Simulation-Based Training for Autism

Overseen By Kevin Ching

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Weill Medical College of Cornell University

Disqualifiers: Non-nurses, Non-medical assistants, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

84 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to improve the confidence and skills of medical assistants and nurses in taking vital signs in children with Autism Spectrum Disorder. Participants will watch an online video lesson and practice what they've learned in a realistic training session. The goal is to make them more comfortable and effective in their roles.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Educational Intervention, PRE-ACT Model, Patient Navigator Model for autism?

The Patient Navigator Model has been shown to improve access to services for children with autism, particularly in reducing disparities in care for vulnerable populations. Additionally, simulation-based education, similar to the PRE-ACT Model, has been used to train healthcare staff in managing behaviors associated with autism, suggesting potential benefits in educational interventions for autism care. ^{1 2 3 4 5}

Is simulation-based training generally safe for use in humans?

The research articles focus on using simulation to improve safety in healthcare settings, particularly in pediatrics, by identifying and preventing errors. While they do not directly address the safety of simulation-based training for autism, they suggest that simulation is a tool used to enhance safety and reduce harm in healthcare. ^{6 7 8 9 10}

How is the Simulation-Based Training for Autism treatment different from other treatments?

Simulation-Based Training for Autism is unique because it uses realistic practice scenarios to help healthcare workers improve their skills before working with actual patients, focusing on both technical and non-technical skills. This approach is different from traditional treatments as it emphasizes experiential learning and reflective practice, which are not typically part of standard autism interventions. ^{11 12 13 14 15}

Research Team

Kevin Ching

Principal Investigator

Weill Medical College of Cornell University

Eligibility Criteria

This trial is for nurses and medical assistants at pediatric clinics HT3 and HT5, aiming to improve their skills in taking vital signs from children with Autism Spectrum Disorder. Children aged 1-17 with autism who visit these clinics are also part of the study if accompanied by an English-literate guardian.

Inclusion Criteria

I am a child aged 1-17 with autism and need my vital signs checked at the HT3 or HT5 clinic, and I will be with a parent or guardian who understands English.

I am a nurse or medical assistant working in pediatric clinics at HT3 or HT5.

Exclusion Criteria

I am not diagnosed with Autism, am 18 or older, don't need vital signs checked, or my guardian can't understand English.

[Primary study participants] Persons who are not nurses or medical assistants employed in the pediatric clinics of HT3 and HT5

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

1 visit (virtual)

Educational Intervention

Participants complete an online didactic lecture and participate in a simulation activity to improve skills in taking vital signs in children with Autism Spectrum Disorder.

12 weeks

2 visits (virtual), 1 visit (in-person)

Follow-up

Participants are monitored for changes in confidence, competence, and knowledge scores after the educational intervention.

4 weeks

1 visit (virtual)

Treatment Details

Interventions

• Educational Intervention

Trial Overview The trial tests whether an online educational module plus simulation-based training boosts confidence and competence in healthcare workers when measuring vitals of autistic children. It will check if this method translates into better clinical practice.

Participant Groups

Group I: Educational Intervention: online didactic lecture and educational simulation activity Experimental Treatment 1 Intervention

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.

Group II: Caregiver Satisfaction Active Control 1 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 Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials

1,103

Recruited

1,157,000+

Findings from Research

This study is testing the effectiveness of Patient Navigation (PN) as a strategy to improve access to evidence-based services for children with autism spectrum disorder (ASD), involving 250 families across multiple clinics in the northeastern U.S.

The trial aims to measure how PN affects the time it takes for families to receive a diagnosis and access recommended services compared to conventional care management, potentially revealing important insights into reducing disparities in care for vulnerable populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A hybrid type I randomized effectiveness-implementation trial of patient navigation to improve access to services for children with autism spectrum disorder. Broder-Fingert, S., Walls, M., Augustyn, M., et al.[2021]

LEND programs across the U.S. provide essential interdisciplinary training for pediatric providers, addressing the growing demand for services for children with developmental disabilities like autism spectrum disorder (ASD).

