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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an online learning module combined with a hands-on simulation can boost nurses' and medical assistants' confidence and skills in taking vital signs for children with Autism Spectrum Disorder (ASD). The trial evaluates whether this educational intervention, known as the PRE-ACT Model or Patient Navigator Model, can improve interactions between healthcare workers and children with autism in a clinic setting. Nurses and medical assistants in specific pediatric clinics, along with children with autism who visit these clinics, participate in this study. As an unphased trial, it offers participants the chance to contribute to innovative educational methods that could enhance healthcare experiences for children with autism.

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 prior data suggests that this simulation-based training is safe for healthcare workers?

Research has shown that simulation-based training is generally safe and well-tolerated. In this training, healthcare workers practice their skills in a controlled and realistic environment, allowing them to learn without putting real patients at risk. The training itself poses no direct risk to participants or patients.

Previous studies on similar educational programs have not reported any serious side effects. Participants often report feeling more confident and capable in their skills after the training, suggesting that the training is not only safe but also beneficial.

In this trial, the educational program includes an online lecture and a simulation activity. Both parts are designed to be informative and safe. The simulation uses actors and mannequins, ensuring no real patients are involved, which makes the risk of harm extremely low. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel approach to enhancing care for children with Autism Spectrum Disorder (ASD) through simulation-based training for healthcare providers. Unlike traditional educational methods, this intervention combines a concise online lecture with a hands-on simulation, allowing healthcare workers to practice real-life scenarios with actors and mannequins. This immersive experience aims to improve the participants' ability to take vital signs, potentially leading to increased comfort for both the caregivers and children during clinic visits. By focusing on practical application, this method could lead to more empathetic and effective care for children with ASD.

What evidence suggests that this educational intervention is effective for improving self-confidence and competence in taking vital signs in children with Autism?

Research shows that training with realistic practice scenarios can help healthcare workers enhance their skills. In this trial, participants will engage in an educational intervention that includes an online didactic lecture and an educational simulation activity focused on Autism Spectrum Disorder (ASD). Although little research has specifically explored these scenarios for ASD, other training programs have successfully used them to teach important skills. For example, studies have found that these practice scenarios help healthcare workers better apply their knowledge to complex conditions. This suggests that combining online learning with realistic practice could effectively enhance the skills of medical assistants and nurses in caring for children with autism. ^{1 2 3 6 7}

Who Is on the Research Team?

Kevin Ching

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03575429

Autism Adaptive Community-based Treatment to Improve ... Family navigators will engage families to access resources and support when they first learn their child has signs of autism spectrum disorder (ASD) using an ...

2. publications.aap.org publications.aap.org/pediatrics/article/155/4/e2024067947/201180/Family-Navigation-Programs-for-Children-With

Family Navigation Programs for Children With Autism ... This scoping review aimed to map the current evidence to describe the characteristics and synthesize the effectiveness of FN programs for children with ASD.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1876201825001418

Accelerating autism spectrum disorder care: A rapid review ... This rapid review examines these approaches' current applications, benefits, limitations, and ethical considerations while identifying key research gaps and ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5870193/

A hybrid type I randomized effectiveness-implementation ... This study will examine the effectiveness of PN to reduce the time to and receipt of evidence-based services for vulnerable children with ASD.

5. pubs.asha.org pubs.asha.org/doi/10.1044/2022_JSLHR-21-00518

Effectiveness of the SCERTS Model–Based Interventions ... This systematic review aimed to examine the effectiveness of the Social Communication, Emotional Regulation, and Transactional Support (SCERTS) Model–based ...

6. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-018-1661-7

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

7. withpower.com withpower.com/trial/phase-autistic-disorder-4-2022-bae4a

Simulation-Based Training for Autism · Info for Participants 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 ...