Status:
COMPLETED
Adaptive Care in the Perioperative Setting
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Conditions:
Development; Delayed, Mental
Anxiety
Eligibility:
All Genders
3-21 years
Brief Summary
The overall purpose for conducting this research is to improve the safety and efficacy of care for perioperative patients who have developmental delays and behavioral challenges. The specific objectiv...
Detailed Description
For this study the investigators will measure anxiety and distress behaviors using multiple validated scales, including the modified Yale Pre-operative Anxiety Score (m-YPAS), the Induction Compliance...
Eligibility Criteria
Inclusion
- Patients who meet the following criteria for the ACT Program:
- Patient is diagnosed with a developmental disability and/or behavioral condition
- Patient has demonstrated inability to cope and cooperate during a healthcare encounter without additional preparation and support
- Patient scores greater than 7 on the PRAP scale
- Patient has 1 or more of the commonly seen ACT patient diagnoses listed in the diagnoses list below (additional diagnoses may be added the discretion of the principal investigator)
- Patients accompanied to the appointment by parents or legal guardian
- Patients of any gender, race, and ethnicity are potentially eligible for inclusion
- Patients who are scheduled as outpatients or for 23 hour observation
- Patient is ambulatory (able to walk and can use all 4 extremities for activities of daily living)
- Diagnoses list:
- Autism Spectrum Disorder, Autism, Autistic
- Delay in Development, Unspecified delay in development, Developmental Delay, Unspecified intellectual disability
- Down's Syndrome, Trisomy 21
- Other developmental speech or language disorder
- Other specific developmental learning difficulties
- Problems in communication
- Mental and behavioral problems
- ADD/ADHD
- Impulse control disorder
- Anxiety disorder
- Disruptive behavior disorder
- Intermittent explosive disorder
- Obsessive Compulsive Disorder
- Oppositional defiant disorder
- Sensory Integration Disorder
- Pervasive Development Disorder
- Receptive Expressive Language Disorder
Exclusion
- Guardian unable to provide consent
- Wheel chair bound
- Prior enrollment in this research study
- Patients who are scheduled to be admitted (greater than 23 hours) and inpatients
- Patients who do not meet the ACT criteria
- Any patient who, in the judgment of the investigators, has insufficient data to complete analysis
- Adult patients (age 18-21) who have cognitive delays but are their own legal guardian
Key Trial Info
Start Date :
August 15 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2018
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03353129
Start Date
August 15 2017
End Date
February 28 2018
Last Update
August 26 2019
Active Locations (1)
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1
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229