Heart Failure
Conditions
Keywords
ventricular assist device (VAD), heart failure, simulation
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.
Interventions
OTHERSimulation-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.
Sponsors
National Institute of Nursing Research (NINR)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | 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
| Measure | Time frame | Description |
|---|---|---|
| Infections and Re-hospitalizations up to 3 Months After VAD Implant | 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 |
| Self-management Skill Decay in the Five Domains | 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. |
| Comparisons of Self-confidence Between Groups | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Traditional VAD Training (Patients) Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer. | 33 |
| Traditional VAD Training (Caregivers) Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer. | 37 |
| Simulation-based VAD Training (Patients) 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
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. | 36 |
| Simulation-based VAD Training (Caregivers) 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
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. | 37 |
| Total | 143 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | caregiver withdrew bc of pt death | 0 | 6 | 0 | 7 |
| Overall Study | Death | 6 | 0 | 7 | 0 |
| Overall Study | Lost to Follow-up | 2 | 2 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 4 | 4 | 4 |
Baseline characteristics
| Characteristic | Traditional VAD Training (Patients) | Traditional VAD Training (Caregivers) | Simulation-based VAD Training (Patients) | Simulation-based VAD Training (Caregivers) | Total |
|---|---|---|---|---|---|
| Age, Continuous | 54.91 years STANDARD_DEVIATION 13.25 | 53.43 years STANDARD_DEVIATION 14.95 | 51.33 years STANDARD_DEVIATION 14.54 | 55.28 years STANDARD_DEVIATION 12.68 | 53.71 years STANDARD_DEVIATION 13.85 |
| Baseline VAD Checklist Skills Controller change | — | — | 21.42 percent of items correct on checklist | 28.57 percent of items correct on checklist | 24.04 percent of items correct on checklist |
| Baseline VAD Checklist Skills Dressing change | — | — | — | 23.44 percent of items correct on checklist | 23.44 percent of items correct on checklist |
| Baseline VAD Checklist Skills Power source change | — | — | 22.22 percent of items correct on checklist | 76.39 percent of items correct on checklist | 55.56 percent of items correct on checklist |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 2 Participants | 6 Participants | 4 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 30 Participants | 35 Participants | 30 Participants | 33 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 14 Participants | 12 Participants | 12 Participants | 49 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) White | 19 Participants | 21 Participants | 20 Participants | 22 Participants | 82 Participants |
| Region of Enrollment United States | 33 participants | 37 participants | 36 participants | 37 participants | 143 participants |
| Sex: Female, Male Female | 9 Participants | 30 Participants | 10 Participants | 27 Participants | 76 Participants |
| Sex: Female, Male Male | 24 Participants | 7 Participants | 26 Participants | 10 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 10 / 33 | 10 / 36 |
| other Total, other adverse events | 0 / 33 | 0 / 36 |
| serious Total, serious adverse events | 0 / 33 | 0 / 36 |
Outcome results
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.
Time frame: 3 months
Population: Patient and caregiver pairs were included if both the patient and their caregiver completed training and assessments through discharge testing. (\*Note- Only caregivers were assessed on dressing change as patients do not independently complete this task.)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Traditional VAD Training (Patients) | Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | Controller change | 92.9 percentage of checklist items correct |
| Traditional VAD Training (Patients) | Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | Written examination | 100 percentage of checklist items correct |
| Traditional VAD Training (Patients) | Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | Power source change | 88.9 percentage of checklist items correct |
| Traditional VAD Training (Caregivers) | Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | Controller change | 100 percentage of checklist items correct |
| Traditional VAD Training (Caregivers) | Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | Power source change | 88.9 percentage of checklist items correct |
| Traditional VAD Training (Caregivers) | Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | Written examination | 97.1 percentage of checklist items correct |
| Traditional VAD Training (Caregivers) | Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | Dressing change | 81.3 percentage of checklist items correct |
| Simulation-based VAD Training (Patients) | Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | Written examination | 100 percentage of checklist items correct |
| Simulation-based VAD Training (Patients) | Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | Controller change | 100 percentage of checklist items correct |
| Simulation-based VAD Training (Patients) | Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | Power source change | 100 percentage of checklist items correct |
| Simulation-based VAD Training (Caregivers) | Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | Dressing change | 100 percentage of checklist items correct |
| Simulation-based VAD Training (Caregivers) | Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | Written examination | 100 percentage of checklist items correct |
| Simulation-based VAD Training (Caregivers) | Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | Controller change | 100 percentage of checklist items correct |
| Simulation-based VAD Training (Caregivers) | Comparisons of VAD-care Checklist Assessment on the Patient and Written Examination Scores Between SBML and Usual Training Groups | Power source change | 100 percentage of checklist items correct |
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.
