Exploratory trial of brief alcohol advice in dental surgeries

ISRCTN ISRCTN81193263
DOI https://doi.org/10.1186/ISRCTN81193263
Secondary identifying numbers 15167; PBPG021227029
Submission date
04/10/2013
Registration date
04/10/2013
Last edited
26/11/2018
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

Plain English Summary

Background and study aims
Alcohol misuse is an important public health problem in the UK. There are evidences about the how well brief alcohol interventions given in GP surgeries. No studies have however been conducted to find out how well these work in general dental practice. Excessive alcohol consumption is a major risk factor for oral cancer, injury and dental erosion. The majority of the UK adult population visits a dentist within a two year period. This provides a unique opportunity to give preventive advice to dental patients to promote both their oral and general health. Increasingly general dental practitioners ask their patients about their tobacco and alcohol habits but few dentists offer brief alcohol advice to patients who are drinking excessively. The aim of the study is to find out the acceptability and feasibility of giving a brief alcohol intervention.

Who can participate?
Any adult patient with a positive alcohol screening result attending the participating dental practice can participate in the study.

What does the study involve?
Participating dental practices will be randomly allocated to one of two groups: control and intervention practices. In control practices participants will be given an oral cancer prevention leaflet about reducing alcohol intake and stopping smoking. Participants attending the intervention practices will be given up to five minutes of brief advice about alcohol consumption. All participants will be contacted through telephone after 6 months. At the end of the study all participants will be sent a summary of the study results and an information leaflet on responsible alcohol consumption.

What are the possible benefits and risks of participating?
Participants in the intervention group will potentially benefit through changing their alcohol consumption pattern. Those attending the other dental surgeries will still receive standard advice and support from dental teams and at the end of the study they will also receive the brief advice. No additional appointments will be required for the study. All participants will be sent by post a £10 gift token after they complete the 6 month follow up phone call. In this study the intervention is non-invasive in nature but alcohol is a sensitive issue. Carefully designed procedures and policies will be developed to minimise participants' potential feelings of guilt or pressure and their time involvement.

Where is the study run from?
The study is being conducted in the general dental practices across North Central London, UK.

When is the study starting and how long is it expected to run for?
August 2013 to February 2016.

Who is funding the study?
National Institute for Health Research (NIHR), UK.

Who is the main contact?
Professor Richard Watt: r.watt@ucl.ac.uk
Ms Antiopi Ntouva: a.ntouva@ucla.c.uk

Contact information

Ms Antiopi Ntouva
Scientific

UCL Department of Epidemiology and Public Health
1-19 Torrington Place
London
WC1E 7HB
United Kingdom

Phone +44 (0)20 7679 1703
Email a.ntouva@ucl.ac.uk

Study information

Study designCluster randomized controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)GP practice
Study typePrevention
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet.
Scientific titleAn exploratory cluster randomized controlled trial of brief alcohol advice delivered in general dental practice
Study acronymDART (Dental Alcohol Reduction Trial)
Study hypothesisWe are hypothesizing that the brief advice intervention will be more effective at reducing alcohol consumption than the standard advice currently given at dental surgeries.
Ethics approval(s)Camden and Islington REC, 22/04/2013, Ref: 13/LO/0292
ConditionAlcohol consumption
InterventionIn the control practices participants who have a positive screening result will be initially given an oral cancer prevention leaflet which includes brief guidance on reducing alcohol intake and stopping smoking.

Participants attending the intervention practices who have a positive screening result will be given up to five minutes of simple structured brief advice using the Screening and Intervention Programme for Sensible drinking (SIPS) brief advice tool 'Brief advice about alcohol risk' which was based on the Simple Structured Advice intervention tool as part of the UK version of the WHO collaborative Drink Less brief intervention programme. To support and reinforce the advice, the Department of Health leaflet 'How much is too much?' will also be given.

Any participants in either the control or intervention groups who are identified as being alcohol dependent will be referred to local services for help.

After all the follow-up data has been collected, those participants attending the control practices who had a positive screening result will then also be offered the 5 minute brief advice and given a copy of the Department of Health alcohol leaflet.

Secondary sponsor:
Professor Richard G Watt
Intervention typeOther
Primary outcome measureScore on Extended AUDIT questionnaire cut off 8 or more as used in SIPS programme measured at baseline and 6 months
Secondary outcome measures1. Mean weekly units of alcohol consumed during the previous 90 days using the Form 90
2. Average drinks (8 mg of pure ethanol) per day
3. Percentage days abstinent from work due to alcohol
4. Readiness to change measured by modified readiness to change ruler
5. Health related quality of life measure using EQ5D
All outcomes measured at baseline and 6 months
Overall study start date12/08/2013
Overall study end date12/02/2016

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants248 - 200 for main intervention and 48 for the exploratory and process evaluation focus groups.
Participant inclusion criteriaAny patient with a positive screening result on Fast Alcohol Screening Test (FAST), aged 18 years or above, attending dental practice and able to speak, read and write English sufficiently well to complete study questionnaires/interviews.
Participant exclusion criteriaPatients already involved in any research study conducted in dental practice and those seeking help for alcohol dependence will be excluded
Recruitment start date12/08/2013
Recruitment end date12/02/2016

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UCL Department of Epidemiology and Public Health
London
WC1E 7HB
United Kingdom

Sponsor information

Central and North West London NHS Foundation Trust (UK)
Hospital/treatment centre

Greater London House
Hampstead Road
London
NW1 7QY
England
United Kingdom

ROR logo "ROR" https://ror.org/05drfg619

Funders

Funder type

Government

National Institute for Health Research (NIHR) (UK) - Patient Benefit Programme; Ref: PBPG021227029
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 06/10/2015 Yes No
Results article results 01/02/2018 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

26/11/2018: Publication reference added.