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Improving Anxiety Detection in Pediatrics Using Health Information Technology

Primary Purpose

Anxiety, Attention Deficit Hyperactivity Disorder, Disorder, Pediatric

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Automated screening for pediatric anxiety
Usual Care
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

FOR TELEPHONE INTERVIEWS

  • Caregivers of children ages 6 to 12 whose parents have concerns of disruptive behavior
  • Screening for anxiety is positive using the SCARED tool
  • Caregivers must have completed both the SCARED and Vanderbilt tools at the index visit

Exclusion Criteria:

  • Primary language is not English or Spanish
  • Does not receive medical care at the intervention clinics
  • Did not complete both screening tools
  • Child did not screen positive for anxiety using the SCARED

FOR PHYSICIAN SATISFACTION

Inclusion criteria:

  • all participating providers at all four participating study clinics with CHICA

Exclusion criteria:

  • does not provide medical care at any of the four participating study clinics

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Intervention

    Control

    Arm Description

    Randomization is at the clinic level. Two clinics will be randomized to receive the revised module to screen for anxiety and ADHD among children who present with parental concern of disruptive behaviors. Parents who have concerns of disruptive behaviors will trigger the module and be administered both the Vanderbilt for ADHD and Screen for Childhood Anxiety Related Emotional Disorders (SCARED) screening tools.

    Randomization is at the clinic level. Two clinics will be randomized as the control clinics meaning that they will continue to provide care as usual for families who present to the clinic with concerns of disruptive behaviors. Currently, CHICA administers the Vanderbilt for ADHD screening tool.

    Outcomes

    Primary Outcome Measures

    Caregiver perception about screening process and satisfaction with index visit
    families will be randomly selected to participate in a one-time telephone interview

    Secondary Outcome Measures

    Physician satisfaction
    Physician acceptance of the CHICA anxiety module will be obtained via quantitative surveys addressing physician comfort with anxiety and ADHD identification and acceptance of the anxiety module. These surveys are administered annually as part of ongoing quality improvement. The 30-item survey will include 4 items related specifically to the anxiety module and alterations in the ADHD algorithm. It will require approximately 10 minutes to complete. The survey for will incorporate Likert scales to measure physician comfort with anxiety identification, referral for inattentive behaviors and treatment initiation for anxiety and ADHD. These data will be compared to previously administered surveys that included items capturing physician acceptance of the ADHD module and subsequent management. Results will be aggregated by intervention and control clinics

    Full Information

    First Posted
    September 25, 2015
    Last Updated
    April 18, 2019
    Sponsor
    Indiana University
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02562248
    Brief Title
    Improving Anxiety Detection in Pediatrics Using Health Information Technology
    Official Title
    Improving Anxiety Detection in Pediatrics Using Health Information Technology
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2015 (Actual)
    Primary Completion Date
    August 31, 2017 (Actual)
    Study Completion Date
    July 31, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Indiana University
    Collaborators
    Agency for Healthcare Research and Quality (AHRQ)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Inattentive behaviors are a common childhood condition that presents to the general pediatrician. While some of these behaviors are expected during childhood, others need work-up to ensure optimal functioning at home and school. A number of these children ultimately go on to have a mental health conditions, such as ADHD. However, inattentive symptoms represent a broad spectrum of potential behavioral and mental health conditions, such as pediatric anxiety which can masquerade as or co-exist with ADHD. Treatment is quite different and general pediatricians must have ways to facilitate the accurate identification of children needing further work-up and referral. Health information technology can greatly improve pediatricians' ability to identify and refer children with inattentive symptoms for further work-up. This study represents initial work to revise an existing computer decision support system's module for identification of ADHD to include screening questions and prompts for anxiety.
    Detailed Description
    The rapid rate at which childhood mental health and behavioral (MHB) disorders are being identified in primary care practice represents a public health crisis that demands critical examination. Approximately 20% of children and adolescents suffer from a MHB disorder each year. The most commonly recognized childhood MHB disorder is attention deficit hyperactivity disorder (ADHD). Since 2001, when clinical care guidelines were published to help primary care physicians identify ADHD early and initiate psychotropic treatment, ADHD identification has rapidly increased. Children with ADHD are at increased risk of having co-morbid disorders, such as anxiety and depression, oppositional defiant disorder, and learning disabilities, with ADHD symptoms presenting first. Primary care physicians encounter children with symptoms as severe as those in psychiatry clinics; yet a majority in primary care physicians feel ill-equipped to handle MHBs other than ADHD. Two particularly common and vexing problems that can co-occur or masquerade as ADHD are learning disabilities and anxiety. ADHD and anxiety often share behaviors of inattention as the presenting complaint, yet the treatment is quite different. Pediatric anxiety is even more prevalent than ADHD, but often goes undetected and untreated. In order to improve the detection of ADHD and co-morbidities and prevent undue polypharmacy, validated screening tools are essential in the primary care setting. However, general pediatric practice is fast paced and high volume. Clearly, the ideal diagnostic evaluation of children with symptoms of inattention would involve concurrent administration of validated screening tools for ADHD and anxiety, despite the constraints of a busy pediatric practice. The investigators believe health information technology combined with ongoing quality improvement with input from providers and families can achieve this ideal. At our institution, we have a computer decision support system, the Child Health Improvement through Computer Automation (CHICA) system that routinely conducts surveillance and screening of commonly encountered pediatric topics. The investigators will build upon the existing ADHD CHICA module, which conducts annual surveillance for inattentive symptoms and integrate validated screening tool for anxiety, associated surveillance items and prompts for the pediatrician to begin to improve the identification of ADHD and anxiety. Aim 1: Expand and modify the CHICA decision support system to improve the diagnostic processes for screening of children with inattention, including screening in the waiting room, physician prompts, and tailored diagnostic and brief counseling tools. Aim 2: Improve physician awareness of identification and referral patterns for children presenting with inattentive symptoms by providing run charts for each physician of their screening, referral and medication prescribing patterns paired with facilitated discussion to share strategies to improve diagnostic process and obtain preliminary feedback for future health information technology development of a comprehensive anxiety module. Aim 3: Examine the effect of the CHICA anxiety module on the diagnostic processes of physicians when screening children with inattentive symptoms. Sub-aim 3(a): Evaluate the agreement between positive anxiety screening results obtained by the Vanderbilt and a validated anxiety-specific screening tool. Sub-aim 3(b): Evaluate the actions taken by pediatricians when prompted to results of a positive screen. Sub-aim 3(c): Compare rates of ICD-9 diagnoses of anxiety and ADHD using billing data and rates of psychotropic medication (stimulants for ADHD versus anxiolytics for anxiety) using e-prescribing data.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anxiety, Attention Deficit Hyperactivity Disorder, Disorder, Pediatric

