Contact information
Type
Scientific
Primary contact
Dr Margaret Watson
ORCID ID
Contact details
Centre of Academic Primary Care
University of Aberdeen
Westburn Road
Aberdeen
AB25 2AY
United Kingdom
+44 (0)1224 553785
m.c.watson@abdn.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Screening and brief interventions for alcohol misuse delivered in the community pharmacy setting: a pilot study using a pragmatic cluster randomised controlled trial design
Acronym
Study hypothesis
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.
Ethics approval
Grampian Local Ethics Committee and NHS R&D, 14/01/2010, ref: 09/S0802/119
Study design
Pragmatic cluster randomised controlled pilot study
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Other
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Alcohol misuse
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
05/02/2010
Overall trial end date
05/02/2011
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
100 clients to be screened within a two-month period (in 20 pharmacies)
Participant exclusion criteria
1. Clients who have already been screened
2. Received an alcohol brief intervention elsewhere
3. Clients identified as dependent drinkers
Recruitment start date
05/02/2010
Recruitment end date
05/02/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Aberdeen
Aberdeen
AB25 2AY
United Kingdom
Sponsor information
Organisation
University of Aberdeen (UK)
Sponsor details
c/o Dr Liz Rattray
Deputy Director
Research & Innovation
King's College
Aberdeen
AB24 3FX
United Kingdom
+44 (0)1224 274 369
e.rattray@abdn.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office
Alternative name(s)
CSO
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary