Alcohol Use DisorderCHOICENCT01400581
Considering Healthier Drinking Options in Collaborative Care
A study testing Collaborative Care Intervention in people with Alcohol Use Disorder, run by Kaiser Permanente at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a collaborative care intervention for evidence based management of alcohol use disorders in primary care settings within the Veterans Administration Puget Sound Health Care System (Seattle and American Lake Divisions). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Collaborative Care Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2015
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- AUDIT-C score 5 or more (modification described below)
- Age less than 65 at time of AUDIT-C screen (modification described below)
- Phone number available in electronic medical record
- Frequent heavy drinking reported during brief telephone screen (8 heavy drinking days in past 4 weeks, 5 or more drinks in a day for men, 4 or more for women; OR 4 heavy drinking days past four weeks and prior alcohol treatment or attendance at AA)
Who cannot join
- Missing address or phone number in electronic medical record
- Warning flag regarding violent behavior in medical record
- Patient participating in addictions treatment
- Primary care provider or patient indicates not to contact patient
- Barriers to telephone assessment (hearing, non-English)
- Unable to provide adequate collateral contacts
Show all 14Show fewer
- Cognitive impairment
- Unstable or acute medical, surgical, or psychiatric problem requiring emergency care
- Not available for follow-up (planning to move, life expectancy <1 yr, hospice)
- Pregnancy
- VA employee
- Prior to the start of the trial these changes were made (VA IRB approval: 8/2011):
- Changed from AUDIT-C score ≥5 for both men and women TO: AUDIT-C score ≥5 for men; AUDIT-C score ≥4 for women (to increase the pool of potentially eligible women)
- From age 65 years and younger to age ≤75 years
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101
About this study
Official title: Collaborative Care for Primary Care Patients With Alcohol Use Disorders
The purpose of this study is to evaluate the effectiveness of a collaborative care intervention for evidence based management of alcohol use disorders in primary care settings within the Veterans Administration Puget Sound Health Care System (Seattle and American Lake Divisions). The study will test whether patients offered the collaborative care intervention have fewer heavy drinking days at 12 months follow-up and to be abstinent or drinking below recommended limits without problems.
Read the detailed description
The proposed study will evaluate the effectiveness of a collaborative care intervention for evidence-based management of alcohol use disorders in primary care settings. The investigators will specifically test whether patients offered Collaborative Care:
Have fewer heavy drinking days at 12 months follow-up; and Are more likely to be abstinent or drinking below recommended limits without problems at 12 months follow-up.
Research Design:
The study is a randomized controlled encouragement trial. Consenting patients who complete all baseline assessments will be randomized to be offered the Collaborative Care (CC) intervention or receive Usual Care and will be assessed prospectively. Due to the powerful effect of alcohol assessments on drinking behavior, a cohort of men identified through VISTA/CPRS queries as being potentially eligible for the study will be followed electronically for the following year. A random 25% sample of these men will serve as a "no contact control group" and will have no contact with the study. The remaining 75% will be eligible for screening and recruitment.
Methodology The study will enroll up to 400 subjects (age < 65 years) with probable alcohol use disorders, in order to randomize 300 subjects who complete all baseline assessments. Eligibility criteria include a recent AUDIT-C screening score ≥ 5, phone number available in CPRS, and frequent heavy drinking days in the past four weeks (≥ 5 drinks for men, ≥4 drinks for women).
The CC intervention will consist of offering subjects: 1) an in-depth baseline assessment, 2) frequent (weekly first, then monthly) visits with a nurse care manager, 3) alcohol dependence medications prescribed by a Nurse Practitioner. An interdisciplinary CC team will supervise nurse care managers weekly.
All enrolled participants will have telephone surveys at baseline, 3 months and 12 months; and lab testing at baseline and 12 months. Main study outcomes include: 1) number of heavy drinking days in the past four weeks, and 2) abstinence or drinking below recommended limits at 12 months. Secondary analyses will compare CC and Usual Care groups on process measures of engagement in alcohol-related care, secondary drinking outcomes, laboratory markers, health-related quality of life, health care utilization, and health care costs. For the observational cohort, secondary analyses will compare drinking behaviors (AUDIT-C scores), alcohol-related diagnoses, and health care utilization between men who have no contact with study procedures and other subgroups who are eligible for screening and recruitment.
The investigators hypothesize that subjects in the intervention group will decrease their frequency of heavy drinking and will be more likely to be abstinent or drinking below recommended limits at 12 months follow-up.
- Conditions
- Alcohol Use Disorder
- Being tested
- Collaborative Care Intervention
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Care InterventionBehavioural
See description of Intervention arm
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care [CC] Intervention | Experimental | The CC intervention will consist of offering subjects: 1) an in-depth baseline assessment, 2) frequent (weekly first, then monthly) visits with a nurse care manager, 3) alcohol dependence medications prescribed by a Nurse Practitioner. An interdisciplinary CC team will supervise nurse care managers weekly. Receives: Behavioral: Collaborative Care Intervention |
| Usual Care | No intervention | Observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
1) number of heavy drinking days
Measured: at 12 months
2) abstinence or drinking below recommended limits without problems
Measured: at 12 months
Secondary outcomes (6)
Engagement in alcohol-related care
Measured: 12-months
secondary drinking outcomes and laboratory markers
Measured: 12-months
health-related quality of life
Measured: 12-months
health care utilization
Measured: 12-months
health care costs
Measured: 12-months
Outcomes 1-7 listed above and secondary drinking, readiness to change, and engagement outcomes.
