Autism Spectrum DisorderNCT05288868
The Effect of Simulation-based Training on Confidence and Competence in Obtaining Vitals in a Child With Autism
A study testing Educational Intervention: online didactic lecture and educational simulation activity in people with Autism Spectrum Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Educational Intervention: online didactic lecture and educational simulation activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2022to 8 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- [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.
Who cannot join
- [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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Educational Intervention: online didactic lecture and educational simulation activity
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Intervention: online didactic lecture and educational simulation activityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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
Minimum score = 0 (least knowledgeable); Maximum score = 7 (most knowledgeable)
Measured: 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
Least satisfied = 5. Most satisfied = 1.
Measured: 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
Maximum # of times vital signs obtained = unknown. Minimum # of times vital signs obtained = 1.
Measured: 0 weeks = baseline; 6-10 weeks = interim survey; 12-16 weeks = final survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start7 Jun 2022
- Primary completion8 May 2024
- Study completion8 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Ching, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288868
- Sponsor's protocol ID
- 21-05023509
- Status last verified
- Nov 2024
- First submitted
- 11 Mar 2022
- Last updated
- 5 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Simulation-based Training on Confidence and Competence in Obtaining Vitals in a Child With Autism
- ClinicalTrials.gov ID
- NCT05288868
- Acronym / sponsor ID
- 21-05023509
- Conditions
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 8 May 2024 (actual)
- Study completion
- 8 May 2024 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Educational Intervention: online didactic lecture and educational simulation activity | Experimental | Other: Educational Intervention: online didactic lecture and educational simulation activityThe 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. |
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- [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.
Key exclusion criteria (2 listed)
- [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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Intervention: online didactic lecture and educational simulation activityThe 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 |
Primary outcome
Mean change from baseline in confidence scores on the employee questionnaire at weeks 10 and 16
Time frame: 0 weeks = baseline; 10 weeks = interim survey; 16 weeks = final survey
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
Time frame: 0 weeks = baseline; 10 weeks = interim survey; 16 weeks = final survey
Minimum score = 8 (least competent). Maximum score = 40 (most competent).
3 secondary outcomes
Mean change from baseline in knowledge scores on the employee questionnaire at weeks 10 and 16
Time frame: 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
Time frame: 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
Time frame: 0 weeks = baseline; 6-10 weeks = interim survey; 12-16 weeks = final survey
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Ching principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention: online didactic lecture and educational simulation activity in people with Autism Spectrum Disorder, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from baseline in confidence scores on the employee questionnaire at weeks 10 and 16 (time frame: 0 weeks = baseline; 10 weeks = interim survey; 16 weeks = final survey). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.