Dataset Information

Effectiveness of alcohol brief intervention delivered by community pharmacists: study protocol of a two-arm randomised controlled trial.

ABSTRACT:

Background

There is strong evidence to support the effectiveness of Brief Intervention (BI) in reducing alcohol consumption in primary healthcare.

Methods and design

This study is a two-arm randomised controlled trial to determine the effectiveness of BI delivered by community pharmacists in their pharmacies. Eligible and consenting participants (aged 18 years or older) will be randomised in equal numbers to either a BI delivered by 17 community pharmacists or a non-intervention control condition. The intervention will be a brief motivational discussion to support a reduction in alcohol consumption and will take approximately 10 minutes to deliver. Participants randomised to the control arm will be given an alcohol information leaflet with no opportunity for discussion. Study pharmacists will be volunteers who respond to an invitation to participate, sent to all community pharmacists in the London borough of Hammersmith and Fulham. Participating pharmacists will receive 7 hours training on trial procedures and the delivery of BI. Pharmacy support staff will also receive training (4 hours) on how to approach and inform pharmacy customers about the study, with formal trial recruitment undertaken by the pharmacist in a consultation room. At three month follow up, alcohol consumption and related problems will be assessed with the Alcohol Use Disorders Identification Test (AUDIT) administered by telephone.

Discussion

The UK Department of Health's stated aim is to involve community pharmacists in the delivery of BI to reduce alcohol harms. This will be the first RCT study to assess the effectiveness of BI delivered by community pharmacists. Given this policy context, it is pragmatic in design.

Trial registration

Current Controlled Trials ISRCTN95216873.

SUBMITTER: Dhital R

PROVIDER: S-EPMC3583737 | biostudies-literature | 2013 Feb

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of alcohol brief intervention delivered by community pharmacists: study protocol of a two-arm randomised controlled trial.

Dhital Ranjita R Norman Ian I Whittlesea Cate C McCambridge Jim J

BMC public health 20130218

<h4>Background</h4>There is strong evidence to support the effectiveness of Brief Intervention (BI) in reducing alcohol consumption in primary healthcare.<h4>Methods and design</h4>This study is a two-arm randomised controlled trial to determine the effectiveness of BI delivered by community pharmacists in their pharmacies. Eligible and consenting participants (aged 18 years or older) will be randomised in equal numbers to either a BI delivered by 17 community pharmacists or a non-intervention c ...[more]

PMID: 23419053

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Project description:To undertake the first randomized controlled trial to evaluate the effectiveness of a brief intervention delivered by community pharmacists to reduce hazardous or harmful drinking.This parallel group randomized trial allocated participants individually to brief alcohol intervention (n?=?205) or a leaflet-only control condition (n?=?202), with follow-up study after 3 months.Sixteen community pharmacies in one London Borough, UK.A total of 407 pharmacy customers (aged 18?years or over) with Alcohol Use Disorder Identification Test (AUDIT) scores 8-19, inclusive.A brief motivational discussion of approximately 10 minutes' duration, for which 17 pharmacists received a half-day of training.Hazardous or harmful drinking was assessed using the AUDIT administered by telephone by a researcher blind to allocation status. The two primary outcomes were: (1) change in AUDIT total scores and (2) the proportions no longer hazardous or harmful drinkers (scoring <?8) at 3?months. The four secondary outcomes were: the three subscale scores of the AUDIT (for consumption, problems and dependence) and health status according to the EQ-5D (a standardized instrument for use as a measure of health outcome).At 3 months 326 (80% overall; 82% intervention, 78% control) participants were followed-up. The difference in reduction in total AUDIT score (intervention minus control) was -0.57, 95% confidence interval (CI)?=?-1.59 to 0.45, P?=?0.28. The odds ratio for AUDIT ??8 (control as reference) was 0.87, 95% CI?=?0.50 to 1.51, P?=?0.61). For two of the four secondary outcomes (dependence score: -0.46, 95% CI?=?-0.82 to -0.09, P?=?0.014; health status score: -0.09, 95% CI?=?-0.16 to -0.02, P?=?0.013) the control group did better, and in the other two there were no differences (consumption score: -0.05, 95% CI?=?-0.54 to 0.44, P?=?0.85; non-dependence problems score: -0.13, 95% CI?=?-0.66 to 0.41). Sensitivity analyses did not change these findings.A brief intervention delivered by community pharmacists appears to have had no effect in reducing hazardous or harmful alcohol consumption.

