NCT04186364

Brief Summary

The investigators are evaluating the implementation and the effectiveness of a medical student staffed support program (ASAP) for children diagnosed with Autism Spectrum Disorder coming into Penn State Hershey Children's Hospital Emergency Department. The ASAP program involves training and assigning a medical student as an Ambassador to help advocate for the special needs of a child with ASD. This study is designed to compare patient satisfaction of children and families who are assigned an Ambassador to those who are not assigned an Ambassador during their time in the Emergency Department. The secondary objectives are to measure overall medical student satisfaction with the program, medical student career interests before and after participation, and medical student comfort level interacting with children with ASD before and after participation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

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

December 2, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2019

Completed
1.3 years until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2021

Completed
Last Updated

April 13, 2021

Status Verified

April 1, 2021

Enrollment Period

7 days

First QC Date

December 2, 2019

Last Update Submit

April 8, 2021

Conditions

Keywords

AustismAmbassador

Outcome Measures

Primary Outcomes (1)

  • Patient Satisfaction Survey (Questionnaire)

    Improved patient satisfaction and fewer behavioral complications during the procedure day; data collected using REDCap. The questionnaire, likely titled "ASAP Patient Satisfaction Survey", will include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied.

    1 year.

Secondary Outcomes (3)

  • Medical Student Satisfaction Survey (Questionnaire)

    1 year

  • Medical Student Career Interest (Questionnaire)

    1 year

  • Medical Student Comfort Level (Questionnaire)

    1 year

Study Arms (2)

Assigned Ambassador (Intervention Group)

EXPERIMENTAL

Patients who were consented, completed the accommodations survey, and for whom a medical student was available during the time of the ED visit will serve as our intervention group. The participants will be assigned an Ambassador throughout the child's ED visit and will complete a patient satisfaction survey afterwards. The investigators hold to enroll 120 controls.

Behavioral: Assigned Ambassador

Control Group

NO INTERVENTION

Patients who were consented, completed the accommodations survey, but for whom a medical student was not available during the time of the ED visit will serve as our control group. The controls will fill out both an accommodations survey before and a patient satisfaction survey after the ED visit, however no ambassador will be assigned during the ED visit. The investigators hope to enroll 120 controls.

Interventions

If assigned to the intervention group, participants will be assigned a medical student ambassador on arrival to the Emergency Department. A brief discussion may take place to review the child's history and survey results, and a copy of the survey will be placed near the patient's bedside for healthcare personnel to review. The student ambassador will accompany the child and their family through key points of their visit and will be expected to make accommodations for the child as determined by the accommodation survey results. The family will be required to allow the ambassador to stay throughout the ED visit.

Assigned Ambassador (Intervention Group)

Eligibility Criteria

Age30 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \. Study Participants:
  • Must be children 30 months to 17 years of age.
  • Study participants will be boys and girls.
  • Study participants will have a a diagnosis of Autism Spectrum Disorder.
  • Study participants will be presenting through the pediatric emergency room at the Penn State Hershey Medical Center.
  • Study participants must be English Speaking.
  • \. Medical Student Ambassadors:
  • Ambassadors must be enrolled as first, second, third, or fourth year medical students at the Penn State College of Medicine
  • Ambassadors must complete training successfully

You may not qualify if:

  • \. Study Participants:
  • Children under 30 months or older than 17 years.
  • Children who do not have a diagnosis of Autism Spectrum Disorder.
  • Children who cannot understand and communicate in English.
  • \. Medical Student Ambassadors:
  • Individuals who are not a medical student at the Penn State College of Medicine.
  • Medical students who do not complete the training course.
  • Medical students who are not deemed appropriate the ASAP Ambassador role as per the discretion of study personnel.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (3)

  • Gimbler Berglund I, Huus K, Enskar K, Faresjo M, Bjorkman B. Perioperative and Anesthesia Guidelines for Children with Autism: A Nationwide Survey from Sweden. J Dev Behav Pediatr. 2016 Jul-Aug;37(6):457-64. doi: 10.1097/DBP.0000000000000289.

    PMID: 27011004BACKGROUND
  • Nayfack AM, Huffman LC, Feldman HM, Chan J, Saynina O, Wise PH. Hospitalizations of children with autism increased from 1999 to 2009. J Autism Dev Disord. 2014 May;44(5):1087-94. doi: 10.1007/s10803-013-1965-x.

    PMID: 24122446BACKGROUND
  • Broder-Fingert S, Shui A, Ferrone C, Iannuzzi D, Cheng ER, Giauque A, Connors S, McDougle CJ, Donelan K, Neumeyer A, Kuhlthau K. A Pilot Study of Autism-Specific Care Plans During Hospital Admission. Pediatrics. 2016 Feb;137 Suppl 2:S196-204. doi: 10.1542/peds.2015-2851R.

    PMID: 26908475BACKGROUND

Related Links

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Cheryl Tierney, M.D.

    Developmental Pediatrics, Penn State Hershey Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Pediatrics

Study Record Dates

First Submitted

December 2, 2019

First Posted

December 4, 2019

Study Start

April 1, 2021

Primary Completion

April 8, 2021

Study Completion

April 8, 2021

Last Updated

April 13, 2021

Record last verified: 2021-04

Locations