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Completed

NCT Number: NCT03073005

Use of Simulation to Improve VAD Self-management

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups

    Time frame: 3 months

    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 outcomes

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

    Time frame: 3 months after discharge

    All VAD related driveline infections and re-hospitalizations between the SBML intervention group as compared to the usual VAD training group

  2. Self-management Skill Decay in the Five Domains

    Time frame: 1 month and 3 months after discharge (*1 month SBML-trained only)

    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.

  3. Comparisons of Self-confidence Between Groups

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Official study title

Use of Simulation to Improve Ventricular Assist Device Self-management

Acronym: SimVAD

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2017
Registry last updated
May 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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