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| ID | Type | Description | Link |
|---|---|---|---|
| 5R21NR016745-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional VAD training | No Intervention | Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer. | |
| Simulation-based VAD training | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 months after discharge |
| Self-management Skill Decay in the Five Domains |
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Patient Inclusion Criteria:
Caregiver inclusion criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Barsuk, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31601111 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Traditional VAD Training (Patients) | Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer. |
| FG001 | Traditional VAD Training (Caregivers) | Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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in order to be considered for final analysis both the patient participant plus their caregiver (pairs) must still be enrolled in the study
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| ID | Title | Description |
|---|---|---|
| BG000 | Traditional VAD Training (Patients) | Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer. |
| BG001 | Traditional VAD Training (Caregivers) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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.) | Posted | Median | Inter-Quartile Range | percentage of checklist items correct | 3 months |
|
1 year post patient discharge
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Traditional VAD Training (Patients) | Patients will receive traditional training for their VAD via a video produced by the VAD manufacturer. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey H Barsuk | Northwestern University | 312-926-5924 | jbarsuk@nm.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 3, 2017 | Sep 9, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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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. |
| 1 month and 3 months after discharge (*1 month SBML-trained only) |
| 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. | 3 months |
| caregiver withdrew bc of pt death |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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Patients and caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer.
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline VAD Checklist Skills | Baseline skills assessed via checklists for SBML-trained patients and caregivers ONLY on controller change, power source change and dressing change (caregiver only). Scored in terms of percent checklist items correct. | 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 | Median | Inter-Quartile Range | percent of items correct on checklist |
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| OG001 | Traditional VAD Training (Caregivers) | Caregivers will receive traditional training for their VAD via a video produced by the VAD manufacturer. |
| OG002 | 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. |
| OG003 | 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. |
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| 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 | This outcome is for patients only | Posted | Count of Participants | Participants | 3 months after discharge |
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| 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. | 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. | Posted | Median | Inter-Quartile Range | percentage of checklist items correct | 1 month and 3 months after discharge (*1 month SBML-trained only) |
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| 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. | patients and caregiver who completed training through hospital discharge | Posted | Median | Inter-Quartile Range | score on a scale | 3 months |
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| 10 |
| 33 |
| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | 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. | 10 | 36 | 0 | 36 | 0 | 36 |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| Title | Measurements |
|---|---|
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| One month power source change |
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| One month dressing change |
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| 3 month controller change |
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| 3 month power source change |
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| 3 month dressing change |
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| Changing the VAD controller during emergencies |
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| Changing power sources on the VAD |
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| Troubleshooting emergency VAD-related malfunction |
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| Recognizing VAD-specific signs and symptoms |
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