Trial Outcomes & Findings for Use of Simulation to Improve VAD Self-management (NCT NCT03073005)

Last Updated: 2021-05-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

143 participants

Primary outcome timeframe

3 months

Results posted on

2021-05-10

Participant Flow

Participant milestones

Participant milestones
Measure	Traditional VAD Training (Patients) Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Traditional VAD Training (Caregivers) Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Simulation-based VAD Training (Patients) Patients 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.	Simulation-based VAD Training (Caregivers) 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.
Overall Study STARTED	33	37	36	37
Overall Study Received Initial Training	29	29	33	33
Overall Study COMPLETED	25	25	24	24
Overall Study NOT COMPLETED	8	12	12	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Traditional VAD Training (Patients) Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Traditional VAD Training (Caregivers) Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Simulation-based VAD Training (Patients) Patients 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.	Simulation-based VAD Training (Caregivers) 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.
Overall Study Death	6	0	7	0
Overall Study caregiver withdrew bc of pt death	0	6	0	7
Overall Study Lost to Follow-up	2	2	1	2
Overall Study Withdrawal by Subject	0	4	4	4

Baseline Characteristics

ONLY SBML-trained patients and caregivers took a baseline exam. Traditionally-trained patients and caregivers scores in the study were considered their "baseline". Those are reported in the outcomes section. \*dressing change is for caregivers only

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Traditional VAD Training (Patients) n=33 Participants Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Traditional VAD Training (Caregivers) n=37 Participants Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Simulation-based VAD Training (Patients) n=36 Participants 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.	Simulation-based VAD Training (Caregivers) n=37 Participants 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.	Total n=143 Participants Total of all reporting groups
Age, Continuous	54.91 years STANDARD_DEVIATION 13.25 • n=33 Participants	53.43 years STANDARD_DEVIATION 14.95 • n=37 Participants	51.33 years STANDARD_DEVIATION 14.54 • n=36 Participants	55.28 years STANDARD_DEVIATION 12.68 • n=37 Participants	53.71 years STANDARD_DEVIATION 13.85 • n=143 Participants
Sex: Female, Male Female	9 Participants n=33 Participants	30 Participants n=37 Participants	10 Participants n=36 Participants	27 Participants n=37 Participants	76 Participants n=143 Participants
Sex: Female, Male Male	24 Participants n=33 Participants	7 Participants n=37 Participants	26 Participants n=36 Participants	10 Participants n=37 Participants	67 Participants n=143 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=33 Participants	2 Participants n=37 Participants	6 Participants n=36 Participants	4 Participants n=37 Participants	15 Participants n=143 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=33 Participants	35 Participants n=37 Participants	30 Participants n=36 Participants	33 Participants n=37 Participants	128 Participants n=143 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=33 Participants	0 Participants n=37 Participants	0 Participants n=36 Participants	0 Participants n=37 Participants	0 Participants n=143 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=33 Participants	0 Participants n=37 Participants	1 Participants n=36 Participants	1 Participants n=37 Participants	2 Participants n=143 Participants
