Alcohol Drinking as a Vital Sign

Alcohol Dependence Clinical Trial

— ADVISE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01135654
• Other study ID #: CN-09JMert-03-H
• Secondary ID: R01AA018660
• Status: Completed
• Phase: N/A
• Start date: January 2010
• Est. completion date: December 2018

Study information

• Verified date: April 2019
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 639613
• Est. completion date: December 2018
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Unhealthy Drinking

Intervention

Other:
• Training & 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".

Locations

Country	Name	City	State
United States	Kaiser Permanente Northern California	Oakland	California

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	One year
Primary	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.	One year.
Primary	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.	one year
Secondary	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.	one year