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Autism Spectrum Ambassador Program (ASAP)

Primary Purpose

Autism Spectrum Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Assigned Ambassador
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Autism Spectrum Disorder focused on measuring autism, ambassador

Eligibility Criteria

30 Months - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

1. Study participants will be children 30 months to 17 years 2. Study participants will be boys and girls 3. Study participants will have a diagnosis of Autism Spectrum Disorder 4. Study participants will be presenting through the pediatric anesthesia clinic in preparation for a surgical or nonsurgical procedure at the Children's Hospital 5. Study participants must be English Speaking

  1. Ambassadors must be enrolled as first, second, third, or fourth year medical students at the Penn State College of Medicine
  2. Ambassadors must complete training successfully

Exclusion Criteria:

  1. Children under 30 months or older than 17 years
  2. Children who do not have a diagnosis of Autism Spectrum Disorder
  3. Children who are not having surgery at the Children's Hospital
  4. Children who are having a procedure but are not being seen for a pre-anesthesia visit
  5. Children who cannot understand and communicate in English

1. Individuals who are not a medical student at the Penn State College of Medicine 2. Medical students who do not complete the training course 3. Medical students who are not deemed appropriate the ASAP Ambassador role as per the discretion of study personnel.

Sites / Locations

  • Penn State Hershey Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Assigned Ambassador (Intervention Group)

Control Group

Arm Description

Patients who were consented, completed the accommodations survey, and for whom a medical student was available during the time of the the procedure will serve as our intervention group. The participants will be assigned an Ambassador throughout the procedure and will complete a patient satisfaction survey afterwards. The investigators hope to enroll 25 controls.

Patients who were consented, completed the accommodations survey, but for whom a medical student was not available during the time of the patient's procedure will serve as our control group. The controls will fill out both an accommodations survey before and a patient satisfaction survey after the procedure. No ambassador will be assigned for the procedure day. The investigators hope to enroll 25 controls.

Outcomes

Primary Outcome Measures

Patient Satisfaction Survey (questionnaire)
Improved patient satisfaction and fewer behavioral complications during the procedure day; data collected using REDCap

Secondary Outcome Measures

Medical Student Satisfaction Survey (questionnaire)
Overall medical student satisfaction with the ambassador program; data collected using REDCap
Medical Student Career Interest (questionnaire)
Medical student career interests before and after participation in this program; data collected using REDCap
Medical Student Comfort Level (questionnaire)
Medical student comfort level interacting with autistic children before and after participation in this program; data collected using REDCap

Full Information

First Posted
July 13, 2016
Last Updated
June 16, 2021
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02842671
Brief Title
Autism Spectrum Ambassador Program
Acronym
ASAP
Official Title
The Implementation and Evaluation of the Autism Spectrum Ambassador Program
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
November 25, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 for a medical procedure. 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 the procedure. 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.
Detailed Description
The Autism Spectrum Ambassador Program (ASAP) is a medical student staffed program designed to improve the experience for children with Autism Spectrum Disorder coming into the Children's Hospital for a day procedure involving anesthesia. This program will pair an interested and trained medical student with a family whose child is scheduled for an outpatient procedure and who is identified as possibly needing special accommodations to improve cooperation and procedure tolerance. Patients will be identified using the Anesthesia clinic's schedule via PowerChart, consented at the pre-operative anesthesia clinic visit, and enrolled in our program by study personnel. Once enrolled, families will be asked to complete a confidential survey that will identify areas that can be accommodated on the procedure day. Students will gain access to these survey results, contact the family at least 1 day prior to the procedure. A brief discussion will take place to review the child's history and survey results. The student will then create a written, personalized Accommodation Plan to be distributed to personnel and the family. The student will meet the family at the hospital and accompany the family check in until the patient is in the post anesthesia recovery unit. Students will be trained to chart a child's Accommodation Plan for each member of the treatment team which will be distributed by the student with ample time before the procedure. This accommodation plan will alert each treatment team member including surgical nursing, anesthesia, registration, and to the extent possible surgeons, to what accommodations will be needed to improve the experience of the child. Students will be trained to assist with accommodations by communicating on the family's behalf to hospital personnel to include surgical nursing, anesthesia, registration, and to the extent possible surgeons, among others. To the extent possible, the investigators hope that having a student advocate, educate staff on the procedure day, and implement changes as needed will improve patient satisfaction with the experience and improve the ease with which a procedure can be carried out for a child with ASD. Students will also be queried as to the experience and survey data will be used to improve the program over time. Training will be completed so that all members of the treatment team will be aware of the program and aware of the possible accommodations. Treatment team members will be provided additional training to enhance the success of the ASAP program and all treatment team members will be encouraged to work together for the best possible outcome for all patients. Treatment team services include: surgical nursing, anesthesia, registration, and to the extent possible the surgeons involved in the care of these children.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
Keywords
autism, ambassador

