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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Simulation-based Mastery Learning (SBML)
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Heart Failure focused on measuring ventricular assist device (VAD), heart failure, simulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Northwestern University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Traditional VAD training

Simulation-based VAD training

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.

Full Information

First Posted
February 20, 2017
Last Updated
May 7, 2021
Sponsor
Northwestern University
Collaborators
National Institute of Nursing Research (NINR)
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1. Study Identification

Unique Protocol Identification Number
NCT03073005
Brief Title
Use of Simulation to Improve VAD Self-management
Acronym
SimVAD
Official Title
Use of Simulation to Improve Ventricular Assist Device Self-management
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
Collaborators
National Institute of Nursing Research (NINR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
ventricular assist device (VAD), heart failure, simulation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Traditional VAD training
Arm Type
No Intervention
Arm Description
Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.
Arm Title
Simulation-based VAD training
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Simulation-based Mastery Learning (SBML)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Infections and Re-hospitalizations up to 3 Months After VAD Implant
Description
All VAD related driveline infections and re-hospitalizations between the SBML intervention group as compared to the usual VAD training group
Time Frame
3 months after discharge
Title
Self-management Skill Decay in the Five Domains
Description
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.
Time Frame
1 month and 3 months after discharge (*1 month SBML-trained only)
Title
Comparisons of Self-confidence Between Groups
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Barsuk, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31601111
Citation
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.
Results Reference
derived

Learn more about this trial

Use of Simulation to Improve VAD Self-management

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