NCT05288868

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 7, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2024

Completed
Last Updated

November 5, 2024

Status Verified

November 1, 2024

Enrollment Period

1.9 years

First QC Date

March 11, 2022

Last Update Submit

November 4, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

    0 weeks = baseline; 10 weeks = interim survey; 16 weeks = final survey

  • 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).

    0 weeks = baseline; 10 weeks = interim survey; 16 weeks = final survey

Secondary Outcomes (3)

  • Mean change from baseline in knowledge scores on the employee questionnaire at weeks 10 and 16

    0 weeks = baseline; 10 weeks = interim survey; 16 weeks = final survey

  • Mean change from baseline in caregiver satisfaction score on the caregiver survey between weeks 6-10 and 12-16

    0 weeks = baseline; 6-10 weeks = interim survey; 12-16 weeks = final survey

  • Mean change in the number of times vital signs obtained between weeks 0-4, weeks 6-10, and weeks 12-16

    0 weeks = baseline; 6-10 weeks = interim survey; 12-16 weeks = final survey

Study Arms (2)

Educational Intervention: online didactic lecture and educational simulation activity

EXPERIMENTAL

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.

Other: Educational Intervention: online didactic lecture and educational simulation activity

Caregiver Satisfaction

NO INTERVENTION

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

Interventions

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.

Educational Intervention: online didactic lecture and educational simulation activity

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \[Primary study participants\] 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.

You may not qualify if:

  • \[Primary study participants\] 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Kevin Ching

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2022

First Posted

March 21, 2022

Study Start

June 7, 2022

Primary Completion

May 8, 2024

Study Completion

May 8, 2024

Last Updated

November 5, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations