Use of Simulation to Improve VAD Self-management

Study Overview
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Brief Summary
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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.

Official Title
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Use of Simulation to Improve Ventricular Assist Device Self-management

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Simulation-based Mastery Learning (SBML)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Traditional VAD training<br>Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer. | |
| Experimental: Simulation-based VAD training<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infections and Re-hospitalizations up to 3 Months After VAD Implant | All VAD related driveline infections and re-hospitalizations between the SBML intervention group as compared to the usual VAD training group | 3 months after discharge | 
| Self-management Skill Decay in the Five Domains | 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 (controller change, power source change and dressing change) throughout the study period. | 1 month and 3 months after discharge (*1 month SBML-trained only) | 
| Comparisons of Self-confidence Between Groups | Simulation-based Mastery Learning (SBML) Trained and Usual Trained Patient and Caregiver Reported Self-Confidence (0=very low confidence to 100=very high confidence) before Discharge Testing on Five VAD Skills. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ventricular assist device (VAD), heart failure, simulation