Project description:BackgroundAlcohol misuse in England costs around £7.3 billion (US$12.2 billion) annually from lost productivity and absenteeism. Delivering brief alcohol interventions to employees as part of a health check may be acceptable, particularly with online delivery which can provide privacy for this stigmatised behaviour. Research to support this approach is limited and methodologically weak. The aim was to determine the effectiveness of online screening and personalised feedback on alcohol consumption, delivered in a workplace as part of a health check.Methods and findingsThis two-group online individually randomised controlled trial recruited employees from a UK-based private sector organisation (approx. 100,000 employees). 3,375 employees completed the online health check in the three week recruitment period. Of these, 1,330 (39%) scored five or more on the AUDIT-C (indicating alcohol misuse) and were randomised to receive personalised feedback on their alcohol intake, alongside feedback on other health behaviours (n = 659), or to receive feedback on all health behaviours except alcohol intake (n = 671). Participants were mostly male (75%), with a median age of 48 years and half were in managerial positions (55%). Median Body Mass Index was 26, 12% were smokers, median time undertaking moderate/vigorous physical activity a week was 173 minutes and median fruit and vegetable consumption was three portions a day. Eighty percent (n = 1,066) of participants completed follow-up questionnaires at three months. An intention to treat analysis found no difference between experimental groups for past week drinking (primary outcome) (5.6% increase associated with the intervention (95% CI -4.7% to 16.9%; p = .30)), AUDIT (measure of alcohol-related harm) and health utility (EQ-5D).ConclusionsThere was no evidence to support the use of personalised feedback within an online health check for reducing alcohol consumption among employees in this organisation. Further research is needed on how to engage a larger proportion of employees in screening.Trial registrationInternational Standard Randomised Controlled Trial Number Register ISRCTN50658915.

Project description:BackgroundVarious hospital accreditation and quality assurance entities in the United States have approved and endorsed performance measures promoting alcohol brief intervention (BI) for hospitalized individuals who screen positive for unhealthy alcohol use, the spectrum of use ranging from hazardous use to alcohol use disorders. These performance measures have been controversial due to the limited and equivocal evidence for the efficacy of BI among hospitalized individuals. The few BI trials conducted with hospital inpatients vary widely in methodological quality. While the majority of these studies indicate limited to no effects of BI in this population, none have been designed to account for the most pervasive methodological issue in BI studies presumed to drive study findings towards the null: assessment reactivity (AR).Methods/designThis is a three-arm, single-site, randomized controlled trial of BI for hospitalized patients at a large academic medical center affiliated with the U.S. Department of Veterans Affairs who use alcohol at hazardous levels but do not have an alcohol use disorder. Participants are randomized to one of three study conditions. Study Arm 1 receives a three-part alcohol BI. Study Arm 2 receives attention control. To account for potential AR, Study Arm 3 receives AC with limited assessment. Primary outcomes will include the number of standard drinks/week and binge drinking episodes reported in the 30-day period prior to a final measurement visit obtained 6 months after hospital discharge. Additional outcomes will include readiness to change drinking behavior and number of adverse consequences of alcohol use. To assess differences in primary outcomes across the three arms, we will use mixed-effects regression models that account for a patient's repeated measures over the timepoints and clustering within medical units. Intervention implementation will be assessed by: a) review of intervention audio recordings to characterize barriers to intervention fidelity; and b) feasibility of participant recruitment, enrollment, and follow-up.DiscussionThe results of this methodologically rigorous trial will provide greater justification for or against the use of BI performance measures in the inpatient setting and inform organizational responses to BI-related hospital accreditation and performance measures.Trial registrationNCT01602172.

Project description:ObjectiveTo evaluate the effectiveness of different brief intervention strategies at reducing hazardous or harmful drinking in primary care. The hypothesis was that more intensive intervention would result in a greater reduction in hazardous or harmful drinking.DesignPragmatic cluster randomised controlled trial.SettingPrimary care practices in the north east and south east of England and in London.Participants3562 patients aged 18 or more routinely presenting in primary care, of whom 2991 (84.0%) were eligible to enter the trial: 900 (30.1%) screened positive for hazardous or harmful drinking and 756 (84.0%) received a brief intervention. The sample was predominantly male (62%) and white (92%), and 34% were current smokers.InterventionsPractices were randomised to three interventions, each of which built on the previous one: a patient information leaflet control group, five minutes of structured brief advice, and 20 minutes of brief lifestyle counselling. Delivery of the patient leaflet and brief advice occurred directly after screening and brief lifestyle counselling in a subsequent consultation.Main outcome measuresThe primary outcome was patients' self reported hazardous or harmful drinking status as measured by the alcohol use disorders identification test (AUDIT) at six months. A negative AUDIT result (score <8) indicated non-hazardous or non-harmful drinking. Secondary outcomes were a negative AUDIT result at 12 months, experience of alcohol related problems (alcohol problems questionnaire), health utility (EQ-5D), service utilisation, and patients' motivation to change drinking behaviour (readiness to change) as measured by a modified readiness ruler.ResultsPatient follow-up rates were 83% at six months (n=644) and 79% at 12 months (n=617). At both time points an intention to treat analysis found no significant differences in AUDIT negative status between the three interventions. Compared with the patient information leaflet group, the odds ratio of having a negative AUDIT result for brief advice was 0.85 (95% confidence interval 0.52 to 1.39) and for brief lifestyle counselling was 0.78 (0.48 to 1.25). A per protocol analysis confirmed these findings.ConclusionsAll patients received simple feedback on their screening outcome. Beyond this input, however, evidence that brief advice or brief lifestyle counselling provided important additional benefit in reducing hazardous or harmful drinking compared with the patient information leaflet was lacking.Trial registrationCurrent Controlled Trials ISRCTN06145674.

Project description:IntroductionEffective, brief, low-cost interventions for suicide attempt survivors are essential to saving lives and achieving the goals of the National Strategy for Suicide Prevention and Zero Suicide. This study aims to examine the effectiveness of the Attempted Suicide Short Intervention Program (ASSIP) in averting suicide reattempts in the United States healthcare system, its psychological mechanisms as predicted by the Interpersonal Theory of Suicide, and the potential implementation costs, barriers and facilitators for delivering it.Methods and analysisThis study is a hybrid type 1 effectiveness-implementation randomised controlled trial (RCT). ASSIP is delivered at three outpatient mental healthcare clinics in New York State. Participant referral sites include three local hospitals with inpatient and comprehensive psychiatric emergency services, and outpatient mental health clinics. Participants include 400 adults who have had a recent suicide attempt. All are randomised to 'Zero Suicide-Usual Care plus ASSIP' or 'Zero Suicide-Usual Care'. Randomisation is stratified by sex and whether the index attempt is a first suicide attempt or not. Participants complete assessments at baseline, 6 weeks, and 3, 6, 12 and, 18 months. The primary outcome is the time from randomisation to the first suicide reattempt. Prior to the RCT, a 23-person open trial took place, in which 13 participants received 'Zero Suicide-Usual Care plus ASSIP' and 14 completed the first follow-up time point.Ethics and disseminationThis study is overseen by the University of Rochester, with single Institutional Review Board (#3353) reliance agreements from Nathan Kline Institute (#1561697) and SUNY Upstate Medical University (#1647538). It has an established Data and Safety Monitoring Board. Results will be published in peer-reviewed academic journals, presented at scientific conferences, and communicated to referral organisations. Clinics considering ASSIP may use a stakeholder report generated by this study, including incremental cost-effectiveness data from the provider point of view.Trial registration numberNCT03894462.

Dataset Information

Effectiveness of alcohol brief intervention delivered by community pharmacists: study protocol of a two-arm randomised controlled trial.

Background

Methods and design

Discussion

Trial registration

Publications

Effectiveness of alcohol brief intervention delivered by community pharmacists: study protocol of a two-arm randomised controlled trial.

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