Data from 22 LEND programs over five years show that trainees significantly improved their knowledge, skills, and attitudes in key areas such as team building and family partnerships, highlighting the effectiveness of these training programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Quality Improvement Network for Interdisciplinary Training in Developmental Disabilities. Smith, JD., Nidey, N., Chödrön, GS., et al.[2022]

ECHO Autism is an educational program designed to train local healthcare providers in diagnosing and managing autism spectrum disorder (ASD), addressing the shortage of trained professionals and improving access to quality care for children with ASD.

The program is effective in meeting the complex needs of children with ASD, particularly in rural and underserved areas, and its flexible model allows for global adaptation to different social contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Project Extension for Community Health Outcomes (ECHO) Autism: A Successful Model to Increase Capacity in Community-Based Care. Sohl, K., Rynkiewicz, A., Nanclares-Nogués, V., et al.[2022]

This study aims to assess the frequency and types of adverse events in Australian pediatric care by reviewing 6000-8000 medical records of children under 16 years from various healthcare settings during 2012 and 2013.

The research will utilize a modified version of the Global Trigger Tool for data collection, which is a systematic approach to identifying potential safety issues in healthcare, highlighting the importance of improving patient safety in children's healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CareTrack Kids-part 3. Adverse events in children's healthcare in Australia: study protocol for a retrospective medical record review. Hibbert, PD., Hallahan, AR., Muething, SE., et al.[2019]

From 2013 to 2016, the incidence of adverse events (AEs) in Swedish hospitals decreased from 13.1% to an average of 11.4%, indicating improvements in patient safety during this period.

Preventable AEs were significantly more common (84% more) in patients cared for in inappropriate units ('off-site'), highlighting the importance of proper patient placement and the substantial economic burden of these events, which accounted for 13%-14% of total hospital care costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of adverse events in Sweden during 2013-2016: a cohort study describing the implementation of a national trigger tool. Nilsson, L., Borgstedt-Risberg, M., Soop, M., et al.[2019]

A simulation training program significantly improved the self-efficacy of medical students and interns in identifying and reporting patient safety hazards, indicating its effectiveness as a training tool.

Participants were particularly good at recognizing patient misidentification hazards, but often missed safety issues related to electronic health records (EHRs), highlighting a need for targeted interventions in that area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Good Catch, Kiddo"-Enhancing Patient Safety in the Pediatric Emergency Department Through Simulation. Shaikh, U., Natale, JE., Till, DA., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

A hybrid type I randomized effectiveness-implementation trial of patient navigation to improve access to services for children with autism spectrum disorder. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

A Quality Improvement Network for Interdisciplinary Training in Developmental Disabilities. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Simulation-Based Education for Staff Managing Aggression and Externalizing Behaviors in Children With Autism Spectrum Disorder in the Hospital Setting: Pilot and Feasibility Study Protocol for a Cluster Randomized Controlled Trial. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Project Extension for Community Health Outcomes (ECHO) Autism: A Successful Model to Increase Capacity in Community-Based Care. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Development and psychometric testing of the AASPIRE Adult Autism Healthcare Provider Self-Efficacy Scale. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Improving Safety Recommendations Before Implementation: A Simulation-Based Event Analysis to Optimize Interventions Designed to Prevent Recurrence of Adverse Events. [2023]

7. England pubmed.ncbi.nlm.nih.gov

CareTrack Kids-part 3. Adverse events in children's healthcare in Australia: study protocol for a retrospective medical record review. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Incidence of adverse events in Sweden during 2013-2016: a cohort study describing the implementation of a national trigger tool. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Serious Experience Events: Applying Patient Safety Concepts to Improve Patient Experience. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

"Good Catch, Kiddo"-Enhancing Patient Safety in the Pediatric Emergency Department Through Simulation. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Using simulation-based training to improve patient safety: what does it take? [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Millennium conference 2005 on medical simulation: a summary report. [2008]

13. United States pubmed.ncbi.nlm.nih.gov

An overview of the uses of standardized patients for teaching and evaluating clinical skills. AAMC. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

The Template of Events for Applied and Critical Healthcare Simulation (TEACH Sim): a tool for systematic simulation scenario design. [2022]

15. United States pubmed.ncbi.nlm.nih.gov

Building and Participating in a Simulation: Exploring a Continuing Education Intervention Designed to Foster Reflective Practice Among Experienced Clinicians. [2022]