Measured: at 3-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- VA Puget Sound Health Care System, University of Washington, Medical University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Katharine A Bradley, MD, MPH, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400581
- Sponsor's protocol ID
- 1R01AA018702
- Acronym
- CHOICE
- Status last verified
- Sep 2019
- First submitted
- 17 Feb 2011
- Last updated
- 12 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bradley KA, Ludman EJ, Chavez LJ, Bobb JF, Ruedebusch SJ, Achtmeyer CE, Merrill JO, Saxon AJ, Caldeiro RM, Greenberg DM, Lee AK, Richards JE, Thomas RM, Matson TE, Williams EC, Hawkins E, Lapham G, Kivlahan DR. Patient-centered primary care for adults at high risk for AUDs: the Choosing Healthier Drinking Options In primary CarE (CHOICE) trial. Addict Sci Clin Pract. 2017 May 17;12(1):15. doi: 10.1186/s13722-017-0080-2.
PubMed 28514963Bradley KA, Bobb JF, Ludman EJ, Chavez LJ, Saxon AJ, Merrill JO, Williams EC, Hawkins EJ, Caldeiro RM, Achtmeyer CE, Greenberg DM, Lapham GT, Richards JE, Lee AK, Kivlahan DR. Alcohol-Related Nurse Care Management in Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):613-621. doi: 10.1001/jamainternmed.2018.0388.
PubMed 29582088Williams EC, Bobb JF, Lee AK, Ludman EJ, Richards JE, Hawkins EJ, Merrill JO, Saxon AJ, Lapham GT, Matson TE, Chavez LJ, Caldeiro R, Greenberg DM, Kivlahan DR, Bradley KA. Effect of a Care Management Intervention on 12-Month Drinking Outcomes Among Patients With and Without DSM-IV Alcohol Dependence at Baseline. J Gen Intern Med. 2019 Dec 10. doi: 10.1007/s11606-019-05261-7. Online ahead of print.
PubMed 31432438Takahashi T, Lapham G, Chavez LJ, Lee AK, Williams EC, Richards JE, Greenberg D, Rubinsky A, Berger D, Hawkins EJ, Merrill JO, Bradley KA. Comparison of DSM-IV and DSM-5 criteria for alcohol use disorders in VA primary care patients with frequent heavy drinking enrolled in a trial. Addict Sci Clin Pract. 2017 Jul 18;12(1):17. doi: 10.1186/s13722-017-0082-0.
PubMed 28716049
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Collaborative Care for Primary Care Patients With Alcohol Use Disorders
- ClinicalTrials.gov ID
- NCT01400581
- Acronym / sponsor ID
- CHOICE / 1R01AA018702
- Conditions
- Alcohol Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- VA Puget Sound Health Care System, University of Washington, Medical University of South Carolina
- Study start
- Nov 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 22 Jul 2011 (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 evaluate the effectiveness of a collaborative care intervention for evidence based management of alcohol use disorders in primary care settings within the Veterans Administration Puget Sound Health Care System (Seattle and American Lake Divisions). The study will test whether patients offered the collaborative care intervention have fewer heavy drinking days at 12 months follow-up and to be abstinent or drinking below recommended limits without problems.
Detailed description
The proposed study will evaluate the effectiveness of a collaborative care intervention for evidence-based management of alcohol use disorders in primary care settings. The investigators will specifically test whether patients offered Collaborative Care:
Have fewer heavy drinking days at 12 months follow-up; and Are more likely to be abstinent or drinking below recommended limits without problems at 12 months follow-up.
Research Design:
The study is a randomized controlled encouragement trial. Consenting patients who complete all baseline assessments will be randomized to be offered the Collaborative Care (CC) intervention or receive Usual Care and will be assessed prospectively. Due to the powerful effect of alcohol assessments on drinking behavior, a cohort of men identified through VISTA/CPRS queries as being potentially eligible for the study will be followed electronically for the following year. A random 25% sample of these men will serve as a "no contact control group" and will have no contact with the study. The remaining 75% will be eligible for screening and recruitment.
Methodology The study will enroll up to 400 subjects (age < 65 years) with probable alcohol use disorders, in order to randomize 300 subjects who complete all baseline assessments. Eligibility criteria include a recent AUDIT-C screening score ≥ 5, phone number available in CPRS, and frequent heavy drinking days in the past four weeks (≥ 5 drinks for men, ≥4 drinks for women).
The CC intervention will consist of offering subjects: 1) an in-depth baseline assessment, 2) frequent (weekly first, then monthly) visits with a nurse care manager, 3) alcohol dependence medications prescribed by a Nurse Practitioner. An interdisciplinary CC team will supervise nurse care managers weekly.
