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

Use of Simulation to Improve Ventricular Assist Device Self-management

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 Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Simulation-based Mastery Learning (SBML)

• Study Type: Interventional
• Enrollment (Actual): 143
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Jeffrey Barsuk, MD, Northwestern University

Publications and helpful links

General Publications

• Barsuk JH, Wilcox JE, Cohen ER, Harap RS, Shanklin KB, Grady KL, Kim JS, Nonog GP, Schulze LE, Jirak AM, Wayne DB, Cameron KA. Simulation-Based Mastery Learning Improves Patient and Caregiver Ventricular Assist Device Self-Care Skills: A Randomized Pilot Trial. Circ Cardiovasc Qual Outcomes. 2019 Oct;12(10):e005794. doi: 10.1161/CIRCOUTCOMES.119.005794. Epub 2019 Oct 11.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): October 30, 2019

Study Registration Dates

• First Submitted: February 20, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 8, 2017

Study Record Updates

• Last Update Posted (Actual): May 10, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: simulation; heart failure; ventricular assist device (VAD)
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: STU00203530; 5R21NR016745-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No