Adaptive Care in the Perioperative Setting (ACT)
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| ClinicalTrials.gov Identifier: NCT03353129 |
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Recruitment Status :
Completed
First Posted : November 27, 2017
Last Update Posted : August 26, 2019
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| Condition or disease |
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| Development; Delayed, Mental Anxiety Situational Anxiety Fear of Other Medical Care Behavior, Coping Behavior Disorders Psychological Disorder Behavior Disorders in Children |
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 Checklist (ICC), the Child Induction Behavioral Assessment (CIBA) tool and the Post-Anesthesia Emergence Delirium scale (PAED). Each of these scales is observational (as opposed to self-report), so they can be used in young patients who are not-yet verbal or for developmentally delayed children. Other than the PRAP, the scales were not originally developed for patients who have developmental delays (our team is not aware of perioperative behavioral scales that are validated for this population specifically). The scales are reliable with young, minimally verbal children, so the investigators anticipate that the scales will provide adequate measures. The investigators plan to document any challenges in using the scales so that future researchers may consider improving the scales for this population, if indicated.
In addition to understanding distress behaviors, gaining an understanding of what interventions are being used to decrease a patient's risk for having distress is also important. There is limited research describing the use of medication and behavioral interventions for the ACT population. Multiple articles describe behavioral interventions that are recommended, but there is little data on what interventions are being used in clinical practice for high-risk patients. There is also little direct evidence published on the use of oral anxiety medications for children in the ACT population undergoing surgery. In 2011, Cincinnati Children's Hospital Medical Center published a BESt Evidence Statement on the use of anxiolytic medications prior to ambulatory healthcare encounters for individuals with special developmental and behavioral challenges. The statement recommends the use of certain pre-procedural anxiolytic medications when non-pharmacological support interventions have been unsuccessful or when the patient has been assessed as having very high anxiety using a distress assessment tool or clinical judgment. Our anesthesia team has anecdotally found these medication guidelines to be very useful in clinical practice. The investigators have not yet studied the use of these medications in our hospital, however, and dissemination of the practice statement in other settings has been limited. Further evidence of how these guidelines are used is necessary to support their efficacy and to make recommendations for updating the BESt Evidence statement.
In addition to the medications outlined in the BESt Evidence Statement (clonazepam, risperidone, and lorazepam) there are a number of other medications that can contribute to preoperative anxiolysis including midazolam, diazepam, dexmedetomidine, clonidine, olanzapine and ketamine. There are case reports and retrospective data on the use of these medications in patients who would fit the ACT patient criteria, but our team has not come across any prospective study data that describes the use of these medications for high risk patients in clinical practice. This study will provide much needed data to give a better understanding of perioperative experiences and interventions used for ACT patients. This information could facilitate the development of better defined best practices and help to determine areas for further research.
| Study Type : | Observational |
| Actual Enrollment : | 60 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Adaptive Care in the Perioperative Setting: An Observational Study |
| Actual Study Start Date : | August 15, 2017 |
| Actual Primary Completion Date : | February 28, 2018 |
| Actual Study Completion Date : | February 28, 2018 |
- Distress behaviors and interventions used in Adaptive Care Team program [ Time Frame: 6-9 months ]Best practices to foundationalize and guide future research for this patient population
- Expansion of Best Practices to other Healthcare Settings [ Time Frame: 6-9 months ]Implementation of Best Practices in other healthcare settings where this patient population has difficulty with coping and cooperating (ex. vaccinations, placing IVs, dental work, etc.).
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| Ages Eligible for Study: | 3 Years to 21 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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 Expressive Language Disorder
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03353129
| United States, Ohio | |
| Cincinnati Children's Hospital Medical Center | |
| Cincinnati, Ohio, United States, 45229 | |
| Responsible Party: | Children's Hospital Medical Center, Cincinnati |
| ClinicalTrials.gov Identifier: | NCT03353129 |
| Other Study ID Numbers: |
2017-0758 |
| First Posted: | November 27, 2017 Key Record Dates |
| Last Update Posted: | August 26, 2019 |
| Last Verified: | August 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Quality Improvement Patient Safety Outcome Improvements |
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Disease Anxiety Disorders Mental Disorders |
Child Behavior Disorders Pathologic Processes Neurodevelopmental Disorders |