Substance Related DisordersNCT02408952
Screening for Youth Alcohol and Drug Use: A Study of Primary Care Providers
A study testing Primary Care Physician and Behavioral Medicine Specialist in people with Substance Related Disorders, run by Kaiser Permanente at 1 site in United States.
Trial summary
This study evaluates the implementation and effectiveness of two modalities of Screening, Brief Intervention and Referral to Treatment (SBIRT) to reduce adolescent alcohol and other drug (AOD) use in a large pediatrics clinic. Read more about this study
- Who is it for?
- Ages 12 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Related Disorders
- What is being tested?
- Primary Care Physician and Behavioral Medicine Specialist
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9,084 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to 31 Dec 2025
- 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 12 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All adolescent primary care providers at the pediatric primary care clinic will be included.
- All adolescent patient electronic records, ages 12-18, at the pediatric primary care will be examined.
Who cannot join
- Any adolescent primary care providers not practicing at the pediatric primary care clinic research site will be excluded.
- Adolescents electronic records who are not part of the research site pediatric clinic will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the implementation and effectiveness of two modalities of Screening, Brief Intervention and Referral to Treatment (SBIRT) to reduce adolescent alcohol and other drug (AOD) use in a large pediatrics clinic.
Read the detailed description
Health systems have not implemented Screening, Brief Intervention and Referral to Treatment (SBIRT) for adolescents despite research demonstrating its effectiveness. Based on prior research that identified barriers to AOD screening for adolescents in pediatric Primary Care (PC) and a pilot study that found SBIRT was feasible, well-received and promoted referrals to and initiation of specialty treatment, the current research application proposes to randomize 45 Primary Care Physicians (PCPs) in the pediatrics clinic of a medical center within a large, managed care health system, Kaiser Permanente Northern California, to three arms - 1) Usual Care; 2) SBIRT delivered by PCPs; and 3) SBIRT delivered by Behavioral Medicine Specialists (BMS). The study objective is to compare the implementation, effectiveness and cost-effectiveness of SBIRT for adolescents in PC in the three study arms. Patients will complete evidence-based screening and AOD assessment measures which have been embedded in the health plan's electronic medical record (EMR). A mixed model will be used to compare implementation outcomes (rates of screening and identification, brief intervention, referral to Chemical Dependency treatment and treatment initiation), and effectiveness (patient outcomes of AOD use and abstinence) at 12 months. The model accounts for the intra-class correlations across patients within providers. Cost-effectiveness relative to implementation and patient outcomes will be examined. Barriers and facilitators of implementation, and feasibility via qualitative interviews with clinicians and administrators will be examined as well. The study is significant in that it examines issues that must be addressed to spur widespread adaptation of SBIRT. The proposed interventions are highly feasible in the current environment of health reform due to increased resources and training to Federally Qualified Health Centers and private health plans. It is innovative in using the EMR to change clinical practice and systematically integrate AOD in PC, and as a platform for collecting research data.
- Conditions
- Substance Related Disorders
- Being tested
- Primary Care Physician, Behavioral Medicine Specialist
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Care PhysicianBehavioural
The screening, brief intervention and referral to treatment is delivered by the Primary Care Physician
Behavioral Medicine SpecialistBehavioural
The screening, brief intervention and referral to treatment is delivered by the Behavioral Medicine Specialist.
| Study group | Role | What they receive |
|---|---|---|
| Primary Care Physician | Experimental | If the adolescent is identified at risk for substance use, the screening and brief intervention referral to treatment delivered is by the primary care physician Receives: Behavioral: Primary Care Physician |
| Behavioral Medicine Specialist | Experimental | If the adolescent is identified at risk for substance use, the screening and brief intervention referral to treatment delivered by the behavioral medicine specialist Receives: Behavioral: Behavioral Medicine Specialist |
| Usual Care | No intervention | Care is administered as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening rate
The proportion of patients who are screened with the Teen Well Check Questionnaire AOD use or Mood symptom questions, among all patients with Teen well-child visits.
Measured: Initial screening rate - at index well-visit
Problem Identification rate
The proportion of patients screened who answer "yes" to AOD use or Mood symptoms in past 12 months and "yes" to at least one non-car CRAFFT question. (Being in a car with someone using AOD may not be related to child's problem, but to having a parent/other adult who has driven while drinking/using).
Measured: Initital problem identification rate - at index well-visit, following screening
Assessment rate
Proportion of patients screening positive for alcohol or other drug, or mental health risk, who are assessed further using the CRAFFT tool.
Measured: Within 2 weeks following index well-visit date
Brief Intervention rate
The proportion of patients who receive an intervention within 14 days, among those who are identified with AOD risk (based on CRAFFT score). Documented in EHR by clinicians, using an ICD-9 Administrative V-code for substance use counseling or behavioral counseling.
