Satisfaction Rates Among Parents of Children With Autism in the ED

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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What Factors Effect Parental Satisfaction During Their Visit to a Pediatric Emergency Department Among Parents of Children With Autism?

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Behavioral: Questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: aged 2 to 18 years parent/caregiver is fluent and literate in either English or Spanish parental report of a diagnosis of (1) autism, (2) autism spectrum disorder, (3) pervasive developmental disorder, (4) childhood disintegrative disorder, (5) sensory integration disorder Exclusion Criteria: triage level 1 physician provider unable to review questionnaire prior to seeing the patient

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard of Care<br>The control arm participants will receive only a satisfaction survey once disposition is determined by the physician provider. The satisfaction survey will be collected by the research associated and kept in a protected location, along with all other study materials. All patients will receive standard of care, which at this institution is the help of Child Life Specialists, when they are available and requested by the physician. Physicians will be instructed to request Child Life Specialists with the same discretion as with all patients. | |
| Active Comparator: Questionnaire<br>Participants who are randomized to the questionnaire arm will receive a patient-centered questionnaire at the beginning of their visit. This single page document will ask questions about their child including, but not limited to, diagnoses, suggestions for distraction, sensory issues that may affect their visit, and method to best administer medications. The research associate will ask them to fill it out to the best of their ability and will collect the questionnaire prior to a physician provider seeing the patient. At least one physician provider must review the questionnaire prior to seeing the patient. Once disposition is determined, the satisfaction survey will be distributed by the research associate along with an envelope for the parent to seal their survey within. | Behavioral: Questionnaire<br>* There will be a single page document, a patient-centered questionnaire, distributed to parents of study participants who have been randomized to the intervention arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction Scores | Parental satisfaction as rated on a Likert Scale (1-5) | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | ED Length of Stay | through study completion, an average of 1 year | 
| Admission rate | Hospital admission rate | through study completion, an average of 1 year | 
| Number of PIV attempts | The number of attempts necessary to obtain peripheral venous access in those patients who have been determine by the physician to need IV placement for their medical care. | through study completion, an average of 1 year | 
| Sedating medications needed for procedures | The number and type of sedating medications needed for any procedure determined to be necessary for the patient's medical care by the physician. | through study completion, an average of 1 year |