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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02842671
Other study ID # 00004103
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2016
Est. completion date November 25, 2019

Study information

Verified date June 2021
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date November 25, 2019
Est. primary completion date November 25, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 30 Months to 17 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Penn State Hershey Children's Hospital Hershey Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

Gimbler Berglund I, Huus K, Enskär K, Faresjö M, Björkman 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Patient Satisfaction Survey (questionnaire) Improved patient satisfaction and fewer behavioral complications during the procedure day; data collected using REDCap 1 year
Secondary Medical Student Satisfaction Survey (questionnaire) Overall medical student satisfaction with the ambassador program; data collected using REDCap 1 year
Secondary Medical Student Career Interest (questionnaire) Medical student career interests before and after participation in this program; data collected using REDCap 1 year
Secondary Medical Student Comfort Level (questionnaire) Medical student comfort level interacting with autistic children before and after participation in this program; data collected using REDCap 1 year
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