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The Effect of Simulation-based Training on Confidence and Competence in Obtaining Vitals in a Child With Autism

Primary Purpose

Autism Spectrum Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Intervention: online didactic lecture and educational simulation activity
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • [Primary study participants] any nurses and medical assistants employed in the pediatric clinics of HT3 and HT5.
  • [Secondary study participants] pediatric patients ages 1-17 years in HT3 and HT5 clinics with autism spectrum disorder who need vital signs obtained, accompanied by a parent or guardian who can read, write and understand written English.

Exclusion Criteria:

  • [Primary study participants] persons who are not nurses or medical assistants employed in the pediatric clinics of HT3 and HT5.
  • [Secondary study participants] any patients who do not have a diagnosis of Autism Spectrum Disorder documented in the medical record, are not between the ages of 1 and 17, do not need vital signs obtained at their visit, or are not accompanied by a parent/guardian who can read, write and understand written English.

Sites / Locations

  • Weill Cornell MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Educational Intervention: online didactic lecture and educational simulation activity

Caregiver Satisfaction

Arm Description

The didactic was created by the research team and provides information on Autism Spectrum Disorder (ASD) and an approach to taking vital signs in these children. The didactic will be pre-recorded and sent by email to employee study participants. The didactic will last about 10 minutes. The simulation activity will have the premise of a child with ASD and their caregiver at clinic visit. The employee participant will be asked to take vital signs on the patient. The caregiver will be played by an actor and the child will be played by a mannequin. An iterative script will be used by the actor during the scenario. The simulation will last about 20 minutes and will be followed by a 10 minute debrief.

Caregivers who accompany their children with autism to the clinic will be surveyed for their comfort scores before and after the study participants' educational intervention

Outcomes

Primary Outcome Measures

Mean change from baseline in confidence scores on the employee questionnaire at weeks 10 and 16
Minimum score = 3 (least confident). Maximum score = 15 (most confident).
Mean change from baseline in competency scores on the employee questionnaire at weeks 10 and 16
Minimum score = 8 (least competent). Maximum score = 40 (most competent).

Secondary Outcome Measures

Mean change from baseline in knowledge scores on the employee questionnaire at weeks 10 and 16
Minimum score = 0 (least knowledgeable); Maximum score = 7 (most knowledgeable)
Mean change from baseline in caregiver satisfaction score on the caregiver survey between weeks 6-10 and 12-16
Least satisfied = 5. Most satisfied = 1.
Mean change in the number of times vital signs obtained between weeks 0-4, weeks 6-10, and weeks 12-16
Maximum # of times vital signs obtained = unknown. Minimum # of times vital signs obtained = 1.

