Alcohol Drinking as a Vital Sign

Not Applicable

Completed

• Conditions: Unhealthy Drinking; Alcohol Dependence
• Interventions: Other: Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment

• Registration Number: NCT01135654
• Lead Sponsor: Kaiser Permanente

Brief 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.

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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-06-01
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Primary Completion: 2012-10
• Study Completion: 2018-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-23
• Last Update Posted: 2019-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 639613

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Physician Provider	Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment	-
Primary Care Provider	Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment	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.

Primary Outcome Measures

Name	Time	Method
Proportion of patients screened for alcohol	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.
Proportion receiving Brief Intervention among those who screen positive to screener.	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.
Proportion of patients referred to treatment	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 Outcome Measures

Name	Time	Method
Changes in quantity of alcohol consumption - average weekly consumption	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.

Trial Locations

Locations (1)

Kaiser Permanente Northern California; 🇺🇸 Oakland, California, United States