Condition category
Mental and Behavioural Disorders
Date applied
05/02/2010
Date assigned
16/03/2010
Last edited
11/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.abdn.ac.uk/AURIS_Research/

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

Publication citations

Additional files

Editorial Notes

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