Clinical trial NCT00505440: Trial of Automated Risk Appraisal for Adolescents
Official title: Trial of Automated Risk Appraisal for Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use
Depression
Suicidal Ideation
Risk Behavior
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2007-07-23
Enrollment: 1185
Sex: ALL
Minimum age (years): 11
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 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: 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:

1. compare frequency of problem drug use and abuse identification in RA/TS youth vs. youth in usual care (UC+);
2. 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
3. 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.

Eligibility criteria: Inclusion Criteria:

* 11-20 years of age
* non-emergent visit in primary care office
* consent and assent (if applicable)

Exclusion Criteria:

* non-english speaking

Primary outcomes:
measure: 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
timeFrame: 6 months
Secondary outcomes:
measure: receipt of counseling services
timeFrame: 6 months
measure: referral to mental health and other services
timeFrame: 6 months
measure: medications for mental health disorders
timeFrame: 6 months
measure: return to primary care
timeFrame: 6 months
measure: completion of referrals
timeFrame: 6 months
measure: number of primary care visits
timeFrame: 6 months
measure: number of specialty visits
timeFrame: 6 months
measure: satisfaction with RA/TS services
timeFrame: 4 months
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Columbus Children's Research Institute
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Kelly Kelleher, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Penfold RB, Kelleher KJ. Use of surveillance data in developing geographic dissemination strategies: a study of the diffusion of olanzapine to Michigan children insured by medicaid. Clin Ther. 2007 Feb;29(2):359-70; discussion 358. doi: 10.1016/j.clinthera.2007.02.017.
citation: Julian TW, Kelleher K, Julian DA, Chisolm D. Using technology to enhance prevention services for children in primary care. J Prim Prev. 2007 Mar;28(2):155-65. doi: 10.1007/s10935-007-0086-8. Epub 2007 Feb 6.
citation: Kaizar E, Chisolm D, Seltman H, Greenhouse J, Kelleher KJ. The role of care location in diagnosis and treatment of pediatric psychosocial conditions. J Dev Behav Pediatr. 2006 Jun;27(3):219-25. doi: 10.1097/00004703-200606000-00007.
citation: Gardner W, Shear K, Kelleher KJ, Pajer KA, Mammen O, Buysse D, Frank E. Computerized adaptive measurement of depression: a simulation study. BMC Psychiatry. 2004 May 6;4:13. doi: 10.1186/1471-244X-4-13.
citation: Gardner W, Kelleher KJ, Pajer KA. Multidimensional adaptive testing for mental health problems in primary care. Med Care. 2002 Sep;40(9):812-23. doi: 10.1097/00005650-200209000-00010.
citation: Chisolm DJ, Young RR, McAlearney AS. Implementation of a touch-screen new patient registration system: a case study. J Med Pract Manage. 2005 Nov-Dec;21(3):159-62.
citation: Stevens J, Kelleher KJ, Gardner W, Chisolm D, McGeehan J, Pajer K, Buchanan L. Trial of computerized screening for adolescent behavioral concerns. Pediatrics. 2008 Jun;121(6):1099-105. doi: 10.1542/peds.2007-1878.