N/A
N=143
Use of Simulation to Improve VAD Self-management
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT03073005 ↗Enrolled (actual)
143
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups — 100; 97.1; 100; 100 percentage of checklist items correct
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Simulation-based Mastery Learning (SBML) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups |
100; 97.1; 100; 100; 92.9; 100 | — |
| SECONDARY Infections and Re-hospitalizations up to 3 Months After VAD Implant |
6; 0; 20; 15 | — |
| SECONDARY Self-management Skill Decay in the Five Domains |
100; 100; 100; 100; 100; 85.71 | — |
| SECONDARY Comparisons of Self-confidence Between Groups |
40; 90; 50; 100; 90; 100 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03073005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.