Adaptive Care in the Perioperative Setting

Anxiety Clinical Trial

— ACT  

Official title:

Adaptive Care in the Perioperative Setting: An Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03353129
• Other study ID #: 2017-0758
• Status: Completed
• Start date: August 15, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: August 2019
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.).

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Behavior Disorders
• Behavior Disorders in Children
• Behavior, Coping
• Child Behavior Disorders
• Development; Delayed, Mental
• Disease
• Fear of Other Medical Care
• Mental Disorders
• Psychological Disorder
• Situational Anxiety

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (14)

Balakas K, Gallaher CS, Tilley C. Optimizing perioperative care for children and adolescents with challenging behaviors. MCN Am J Matern Child Nurs. 2015 May-Jun;40(3):153-9. doi: 10.1097/NMC.0000000000000124. — View Citation

Beringer RM, Segar P, Pearson A, Greamspet M, Kilpatrick N. Observational study of perioperative behavior changes in children having teeth extracted under general anesthesia. Paediatr Anaesth. 2014 May;24(5):499-504. doi: 10.1111/pan.12362. Epub 2014 Feb 3. — View Citation

Jenkins BN, Fortier MA, Kaplan SH, Mayes LC, Kain ZN. Development of a short version of the modified Yale Preoperative Anxiety Scale. Anesth Analg. 2014 Sep;119(3):643-50. doi: 10.1213/ANE.0000000000000350. — View Citation

Kain ZN, Caldwell-Andrews AA, Maranets I, McClain B, Gaal D, Mayes LC, Feng R, Zhang H. Preoperative anxiety and emergence delirium and postoperative maladaptive behaviors. Anesth Analg. 2004 Dec;99(6):1648-54, table of contents. — View Citation

Kain ZN, Mayes LC, Caldwell-Andrews AA, Karas DE, McClain BC. Preoperative anxiety, postoperative pain, and behavioral recovery in young children undergoing surgery. Pediatrics. 2006 Aug;118(2):651-8. — View Citation

Kain ZN, Mayes LC, Cicchetti DV, Bagnall AL, Finley JD, Hofstadter MB. The Yale Preoperative Anxiety Scale: how does it compare with a "gold standard"? Anesth Analg. 1997 Oct;85(4):783-8. — View Citation

Kain ZN, Mayes LC, O'Connor TZ, Cicchetti DV. Preoperative anxiety in children. Predictors and outcomes. Arch Pediatr Adolesc Med. 1996 Dec;150(12):1238-45. — View Citation

Kain ZN, Mayes LC, Wang SM, Caramico LA, Hofstadter MB. Parental presence during induction of anesthesia versus sedative premedication: which intervention is more effective? Anesthesiology. 1998 Nov;89(5):1147-56; discussion 9A-10A. — View Citation

Karam VY, Barakat H. Perioperative management of the child with behavioral disorders. Middle East J Anaesthesiol. 2011 Jun;21(2):191-7. Review. — View Citation

McCann ME, Kain ZN. The management of preoperative anxiety in children: an update. Anesth Analg. 2001 Jul;93(1):98-105. Review. — View Citation

Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. — View Citation

Staab JH, Klayman GJ, Lin L. Assessing pediatric patient's risk of distress during health-care encounters: The psychometric properties of the Psychosocial Risk Assessment in Pediatrics. J Child Health Care. 2014 Dec;18(4):378-87. doi: 10.1177/1367493513496671. Epub 2013 Aug 12. — View Citation

Thompson DG, Tielsch-Goddard A. Improving management of patients with autism spectrum disorder having scheduled surgery: optimizing practice. J Pediatr Health Care. 2014 Sep-Oct;28(5):394-403. doi: 10.1016/j.pedhc.2013.09.007. Epub 2013 Nov 25. — View Citation

Varughese AM, Nick TG, Gunter J, Wang Y, Kurth CD. Factors predictive of poor behavioral compliance during inhaled induction in children. Anesth Analg. 2008 Aug;107(2):413-21. doi: 10.1213/ane.0b013e31817e616b. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distress behaviors and interventions used in Adaptive Care Team program	Best practices to foundationalize and guide future research for this patient population	6-9 months
Primary	Expansion of Best Practices to other Healthcare Settings	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.).	6-9 months