All enrolled participants will have telephone surveys at baseline, 3 months and 12 months; and lab testing at baseline and 12 months. Main study outcomes include: 1) number of heavy drinking days in the past four weeks, and 2) abstinence or drinking below recommended limits at 12 months. Secondary analyses will compare CC and Usual Care groups on process measures of engagement in alcohol-related care, secondary drinking outcomes, laboratory markers, health-related quality of life, health care utilization, and health care costs. For the observational cohort, secondary analyses will compare drinking behaviors (AUDIT-C scores), alcohol-related diagnoses, and health care utilization between men who have no contact with study procedures and other subgroups who are eligible for screening and recruitment.
The investigators hypothesize that subjects in the intervention group will decrease their frequency of heavy drinking and will be more likely to be abstinent or drinking below recommended limits at 12 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care [CC] Intervention | Experimental | Behavioral: Collaborative Care InterventionThe CC intervention will consist of offering subjects: 1) an in-depth baseline assessment, 2) frequent (weekly first, then monthly) visits with a nurse care manager, 3) alcohol dependence medications prescribed by a Nurse Practitioner. An interdisciplinary CC team will supervise nurse care managers weekly. |
| Usual Care | No intervention | –Observational |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- AUDIT-C score 5 or more (modification described below)
- Age less than 65 at time of AUDIT-C screen (modification described below)
- Phone number available in electronic medical record
- Frequent heavy drinking reported during brief telephone screen (8 heavy drinking days in past 4 weeks, 5 or more drinks in a day for men, 4 or more for women; OR 4 heavy drinking days past four weeks and prior alcohol treatment or attendance at AA)
Key exclusion criteria (14 listed)
- Missing address or phone number in electronic medical record
- Warning flag regarding violent behavior in medical record
- Patient participating in addictions treatment
- Primary care provider or patient indicates not to contact patient
- Barriers to telephone assessment (hearing, non-English)
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 |
|---|---|---|
| Collaborative Care InterventionSee description of Intervention arm | Behavioural | Collaborative Care [CC] Intervention |
Primary outcome
1) number of heavy drinking days
Time frame: at 12 months
2) abstinence or drinking below recommended limits without problems
Time frame: at 12 months
6 secondary outcomes
Engagement in alcohol-related care
Time frame: 12-months
secondary drinking outcomes and laboratory markers
Time frame: 12-months
health-related quality of life
Time frame: 12-months
health care utilization
Time frame: 12-months
health care costs
Time frame: 12-months
Outcomes 1-7 listed above and secondary drinking, readiness to change, and engagement outcomes.
Time frame: at 3-months
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 12 Sep 2019.
- Background: PubMed 28514963Bradley KA, Ludman EJ, Chavez LJ, Bobb JF, Ruedebusch SJ, Achtmeyer CE, Merrill JO, Saxon AJ, Caldeiro RM, Greenberg DM, Lee AK, Richards JE, Thomas RM, Matson TE, Williams EC, Hawkins E, Lapham G, Kivlahan DR. Patient-centered primary care for adults at high risk for AUDs: the Choosing Healthier Drinking Options In primary CarE (CHOICE) trial. Addict Sci Clin Pract. 2017 May 17;12(1):15. doi: 10.1186/s13722-017-0080-2.
- Results publication: PubMed 29582088Bradley KA, Bobb JF, Ludman EJ, Chavez LJ, Saxon AJ, Merrill JO, Williams EC, Hawkins EJ, Caldeiro RM, Achtmeyer CE, Greenberg DM, Lapham GT, Richards JE, Lee AK, Kivlahan DR. Alcohol-Related Nurse Care Management in Primary Care: A Randomized Clinical Trial. JAMA Intern Med. 2018 May 1;178(5):613-621. doi: 10.1001/jamainternmed.2018.0388.
- Derived from this study: PubMed 31432438Williams EC, Bobb JF, Lee AK, Ludman EJ, Richards JE, Hawkins EJ, Merrill JO, Saxon AJ, Lapham GT, Matson TE, Chavez LJ, Caldeiro R, Greenberg DM, Kivlahan DR, Bradley KA. Effect of a Care Management Intervention on 12-Month Drinking Outcomes Among Patients With and Without DSM-IV Alcohol Dependence at Baseline. J Gen Intern Med. 2019 Dec 10. doi: 10.1007/s11606-019-05261-7. Online ahead of print.
- Derived from this study: PubMed 28716049Takahashi T, Lapham G, Chavez LJ, Lee AK, Williams EC, Richards JE, Greenberg D, Rubinsky A, Berger D, Hawkins EJ, Merrill JO, Bradley KA. Comparison of DSM-IV and DSM-5 criteria for alcohol use disorders in VA primary care patients with frequent heavy drinking enrolled in a trial. Addict Sci Clin Pract. 2017 Jul 18;12(1):17. doi: 10.1186/s13722-017-0082-0.
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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.
Katharine A Bradley, MD, MPH 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 Collaborative Care Intervention in people with Alcohol Use Disorder, 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 4 inclusion and 14 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 12 Sep 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?
1) number of heavy drinking days (time frame: at 12 months). The study lists 2 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 NCT01400581, which also lists 4 linked publications.
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 12 Sep 2019.