Measured: Within 14 days of assessment at index well visit
Referral to specialty treatment rate
The proportion of patients who receive referrals to specialty behavioral health treatment, among those identified through the CRAFFT as needing such treatment. Documented in the EHR.
Measured: Within 6 months of index well-visit
Secondary outcomes (3)
Specialty Behavioral Health Treatment Initiation
Defined as the percent referred, who have at least one specialty behavioral health visit among those identified with a behavioral health problem. Documented in the EHR.
Measured: Within 2 years post-intervention
Alcohol and other drug use
Alcohol and drug use: The items in the EHR measure past 30-day and 6-month use of alcohol, marijuana and other drugs and tobacco, including days of use, quantity consumed (any, 3+ and 5+ drinks), and days of binge drinking (3+ and 5+).
Measured: Use in past 6 months, at 1 and 2 years post-intervention
Substance Use-related outcomes
AOD-related legal, school, and family problems: The EHR questions also include measures from the Comprehensive Adolescent Severity Inventory (CASI),148 a semi-structured questionnaire which measures adolescent health and functioning across education, legal, and family relations domains.
Measured: in past 6 months, at 1 and 2 years post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startOct 2011
- Primary completionOct 2013
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (165)Papers the sponsor has linked to this study.
- Other trials for Substance Related DisordersStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 9,084 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408952
- Sponsor's protocol ID
- 11-07796
- Status last verified
- Jul 2023
- First submitted
- 20 Mar 2015
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Schmittdiel JA, Shortell SM, Rundall TG, Bodenheimer T, Selby JV. Effect of primary health care orientation on chronic care management. Ann Fam Med. 2006 Mar-Apr;4(2):117-23. doi: 10.1370/afm.520.
PubMed 16569714Selby JV, Uratsu CS, Fireman B, Schmittdiel JA, Peng T, Rodondi N, Karter AJ, Kerr EA. Treatment intensification and risk factor control: toward more clinically relevant quality measures. Med Care. 2009 Apr;47(4):395-402. doi: 10.1097/mlr.0b013e31818d775c.
PubMed 19330888Saunders KW, Davis RL, Stergachis A. Group Health Cooperative. In: Strom BL, ed. Pharmacoepidemiology. 4th ed. New York: Wiley, 2005:223-239
Selby JV, Smith DH, Johnson ES, et al. Kaiser Permanente Medical Care Program. In: Strom BL, ed. Pharmacoepidemiology. 4th ed. New York: Wiley, 2005:241-259
Babor TE, Higgins-Biddle J, Dauser D, Higgins P, Burleson JA. Alcohol screening and brief intervention in primary care settings: implementation models and predictors. J Stud Alcohol. 2005 May;66(3):361-8. doi: 10.15288/jsa.2005.66.361.
PubMed 16047525Brindis C, Park MJ, Ozer EM, Irwin CE Jr. Adolescents' access to health services and clinical preventive health care: crossing the great divide. Pediatr Ann. 2002 Sep;31(9):575-81. doi: 10.3928/0090-4481-20020901-10. No abstract available.
PubMed 12271742Blum R. Physicians' assessment of deficiencies and desire for training in adolescent care. J Med Educ. 1987 May;62(5):401-7. doi: 10.1097/00001888-198705000-00005.
PubMed 3573019Shrier LA, Harris SK, Kurland M, Knight JR. Substance use problems and associated psychiatric symptoms among adolescents in primary care. Pediatrics. 2003 Jun;111(6 Pt 1):e699-705. doi: 10.1542/peds.111.6.e699.
PubMed 12777588Cowell AJ, Bray JW, Mills MJ, Hinde JM. Conducting economic evaluations of screening and brief intervention for hazardous drinking: Methods and evidence to date for informing policy. Drug Alcohol Rev. 2010 Nov;29(6):623-30. doi: 10.1111/j.1465-3362.2010.00238.x.
PubMed 20973847Ockene JK, Adams A, Hurley TG, Wheeler EV, Hebert JR. Brief physician- and nurse practitioner-delivered counseling for high-risk drinkers: does it work? Arch Intern Med. 1999 Oct 11;159(18):2198-205. doi: 10.1001/archinte.159.18.2198.
PubMed 10527297Reiff-Hekking S, Ockene JK, Hurley TG, Reed GW. Brief physician and nurse practitioner-delivered counseling for high-risk drinking. Results at 12-month follow-up. J Gen Intern Med. 2005 Jan;20(1):7-13. doi: 10.1111/j.1525-1497.2005.21240.x.
PubMed 15693921McIntosh MC, Leigh G, Baldwin NJ, Marmulak J. Reducing alcohol consumption. Comparing three brief methods in family practice. Can Fam Physician. 1997 Nov;43:1959-62, 1965-7.
