Satisfaction Rates Among Parents of Children With Autism in the ED (ASD)

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.

Study Overview

• Status: Terminated
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Questionnaire

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78723
      • Dell Children's Medical Center of Central Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard of Care; 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; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seton Healthcare Family
• Investigators: Principal Investigator: Catherine E Yee, MD, Pediatric Emergency Medicine Fellow

Publications and helpful links

General Publications

• Institute of Medicine (US) Committee on Quality of Health Care in America. Crossing the Quality Chasm: A New Health System for the 21st Century. Washington (DC): National Academies Press (US); 2001. Available from http://www.ncbi.nlm.nih.gov/books/NBK222274/
• Autism and Developmental Disabilities Monitoring Network Surveillance Year 2008 Principal Investigators; Centers for Disease Control and Prevention. Prevalence of autism spectrum disorders--Autism and Developmental Disabilities Monitoring Network, 14 sites, United States, 2008. MMWR Surveill Summ. 2012 Mar 30;61(3):1-19.
• Jo H, Schieve LA, Rice CE, Yeargin-Allsopp M, Tian LH, Blumberg SJ, Kogan MD, Boyle CA. Age at Autism Spectrum Disorder (ASD) Diagnosis by Race, Ethnicity, and Primary Household Language Among Children with Special Health Care Needs, United States, 2009-2010. Matern Child Health J. 2015 Aug;19(8):1687-97. doi: 10.1007/s10995-015-1683-4.

Helpful Links

• 2001 National Survey of Children with Special Health Care Needs
• 2005-2006 National Survey of Children with Special Health Care Needs
• 2009-2010 National Survey of Children with Special Health Care Needs

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): January 6, 2017
• Study Completion (Actual): January 6, 2017

Study Registration Dates

• First Submitted: January 31, 2016
• First Submitted That Met QC Criteria: February 4, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Actual): August 2, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: CR-15-162

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Satisfaction Survey
   Information identifier: Satisfaction survey
   Information comments: Please email if there are any issues downloading from google drive at ceyee@seton.org
2. Questionnaire
   Information identifier: Questionnaire
   Information comments: Please email me if there are any issues downloading from google drive at ceyee@seton.org