid of multidisciplinary team care and standard-of-care visits.
Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires)
Subject will receive care from a multidisciplinary team (physical therapy, occupational therapy, palliative care, social work) in addition to their standard of care VAD clinic visits. Subject will also perform a CPET, six-minute-walk-test, MoCA, and be administered quality of life questionnaires.
Retrospective control cohort
The historical control cohort will consist of retrospective data collection on patients who have undergone LVAD implantation in the past and no longer have an LVAD implanted (due to transplant, death, explant, etc.).
No interventions assigned to this group
Primary caregiver cohort
This cohort will consist of primary caregivers of VAD patients from the two interventional cohorts. They will be administered a questionnaire at two timepoints. Each VAD patient will be associated with only one primary caregiver for the duration of the study.
Caregiver Self-Assessment
Primary caregivers of both interventional VAD patient cohorts will be administered a Caregiver Self-Assessment to assess burnout.
Interventions
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Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires)
Subject will receive care from a multidisciplinary team (physical therapy, occupational therapy, palliative care, social work) in addition to their standard of care VAD clinic visits. Subject will also perform a CPET, six-minute-walk-test, MoCA, and be administered quality of life questionnaires.
Caregiver Self-Assessment
Primary caregivers of both interventional VAD patient cohorts will be administered a Caregiver Self-Assessment to assess burnout.
Eligibility Criteria
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Inclusion Criteria
* Individuals with ventricular assist device (VAD) implanted
* Individuals who have not previously attended standard-of-care VAD follow-up clinic visits
* Ages 18+
* Individuals with ventricular assist device (VAD) implanted
* Individuals who have previously attended standard-of-care VAD follow-up clinic visits
Exclusion Criteria
* Inability to perform the 6-minute walk test and Cardiopulmonary Exercise Test (CPET)
* Individuals who have previously attended standard-of-care VAD follow-up clinic visits
* Inability to answer quality of life questionnaires
* Inability to perform the 6-minute walk test and CPET
18 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Erin Coglianese
Medical Director, Mechanical Cardiac Support Program
Principal Investigators
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Erin Coglianese, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Tractenberg RE, Yumoto F, Aisen PS. Detecting When "Quality of Life" Has Been "Enhanced": Estimating Change in Quality of Life Ratings. Open J Philos. 2013 Nov 1;3(4A):24-31. doi: 10.4236/ojpp.2013.34A005.
Other Identifiers
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2021P00351
Identifier Type: -
Identifier Source: org_study_id