Improving Anxiety Detection in Pediatrics Using Health Information Technology

Anxiety Clinical Trial

Official title:

Improving Anxiety Detection in Pediatrics Using Health Information Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562248
• Other study ID #: 1508683196
• Secondary ID: 1508624213
• Status: Completed
• Phase: N/A
• Start date: September 1, 2015
• Est. completion date: July 31, 2018

Study information

• Verified date: April 2019
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3267
• Est. completion date: July 31, 2018
• Est. primary completion date: August 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Disease
• Disorder, Pediatric

Intervention

Other:
• Automated screening for pediatric anxiety
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
• Usual Care
families receiving care at the control clinics with concern for disruptive behaviors will be administered the Vanderbilt tool for ADHD only

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Agency for Healthcare Research and Quality (AHRQ)

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of children screening positive for anxiety	Evaluate the agreement between positive anxiety screening results obtained by the Vanderbilt and a validated anxiety-specific screening tool	12 months after implementation of revised module
Other	Actions taken by pediatricians after alert of positive anxiety or ADHD prompt	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	12 months after implementation of revised module
Other	Proportion of ICD-10 Anxiety and ADHD diagnoses	Compare rates of ICD-9 diagnoses of anxiety and ADHD using billing data. Results will be aggregated by intervention and control clinics	12 months after implementation of revised module
Other	Comparison of rates of psychotropic medication prescribing for anxiety vs ADHD	Rates of psychotropic medication (stimulants for ADHD versus anxiolytics for anxiety) using e-prescribing data. Results will be aggregated by intervention and control clinics	12 months after implementation of revised module
Primary	Caregiver perception about screening process and satisfaction with index visit	families will be randomly selected to participate in a one-time telephone interview	Quarterly, from date of index visit up to 12 weeks
Secondary	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	annually, from the time module was revised and implemented, up to 2 years