Full Information

First Posted
March 11, 2022
Last Updated
February 27, 2023
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT05288868
Brief Title
The Effect of Simulation-based Training on Confidence and Competence in Obtaining Vitals in a Child With Autism
Official Title
The Effect of Simulation-based Training on Confidence and Competence in Obtaining Vitals in a Child With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 7, 2022 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The objective is to evaluate the efficacy of an online learning module combined with high fidelity simulation-based training in improving medical assistants' and registered nurses' self-confidence and competence scores in taking vital signs in a child with Autism Spectrum Disorder in clinic. The study will explore the efficacy of high-fidelity simulation which has not been studied to date as a training modality for teaching healthcare workers about Autism Spectrum Disorder. The investigators will also evaluate patient encounter data to provide insight into trainees' transformation of knowledge into clinical practice. The hypothesis is that nurses and medical assistants who participate in an online learning module combined with simulation-based training will demonstrate improved self-confidence and competence scores in evaluating children with Autism.
Detailed Description
The study is an interrupted time series design trial. The employee participants will undergo two educational interventions: an online didactic lecture and an educational simulation activity. These activities are both standard educational activities. The online didactic lecture will be recorded and viewed by the participant within a two-week time frame. The simulation activity will be completed in a clinic room in Helmsley Tower 3 or 5 which is an accepted WCM educational setting. An iterative script will be used for the simulation. The recruitment period for primary study population will last 4 weeks (Week 0 - Week 4). During this period employee participants will be emailed the study invitation letter, consent form, and survey. A roster of participant names and email addresses will be collected from the consent forms and used throughout the study to email study participants to complete the surveys and participate in the educational interventions. At the start of Week 4 the employee participants will be emailed an online didactic lecture on taking vital signs in children with ASD and they will have 2 weeks to complete the lecture. At the start of Week 9 the employees will be emailed a second survey (post-didactic survey) and will have 1 week to complete it. Prior to week 10 the participants will be emailed to set up a time for their simulation. Then, between Weeks 10-12 they will participate in a simulation activity. At the start of Weeks 15 the participants will be emailed the final survey (post-simulation survey) which they will have 1 week to complete. The employee survey will be completed on RedCap and consist of knowledge assessment questions and self-assessment questions. Parent/guardian surveys will be administered and collected throughout the duration of the study (16 weeks). The parent/guardian surveys will be completed through RedCap or on paper. All surveys completed on paper will not ask for identifying information. A consent document will be provided to participants but will not require a signature for parents electing to complete the survey anonymously on paper. All surveys completed through RedCap will include questions that have identifying information and informed consent will be obtained for participants enrolling in this part of the study. Both the paper and RedCap surveys for guardians will consist of questions inquiring about prior difficulties their child had when having vitals taken, the degree of distress of their child while vital signs were taken during this encounter, strategies the nurse or medical assistant used to approach taking vital signs, and how helpful the strategies were. The number or vital signs obtained during the visit and the duration of time from check-in to rooming will be collected from patient chart review. The patient data will not be linked to data collected from the nurses and medical assistants or to nurses or medical assistants involved in the encounter. The didactic was created by the research team and provides information on Autism Spectrum Disorder and an approach to taking vital signs in these children. The didactic will be pre-recorded and sent by email to employee study participants. The didactic will last about 10 minutes. The simulation activity will have the premise of a child with ASD and their caregiver at clinic visit. The employee participant will be asked to take vital signs on the patient. The caregiver will be played by an actor and the child will be played by a mannequin. An iterative script will be used by the actor during the scenario. The simulation will last about 20 minutes and will be followed by a 10 minute debrief.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Educational Intervention: online didactic lecture and educational simulation activity
Arm Type
Experimental
Arm Description
The didactic was created by the research team and provides information on Autism Spectrum Disorder (ASD) and an approach to taking vital signs in these children. The didactic will be pre-recorded and sent by email to employee study participants. The didactic will last about 10 minutes. The simulation activity will have the premise of a child with ASD and their caregiver at clinic visit. The employee participant will be asked to take vital signs on the patient. The caregiver will be played by an actor and the child will be played by a mannequin. An iterative script will be used by the actor during the scenario. The simulation will last about 20 minutes and will be followed by a 10 minute debrief.
Arm Title
Caregiver Satisfaction
Arm Type
No Intervention
Arm Description
Caregivers who accompany their children with autism to the clinic will be surveyed for their comfort scores before and after the study participants' educational intervention
Intervention Type
Other
Intervention Name(s)
Educational Intervention: online didactic lecture and educational simulation activity
Intervention Description
The didactic was created by the research team and provides information on Autism Spectrum Disorder (ASD) and an approach to taking vital signs in these children. The didactic will be pre-recorded and sent by email to employee study participants. The didactic will last about 10 minutes. The simulation activity will have the premise of a child with ASD and their caregiver at clinic visit. The employee participant will be asked to take vital signs on the patient. The caregiver will be played by an actor and the child will be played by a mannequin. An iterative script will be used by the actor during the scenario. The simulation will last about 20 minutes and will be followed by a 10 minute debrief.
Primary Outcome Measure Information:
Title
Mean change from baseline in confidence scores on the employee questionnaire at weeks 10 and 16
Description
Minimum score = 3 (least confident). Maximum score = 15 (most confident).
Time Frame
0 weeks = baseline; 10 weeks = interim survey; 16 weeks = final survey
Title
Mean change from baseline in competency scores on the employee questionnaire at weeks 10 and 16
Description
Minimum score = 8 (least competent). Maximum score = 40 (most competent).
Time Frame
0 weeks = baseline; 10 weeks = interim survey; 16 weeks = final survey
Secondary Outcome Measure Information:
Title
Mean change from baseline in knowledge scores on the employee questionnaire at weeks 10 and 16
Description
Minimum score = 0 (least knowledgeable); Maximum score = 7 (most knowledgeable)
Time Frame
0 weeks = baseline; 10 weeks = interim survey; 16 weeks = final survey
Title
Mean change from baseline in caregiver satisfaction score on the caregiver survey between weeks 6-10 and 12-16
Description
Least satisfied = 5. Most satisfied = 1.
Time Frame
0 weeks = baseline; 6-10 weeks = interim survey; 12-16 weeks = final survey
Title
Mean change in the number of times vital signs obtained between weeks 0-4, weeks 6-10, and weeks 12-16
Description
Maximum # of times vital signs obtained = unknown. Minimum # of times vital signs obtained = 1.
Time Frame
0 weeks = baseline; 6-10 weeks = interim survey; 12-16 weeks = final survey

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: [Primary study participants] any nurses and medical assistants employed in the pediatric clinics of HT3 and HT5. [Secondary study participants] pediatric patients ages 1-17 years in HT3 and HT5 clinics with autism spectrum disorder who need vital signs obtained, accompanied by a parent or guardian who can read, write and understand written English. Exclusion Criteria: [Primary study participants] persons who are not nurses or medical assistants employed in the pediatric clinics of HT3 and HT5. [Secondary study participants] any patients who do not have a diagnosis of Autism Spectrum Disorder documented in the medical record, are not between the ages of 1 and 17, do not need vital signs obtained at their visit, or are not accompanied by a parent/guardian who can read, write and understand written English.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Ching
Phone
2127460871
Email
kec9012@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Ching
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Ching, MD
Phone
212-746-0871
Email
kec9012@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Leida Voulgaropoulos, MD
Email
lev9033@nyp.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Simulation-based Training on Confidence and Competence in Obtaining Vitals in a Child With Autism

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