Time frame: 3 months
Population: patients and caregiver who completed training through hospital discharge
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Traditional VAD Training (Patients) | Comparisons of Self-confidence Between Groups | Troubleshooting emergency VAD-related malfunction | 90 score on a scale |
| Traditional VAD Training (Patients) | Comparisons of Self-confidence Between Groups | Changing the VAD controller during emergencies | 90 score on a scale |
| Traditional VAD Training (Patients) | Comparisons of Self-confidence Between Groups | Recognizing VAD-specific signs and symptoms | 100 score on a scale |
| Traditional VAD Training (Patients) | Comparisons of Self-confidence Between Groups | Changing power sources on the VAD | 100 score on a scale |
| Traditional VAD Training (Patients) | Comparisons of Self-confidence Between Groups | VAD Driveline exit site sterile dressing changes | 40 score on a scale |
| Traditional VAD Training (Caregivers) | Comparisons of Self-confidence Between Groups | Changing power sources on the VAD | 100 score on a scale |
| Traditional VAD Training (Caregivers) | Comparisons of Self-confidence Between Groups | Troubleshooting emergency VAD-related malfunction | 90 score on a scale |
| Traditional VAD Training (Caregivers) | Comparisons of Self-confidence Between Groups | Recognizing VAD-specific signs and symptoms | 100 score on a scale |
| Traditional VAD Training (Caregivers) | Comparisons of Self-confidence Between Groups | Changing the VAD controller during emergencies | 100 score on a scale |
| Traditional VAD Training (Caregivers) | Comparisons of Self-confidence Between Groups | VAD Driveline exit site sterile dressing changes | 90 score on a scale |
| Simulation-based VAD Training (Patients) | Comparisons of Self-confidence Between Groups | Changing power sources on the VAD | 100 score on a scale |
| Simulation-based VAD Training (Patients) | Comparisons of Self-confidence Between Groups | VAD Driveline exit site sterile dressing changes | 50 score on a scale |
| Simulation-based VAD Training (Patients) | Comparisons of Self-confidence Between Groups | Changing the VAD controller during emergencies | 95 score on a scale |
| Simulation-based VAD Training (Patients) | Comparisons of Self-confidence Between Groups | Troubleshooting emergency VAD-related malfunction | 90 score on a scale |
| Simulation-based VAD Training (Patients) | Comparisons of Self-confidence Between Groups | Recognizing VAD-specific signs and symptoms | 100 score on a scale |
| Simulation-based VAD Training (Caregivers) | Comparisons of Self-confidence Between Groups | Troubleshooting emergency VAD-related malfunction | 95 score on a scale |
| Simulation-based VAD Training (Caregivers) | Comparisons of Self-confidence Between Groups | Changing the VAD controller during emergencies | 100 score on a scale |
| Simulation-based VAD Training (Caregivers) | Comparisons of Self-confidence Between Groups | VAD Driveline exit site sterile dressing changes | 100 score on a scale |
| Simulation-based VAD Training (Caregivers) | Comparisons of Self-confidence Between Groups | Changing power sources on the VAD | 100 score on a scale |
| Simulation-based VAD Training (Caregivers) | Comparisons of Self-confidence Between Groups | Recognizing VAD-specific signs and symptoms | 100 score on a scale |
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
Time frame: 3 months after discharge
Population: This outcome is for patients only
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Traditional VAD Training (Patients) | Infections and Re-hospitalizations up to 3 Months After VAD Implant | Infections | 6 Participants |
| Traditional VAD Training (Patients) | Infections and Re-hospitalizations up to 3 Months After VAD Implant | Re-hospitalizations | 20 Participants |
| Traditional VAD Training (Caregivers) | Infections and Re-hospitalizations up to 3 Months After VAD Implant | Infections | 0 Participants |
| Traditional VAD Training (Caregivers) | Infections and Re-hospitalizations up to 3 Months After VAD Implant | Re-hospitalizations | 15 Participants |
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.
Time frame: 1 month and 3 months after discharge (*1 month SBML-trained only)
Population: Of the 49 patient and caregiver pairs who completed discharge testing, 15 patient and caregiver pairs in the SBML group completed 1 month and 3 month followup testing and 20 pairs in the usual care group completed 3 month follow-up testing only.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Traditional VAD Training (Patients) | Self-management Skill Decay in the Five Domains | 3 month controller change | 85.71 percentage of checklist items correct |
| Traditional VAD Training (Patients) | Self-management Skill Decay in the Five Domains | 3 month power source change | 88.89 percentage of checklist items correct |
| Traditional VAD Training (Caregivers) | Self-management Skill Decay in the Five Domains | 3 month controller change | 78.57 percentage of checklist items correct |
| Traditional VAD Training (Caregivers) | Self-management Skill Decay in the Five Domains | 3 month dressing change | 78.13 percentage of checklist items correct |
| Traditional VAD Training (Caregivers) | Self-management Skill Decay in the Five Domains | 3 month power source change | 88.89 percentage of checklist items correct |
| Simulation-based VAD Training (Patients) | Self-management Skill Decay in the Five Domains | One month controller change | 100 percentage of checklist items correct |
| Simulation-based VAD Training (Patients) | Self-management Skill Decay in the Five Domains | One month power source change | 100 percentage of checklist items correct |
| Simulation-based VAD Training (Patients) | Self-management Skill Decay in the Five Domains | 3 month controller change | 100 percentage of checklist items correct |
| Simulation-based VAD Training (Patients) | Self-management Skill Decay in the Five Domains | 3 month power source change | 100 percentage of checklist items correct |
| Simulation-based VAD Training (Caregivers) | Self-management Skill Decay in the Five Domains | One month dressing change | 100 percentage of checklist items correct |
| Simulation-based VAD Training (Caregivers) | Self-management Skill Decay in the Five Domains | One month power source change | 100 percentage of checklist items correct |
| Simulation-based VAD Training (Caregivers) | Self-management Skill Decay in the Five Domains | 3 month dressing change | 100 percentage of checklist items correct |
| Simulation-based VAD Training (Caregivers) | Self-management Skill Decay in the Five Domains | 3 month power source change | 100 percentage of checklist items correct |
| Simulation-based VAD Training (Caregivers) | Self-management Skill Decay in the Five Domains | One month controller change | 100 percentage of checklist items correct |
| Simulation-based VAD Training (Caregivers) | Self-management Skill Decay in the Five Domains | 3 month controller change | 100 percentage of checklist items correct |