Use of Simulation to Improve Ventricular Assist Device Self-management
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 143
- Locations
- 1
- Primary Endpoint
- Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion 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
Arms & Interventions
Traditional VAD training
Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.
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
Intervention: Simulation-based Mastery Learning (SBML) (Other)
Outcomes
Primary Outcomes
Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups
Time Frame: 3 months
The investigators will compare the performance of the SBML intervention group to the usual VAD training group during actual VAD care activities (controller change, power source change and dressing change) plus a written examination. Only caregivers were assessed on dressing change as patients do not independently complete this task.
Secondary Outcomes
- Self-management Skill Decay in the Five Domains(1 month and 3 months after discharge (*1 month SBML-trained only))
- Comparisons of Self-confidence Between Groups(3 months)
- Infections and Re-hospitalizations up to 3 Months After VAD Implant(3 months after discharge)
Investigators
Jeffrey Barsuk
Professor
Northwestern University