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 : March 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Other: Simulation-based Mastery Learning (SBML)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|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 :||May 2019|
|Estimated Study Completion Date :||December 2019|
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.
- 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
- 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
- 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.
- 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
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
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Principal Investigator:||Jeffrey Barsuk, MD||Northwestern University|