Race (NIH/OMB) Asian	1 Participants n=33 Participants	1 Participants n=37 Participants	2 Participants n=36 Participants	1 Participants n=37 Participants	5 Participants n=143 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=33 Participants	0 Participants n=37 Participants	0 Participants n=36 Participants	0 Participants n=37 Participants	0 Participants n=143 Participants
Race (NIH/OMB) Black or African American	11 Participants n=33 Participants	14 Participants n=37 Participants	12 Participants n=36 Participants	12 Participants n=37 Participants	49 Participants n=143 Participants
Race (NIH/OMB) White	19 Participants n=33 Participants	21 Participants n=37 Participants	20 Participants n=36 Participants	22 Participants n=37 Participants	82 Participants n=143 Participants
Race (NIH/OMB) More than one race	0 Participants n=33 Participants	0 Participants n=37 Participants	0 Participants n=36 Participants	0 Participants n=37 Participants	0 Participants n=143 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=33 Participants	1 Participants n=37 Participants	1 Participants n=36 Participants	1 Participants n=37 Participants	5 Participants n=143 Participants
Region of Enrollment United States	33 participants n=33 Participants	37 participants n=37 Participants	36 participants n=36 Participants	37 participants n=37 Participants	143 participants n=143 Participants
Baseline VAD Checklist Skills Controller change	—	—	21.42 percent of items correct on checklist n=36 Participants • ONLY SBML-trained patients and caregivers took a baseline exam. Traditionally-trained patients and caregivers scores in the study were considered their "baseline". Those are reported in the outcomes section. \*dressing change is for caregivers only	28.57 percent of items correct on checklist n=37 Participants • ONLY SBML-trained patients and caregivers took a baseline exam. Traditionally-trained patients and caregivers scores in the study were considered their "baseline". Those are reported in the outcomes section. \*dressing change is for caregivers only	24.04 percent of items correct on checklist n=73 Participants • ONLY SBML-trained patients and caregivers took a baseline exam. Traditionally-trained patients and caregivers scores in the study were considered their "baseline". Those are reported in the outcomes section. \*dressing change is for caregivers only
Baseline VAD Checklist Skills Power source change	—	—	22.22 percent of items correct on checklist n=36 Participants • ONLY SBML-trained patients and caregivers took a baseline exam. Traditionally-trained patients and caregivers scores in the study were considered their "baseline". Those are reported in the outcomes section. \*dressing change is for caregivers only	76.39 percent of items correct on checklist n=37 Participants • ONLY SBML-trained patients and caregivers took a baseline exam. Traditionally-trained patients and caregivers scores in the study were considered their "baseline". Those are reported in the outcomes section. \*dressing change is for caregivers only	55.56 percent of items correct on checklist n=73 Participants • ONLY SBML-trained patients and caregivers took a baseline exam. Traditionally-trained patients and caregivers scores in the study were considered their "baseline". Those are reported in the outcomes section. \*dressing change is for caregivers only
Baseline VAD Checklist Skills Dressing change	—	—	—	23.44 percent of items correct on checklist n=37 Participants • ONLY SBML-trained patients and caregivers took a baseline exam. Traditionally-trained patients and caregivers scores in the study were considered their "baseline". Those are reported in the outcomes section. \*dressing change is for caregivers only	23.44 percent of items correct on checklist n=37 Participants • ONLY SBML-trained patients and caregivers took a baseline exam. Traditionally-trained patients and caregivers scores in the study were considered their "baseline". Those are reported in the outcomes section. \*dressing change is for caregivers only

