Screening and brief interventions for alcohol misuse delivered in the community pharmacy setting

ISRCTN	ISRCTN40380499
DOI	https://doi.org/10.1186/ISRCTN40380499
Secondary identifying numbers	N/A

Submission date: 05/02/2010
Registration date: 16/03/2010
Last edited: 11/07/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Margaret Watson
Scientific

Centre of Academic Primary Care
University of Aberdeen
Westburn Road
Aberdeen
AB25 2AY
United Kingdom

Phone	+44 (0)1224 553785
Email	m.c.watson@abdn.ac.uk

Study information

Study design	Pragmatic cluster randomised controlled pilot study
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	Other
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
Study objectives	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(s)	Grampian Local Ethics Committee and NHS R&D, 14/01/2010, ref: 09/S0802/119
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	05/02/2010
Completion date	05/02/2011

Eligibility

Participant type(s)	Mixed
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	100 clients to be screened within a two-month period (in 20 pharmacies)
Key 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
Key exclusion criteria	1. Clients who have already been screened 2. Received an alcohol brief intervention elsewhere 3. Clients identified as dependent drinkers
Date of first enrolment	05/02/2010
Date of final enrolment	05/02/2011

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

University of Aberdeen

Aberdeen
AB25 2AY
United Kingdom

Sponsor information

University of Aberdeen (UK)
University/education

c/o Dr Liz Rattray, Deputy Director
Research & Innovation
King's College
Aberdeen
AB24 3FX
Scotland
United Kingdom

Phone	+44 (0)1224 274 369
Email	e.rattray@abdn.ac.uk
Website	http://www.abdn.ac.uk/AURIS_Research/
"ROR"	https://ror.org/016476m91

Funders

Funder type

Government

Chief Scientist Office
Government organisation / Local government

Alternative name(s): CSO
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

11/07/2016: No publications found, verifying study status with principal investigator.