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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04186364
Other study ID # 00002020
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date April 1, 2021
Est. completion date April 8, 2021

Study information

Verified date April 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 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.


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 Emergency Department (ED) for an acute visit. This program will pair an interested and trained medical student with a family whose child presents to the Children's Hospital ED and identifies as having Autism and requiring special accommodations to improve cooperation and procedure tolerance. Patients will be identified by the study team members, who are ages 30 months to 17years with the diagnosis of Autism Spectrum Disorder. Participants will be recruited through posters and flyers in the Pediatric Emergency Room Waiting area; families who are interested in enrolling will enter the research study. Interested caregivers will be asked to complete a confidential survey that will identify areas that can be accommodated during their visit. This survey will then be automatically be printed for the ED staff and ambassador to review. The student will meet the family in the ED and accompany the family through their visit; the student will print the child's Accommodation Plan, place it at the bedside, and make it available for each member of the treatment team. Students will be trained to chart a child's Accommodation Plan for each member of the treatment team and place it at bedside, as well to advocate on behalf of the child and their family, communicate with the staff (including nurses, primary care providers (physicians and Physician Assistants (PAs)), and techs (radiology, phlebotomy, transport). To the extent possible, the investigators hope that having a student advocate, educate staff in the ED, 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: nursing, ED physicians, PAs, technicians (radiology, phlebotomy, transport), registration, and to the extent possible, the personnel involved in the care of these children.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date April 8, 2021
Est. primary completion date April 8, 2021
Accepts healthy volunteers No
Gender All
Age group 30 Months to 17 Years
Eligibility Inclusion Criteria: 1. Study Participants: 1. Must be children 30 months to 17 years of age. 2. Study participants will be boys and girls. 3. Study participants will have a a diagnosis of Autism Spectrum Disorder. 4. Study participants will be presenting through the pediatric emergency room at the Penn State Hershey Medical Center. 5. Study participants must be English Speaking. 2. Medical Student Ambassadors: 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. Study Participants: 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 cannot understand and communicate in English. 2. Medical Student Ambassadors: 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

Behavioral:
Assigned Ambassador
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.

Locations

Country Name City State
United States Penn State Hershey Medical Center 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. 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 Medical Student Satisfaction Survey (Questionnaire) Overall medical student satisfaction with the ambassador program; data collected using REDCap.The questionnaire, likely titled "ASAP Medical Student 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 Medical Student Career Interest (Questionnaire) Medical student career interests before and after participation in this program; data collected using REDCAP. The questionnaire, likely titled "Impact of ASAP on Career Interest" may include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied but will also include unscaled questions with answers such as "very interested, somewhat interested, not interested, etc.". 1 year
Secondary Medical Student Comfort Level (Questionnaire) Medical student comfort level interacting with autistic children before and after participation in the program; data collected using REDCap.The questionnaire, likely titled "Impact of ASAP on Medical Student Comfort Levels with Patients with Autism", may include scales of 0-10 rating satisfaction in various categories with 10 being extremely satisfied and 0 being very unsatisfied among unscaled questions with answers such as "very comfortable, neutral, and very uncomfortable." 1 year
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