PRIMARY outcome

Timeframe: 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.)

Outcome measures

Outcome measures
Measure	Traditional VAD Training (Patients) n=25 Participants Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Traditional VAD Training (Caregivers) n=25 Participants Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Simulation-based VAD Training (Patients) n=24 Participants Patients 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.	Simulation-based VAD Training (Caregivers) n=24 Participants 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.
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 Interval 97.1 to 100.0	97.1 percentage of checklist items correct Interval 97.1 to 100.0	100 percentage of checklist items correct Interval 97.1 to 100.0	100 percentage of checklist items correct Interval 97.1 to 100.0
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 Interval 78.6 to 100.0	100 percentage of checklist items correct Interval 100.0 to 100.0	100 percentage of checklist items correct Interval 100.0 to 100.0	100 percentage of checklist items correct Interval 100.0 to 100.0
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 Interval 88.9 to 88.9	88.9 percentage of checklist items correct Interval 88.9 to 96.2	100 percentage of checklist items correct Interval 100.0 to 100.0	100 percentage of checklist items correct Interval 100.0 to 100.0
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 Interval 68.8 to 87.5	—	100 percentage of checklist items correct Interval 100.0 to 100.0

SECONDARY outcome

Timeframe: 3 months after discharge

Population: This outcome is for patients only

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

Outcome measures

Outcome measures
Measure	Traditional VAD Training (Patients) n=25 Participants Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Traditional VAD Training (Caregivers) n=24 Participants Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Simulation-based VAD Training (Patients) Patients 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.	Simulation-based VAD Training (Caregivers) 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.
Infections and Re-hospitalizations up to 3 Months After VAD Implant Infections	6 Participants	0 Participants	—	—
Infections and Re-hospitalizations up to 3 Months After VAD Implant Re-hospitalizations	20 Participants	15 Participants	—	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Traditional VAD Training (Patients) n=20 Participants Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Traditional VAD Training (Caregivers) n=20 Participants Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Simulation-based VAD Training (Patients) n=15 Participants Patients 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.	Simulation-based VAD Training (Caregivers) n=15 Participants 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.
Self-management Skill Decay in the Five Domains One month controller change	—	—	100 percentage of checklist items correct Interval 78.57 to 100.0	100 percentage of checklist items correct Interval 100.0 to 100.0
Self-management Skill Decay in the Five Domains One month power source change	—	—	100 percentage of checklist items correct Interval 100.0 to 100.0	100 percentage of checklist items correct Interval 100.0 to 100.0
Self-management Skill Decay in the Five Domains One month dressing change	—	—	—	100 percentage of checklist items correct Interval 90.63 to 100.0
Self-management Skill Decay in the Five Domains 3 month controller change	85.71 percentage of checklist items correct Interval 62.5 to 100.0	78.57 percentage of checklist items correct Interval 28.57 to 100.0	100 percentage of checklist items correct Interval 78.57 to 100.0	100 percentage of checklist items correct Interval 100.0 to 100.0
Self-management Skill Decay in the Five Domains 3 month power source change	88.89 percentage of checklist items correct Interval 88.89 to 97.22	88.89 percentage of checklist items correct Interval 88.89 to 88.89	100 percentage of checklist items correct Interval 100.0 to 100.0	100 percentage of checklist items correct Interval 100.0 to 100.0
Self-management Skill Decay in the Five Domains 3 month dressing change	—	78.13 percentage of checklist items correct Interval 67.99 to 86.42	—	100 percentage of checklist items correct Interval 93.75 to 100.0

SECONDARY outcome

Timeframe: 3 months

Population: patients and caregiver who completed training through hospital discharge

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.

Outcome measures

Outcome measures
Measure	Traditional VAD Training (Patients) n=25 Participants Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Traditional VAD Training (Caregivers) n=25 Participants Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Simulation-based VAD Training (Patients) n=24 Participants Patients 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.	Simulation-based VAD Training (Caregivers) n=24 Participants 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.
Comparisons of Self-confidence Between Groups VAD Driveline exit site sterile dressing changes	40 score on a scale Interval 10.0 to 65.0	90 score on a scale Interval 75.0 to 100.0	50 score on a scale Interval 0.0 to 87.5	100 score on a scale Interval 90.0 to 100.0
Comparisons of Self-confidence Between Groups Changing the VAD controller during emergencies	90 score on a scale Interval 72.5 to 100.0	100 score on a scale Interval 90.0 to 100.0	95 score on a scale Interval 80.0 to 100.0	100 score on a scale Interval 92.5 to 100.0
Comparisons of Self-confidence Between Groups Changing power sources on the VAD	100 score on a scale Interval 92.5 to 100.0	100 score on a scale Interval 95.0 to 100.0	100 score on a scale Interval 90.0 to 100.0	100 score on a scale Interval 100.0 to 100.0
Comparisons of Self-confidence Between Groups Troubleshooting emergency VAD-related malfunction	90 score on a scale Interval 80.0 to 100.0	90 score on a scale Interval 70.0 to 100.0	90 score on a scale Interval 80.0 to 100.0	95 score on a scale Interval 72.5 to 100.0
Comparisons of Self-confidence Between Groups Recognizing VAD-specific signs and symptoms	100 score on a scale Interval 80.0 to 100.0	100 score on a scale Interval 75.0 to 100.0	100 score on a scale Interval 92.5 to 100.0	100 score on a scale Interval 90.0 to 100.0

Adverse Events

Traditional VAD Training (Patients)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Simulation-based VAD Training (Patients)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 10 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jeffrey H Barsuk

Northwestern University

Phone: 312-926-5924

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place