PubMed 9386883Babor TF, Higgins-Biddle JC, Dauser D, Burleson JA, Zarkin GA, Bray J. Brief interventions for at-risk drinking: patient outcomes and cost-effectiveness in managed care organizations. Alcohol Alcohol. 2006 Nov-Dec;41(6):624-31. doi: 10.1093/alcalc/agl078. Epub 2006 Oct 10.
PubMed 17035245Burke PJ, Da Silva JD, Vaughan BL, Knight JR. Training high school counselors on the use of motivational interviewing to screen for substance abuse. Subst Abus. 2005 Dec;26(3-4):31-4. doi: 10.1300/j465v26n03_07.
PubMed 16837410Goodall CA, Ayoub AF, Crawford A, Smith I, Bowman A, Koppel D, Gilchrist G. Nurse-delivered brief interventions for hazardous drinkers with alcohol-related facial trauma: a prospective randomised controlled trial. Br J Oral Maxillofac Surg. 2008 Mar;46(2):96-101. doi: 10.1016/j.bjoms.2007.11.014. Epub 2007 Dec 21.
PubMed 18160192
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Youth Alcohol and Drug Use: A Study of Primary Care Providers
- ClinicalTrials.gov ID
- NCT02408952
- Acronym / sponsor ID
- 11-07796
- Conditions
- Substance Related Disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9,084 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Apr 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.
This study evaluates the implementation and effectiveness of two modalities of Screening, Brief Intervention and Referral to Treatment (SBIRT) to reduce adolescent alcohol and other drug (AOD) use in a large pediatrics clinic.
Detailed description
Health systems have not implemented Screening, Brief Intervention and Referral to Treatment (SBIRT) for adolescents despite research demonstrating its effectiveness. Based on prior research that identified barriers to AOD screening for adolescents in pediatric Primary Care (PC) and a pilot study that found SBIRT was feasible, well-received and promoted referrals to and initiation of specialty treatment, the current research application proposes to randomize 45 Primary Care Physicians (PCPs) in the pediatrics clinic of a medical center within a large, managed care health system, Kaiser Permanente Northern California, to three arms - 1) Usual Care; 2) SBIRT delivered by PCPs; and 3) SBIRT delivered by Behavioral Medicine Specialists (BMS). The study objective is to compare the implementation, effectiveness and cost-effectiveness of SBIRT for adolescents in PC in the three study arms. Patients will complete evidence-based screening and AOD assessment measures which have been embedded in the health plan's electronic medical record (EMR). A mixed model will be used to compare implementation outcomes (rates of screening and identification, brief intervention, referral to Chemical Dependency treatment and treatment initiation), and effectiveness (patient outcomes of AOD use and abstinence) at 12 months. The model accounts for the intra-class correlations across patients within providers. Cost-effectiveness relative to implementation and patient outcomes will be examined. Barriers and facilitators of implementation, and feasibility via qualitative interviews with clinicians and administrators will be examined as well. The study is significant in that it examines issues that must be addressed to spur widespread adaptation of SBIRT. The proposed interventions are highly feasible in the current environment of health reform due to increased resources and training to Federally Qualified Health Centers and private health plans. It is innovative in using the EMR to change clinical practice and systematically integrate AOD in PC, and as a platform for collecting research data.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary Care Physician | Experimental | Behavioral: Primary Care PhysicianIf the adolescent is identified at risk for substance use, the screening and brief intervention referral to treatment delivered is by the primary care physician |
| Behavioral Medicine Specialist | Experimental | Behavioral: Behavioral Medicine SpecialistIf the adolescent is identified at risk for substance use, the screening and brief intervention referral to treatment delivered by the behavioral medicine specialist |
| Usual Care | No intervention | –Care is administered as usual |
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All adolescent primary care providers at the pediatric primary care clinic will be included.
- All adolescent patient electronic records, ages 12-18, at the pediatric primary care will be examined.
Key exclusion criteria (2 listed)
- Any adolescent primary care providers not practicing at the pediatric primary care clinic research site will be excluded.
- Adolescents electronic records who are not part of the research site pediatric clinic will be excluded.
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 |
|---|---|---|
| Primary Care PhysicianThe screening, brief intervention and referral to treatment is delivered by the Primary Care Physician | Behavioural | Primary Care Physician |
| Behavioral Medicine SpecialistThe screening, brief intervention and referral to treatment is delivered by the Behavioral Medicine Specialist. | Behavioural | Behavioral Medicine Specialist |
Primary outcome
Screening rate
Time frame: Initial screening rate - at index well-visit
The proportion of patients who are screened with the Teen Well Check Questionnaire AOD use or Mood symptom questions, among all patients with Teen well-child visits.
Problem Identification rate
Time frame: Initital problem identification rate - at index well-visit, following screening
The proportion of patients screened who answer "yes" to AOD use or Mood symptoms in past 12 months and "yes" to at least one non-car CRAFFT question. (Being in a car with someone using AOD may not be related to child's problem, but to having a parent/other adult who has driven while drinking/using).
