Trial of Automated Risk Appraisal for Adolescents

Study Overview
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Brief Summary
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This is a study to find out which type of computer screening and nursing support can improve screening for high risk behaviors in doctor's offices. Recommendations call for doctors to screen young people for many different behaviors and feelings such as depression, not wearing seat belts, alcohol and drug use. Doctors rarely have time to complete these screenings. New computers can help ask some of these questions and protect patient information. In addition, nurse telephone calls can often help young persons with some of the behaviors receive treatment. This study will examine which type of computer screening and follow-up will help patients the most.

Detailed Description
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The pandemic of problem drug use and abuse and related health problems among young persons aged 12-25 in the U.S. continues unabated, in part, because opportunities for early identification and monitoring are missed. In particular, improved recognition of, and ongoing contact for, problem drug use and abuse among pre-teens and early adolescents in primary care settings could provide important information to health care professionals and engage early intervention services. Unfortunately, many barriers exist to routine screening and monitoring in primary care settings. These include the expense of traditional paper and pencil screening, competing demands on primary care clinicians and office staff, complex scoring programs and the ability to track youth over time. Innovative information technology and support services can overcome many of these barriers. New primary care information systems allow for direct data entry by youth in healthcare settings, automated scoring and printing, decreased staff time, individual or practice level results and patient follow-up for intervention services. However, these assessment tools and systems have not been adequately assessed for their roles in detecting problem drug use and abuse in youth, and appropriate follow-up and tracking systems for those identified have not been implemented. Our goal is to improve services for problem drug use and abuse and other related health risking behaviors for youth in primary care settings through early identification and monitoring. We expand an innovative partnership among the Columbus Children's Hospital, the Close To Home Primary Care Centers and Flipsidemedia.com to test the efficacy and acceptability of an early identification and monitoring system for problem drug use and abuse, depression and related mental disorders among pre-teens and teenagers in a randomized trial. We propose to compare care in nine Close To Home Centers with Automated Risk Appraisal for Adolescents/Telephone Support (RA/TS) compared to usual care plus mailed screening results (UC+). Each site will be randomly assigned to start with six months on RA/TS or six months on UC+ and follow with the alternative in a crossover design. RA/TS is a web-based screening and assessment tool completed by adolescents during primary care visits and a linked, structured telephone tracking intervention consisting of three follow-up telephone calls to youth and their families monitoring identified problems and barriers to services. Specifically, we aim to: compare frequency of problem drug use and abuse identification in RA/TS youth vs. youth in usual care (UC+); examine frequency of counseling, referral, psychotropic medication or other interventions for youth screening positive for problem drug use and abuse on RA (Risk Appraisal) in RA/TS youth vs. UC+ youth; and evaluate the effects of the TS (Telephone Support) program on return to primary care, likelihood of completing referrals, number of primary care visits, number of specialty visits, and satisfaction with services after four months for youth screening positive for problem drug use and abuse.

Official Title
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Trial of Automated Risk Appraisal for Adolescents

Conditions
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Substance Use, Depression, Suicidal Ideation, Risk Behavior

Intervention / Treatment
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* Behavioral: Telephone case management and motivational interviewing
* Behavioral: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 11-20 years of age non-emergent visit in primary care office consent and assent (if applicable) Exclusion Criteria: non-english speaking

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerized screening and referral<br>Computerized screening and referral: Intervention is a web-based screening and assessment tool completed by adolescents during primary care visits. Patient reported screening provided to primary care physicians in real time with recommendations for behavioral referrals. | Behavioral: Telephone case management and motivational interviewing<br>* 'Telephone case management and motivational interviewing': Immediate screening results are given to the physician during the patient's visit. Telephone case management and motivational interviewing (MI) at 1, 6, and 9 weeks to enhance engagement and commitment to change<br>|
| Active Comparator: Delayed feedback from screening<br>Active comparator is Usual pediatric care plus mailed screening results from computerized waiting room screens that arrive three days after screening. | Behavioral: Usual care<br>* Usual care with mailed screening results<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| identification of problem drug use and abuse, depression, and other mental disorders using the Automated Risk Appraisal for Adolescents / Telephone Support (RA/TS) tool compared with usual care practices |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| receipt of counseling services |  | 6 months | 
| referral to mental health and other services |  | 6 months | 
| medications for mental health disorders |  | 6 months | 
| return to primary care |  | 6 months | 
| completion of referrals |  | 6 months | 
| number of primary care visits |  | 6 months | 
| number of specialty visits |  | 6 months | 
| satisfaction with RA/TS services |  | 4 months |