Katharine A Bradley1,2,3,4, Jennifer F Bobb1, Evette J Ludman1,5, Laura J Chavez6,7, Andrew J Saxon5,8, Joseph O Merrill2, Emily C Williams3,4, Eric J Hawkins4,5,8, Ryan M Caldeiro9, Carol E Achtmeyer4,8,10, Diane M Greenberg10,11, Gwen T Lapham1,3, Julie E Richards1,3, Amy K Lee1, Daniel R Kivlahan4,5. 1. Kaiser Permanente Washington Health Research Institute, Seattle. 2. Department of Medicine, University of Washington, Seattle. 3. Department of Health Services, University of Washington, Seattle. 4. Health Services Research & Development Center of Innovation for Veteran-Centered and Value-Driven Care, Veterans Affairs Puget Sound Health Care System, Seattle, Washington. 5. Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle. 6. Division of Health Services Management and Policy, College of Public Health, Ohio State University, Columbus. 7. Center for Innovation in Pediatric Practice, Nationwide Children's Hospital, Columbus, Ohio. 8. Center of Excellence in Substance Abuse Treatment and Education, Veterans Affairs Puget Sound Health Care System, Seattle, Washington. 9. Behavioral Health Support Services, Kaiser Foundation Health Plan of Washington, Seattle. 10. General Medicine Service, Veterans Affairs Puget Sound Health Care System, Seattle, Washington. 11. Innovative Programs Research Group, School of Social Work, University of Washington, Seattle.
Abstract
Importance: Experts recommend that alcohol use disorders (AUDs) be managed in primary care, but effective approaches are unclear. Objective: To test whether 12 months of alcohol care management, compared with usual care, improved drinking outcomes among patients with or at high risk for AUDs. Design, Setting, and Participants: This randomized clinical trial was conducted at 3 Veterans Affairs (VA) primary care clinics. Between October 11, 2011, and September 30, 2014, the study enrolled 304 outpatients who reported heavy drinking (≥4 drinks per day for women and ≥5 drinks per day for men). Interventions: Nurse care managers offered outreach and engagement, repeated brief counseling using motivational interviewing and shared decision making about treatment options, and nurse practitioner-prescribed AUD medications (if desired), supported by an interdisciplinary team (CHOICE intervention). The comparison was usual primary care. Main Outcomes and Measures: Primary outcomes, assessed by blinded telephone interviewers at 12 months, were percentage of heavy drinking days in the prior 28 days measured by timeline follow-back interviews and a binary good drinking outcome, defined as abstinence or drinking below recommended limits in the prior 28 days (according to timeline follow-back interviews) and no alcohol-related symptoms in the past 3 months as measured by the Short Inventory of Problems. Results:Of 304 participants, 275 (90%) were male, 206 (68%) were white, and the mean (SD) age was 51.4 (13.8) years. At baseline, both the CHOICE intervention (n = 150) and usual care (n = 154) groups reported heavy drinking on 61% of days (95% CI, 56%-66%). During the 12-month intervention, 137 of 150 patients in the intervention group (91%) had at least 1 nurse visit, and 77 of 150 (51%) had at least 6 nurse visits. A greater proportion of patients in the intervention group than in the usual care group received alcohol-related care: 42% (95% CI, 35%-49%; 63 of 150 patients) vs 26% (95% CI, 19%-35%; 40 of 154 patients). Alcohol-related care included more AUD medication use: 32% (95% CI, 26%-39%; 48 of 150 patients in the intervention group) vs 8% (95% CI, 5%-13%; 13 of 154 patients in the usual care group). No significant differences in primary outcomes were observed at 12 months between patients in both groups. The percentages of heavy drinking days were 39% (95% CI, 32%-47%) and 35% (95% CI, 28%-42%), and the percentages of patients with a good drinking outcome were 15% (95% CI, 9%-22%; 18 of 124 patients) and 20% (95 % CI, 14%-28%; 27 of 134 patients), in the intervention and usual care groups, respectively (P = .32-.44). Findings at 3 months were similar. Conclusions and Relevance: The CHOICE intervention did not decrease heavy drinking or related problems despite increased engagement in alcohol-related care. Trial Registration: clinicaltrials.gov Identifier: NCT01400581.
RCT Entities:
Importance: Experts recommend that alcohol use disorders (AUDs) be managed in primary care, but effective approaches are unclear. Objective: To test whether 12 months of alcohol care management, compared with usual care, improved drinking outcomes among patients with or at high risk for AUDs. Design, Setting, and Participants: This randomized clinical trial was conducted at 3 Veterans Affairs (VA) primary care clinics. Between October 11, 2011, and September 30, 2014, the study enrolled 304 outpatients who reported heavy drinking (≥4 drinks per day for women and ≥5 drinks per day for men). Interventions: Nurse care managers offered outreach and engagement, repeated brief counseling using motivational interviewing and shared decision making about treatment options, and nurse practitioner-prescribed AUD medications (if desired), supported by an interdisciplinary team (CHOICE intervention). The comparison was usual primary care. Main Outcomes and Measures: Primary outcomes, assessed by blinded telephone interviewers at 12 months, were percentage of heavy drinking days in the prior 28 days measured by timeline follow-back interviews and a binary good drinking outcome, defined as abstinence or drinking below recommended limits in the prior 28 days (according to timeline follow-back interviews) and no alcohol-related symptoms in the past 3 months as measured by the Short Inventory of Problems. Results: Of 304 participants, 275 (90%) were male, 206 (68%) were white, and the mean (SD) age was 51.4 (13.8) years. At baseline, both the CHOICE intervention (n = 150) and usual care (n = 154) groups reported heavy drinking on 61% of days (95% CI, 56%-66%). During the 12-month intervention, 137 of 150 patients in the intervention group (91%) had at least 1 nurse visit, and 77 of 150 (51%) had at least 6 nurse visits. A greater proportion of patients in the intervention group than in the usual care group received alcohol-related care: 42% (95% CI, 35%-49%; 63 of 150 patients) vs 26% (95% CI, 19%-35%; 40 of 154 patients). Alcohol-related care included more AUD medication use: 32% (95% CI, 26%-39%; 48 of 150 patients in the intervention group) vs 8% (95% CI, 5%-13%; 13 of 154 patients in the usual care group). No significant differences in primary outcomes were observed at 12 months between patients in both groups. The percentages of heavy drinking days were 39% (95% CI, 32%-47%) and 35% (95% CI, 28%-42%), and the percentages of patients with a good drinking outcome were 15% (95% CI, 9%-22%; 18 of 124 patients) and 20% (95 % CI, 14%-28%; 27 of 134 patients), in the intervention and usual care groups, respectively (P = .32-.44). Findings at 3 months were similar. Conclusions and Relevance: The CHOICE intervention did not decrease heavy drinking or related problems despite increased engagement in alcohol-related care. Trial Registration: clinicaltrials.gov Identifier: NCT01400581.
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