Assessment rate
Time frame: Within 2 weeks following index well-visit date
Proportion of patients screening positive for alcohol or other drug, or mental health risk, who are assessed further using the CRAFFT tool.
Brief Intervention rate
Time frame: Within 14 days of assessment at index well visit
The proportion of patients who receive an intervention within 14 days, among those who are identified with AOD risk (based on CRAFFT score). Documented in EHR by clinicians, using an ICD-9 Administrative V-code for substance use counseling or behavioral counseling.
Referral to specialty treatment rate
Time frame: Within 6 months of index well-visit
The proportion of patients who receive referrals to specialty behavioral health treatment, among those identified through the CRAFFT as needing such treatment. Documented in the EHR.
3 secondary outcomes
Specialty Behavioral Health Treatment Initiation
Time frame: Within 2 years post-intervention
Alcohol and other drug use
Time frame: Use in past 6 months, at 1 and 2 years post-intervention
Substance Use-related outcomes
Time frame: in past 6 months, at 1 and 2 years post-intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Background: PubMed 16569714Schmittdiel JA, Shortell SM, Rundall TG, Bodenheimer T, Selby JV. Effect of primary health care orientation on chronic care management. Ann Fam Med. 2006 Mar-Apr;4(2):117-23. doi: 10.1370/afm.520.
- Background: PubMed 19330888Selby JV, Uratsu CS, Fireman B, Schmittdiel JA, Peng T, Rodondi N, Karter AJ, Kerr EA. Treatment intensification and risk factor control: toward more clinically relevant quality measures. Med Care. 2009 Apr;47(4):395-402. doi: 10.1097/mlr.0b013e31818d775c.
- BackgroundSaunders KW, Davis RL, Stergachis A. Group Health Cooperative. In: Strom BL, ed. Pharmacoepidemiology. 4th ed. New York: Wiley, 2005:223-239
- BackgroundSelby JV, Smith DH, Johnson ES, et al. Kaiser Permanente Medical Care Program. In: Strom BL, ed. Pharmacoepidemiology. 4th ed. New York: Wiley, 2005:241-259
- Background: PubMed 16047525Babor TE, Higgins-Biddle J, Dauser D, Higgins P, Burleson JA. Alcohol screening and brief intervention in primary care settings: implementation models and predictors. J Stud Alcohol. 2005 May;66(3):361-8. doi: 10.15288/jsa.2005.66.361.
- Background: PubMed 12271742Brindis C, Park MJ, Ozer EM, Irwin CE Jr. Adolescents' access to health services and clinical preventive health care: crossing the great divide. Pediatr Ann. 2002 Sep;31(9):575-81. doi: 10.3928/0090-4481-20020901-10. No abstract available.
- Background: PubMed 3573019Blum R. Physicians' assessment of deficiencies and desire for training in adolescent care. J Med Educ. 1987 May;62(5):401-7. doi: 10.1097/00001888-198705000-00005.
- Background: PubMed 12777588Shrier LA, Harris SK, Kurland M, Knight JR. Substance use problems and associated psychiatric symptoms among adolescents in primary care. Pediatrics. 2003 Jun;111(6 Pt 1):e699-705. doi: 10.1542/peds.111.6.e699.
- Background: PubMed 20973847Cowell AJ, Bray JW, Mills MJ, Hinde JM. Conducting economic evaluations of screening and brief intervention for hazardous drinking: Methods and evidence to date for informing policy. Drug Alcohol Rev. 2010 Nov;29(6):623-30. doi: 10.1111/j.1465-3362.2010.00238.x.
- Background: PubMed 10527297Ockene JK, Adams A, Hurley TG, Wheeler EV, Hebert JR. Brief physician- and nurse practitioner-delivered counseling for high-risk drinkers: does it work? Arch Intern Med. 1999 Oct 11;159(18):2198-205. doi: 10.1001/archinte.159.18.2198.
- Background: PubMed 15693921Reiff-Hekking S, Ockene JK, Hurley TG, Reed GW. Brief physician and nurse practitioner-delivered counseling for high-risk drinking. Results at 12-month follow-up. J Gen Intern Med. 2005 Jan;20(1):7-13. doi: 10.1111/j.1525-1497.2005.21240.x.
- Background: PubMed 9386883McIntosh MC, Leigh G, Baldwin NJ, Marmulak J. Reducing alcohol consumption. Comparing three brief methods in family practice. Can Fam Physician. 1997 Nov;43:1959-62, 1965-7.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Care Physician and Behavioral Medicine Specialist in people with Substance Related Disorders, run by Kaiser Permanente at 1 site in United States.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Screening rate (time frame: Initial screening rate - at index well-visit). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02408952, which also lists 165 linked publications.
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 18 Jul 2023.