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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02675933
Other study ID # CR-15-162
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date January 6, 2017

Study information

Verified date July 2018
Source Seton Healthcare Family
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 116
Est. completion date January 6, 2017
Est. primary completion date January 6, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Dell Children's Medical Center of Central Texas Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
Seton Healthcare Family

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Satisfaction Scores Parental satisfaction as rated on a Likert Scale (1-5) through study completion, an average of 1 year
Secondary Length of Stay ED Length of Stay through study completion, an average of 1 year
Secondary Admission rate Hospital admission rate through study completion, an average of 1 year
Secondary 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
Secondary 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
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