Use of Simulation to Improve VAD Self-management

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Simulation-based Mastery Learning (SBML)

• Registration Number: NCT03073005
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-20
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-08
• Study Start: 2017-06-01
• Primary Completion: 2019-10-30
• Study Completion: 2019-10-30
• Results First Submitted: 2021-04-12
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-07
• Last Update Submitted: 2021-05-07
• Results First Posted: 2021-05-10
• Last Update Posted: 2021-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 143

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simulation-based VAD training	Simulation-based Mastery Learning (SBML)	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

Primary Outcome Measures

Name	Time	Method
Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups	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 Outcome Measures

Name	Time	Method
Self-management Skill Decay in the Five Domains	1 month and 3 months after discharge (*1 month SBML-trained only)	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.
Comparisons of Self-confidence Between Groups	3 months	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.
Infections and Re-hospitalizations up to 3 Months After VAD Implant	3 months after discharge	All VAD related driveline infections and re-hospitalizations between the SBML intervention group as compared to the usual VAD training group

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States