Adaptive Care in the Perioperative Setting (ACT)

August 22, 2019 updated by: Children's Hospital Medical Center, Cincinnati

Adaptive Care in the Perioperative Setting: An Observational Study

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.).

Study Overview

Status

Completed

Conditions

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 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

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who meet the ACT criteria presenting to the Same Day Surgery clinic. A convenience sample of patients in the ACT program will be chosen based upon the availability of patients in the pre-operative clinic. As this is an observational, descriptive study, we chose the sample size in order to obtain data from 60 ACT patients who have a variety of diagnoses and PRAP scores.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6-9 months
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.).
6-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Medical Center, Cincinnati

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 15, 2017

Primary Completion (Actual)

February 28, 2018

Study Completion (Actual)

February 28, 2018

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 22, 2017

First Posted (Actual)

November 27, 2017

Study Record Updates

Last Update Posted (Actual)

August 26, 2019

Last Update Submitted That Met QC Criteria

August 22, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-0758

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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