Ignite Creation Date:
2024-05-06 @ 10:48 AM
Last Modification Date:
2024-10-26 @ 12:35 PM
Study NCT ID:
NCT03353129
Status:
COMPLETED
Last Update Posted:
2019-08-26
First Post:
2017-11-13
Brief Title:
Adaptive Care in the Perioperative Setting
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Adaptive Care in the Perioperative Setting An Observational Study
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACT
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 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
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 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 patients 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 Childrens 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
In addition to understanding distress behaviors gaining an understanding of what interventions are being used to decrease a patients 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 Childrens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None