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Trial record 1 of 1 for:    NCT04308109
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Simulation Training in the Pediatric Tracheostomy and Home Ventilator Population

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ClinicalTrials.gov Identifier: NCT04308109
Recruitment Status : Recruiting
First Posted : March 13, 2020
Last Update Posted : March 13, 2020
Sponsor:
Collaborator:
Children's Hospital and Health System Foundation, Wisconsin
Information provided by (Responsible Party):
Jennifer Henningfeld, Medical College of Wisconsin

Brief Summary:
The investigators will develop, refine and pilot a highly-realistic simulation program that will allow caregivers opportunities to manage critical situations as it pertains to a medically complex child dependent on tracheostomy with or without home ventilation. The investigators hope to demonstrate that the use of highly realistic simulation training will improve hospital utilization as caregivers will have a more realistic understanding of clinical and equipment-related emergencies that may occur outpatient.

Condition or disease Intervention/treatment Phase
Tracheostomy Complication Simulation of Physical Illness Teach-Back Communication Behavioral: Simulation Not Applicable

Detailed Description:

The investigators propose a prospective randomized control trial evaluating the use of simulation to prepare caregivers for the discharge of children dependent on respiratory technology. All caregivers of children who are (1) inpatient with a newly placed tracheostomy tube and (2) anticipated to start discharge teaching after the first date of Institutional Review Board (IRB) approval will be enrolled, regardless of home ventilator need. Caregivers with prior experience caring for tracheostomies within the last 10 years will be excluded. Estimated sample size is 60 caregivers (trainees) (2 trained caregivers anticipated per child). Trainees must be able to speak and read English.

All trainees will be randomized by child (up to 4 per child) into one of three arms (Figure 1), stratified by the need for invasive home ventilation and randomized in blocks of four. All trainees will complete our current state of education including bedside education provided by Pediatric Intensive Care Unit (PICU) or Neonatal Intensive Care Unit (NICU) nursing staff and a formal classroom-based skills class (either a 'tracheostomy-only' or a 'tracheostomy/home ventilator' class) taught by a Children's Hospital of Wisconsin (CHW) Tracheostomy and Home Ventilator respiratory therapist or durable medical equipment company (DME) respiratory therapist, and an individual scenario-based review of equipment and skills workshop with a CHW Tracheostomy and Home Ventilator Respiratory Therapist.

In addition to the current state of education, the active study group will also undergo highly realistic simulation. This involves the use of a highly realistic tracheostomy mannequin and audiovisual devices which will be used to replicate emergent clinical situations. If home invasive ventilation is anticipated, a home ventilator will be used. The active control will undergo low-fidelity simulation that approximates the highly realistic clinical scenarios except with the use of a low-fidelity doll equipped with a tracheostomy and without the audiovisual inputs. Both active arms will occur in the simulation center or sleep lab and replicate the same clinical situations by the simulation instructor. After the simulation, participants will be debriefed by the instructor, who will use a tape of their session as a teaching tool.

Commonly encountered emergent outpatient problems to be simulated include 1) obstructed tracheostomy tube leading to the need for cardiopulmonary resuscitation; 2) bleeding from the tracheostomy tube; 3) acute desaturation and/or bradycardia; and 4) accidental decannulation. If invasive home ventilation is anticipated, ventilator alarm troubleshooting for high pressure alarms, low minute ventilation alarms, auto-cycling of the ventilator and water in the tubing will be included in the simulation.

All trainees will undergo a teach-back session with a CHW Tracheostomy and Home Ventilator Program respiratory therapist during which essential skills and responses to clinical situations are assessed. If a trainee passes this session, the respiratory therapist has determined that they have met criteria to move onto independent care sessions and the trainees have acquired the trach and home ventilator knowledge to provide care in the home. If a trainee fails this teach-back session, the information failed will be reviewed and the family will repeat the teach-back session until they pass and then move into independent care sessions. Independent care sessions are practical demonstrations of all skills needed to take care of the child at home. Independent care sessions are repeated until all skills have been passed. Teach-back and independent care sessions are part of the current state of education.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Simulation Training in the Pediatric Tracheostomy and Home Ventilator Population
Actual Study Start Date : September 22, 2017
Estimated Primary Completion Date : September 22, 2021
Estimated Study Completion Date : September 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers

Arm Intervention/treatment
No Intervention: Control
No intervention, the same as the current state of education. Caregivers will still complete the teaching and post-discharge surveys (QDTS and PDCDS) and be followed for a year after discharge.
Experimental: Active study
In addition to the current state of education, the active study group will undergo highly realistic simulation. This involves the use of a highly realistic tracheostomy mannequin and audiovisual devices which will be used to replicate emergent clinical situations. If home invasive ventilation is anticipated, a home ventilator will be used. Caregivers will complete the teaching and post-discharge surveys (QDTS and PDCDS) and be followed for a year after discharge.
Behavioral: Simulation
Simulation involves the use of a highly realistic tracheostomy mannequin and audiovisual devices which will be used to replicate emergent clinical situations. If home invasive ventilation is anticipated, a home ventilator will be used. The simulation will last approximately 2 hours and will end with reviewing the taped session as part of debriefing. Both active arms will occur in the simulation center or sleep lab and replicate the same clinical situations by the same simulation instructor.

Active Comparator: Active control
In addition to the current state of education, the active control will undergo low-fidelity simulation that approximates the highly realistic clinical scenarios except with the use of a low-fidelity doll equipped with a tracheostomy and without the audiovisual inputs. If home invasive ventilation is anticipated, a home ventilator will be used. Caregivers still complete the teaching and post-discharge surveys (QDTS and PDCDS) and be followed for a year after discharge.
Behavioral: Simulation
Simulation involves the use of a highly realistic tracheostomy mannequin and audiovisual devices which will be used to replicate emergent clinical situations. If home invasive ventilation is anticipated, a home ventilator will be used. The simulation will last approximately 2 hours and will end with reviewing the taped session as part of debriefing. Both active arms will occur in the simulation center or sleep lab and replicate the same clinical situations by the same simulation instructor.




Primary Outcome Measures :
  1. Teach-back session performance [ Time Frame: Within 4 weeks of hospital discharge ]
    Difference in Teach-back performance between active study and control groups. Measured from 0-24, with higher scores being better.

  2. Independent Care session performance [ Time Frame: Within 4 weeks of hospital discharge ]
    Independent Care performance between active study and control groups.

  3. Hospital length of stay [ Time Frame: First teaching session to discharge, an average of 4 weeks ]
    Difference in hospital length of stay between active study and active control groups. Measured from 0-7, with higher scores being better.

  4. Phone Calls [ Time Frame: 1 year after initial discharge ]
    Difference in number of Phone Calls (from participants to medical providers/home care company) between active and control groups.

  5. Number of Hospital Re-admissions/Emergency Room (ER) visits [ Time Frame: 1 year after initial discharge ]
    Difference in the number of Hospital Re-admissions/ER visit counts between active and control groups.


Secondary Outcome Measures :
  1. Quality of discharge teaching scores [ Time Frame: Within 48 hours of initial hospital discharge ]
    Quality of Discharge Teaching Scale measured on day of discharge; scale of 0 to 10; very high/very low scores indicate stronger opinions

  2. Caregiver post-discharge coping scores [ Time Frame: Scale administered 24 hours after discharge and about 1 month after discharge ]
    Post Discharge Coping Difficulty Scale administered 24 hours after discharge and at first Tracheostomy/Home Ventilator clinic visit; scale of 0 to 10; very high/very low scores indicate stronger opinions



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Anticipated count of 90 participants includes 30 patients and 60 caregivers (2 per patient). Caregivers are the primary subjects, and patients are enrolled so the investigators can use their medical records.

Caregivers:

Inclusion Criteria

  • Must be able to read and speak English
  • Caring for a patient with a tracheostomy being discharged from the NICU/PICU for the first time

Exclusion Criteria

- Can not have cared for a child with a tracheostomy in the last 10 years


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04308109


Contacts
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Contact: Jennifer Henningfeld, MD 4142666730 jhenningfeld@mcw.edu
Contact: Thomas M Wade, BS 4142665435 tmwade@mcw.edu

Locations
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United States, Wisconsin
Children's Hospital of Wisconsin Recruiting
Wauwatosa, Wisconsin, United States, 53226
Contact: Jennifer Henningfeld, MD    414-266-6730    jhenningfeld@mcw.edu   
Sponsors and Collaborators
Medical College of Wisconsin
Children's Hospital and Health System Foundation, Wisconsin
Investigators
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Principal Investigator: Jennifer Henningfeld, MD Medical College of Wisconsin
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Responsible Party: Jennifer Henningfeld, Assistant Professor, Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT04308109    
Other Study ID Numbers: 979984
First Posted: March 13, 2020    Key Record Dates
Last Update Posted: March 13, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jennifer Henningfeld, Medical College of Wisconsin:
Simulation
Teach-back
Caregiver