Clinical trial NCT01135654: Alcohol Drinking as a Vital Sign
Official title: Alcohol SBIRT Implementation in an HMO: Non-Physician Providers Vs Physicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unhealthy Drinking
Alcohol Dependence
Keywords: alcohol dependence
unhealthy drinking
SBIRT
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2010-06-03
Enrollment: 639613
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of patients screened for alcohol
timeFrame: One year
measure: Proportion receiving Brief Intervention among those who screen positive to screener.
timeFrame: One year.
measure: Proportion of patients referred to treatment
timeFrame: one year
Secondary outcomes:
measure: Changes in quantity of alcohol consumption - average weekly consumption
timeFrame: one year
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
Study officials:
affiliation: Kaiser Permanente
name: Stacy Sterling, DrPH, MSW
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.