Journal Club Alcohol, Other Drugs, and Health: Current Evidence September–October 2013

Featured Article Reducing heavy drinking in HIV primary care: a randomized trial of brief intervention, with and without technological enhancement. Hasin DS, et al. Addiction. 2013;108(7):1230–1240.

Study Objective To determine the efficacy of brief motivational intervention (MI)—with and without the addition of an automated telephone system with personalized feedback—in primary care to reduce alcohol consumption among individuals with HIV and heavy alcohol use.

4 Study Design Population was 258 patients from a large urban primary care clinic with HIV and alcohol consumption of ≥4 drinks at least once in prior 30 days. Parallel individually randomized assignment of patients to one of three groups. At baseline: –Control (N=88): received advice/education from a counselor. –MI-only (N=82): received a 20–25 minute individual MI to motivate reduced drinking. –MI+HealthCall (N=88): received MI and were taught to use HealthCall automated telephone service for daily 1–3 minute calls answering pre- recorded questions about alcohol consumption. At 30 and 60 days: –Control group received assessment and ~5-minute counselor meeting. –MI-only group received 10–15 minute counselor meeting. –MI+HealthCall group received 10–15 minute counselor meeting and personalized data results from HealthCall.

5 Assessing Validity of an Article about Therapy Are the results valid? What are the results? How can I apply the results to patient care?

Are the Results Valid? Were patients randomized? Was randomization concealed? Were patients analyzed in the groups to which they were randomized? Were patients in the treatment and control groups similar with respect to known prognostic variables?

Are the Results Valid? (cont‘d) Were patients aware of group allocation? Were clinicians aware of group allocation? Were outcome assessors aware of group allocation? Was follow-up complete?

Were patients randomized? Yes. –Using a parallel three-arm individually randomized design (urn randomization), patients were assigned to one of three groups

Was randomization concealed? Yes. –Subjects were randomized using a computer-generated randomization sequence

Were patients analyzed in the groups to which they were randomized? Yes.

Were the patients in the treatment and control groups similar? Yes. –Patient inclusion criteria were: ≥4 drinks of alcohol at least once in the prior 30 days HIV-positive English or Spanish-speaking ≥18 years of age Treated at the clinic

Were patients aware of group allocation? Yes. –Participants were not blinded to treatments after assignment

Were clinicians aware of group allocation? Yes. –Counselors were not blinded to treatments after assignment

Were outcome assessors aware of group allocation? Yes. –Assessment was self-administered and computerized

Was follow-up complete? No, but nearly so. –Number of patients who provided 60-day data for analysis: Control group: N=87 of 88 MI-only group: N=78 of 82 MI+HealthCall group: N=75 of 88

What Are the Results? How large was the treatment effect? How precise was the estimate of the treatment effect?

How large was the treatment effect? At 60 days, the mean number of drinks/day was: Control group = 4.75 MI-only group = 3.94 MI+HealthCall group = 3.58 Among patients with DSM-IV alcohol dependence, the mean number of drinks/day was: Control group = 6.07 MI-only group = 5.12 MI+HealthCall group = 3.55 Among patients without DSM-IV alcohol dependence, number of drinks/day ranged from 3.03 to 3.64 and no differences were significant.

How Can I Apply the Results to Patient Care? Were the study patients similar to the patients in my practice? Were all clinically important outcomes considered? Are the likely treatment benefits worth the potential harm and costs?

Were the study patients similar to those in my practice? The patients came from a large, urban primary care clinic. Demographics included: –45% Hispanic; 49% African American –53% Spanish-speaking –Mean age of 45 years –56% female Clinical characteristics: –48% DSM-IV alcohol dependence –100% HIV-positive

Were all clinically important outcomes considered? No. -It would be useful to see if there were improvements in HIV outcomes (e.g., adherence, viral load, CD4 count, transmission risk) that accompanied the changes in alcohol consumption

Are the likely treatment benefits worth the potential harm and costs? Yes. –There are thought to be limited harms associated with motivational enhancement strategies –The HealthCall platform cost was <US$11,000