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

Northwestern University

Status: Completed

Conditions: Heart Failure

Treatments: Other: Simulation-based Mastery Learning (SBML)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03073005

5R21NR016745-02 (U.S. NIH Grant/Contract)

STU00203530

Details and patient eligibility

About

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.

Enrollment: 143 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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143 participants in 2 patient groups

Traditional VAD training

No Intervention group

Description:

Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.

Simulation-based VAD training

Experimental group

Description:

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

Treatment:

Other: Simulation-based Mastery Learning (SBML)