Clinical trial NCT03073005: Use of Simulation to Improve VAD Self-management
Official title: Use of Simulation to Improve Ventricular Assist Device Self-management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: ventricular assist device (VAD)
heart failure
simulation
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-03-08
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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

Primary outcomes:
measure: Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups
timeFrame: 3 months
Secondary outcomes:
measure: Infections and Re-hospitalizations up to 3 Months After VAD Implant
timeFrame: 3 months after discharge
measure: Self-management Skill Decay in the Five Domains
timeFrame: 1 month and 3 months after discharge (*1 month SBML-trained only)
measure: Comparisons of Self-confidence Between Groups
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Jeffrey Barsuk, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.