Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autism Spectrum Ambassador Program (ASAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02842671
Recruitment Status : Enrolling by invitation
First Posted : July 25, 2016
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Cheryl Tierney, Milton S. Hershey Medical Center

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Other: Assigned Ambassador Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Implementation and Evaluation of the Autism Spectrum Ambassador Program
Actual Study Start Date : December 1, 2016
Actual Primary Completion Date : March 31, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Assigned Ambassador (Intervention Group)
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.
Other: Assigned Ambassador
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.

No Intervention: Control Group
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.



Primary Outcome Measures :
  1. Patient Satisfaction Survey (questionnaire) [ Time Frame: 1 year ]
    Improved patient satisfaction and fewer behavioral complications during the procedure day; data collected using REDCap


Secondary Outcome Measures :
  1. Medical Student Satisfaction Survey (questionnaire) [ Time Frame: 1 year ]
    Overall medical student satisfaction with the ambassador program; data collected using REDCap

  2. Medical Student Career Interest (questionnaire) [ Time Frame: 1 year ]
    Medical student career interests before and after participation in this program; data collected using REDCap

  3. Medical Student Comfort Level (questionnaire) [ Time Frame: 1 year ]
    Medical student comfort level interacting with autistic children before and after participation in this program; data collected using REDCap



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

  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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842671


Locations
Layout table for location information
United States, Pennsylvania
Penn State Hershey Children's Hospital
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Cheryl Tierney, M.D. Developmental Pediatrics

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Informed Consent Form  This link exits the ClinicalTrials.gov site
for participants
Summary Explanation of Research  This link exits the ClinicalTrials.gov site
for medical students

Publications:
Layout table for additonal information
Responsible Party: Cheryl Tierney, Section Chief, Behavior and Developmental Pediatrics, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02842671     History of Changes
Other Study ID Numbers: 00004103
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Keywords provided by Cheryl Tierney, Milton S. Hershey Medical Center:
autism
ambassador
Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders