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ISRCTN
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ISRCTN40380499
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ClinicalTrials.gov identifier
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Public title
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Screening and brief interventions for alcohol misuse delivered in the community pharmacy setting
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Scientific title
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Screening and brief interventions for alcohol misuse delivered in the community pharmacy setting: a pilot study using a pragmatic cluster randomised controlled trial design
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Excessive alcohol consumption causes substantial morbidity and mortality. Screening, followed by brief interventions, is effective in reducing alcohol consumption and can be delivered in primary care. Evidence from small, proof-of-concept studies, shows that screening for excessive alcohol consumption can be delivered in community pharmacies, and can be followed by the delivery of brief interventions to clients identified as harmful or hazardous drinkers. A large-scale randomised controlled trial (RCT) of screening and brief interventions in the community pharmacy setting is needed to derive evidence of the effectiveness and cost-effectiveness of this approach. Firstly, a pilot study is needed to assess recruitment, participation and follow-up rates, to derive accurate data (including loss to follow up rates and effect size estimates) to inform sample size calculations for the RCT. In addition, the acceptability of this novel service to service providers and users needs to be explored.
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Lay summary
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Ethics approval
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Grampian Local Ethics Committee and NHS R&D approved on the 14th January 2010 (ref: 09/S0802/119)
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Study design
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Pragmatic cluster randomised controlled pilot study
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Alcohol misuse
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Participants - inclusion criteria
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1. Community pharmacists and staff from 20 community pharmacies (i.e. 10 pharmacies in each group)
2. Adult clients presenting in participating community pharmacies
3. Clients aged 18 or over, either sex
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Participants - exclusion criteria
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1. Clients who have already been screened
2. Received an alcohol brief intervention elsewhere
3. Clients identified as dependent drinkers
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Anticipated start date
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05/02/2010
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Anticipated end date
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05/02/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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100 clients to be screened within a two-month period (in 20 pharmacies)
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Interventions
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Each pharmacy will be required to screen 100 clients within a two-month period. Based on the proof-of-concept studies, 40% are expected to be identified as harmful or hazardous drinkers.
All adult clients entering the community pharmacy will be eligible for screening (in control and intervention pharmacies). A tally sheet will be used in each participating pharmacy to record clients who refuse to undertake screening or brief interventions. Any trained member of the pharmacy team will invite the client to complete the Fast Alcohol Screening Test (FAST). Clients who score above the threshold score (greater than 3) will be invited to have a consultation with the pharmacist to discuss participation in the study. Clients who do not consent will be given the standard information leaflet about healthy lifestyle mentioned above and thanked for participating in the screening activity. Clients who score below the threshold score will also be given this leaflet.
All clients who are eligible (i.e. FAST score greater than 3) and who consent to participate, will be asked to provide written consent and then asked to complete the baseline questionnaire. The purpose of this questionnaire will be to collect additional information on alcohol consumption and demographic information (including their full postal address for the dissemination of follow-up surveys). They will also be informed that a short questionnaire will be sent to them at three and six months to explore their alcohol consumption.
Clients in the control group pharmacies will then be given a generic information leaflet about healthy lifestyle and thanked for their involvement. Clients in the intervention group pharmacies will receive a brief intervention to raise their awareness of their alcohol consumption in relation to recommended limits. The Reference Group (see later) will devise referral criteria that the pharmacists in both groups can use if they suspect a client requires referral to specialist services.
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Primary outcome measure(s)
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1. Average screening rate per pharmacy per week
2. Average recruitment rate per pharmacy per week
3. Number or proportion of clients who score greater than 3 using FAST
4. Self-reported measures of alcohol consumption (which may include number of episodes of 'binge' drinking, alcohol free days)
5. Follow-up rate at three and six months
6. Number of referrals to other agencies
7. Identification of barriers and facilitators to delivering screening and brief interventions in the community pharmacy setting (pharmacy staff and client perspective)
8. Exploration of the public's opinion of screening and brief interventions in the community pharmacy setting
Data to derive outcome measures (e.g. FAST score, other measures of alcohol consumption) will be collected at baseline, three and six months. Baseline data will be collected by pharmacy staff during the screening process and pharmacist consultation. Data at three and six months will be collected from clients using mailed questionnaires. The pharmacists and staff will be required to document additional information including the duration of screening and brief intervention consultations.
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Secondary outcome measure(s)
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No secondary outcome measures
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Sources of funding
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Chief Scientist Office of the Scottish Executive Health Department (UK)
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Trial website
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Publications
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Contact name
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Dr
Margaret
Watson
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Address
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Centre of Academic Primary Care
University of Aberdeen
Westburn Road
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City/town
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Aberdeen
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Zip/Postcode
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AB25 2AY
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Country
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United Kingdom
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Tel
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+44 (0)1224 553785
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Fax
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+44 (0)1224 550683
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Email
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m.c.watson@abdn.ac.uk
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Sponsor
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University of Aberdeen (UK)
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Address
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c/o Dr Liz Rattray, Deputy Director
Research & Innovation
King's College
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City/town
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Aberdeen
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Zip/Postcode
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AB24 3FX
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Country
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United Kingdom
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Tel
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+44 (0)1224 274 369
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Fax
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+44 (0)1224 272 319
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Email
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e.rattray@abdn.ac.uk
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Sponsor website:
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http://www.abdn.ac.uk/AURIS_Research/
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Date applied
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05/02/2010
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Last edited
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16/03/2010
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Date ISRCTN assigned
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16/03/2010
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