Abstract
BackgroundAlcohol misuse is a significant international public health problem. Screening and brief intervention (SBI) in primary care reduces alcohol consumption by about 15 – 30%, sustained over 12 months in hazardous or harmful drinkers but implementation has proved difficult leading to growing interest in exploring the effectiveness of SBI in other settings, including the workplace. Computerised interventions for alcohol misuse can be as effective as traditional face-to-face interventions and may have advantages, including anonymity, convenience and availability.Methods/designIndividually randomised controlled trial to determine the effectiveness and cost-effectiveness of offering online screening and brief intervention for alcohol misuse in a workplace. Participants: adults (aged 18 or over) employed by participating employers scoring 5 or more on a three item screen for alcohol misuse (the AUDIT-C) indicating possible hazardous or harmful alcohol consumption, recruited through the offer of an online health check providing screening for a range of health behaviours with personalised feedback. Participants who accept the health check and score 5 or more on the alcohol screen will be randomised to receiving immediate feedback on their alcohol consumption and access to an online intervention offering support in reducing alcohol consumption (Down Your Drink) or delayed feedback and access to Down Your Drink after completion of follow-up data at three months. All employees who take the online health check will receive personalised feedback on other screened health behaviours including diet, physical activity, smoking, and body mass index. The primary outcome is alcohol consumption in the past week at three months; secondary outcomes are the AUDIT, EQ-5D, days off work, number and duration of hospital admissions, costs and use of the intervention. A sample size of 1,472 participants (736 in each arm) provides 90% power with 5% significance to determine a 20% reduction in alcohol consumption. Outcomes between groups at three months will be compared following the intention to treat principle and economic analyses will follow NICE guidance.DiscussionThis innovative design avoids recruitment bias by not mentioning alcohol in the invitation and avoids reactivity of assessment by not collecting baseline data on alcohol consumption.
Highlights
Alcohol misuse is a significant international public health problem
Most alcohol misusers are hazardous and harmful drinkers rather than dependent drinkers, for example, in England in 2004 it was estimated that approximately 26% of the population or some 8 million people misused alcohol, of whom over 7 million (21% of the population) were hazardous or harmful drinkers, compared to 1 million (3.6%) dependent drinkers [5]
Comparator and duration of follow-up The trial uses a wait list design, with the comparator group receiving no feedback on their alcohol consumption until they have completed data collection at the primary outcome point (3 months)
Summary
The design of the trial raises some interesting methodological and ethical issues, discussed here. Comparator and duration of follow-up The trial uses a wait list design, with the comparator group receiving no feedback on their alcohol consumption until they have completed data collection at the primary outcome point (3 months). We consider this is ethical as a) this is a non-help seeking population; b) the time-course of alcohol misuse is long (many years) and it is unlikely that three months delay in provision of feedback and advice is likely materially to alter outcomes; and c) all participants are advised to consult their GP if they have any concerns about their health.
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