Adaptive Care in the Perioperative Setting (NCT03353129) | Clinical Trial Compass
CompletedNot Applicable
Adaptive Care in the Perioperative Setting
United States60 participantsStarted 2017-08-15
Plain-language 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 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.).
Who can participate
Age range
3 Years – 21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Expres…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Distress behaviors and interventions used in Adaptive Care Team program
Timeframe: 6-9 months
2
Expansion of Best Practices to other Healthcare Settings
Timeframe: 6-9 months
Trial details
NCT IDNCT03353129
SponsorChildren's Hospital Medical Center, Cincinnati