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OpenTrials
Completed

NCT Number: NCT01135654

Alcohol Drinking as a Vital Sign

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Northern California

Oakland, California, 94112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients younger than 18.

Treatment and study plan

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

Other

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".

Primary outcomes

  1. Proportion of patients screened for alcohol

    Time frame: One year

    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.

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

    Time frame: One year.

    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.

  3. Proportion of patients referred to treatment

    Time frame: one year

    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.

Secondary outcomes

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

    Time frame: one year

    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.

Sponsors and collaborators

Lead sponsor

Kaiser Permanente

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Official study title

Alcohol SBIRT Implementation in an HMO: Non-Physician Providers Vs Physicians

Acronym: ADVISE

Important dates

Study start
2010
Primary completion
2012
Study completion
2018
First posted
Jun 3, 2010
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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