AnxietyNCT02562248
Improving Anxiety Detection in Pediatrics Using Health Information Technology
A study testing Automated screening for pediatric anxiety in people with Anxiety and Attention Deficit Hyperactivity Disorder, run by Indiana University.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Attention Deficit Hyperactivity Disorder, Disorder, Pediatric
- What is being tested?
- Automated screening for pediatric anxiety
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,267 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 31 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- all participating providers at all four participating study clinics with CHICA
Who cannot join
- 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
- does not provide medical care at any of the four participating study clinics
About this study
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.
Read the 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.
- Being tested
- Automated screening for pediatric anxiety, Usual Care
- Medical subject headings
- Anxiety Disorders, Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated screening for pediatric anxietyOther
Also called SCARED
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 CareOther
Also called control
families receiving care at the control clinics with concern for disruptive behaviors will be administered the Vanderbilt tool for ADHD only
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | 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. Receives: Other: Automated screening for pediatric anxiety |
| Control | Active comparator | 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. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver perception about screening process and satisfaction with index visit
families will be randomly selected to participate in a one-time telephone interview
Measured: Quarterly, from date of index visit up to 12 weeks
Secondary outcomes (1)
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
Measured: annually, from the time module was revised and implemented, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study start1 Sep 2015
- Primary completion31 Aug 2017
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 3,267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Nerissa Bauer, Indiana University
- Investigators
- Nerissa S Bauer, MD, MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562248
- Sponsor's protocol ID
- 1508683196
- Other IDs
- 1508624213
- Status last verified
- Apr 2019
- First submitted
- 25 Sep 2015
- Last updated
- 22 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Anxiety Detection in Pediatrics Using Health Information Technology
- ClinicalTrials.gov ID
- NCT02562248
- Acronym / sponsor ID
- 1508683196
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,267 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 31 Aug 2017 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Automated screening for pediatric anxietyRandomization 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. |
| Control | Active comparator | Other: Usual CareRandomization 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- all participating providers at all four participating study clinics with CHICA
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated screening for pediatric anxietyAlso: SCAREDfamilies 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 | Other | Intervention |
| Usual CareAlso: controlfamilies receiving care at the control clinics with concern for disruptive behaviors will be administered the Vanderbilt tool for ADHD only | Other | Control |
Primary outcome
Caregiver perception about screening process and satisfaction with index visit
Time frame: Quarterly, from date of index visit up to 12 weeks
families will be randomly selected to participate in a one-time telephone interview
1 secondary outcome
Physician satisfaction
Time frame: annually, from the time module was revised and implemented, up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nerissa S Bauer, MD, MPH principal investigator
Indiana University
Questions about this trial
What is this clinical trial studying?
A study testing Automated screening for pediatric anxiety in people with Anxiety and Attention Deficit Hyperactivity Disorder, run by Indiana University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver perception about screening process and satisfaction with index visit (time frame: Quarterly, from date of index visit up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2019.