Adaptive Care in the Perioperative Setting

NCT03353129 | Completed

• 1 other identifier: 2017-0758
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.).

Conditions

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

Keywords

Quality Improvement; Patient Safety; Outcome Improvements

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related 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.

  PMID: 25594693 BACKGROUND

• 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.

  PMID: 24491117 BACKGROUND

• 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):643-650. doi: 10.1213/ANE.0000000000000350.

  PMID: 25010821 BACKGROUND

• 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. doi: 10.1097/00000539-199710000-00012.

  PMID: 9322455 BACKGROUND

• 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. doi: 10.1001/archpedi.1996.02170370016002.

  PMID: 8953995 BACKGROUND

• 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. doi: 10.1097/00000542-199811000-00015.

  PMID: 9822003 BACKGROUND

• 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):1648-1654. doi: 10.1213/01.ANE.0000136471.36680.97.

  PMID: 15562048 BACKGROUND

• 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. doi: 10.1542/peds.2005-2920.

  PMID: 16882820 BACKGROUND

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

  PMID: 22435271 BACKGROUND

• McCann ME, Kain ZN. The management of preoperative anxiety in children: an update. Anesth Analg. 2001 Jul;93(1):98-105. doi: 10.1097/00000539-200107000-00022. No abstract available.

  PMID: 11429348 BACKGROUND

• Sikich N, Lerman J. Development and psychometric evaluation of the pediatric anesthesia emergence delirium scale. Anesthesiology. 2004 May;100(5):1138-45. doi: 10.1097/00000542-200405000-00015.

  PMID: 15114210 BACKGROUND

• 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.

  PMID: 23939720 BACKGROUND

• 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.

  PMID: 24287372 BACKGROUND

• 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.

  PMID: 18633018 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Behavior; Mental Disorders; Child Behavior Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 27, 2017
• Study Start: August 15, 2017
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: August 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)