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Use of Simulation to Improve VAD Self-management (Sim VAD)

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ClinicalTrials.gov Identifier: NCT03073005
Recruitment Status : Enrolling by invitation
First Posted : March 8, 2017
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
Jeffrey Barsuk, Northwestern University

Brief Summary:
This study will evaluate the performance of a curriculum using medical simulators to train patients with advanced heart failure and their caregivers to master the self-management of ventricular assist devices (a device implanted into the heart to help circulate the blood). The investigators expect this training will improve self-management skills, and reduce VAD-related infections and re-hospitalizations. In addition to providing innovative training to the patients and their caregivers, the study will advance our knowledge of the effects of simulation-based training on patient self-management and safety.

Condition or disease Intervention/treatment Phase
Heart Failure Other: Simulation-based Mastery Learning (SBML) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Use of Simulation to Improve Ventricular Assist Device Self-management
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
No Intervention: Traditional VAD training
Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.
Experimental: Simulation-based VAD training
Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer and then participate in simulation-based mastery learning for VAD management
Other: Simulation-based Mastery Learning (SBML)
The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.




Primary Outcome Measures :
  1. Comparisons of VAD-care checklist assessment on the patient and written examination scores between SBML and usual training groups [ Time Frame: 24 months ]
    The investigators will compare the performance of the SBML intervention group to the usual VAD training group during actual VAD care activities

  2. VAD-patient driveline infections, and all-cause and infection- related re-hospitalizations up to 3 months after VAD implant, between the SBML intervention group as compared to the usual VAD training group [ Time Frame: 3 months ]
    The infection prevention department also tracks all VAD related driveline infections using definitions in the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) database. The investigators will assess patient factors at time of infection and during re- hospitalization such as age, sex, body mass index, and the Charlson comorbidity codes to evaluate differences between the SBML and usual VAD training groups


Secondary Outcome Measures :
  1. Self-management skill decay in the five domains [ Time Frame: 3 months ]
    The investigators will measure the change in skill decay on the patient from 0 (time of implant), one and three months using VAD self-management checklists throughout the study period.

  2. Comparisons of post-training questionnaires between groups [ Time Frame: 24 months ]
    The investigators will compare training course satisfaction between both training groups using a post-training questionnaire



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Patient Inclusion Criteria:

  • being a previous or current VAD implantation patient,
  • age >18,
  • English-speaking,
  • receiving implantation and VAD care at Northwestern Memorial Hospital (NMH),
  • meet hospital criteria for VAD implantation.

Caregiver inclusion criteria:

  • being a caregiver identified by a previous or current VAD implantation patient,
  • age >18, and
  • English-speaking.

Exclusion Criteria:

  • Vulnerable populations of patients will not be included in this study (including fetuses, neonates, children, pregnant women, prisoners, mentally retarded or incompetent individuals, institutionalized individuals, or individuals unable to give consent due to their medical condition). Fetuses and neonates are not the focus of our study.
  • Pregnant women will not be included since pregnancy is a contraindication to VAD implantation It is possible that VAD caregivers may be pregnant at the time of the study.
  • Patients with mental retardation, mental incompetence, or patients who are unable to give consent due to their medical condition will not be included as they will not be able to complete measures.
  • Lastly, institutionalized individuals will not be included as access will be a problem, and these individuals are rarely referred for VAD implantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03073005


Locations
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United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
National Institute of Nursing Research (NINR)
Investigators
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Principal Investigator: Jeffrey Barsuk, MD Northwestern University

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Responsible Party: Jeffrey Barsuk, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT03073005     History of Changes
Other Study ID Numbers: STU00203530
First Posted: March 8, 2017    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jeffrey Barsuk, Northwestern University:
ventricular assist device (VAD)
heart failure
simulation
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases