Autism Spectrum Disorder Clinical Trial
Official title:
What Factors Effect Parental Satisfaction During Their Visit to a Pediatric Emergency Department Among Parents of Children With Autism?
This study is a randomized controlled trial utilizing a patient-centered questionnaire distributed to parents of children with autism. The study arm will receive the questionnaire and will be compared to the control arm, which will receive standard of care. The results of satisfaction surveys will be the primary endpoint of this study.
This study is a randomized controlled trial utilizing a patient-centered questionnaire
distributed to parents of children with autism. Potential study participants will be
identified during the triage process through medical history taking, which is routine for the
triage process at this institution. The triage nurse will be educated to alert a research
associate if a patient with one of our qualifying diagnoses is identified. This study will
include patients aged 2-18 with parental report of a diagnosis of (1) Autism, (2) Autism
Spectrum Disorder, (3) Pervasive Developmental Disorder, (4) Childhood Disintegrative
Disorder, or (5) Sensory Integration Disorder. All patients whose caregiver is fluent and
literate in either English or Spanish will be included.
Research associates will then attempt to obtain consent from the parent. If consent is
obtained, the research associate will then attempt to obtain assent from patients aged > 6
years. If the research associate feels the child is unable to assent based on their
developmental capabilities, the research associate will then indicate this on the assent form
and sign in the space provided for the research associate.
Once consent and assent, if applicable, are obtained, the research associate will then select
an envelope from the top of a pre-randomized stack. The contents of the envelope will either
contain a questionnaire and satisfaction survey for the intervention arm, or simply a
satisfaction survey if in the control arm.
If the intervention arm is selected, the research associate will then distribute the
questionnaire to the parent and ask them to fill it out to the best of their ability. The
research associate will then return to collect the questionnaire and one of the physician
providers caring for the patient must review the questionnaire prior to seeing the patient.
This hospital is a teaching institution and physician providers may include residents,
fellows, and attendings.
Once reviewed, the physician provider will sign at the bottom of the questionnaire and
proceed with the encounter. Multiple providers, including nursing staff and clinical
assistants may review the questionnaire as well, which will be kept on the paper chart.
When the patient's disposition is determined, the research associate will distribute the
satisfaction survey and an envelope for the survey to be sealed within once completed by the
parent. The satisfaction survey, along with the questionnaire and any other study documents,
will be collected and placed in the envelope. The envelopes will be stored in a badge-access
protected office inside of a locked cabinet behind a password protected door. Only fellows,
attendings, and a few fellowship-associated and research-associated providers have access to
this office.
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