Unhealthy DrinkingADVISENCT01135654
Alcohol Drinking as a Vital Sign
A study testing Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment in people with Unhealthy Drinking and Alcohol Dependence, run by Kaiser Permanente at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unhealthy Drinking, Alcohol Dependence
- What is being tested?
- Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 639,613 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients: All patients aged 18+ who receive primary care visits in the Kaiser Permanente clinics in Northern California.
Who cannot join
- Patients younger than 18.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Northern California
Oakland, California, 94112
About this study
Official title: Alcohol SBIRT Implementation in an HMO: Non-Physician Providers Vs Physicians
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.
Read the 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.
- Conditions
- Unhealthy Drinking, Alcohol Dependence
- Being tested
- Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment
- Keywords
- alcohol dependence, unhealthy drinking, SBIRT
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To TreatmentOther
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".
| Study group | Role | What they receive |
|---|---|---|
| Non-Physician Provider | Experimental | Not described Receives: Other: Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment |
| Control | No intervention | Not described |
| Primary Care Provider | Active comparator | 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. Receives: Other: Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One year
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.
Measured: One year.
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.
Measured: one year
Secondary outcomes (1)
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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startJan 2010
- Primary completionOct 2012
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unhealthy DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 639,613 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Stacy Sterling, DrPH, MSW, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135654
- Sponsor's protocol ID
- CN-09JMert-03-H
- Other IDs
- R01AA018660
- Acronym
- ADVISE
- Status last verified
- Apr 2019
- First submitted
- 1 Jun 2010
- Last updated
- 24 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26585638
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol SBIRT Implementation in an HMO: Non-Physician Providers Vs Physicians
- ClinicalTrials.gov ID
- NCT01135654
- Acronym / sponsor ID
- ADVISE / CN-09JMert-03-H
- Conditions
- Unhealthy Drinking, Alcohol Dependence
- Keywords
- alcohol dependence, unhealthy drinking, SBIRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 639,613 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Jan 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 3 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-Physician Provider | Experimental | Other: Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment |
| Control | No intervention | – |
| Primary Care Provider | Active comparator | Other: Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To TreatmentIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients: All patients aged 18+ who receive primary care visits in the Kaiser Permanente clinics in Northern California.
Key exclusion criteria (1 listed)
- Patients younger than 18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To TreatmentWe 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". | Other | Non-Physician Provider, Primary Care Provider |
Primary outcome
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.
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.
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.
1 secondary outcome
Changes in quantity of alcohol consumption - average weekly consumption
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
- Derived from this study: PubMed 26585638Mertens 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stacy Sterling, DrPH, MSW principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment in people with Unhealthy Drinking and Alcohol Dependence, run by Kaiser Permanente at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients screened for alcohol (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01135654, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2019.