Multidisciplinary Ventricular Assist Device Clinic (MultiVAD)

Multidisciplinary Ventricular Assist Device Clinic: Feasibility Pilot Study and Quality of Life Impact Assessment

Current standard of care for ventricular-assist device (VAD) patients is composed of a multidisciplinary team (MDT), which is required in pre-implant and implant hospitalization care but is lacking in post-implant care. Post-implant care is currently centered around the avoidance of complications of VAD support, including cerebrovascular insult (CVA/TIA), gastrointestinal bleeding and infection. Despite major improvements in survival for VAD patients, quality of life and physical functioning measures have not seen significant improvements.

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Heart Failure
• Intervention / Treatment: Other: Multidisciplinary team clinic and assessments (Cardiopulmonary exercise test, six-minute-walk-test, MoCA, Quality of Life questionnaires); Behavioral: Caregiver Self-Assessment

Detailed Description

The current standard of care for ventricular-assist device (VAD) patients is composed of a multidisciplinary team (MDT), which is a mandated practice in the pre-implant and implant hospitalization phase of care. Each member of the MDT (surgeon, cardiologist, VAD coordinator, physical therapist, occupational therapist, social worker, and palliative care specialist) provides unique and orthogonal data. Post-implant care is currently centered around the avoidance of complications of VAD support, including cerebrovascular insult (CVA/TIA), gastrointestinal bleeding and infection. Although patients are referred to cardiac rehabilitation post VAD implant, assessment of functional capacity improvement post-implant is not well standardized. In our program, PT, OT, SW and palliative care medicine do not routinely see patients at intervals post-implant and are available in a limited fashion if specific concerns arise.

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.

• Study Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria for Group A (newly-implanted):

• Ages 18+
• Individuals with ventricular assist device (VAD) implanted
• Individuals who have not previously attended standard-of-care VAD follow-up clinic visits

Exclusion Criteria for Group A:

• Inability to answer quality of life questionnaires
• 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

Inclusion Criteria for Group B (previously-implanted):

• Ages 18+
• Individuals with ventricular assist device (VAD) implanted
• Individuals who have previously attended standard-of-care VAD follow-up clinic visits

Exclusion Criteria for Group B:

• Inability to answer quality of life questionnaires
• Inability to perform the 6-minute walk test and CPET

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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.
Experimental: 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.	Other: 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.
No Intervention: 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.).
Experimental: 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.	Behavioral: Caregiver Self-Assessment; Primary caregivers of both interventional VAD patient cohorts will be administered a Caregiver Self-Assessment to assess burnout.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak VO2 in mL/kg of body weight/min during Cardiopulmonary Exercise Test	Retrospective review in a patient chart.	Change from pre-implant peak VO2 at 12 months post LVAD implantation
Respiratory Exchange Ratio (RER) in % during Cardiopulmonary Exercise Test	Retrospective review in a patient chart.	Change from pre-implant RER at 12 months post LVAD implantation
Minute ventilation per carbon dioxide production (VE/VCO2) during Cardiopulmonary Exercise Test	Retrospective review in a patient chart.	Change from pre-implant VE/VCO2 at 12 months post LVAD implantation
Blood pressure in mmHg during Cardiopulmonary Exercise Test	Retrospective review in a patient chart.	Change from pre-implant blood pressure at 12 months post LVAD implantation
Heart rate in beats per minute during Cardiopulmonary Exercise Test	Retrospective review in a patient chart.	Change from pre-implant heart rate at 12 months post LVAD implantation
EuroQoL (EQ-5D and EuroVAS) to measure quality of life	Survey administered by research coordinator	Change from pre-implant up to 12 months post LVAD implantation
Kansas City Cardiomyopathy Questionnaire (KCCQ) to measure quality of life	Survey administered by research coordinator	Change from pre-implant up to 12 months post LVAD implantation
Montreal Cognitive Assessment (MoCA) to measure cognitive function	Assessment administered by Occupational Therapist	Change from pre-implant up to 12 months post LVAD implantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of readmissions	Retrospective review in a patient chart	up to 24 months post-LVAD implantation
Time to readmission in days	Retrospective review in a patient chart	up to 24 months post-LVAD implantation
Number of VAD related complications	Retrospective review in a patient chart for GI bleed, CVA, heart failure, and infection	up to 24 months post-LVAD implantation

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Erin Coglianese, MD, Massachusetts General Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2022
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: May 11, 2022
• First Submitted That Met QC Criteria: May 20, 2022
• First Posted (Actual): May 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2021P00351

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No