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Alcohol Drinking as a Vital Sign (ADVISE)

Primary Purpose

Unhealthy Drinking, Alcohol Dependence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Unhealthy Drinking focused on measuring alcohol dependence, unhealthy drinking, SBIRT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Kaiser Permanente Northern California

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Active Comparator

Arm Label

Non-Physician Provider

Control

Primary Care Provider

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 1, 2010
Last Updated
April 23, 2019
Sponsor
Kaiser Permanente
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01135654
Brief Title
Alcohol Drinking as a Vital Sign
Acronym
ADVISE
Official Title
Alcohol SBIRT Implementation in an HMO: Non-Physician Providers Vs Physicians
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unhealthy Drinking, Alcohol Dependence
Keywords
alcohol dependence, unhealthy drinking, SBIRT

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
639613 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-Physician Provider
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Arm Title
Primary Care Provider
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment
Intervention Description
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 Outcome Measure Information:
Title
Proportion of patients screened for alcohol
Description
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
Title
Proportion receiving Brief Intervention among those who screen positive to screener.
Description
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.
Title
Proportion of patients referred to treatment
Description
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 Outcome Measure Information:
Title
Changes in quantity of alcohol consumption - average weekly consumption
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacy Sterling, DrPH, MSW
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Northern California
City
Oakland
State/Province
California
ZIP/Postal Code
94112
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26585638
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.
Results Reference
derived

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Alcohol Drinking as a Vital Sign

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