Ockene 1999.

Methods	Cluster RCT: special intervention versus usual care, average cluster size = 111. ITT: yes.
Participants	Setting: USA, primary care centres. Participants: 21 to 70 years consuming > 12 standard drinks per week or ≥ 5 standard drinks on ≥ 1 occasion in previous month for men, or > 9 standard drinks per week or ≥ 4 standard drinks on ≥ 1 occasion in previous month for women (1 standard drink = 12.8 g alcohol); screened by Health Habits Survey with embedded CAGE; excluded if pregnant, or planning to move away from the area within one year, or did not have telephone, or already participating in alcohol intervention programme, or psychiatric disorder. Number randomised = 530; 64.7% male; mean age = 43.9 years; 94.6% White, 5.4% non‐white; less than high school level = 8.6%, high school graduate or some college = 51.0%, college graduate or more = 40.4%. At baseline: mean drinks per week = 17.8.
Interventions	SI group (N = 274) participants were told that at their next regularly scheduled appointment their providers probably would discuss one of the health issues that was asked about in their lifestyle interview. They were given the same booklet as the UC participants. The SI providers received 2.5 hours training in the patient‐centred alcohol intervention program during which the change in orientation required to work with high‐risk drinkers (where the goal may be reduction in drinking) vs alcohol dependent patients (where the goal is abstinence) was emphasised. The SI providers were asked to carry out the brief 5 to 10 minute patient centred alcohol counselling sequence at the time of a regular visit with patients identified as high‐risk drinkers. Counselling focused on the number of drinks per week, binge drinking, or both, depending on the participant's problem area(s). The SI providers were instructed to request that the patient set a follow‐up visit to review progress. The SI office sites also had a limited office support system designed to assist the busy primary care provider in carrying out the intervention. Although implemented by Project Health RAs, the system was designed to be incorporated easily into usual office procedures and includes the RA affixing the following to the chart of the high risk drinker: the lifestyle interview summary sheet, which reports the participant's alcohol history (drinks per week, history of binge drinking, family history of alcohol abuse); the intervention algorithm to remind the physician of the counselling sequence taught in the training sessions; patient education materials in the form of the tip sheets for the providers' use with patients. UC group (N = 256) received a health booklet that included advice on general health issues and were told to address any health questions with their providers. The UC providers were encouraged to identify and intervene with patients with alcohol‐related issues to whatever extent they thought appropriate. All providers were encouraged to attend the weekly conference series in which the approach to the patient with alcohol problems was presented biannually as part of a two year curriculum.
Outcomes	Mean drinks per week, mean binge drinking episodes (defined as > 5 drinks on one occasion for men and > 4 for women), change in weekly drinking levels and binge drinking episodes. Assessed at 6 and 12 months.
Funding source	This project was supported by grant 5‐R01‐AA09153 from the National Institute on Alcohol Abuse and Alcoholism.
Declaration of interests	The authors have not been engaged in any financial or personal conflicts of interests as a result of the research described in this manuscript.
Notes	HEALTH trial Loss to follow‐up: SI group: 39/274 (14%). UC group: 46/256 (18%). Number of participants assessed = 445 in 4 practice sites. 12 month outcome data reported in separate paper, but baseline data for all randomised participants reported only in Ockene 1999.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Sequence generated using random number generator in SA statistical software (p. 2199).
Allocation concealment (selection bias)	Low risk	Cluster randomised so all patients in a practice received the same intervention.
Blinding of treatment providers	Low risk	Cluster randomised so treatment providers only interacted with one arm.
Blinding of participants	Low risk	Alcohol questions were embedded with other health‐related questions to minimise the intervention effect of the alcohol questions (p. 2199).
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Follow‐up interviews were conducted by blinded RAs (p. 2199).
Incomplete outcome data (attrition bias) All outcomes	Low risk	Loss to follow up similar across both groups and reasons reported (only refused or not available).
Selective reporting (reporting bias)	Low risk	Outcomes specified in methods are reported.