Use of Simulation to Improve VAD Self-management

Heart Failure Clinical Trial

— SimVAD  

Official title:

Use of Simulation to Improve Ventricular Assist Device Self-management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073005
• Other study ID #: STU00203530
• Secondary ID: 5R21NR016745-02
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: October 30, 2019

Study information

• Verified date: May 2021
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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)
Secondary	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