SimVAD: Use of Simulation to Improve VAD Self-management

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03073005
• Collaborator: National Institute of Nursing Research (NINR) (NIH)
• Enrollment: 143
• Location: 1
• Arms: 2
• Actual Duration (Months): 28.9
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Other: Simulation-based Mastery Learning (SBML)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 143 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Use of Simulation to Improve Ventricular Assist Device Self-management
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: Oct 30, 2019
• Actual Study Completion Date: Oct 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Traditional VAD training Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.
Experimental: Simulation-based VAD training 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	Other: 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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• National Institute of Nursing Research (NINR)

Investigators

• Principal Investigator: Jeffrey Barsuk, MD, Northwestern University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 3, 2017

More Information

Publications

None provided.

• Responsible Party: Jeffrey Barsuk, Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT03073005
• Other Study ID Numbers: STU00203530; 5R21NR016745-02
• First Posted: Mar 8, 2017
• Last Update Posted: May 10, 2021
• Last Verified: May 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Jeffrey Barsuk, Professor, Northwestern University: ventricular assist device (VAD); heart failure; simulation
• Additional relevant MeSH terms: Heart Failure

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Traditional VAD Training (Patients)	Traditional VAD Training (Caregivers)	Simulation-based VAD Training (Patients)	Simulation-based VAD Training (Caregivers)	Total
Arm/Group Description	Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.	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.	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 of all reporting groups
Overall Participants	33	37	36	37	143
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.91 (13.25)	53.43 (14.95)	51.33 (14.54)	55.28 (12.68)	53.71 (13.85)
Sex: Female, Male (Count of Participants)
Female	9 27.3%	30 81.1%	10 27.8%	27 73%	76 53.1%
Male	24 72.7%	7 18.9%	26 72.2%	10 27%	67 46.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 9.1%	2 5.4%	6 16.7%	4 10.8%	15 10.5%
Not Hispanic or Latino	30 90.9%	35 94.6%	30 83.3%	33 89.2%	128 89.5%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	1 2.8%	1 2.7%	2 1.4%
Asian	1 3%	1 2.7%	2 5.6%	1 2.7%	5 3.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	11 33.3%	14 37.8%	12 33.3%	12 32.4%	49 34.3%
White	19 57.6%	21 56.8%	20 55.6%	22 59.5%	82 57.3%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	2 6.1%	1 2.7%	1 2.8%	1 2.7%	5 3.5%
Region of Enrollment (participants) [Number]
United States	33 100%	37 100%	36 100%	37 100%	143 100%
Baseline VAD Checklist Skills (percent of items correct on checklist) [Median (Inter-Quartile Range) ]
Controller change	21.42	28.57	24.04
Power source change	22.22	76.39	55.56
Dressing change	23.44	23.44

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

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/Group Title	Traditional VAD Training (Patients)	Traditional VAD Training (Caregivers)	Simulation-based VAD Training (Patients)	Simulation-based VAD Training (Caregivers)
Arm/Group Description	Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.	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.	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.
Measure Participants	25	25	24	24
Written examination	100	97.1	100	100
Controller change	92.9	100	100	100
Power source change	88.9	88.9	100	100
Dressing change	81.3	100

2. Secondary Outcome

Title	Infections and Re-hospitalizations up to 3 Months After VAD Implant
Description	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

Outcome Measure Data

Analysis Population Description

This outcome is for patients only

Arm/Group Title	Traditional VAD Training (Patients)	Simulation-based VAD Training (Patients)
Arm/Group Description	Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.	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.
Measure Participants	25	24
Infections	6 18.2%	0 0%
Re-hospitalizations	20 60.6%	15 40.5%

3. Secondary Outcome

Title	Self-management Skill Decay in the Five Domains
Description	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)

Outcome Measure Data

Analysis Population Description

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/Group Title	Traditional VAD Training (Patients)	Traditional VAD Training (Caregivers)	Simulation-based VAD Training (Patients)	Simulation-based VAD Training (Caregivers)
Arm/Group Description	Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.	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.	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.
Measure Participants	20	20	15	15
One month controller change	100	100
One month power source change	100	100
One month dressing change	100
3 month controller change	85.71	78.57	100	100
3 month power source change	88.89	88.89	100	100
3 month dressing change	78.13	100

4. Secondary Outcome

Title	Comparisons of Self-confidence Between Groups
Description	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

Outcome Measure Data

Analysis Population Description

patients and caregiver who completed training through hospital discharge

Arm/Group Title	Traditional VAD Training (Patients)	Traditional VAD Training (Caregivers)	Simulation-based VAD Training (Patients)	Simulation-based VAD Training (Caregivers)
Arm/Group Description	Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.	Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.	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.	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.
Measure Participants	25	25	24	24
VAD Driveline exit site sterile dressing changes	40	90	50	100
Changing the VAD controller during emergencies	90	100	95	100
Changing power sources on the VAD	100	100	100	100
Troubleshooting emergency VAD-related malfunction	90	90	90	95
Recognizing VAD-specific signs and symptoms	100	100	100	100

Adverse Events

Time Frame	1 year post patient discharge
Adverse Event Reporting Description	NOTE: All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed in "Traditional VAD Training (Caregivers)" and "Simulation-based VAD Training (Caregivers)" participants because they are not followed clinically as part of this study.
Arm/Group Title	Traditional VAD Training (Patients)		Simulation-based VAD Training (Patients)
Arm/Group Description	Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer.		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.
All Cause Mortality
	Traditional VAD Training (Patients)		Simulation-based VAD Training (Patients)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/33 (30.3%)		10/36 (27.8%)
Serious Adverse Events
	Traditional VAD Training (Patients)		Simulation-based VAD Training (Patients)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	Traditional VAD Training (Patients)		Simulation-based VAD Training (Patients)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/33 (0%)		0/36 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.