Considering Healthier Drinking Options in Collaborative Care

NCT01400581 | Completed DMC

• 1 other identifier: 1R01AA018702
• Study Type: interventional
• Target: 304
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

• 1) number of heavy drinking days

  at 12 months

• 2) abstinence or drinking below recommended limits without problems

  at 12 months

Secondary Outcomes (6)

• Engagement in alcohol-related care

  12-months

• secondary drinking outcomes and laboratory markers

  12-months

• health-related quality of life

  12-months

• health care utilization

  12-months

• health care costs

  12-months

Study Arms (2)

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.

Behavioral: Collaborative Care Intervention

Usual Care

NO INTERVENTION

Observational

Interventions

Collaborative Care Intervention BEHAVIORAL

See description of Intervention arm

Collaborative Care [CC] Intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• VA Puget Sound Health Care System: collaborator
• University of Washington: collaborator
• Medical University of South Carolina: collaborator

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (4)

• 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.

  PMID: 28514963 BACKGROUND

• Bradley 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.

  PMID: 29582088 RESULT

• Williams 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.

  PMID: 31432438 DERIVED

• Takahashi 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.

  PMID: 28716049 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Katharine A Bradley, MD, MPH

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: July 22, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 12, 2019

Record last verified: 2019-09

Locations

US (1)