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Care Provider
    Allocation
    Randomized
    Enrollment
    3267 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Active Comparator
    Arm Description
    Randomization is at the clinic level. Two clinics will be randomized to receive the revised module to screen for anxiety and ADHD among children who present with parental concern of disruptive behaviors. Parents who have concerns of disruptive behaviors will trigger the module and be administered both the Vanderbilt for ADHD and Screen for Childhood Anxiety Related Emotional Disorders (SCARED) screening tools.
    Arm Title
    Control
    Arm Type
    Active Comparator
    Arm Description
    Randomization is at the clinic level. Two clinics will be randomized as the control clinics meaning that they will continue to provide care as usual for families who present to the clinic with concerns of disruptive behaviors. Currently, CHICA administers the Vanderbilt for ADHD screening tool.
    Intervention Type
    Other
    Intervention Name(s)
    Automated screening for pediatric anxiety
    Other Intervention Name(s)
    SCARED
    Intervention Description
    families receiving care at the intervention clinics with concern for disruptive behaviors will be administered the SCARED tool for anxiety in addition to the Vanderbilt tool for ADHD
    Intervention Type
    Other
    Intervention Name(s)
    Usual Care
    Other Intervention Name(s)
    control
    Intervention Description
    families receiving care at the control clinics with concern for disruptive behaviors will be administered the Vanderbilt tool for ADHD only
    Primary Outcome Measure Information:
    Title
    Caregiver perception about screening process and satisfaction with index visit
    Description
    families will be randomly selected to participate in a one-time telephone interview
    Time Frame
    Quarterly, from date of index visit up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Physician satisfaction
    Description
    Physician acceptance of the CHICA anxiety module will be obtained via quantitative surveys addressing physician comfort with anxiety and ADHD identification and acceptance of the anxiety module. These surveys are administered annually as part of ongoing quality improvement. The 30-item survey will include 4 items related specifically to the anxiety module and alterations in the ADHD algorithm. It will require approximately 10 minutes to complete. The survey for will incorporate Likert scales to measure physician comfort with anxiety identification, referral for inattentive behaviors and treatment initiation for anxiety and ADHD. These data will be compared to previously administered surveys that included items capturing physician acceptance of the ADHD module and subsequent management. Results will be aggregated by intervention and control clinics
    Time Frame
    annually, from the time module was revised and implemented, up to 2 years
    Other Pre-specified Outcome Measures:
    Title
    Proportion of children screening positive for anxiety
    Description
    Evaluate the agreement between positive anxiety screening results obtained by the Vanderbilt and a validated anxiety-specific screening tool
    Time Frame
    12 months after implementation of revised module
    Title
    Actions taken by pediatricians after alert of positive anxiety or ADHD prompt
    Description
    Evaluate the decision making or actions taken by pediatricians when prompted to results of a positive screen. Results will be aggregated by intervention and control clinics
    Time Frame
    12 months after implementation of revised module
    Title
    Proportion of ICD-10 Anxiety and ADHD diagnoses
    Description
    Compare rates of ICD-9 diagnoses of anxiety and ADHD using billing data. Results will be aggregated by intervention and control clinics
    Time Frame
    12 months after implementation of revised module
    Title
    Comparison of rates of psychotropic medication prescribing for anxiety vs ADHD
    Description
    Rates of psychotropic medication (stimulants for ADHD versus anxiolytics for anxiety) using e-prescribing data. Results will be aggregated by intervention and control clinics
    Time Frame
    12 months after implementation of revised module

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: FOR TELEPHONE INTERVIEWS Caregivers of children ages 6 to 12 whose parents have concerns of disruptive behavior Screening for anxiety is positive using the SCARED tool Caregivers must have completed both the SCARED and Vanderbilt tools at the index visit Exclusion Criteria: Primary language is not English or Spanish Does not receive medical care at the intervention clinics Did not complete both screening tools Child did not screen positive for anxiety using the SCARED FOR PHYSICIAN SATISFACTION Inclusion criteria: all participating providers at all four participating study clinics with CHICA Exclusion criteria: does not provide medical care at any of the four participating study clinics
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nerissa S Bauer, MD, MPH
    Organizational Affiliation
    Indiana University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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