Adaptive Care in the Perioperative Setting

Completed

Conditions studied: Development; Delayed, Mental, Anxiety, Situational Anxiety, Fear of Other Medical Care, Behavior, Coping, Behavior Disorders, Psychological Disorder, Behavior Disorders in Children

In brief

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 objectives for this study are to describe distress behaviors and interventions used in the ACT population. The investigators will also determine the relationship between a predictive measure of distress (the Psychosocial Risk Assessment in Pediatrics score) with the actual distress behaviors exhibited by patients in the perioperative area. This study will provide knowledge that is necessary in order to develop best practices and to guide future research for this patient population. Further understanding the techniques used to improve care in the perioperative setting may also provide useful information to consider in other healthcare settings where this patient population has difficulty with coping and cooperating (ex. vaccinations, placing IVs, dental work, etc.).

Key facts

Study ID

NCT03353129

Run by

Children's Hospital Medical Center, Cincinnati

People needed

60

Starts

2017-08-15

Expected to finish

2018-02-28

Last updated by the study team

2019-08-26

Who can join

Age: 3 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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