Use of Simulation to Improve VAD Self-management

NCT03073005 | Completed Results DMC

• 2 other identifiers: STU002035305R21NR016745-02
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure

Keywords

ventricular assist device (VAD); heart failure; simulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Infections and Re-hospitalizations up to 3 Months After VAD Implant

  3 months after discharge

• 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

Study Arms (2)

Traditional VAD training

NO INTERVENTION

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

Simulation-based VAD training

EXPERIMENTAL

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)

Interventions

Simulation-based Mastery Learning (SBML) OTHER

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.

Simulation-based VAD training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• being a caregiver identified by a previous or current VAD implantation patient,
• age \>18, and
• English-speaking.

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• 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.

  PMID: 31601111 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Dr. Jeffrey H Barsuk
• Organization: Northwestern University

jbarsuk@nm.org

312-926-5924

Study Officials

• Jeffrey Barsuk, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 20, 2017
• First Posted: March 8, 2017
• Study Start: June 1, 2017
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: May 10, 2021
• Results First Posted: May 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)