Adaptive Care in the Perioperative Setting
Condition: Development; Delayed, Mental; Anxiety; Situational Anxiety; Fear of Other Medical Care; Behavior, Coping; Behavior Disorders; Psychological Disorder; Behavior Disorders in Children
MeSH terms: Anxiety Disorders; Mental Disorders; Child Behavior Disorders
Study type: Observational

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 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.
    

Observational model: Cohort
Time perspective: Prospective
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.
      
Keywords: Quality Improvement; Patient Safety; Outcome Improvements