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CompletedNCT01135654ADVISEUpdated Apr 24, 2019

Alcohol Drinking as a Vital Sign

An interventional study of Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment in Unhealthy Drinking and Alcohol Dependence, sponsored by Kaiser Permanente. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-24.

Sponsored by Kaiser Permanente · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
639,613
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether Alcohol Screening, Brief Intervention, and Referral to Specialty Chemical Dependency Treatment (as appropriate) by Non-Physicians versus Primary Care Providers (versus control group) is more likely to be implemented and more effective at reducing unsafe drinking.

Read the detailed description

This health services implementation study is a clustered, randomized trial. We propose to randomize primary care clinics to three arms-a control condition and two alternative modes of delivery of the NIAAA Clinician's Guide to Alcohol Screening, Brief Intervention, and Referral to Treatment (SBIRT) in primary care settings. In the Primary Care Physician or "PCP" arm, PCPs will be trained on the SBIRT protocols outlined in the NIAAA Clinicians' Guide and conduct brief intervention and referrals as needed. In the Non-Physician Provider or "NPP" arm, Medical Assistants will be trained to use the NIAAA screener and enter the results in the Electronic Medical Record, and NPPs (e.g., Behavioral Medicine Specialists, Clinical Nurses and Health Educators) will conduct brief intervention and referral activities. The SBIRT content, based on the NIAAA Guide, is the same in both the NPP and PCP arms; we compare delivery by the two types of providers and versus the control condition, in which providers and staff will not receive any training on SBIRT protocols. We examine implementation outcomes: rates of screening, brief intervention, follow-up screening and brief intervention, referral to Chemical Dependency treatment, and alcohol use disorders medication rates. We also include, as secondary analyses, an effectiveness study examining patient outcomes by study arm.

02

Conditions studied

  • Unhealthy Drinking
  • Alcohol Dependence

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Keywords

  • alcohol dependence
  • unhealthy drinking
  • SBIRT
03

In context

Alcoholism

1,634 studies on the registry are indexed under Alcoholism; 329 are open to participants now.

This study's enrollment of 639,613 is above the median of 88 across 1,395 interventional studies indexed under Alcoholism.

Browse Alcoholism studies →

Lead sponsor

Kaiser Permanente is the lead sponsor of 392 studies on the registry; 42 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 3 (43%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients: All patients aged 18+ who receive primary care visits in the Kaiser Permanente clinics in Northern California.

Exclusion criteria

Exclusion Criteria:

  • Patients younger than 18.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
639,613 participants (actual)

Study arms

  • Experimental
    Non-Physician Provider

    Other: Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment

  • No intervention
    Control
  • Active comparator
    Primary Care Provider

    In clinics randomized to this arm, we will train (and provide technical assistance to) Primary Care providers to conduct Alcohol Screening, Brief Intervention, and Referral to Treatment.

    Other: Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment

Interventions

  • OtherTraining & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment

    We provide training and technical support for providers to conduct Alcohol Screening, Brief Intervention, and Referral to Treatment. The training is based on the NIAAA clinician's guide to "Helping Patients Who Drink Too Much".

06

What researchers measure

Primary outcomes

  1. Proportion of patients screened for alcohol

    We define the Screening Rate as the proportion of patients who receive the NIAAA brief screener (available in the Electronic Medical Record) from among all unique patients who have visits to the clinics in the relevant study arm in the year following the training of providers.

    Time frame: One year

  2. Proportion receiving Brief Intervention among those who screen positive to screener.

    The proportion receiving Brief Intervention Rate is the proportion of patients who receive brief intervention from among all patients who have visits to the clinic in the one year period and screen positive on the NIAAA screener in the EMR.

    Time frame: One year.

  3. Proportion of patients referred to treatment

    The treatment referral rate will be defined as the proportion of patients who receive referrals to Chemical Dependency treatment from among those who receive alcohol dependence diagnoses or whose screener indicates possible alcohol dependence.

    Time frame: one year

Secondary outcomes

  1. Changes in quantity of alcohol consumption - average weekly consumption

    We will examine changes in alcohol consumption measures (average weekly consumption at subsequent visits) for those who have return visits within the study observation period.

    Time frame: one year

07

Study locations

1 site
  • Kaiser Permanente Northern California
    Oakland, California 94112, United States
08

References and documents

Publications

  • Mertens JR, Chi FW, Weisner CM, Satre DD, Ross TB, Allen S, Pating D, Campbell CI, Lu YW, Sterling SA. Physician versus non-physician delivery of alcohol screening, brief intervention and referral to treatment in adult primary care: the ADVISe cluster randomized controlled implementation trial. Addict Sci Clin Pract. 2015 Nov 19;10:26. doi: 10.1186/s13722-015-0047-0. PubMed 26585638 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01135654
Lead sponsor
Kaiser Permanente
Responsible party
Sponsor
First posted
Jun 3, 2010
Start date
Jan 2010
Primary completion
Oct 2012
Completion
Dec 2018
Last update
Apr 24, 2019

Study contacts

Stacy Sterling, DrPH, MSW
principal investigator · Kaiser Permanente

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.

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