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Assigned Ambassador (Intervention Group)
Arm Type
Experimental
Arm Description
Patients who were consented, completed the accommodations survey, and for whom a medical student was available during the time of the the procedure will serve as our intervention group. The participants will be assigned an Ambassador throughout the procedure and will complete a patient satisfaction survey afterwards. The investigators hope to enroll 25 controls.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Patients who were consented, completed the accommodations survey, but for whom a medical student was not available during the time of the patient's procedure will serve as our control group. The controls will fill out both an accommodations survey before and a patient satisfaction survey after the procedure. No ambassador will be assigned for the procedure day. The investigators hope to enroll 25 controls.
Intervention Type
Other
Intervention Name(s)
Assigned Ambassador
Intervention Description
If assigned to the intervention group, participants will be contacted by the assigned medical student ambassador at least 1 day prior to the procedure. A brief discussion will take place to review the child's history and survey results. The family will be met by the Ambassador at the hospital and stay with the family until the patient is in the post anesthesia recovery unit. The ambassador is expected to make accommodations for the child as determined by the accommodations survey results. The family will be required to allow the Ambassador to stay through check-in and the procedure.
Primary Outcome Measure Information:
Title
Patient Satisfaction Survey (questionnaire)
Description
Improved patient satisfaction and fewer behavioral complications during the procedure day; data collected using REDCap
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Medical Student Satisfaction Survey (questionnaire)
Description
Overall medical student satisfaction with the ambassador program; data collected using REDCap
Time Frame
1 year
Title
Medical Student Career Interest (questionnaire)
Description
Medical student career interests before and after participation in this program; data collected using REDCap
Time Frame
1 year
Title
Medical Student Comfort Level (questionnaire)
Description
Medical student comfort level interacting with autistic children before and after participation in this program; data collected using REDCap
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Months
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Study participants will be children 30 months to 17 years 2. Study participants will be boys and girls 3. Study participants will have a diagnosis of Autism Spectrum Disorder 4. Study participants will be presenting through the pediatric anesthesia clinic in preparation for a surgical or nonsurgical procedure at the Children's Hospital 5. Study participants must be English Speaking 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 Exclusion Criteria: Children under 30 months or older than 17 years Children who do not have a diagnosis of Autism Spectrum Disorder Children who are not having surgery at the Children's Hospital Children who are having a procedure but are not being seen for a pre-anesthesia visit Children who cannot understand and communicate in English 1. Individuals who are not a medical student at the Penn State College of Medicine 2. Medical students who do not complete the training course 3. Medical students who are not deemed appropriate the ASAP Ambassador role as per the discretion of study personnel.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Tierney, M.D.
Organizational Affiliation
Developmental Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27011004
Citation
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.
Results Reference
background
PubMed Identifier
24122446
Citation
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.
Results Reference
background
PubMed Identifier
26908475
Citation
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.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
http://irb.psu.edu
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
http://irb.psu.edu
Available IPD/Information Comments
for participants
Available IPD/Information Type
Accommodation Survey
Available IPD/Information URL
http://irb.psu.edu
Available IPD/Information Type
Patient Satisfaction Survey
Available IPD/Information URL
http://irb.psu.edu
Available IPD/Information Type
Medical Student Survey
Available IPD/Information URL
http://irb.psu.edu
Available IPD/Information Type
Summary Explanation of Research
Available IPD/Information URL
http://irb.psu.edu
Available IPD/Information Comments
for medical students

Learn more about this trial

Autism Spectrum Ambassador Program

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