Condition category
Oral Health
Date applied
02/05/2013
Date assigned
12/07/2013
Last edited
12/11/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The majority of dental healthcare professionals (dentists, dental nurses and dental hygienists) do not routinely intervene to reduce the alcohol use of patients with hazardous and harmful drinking habits. The new dental contract being tested in practices across England aims to focus the attention of dental professionals on health promotion. Since harmful alcohol consumption can lead to the development of several mouth diseases such as mouth cancer and mouth and face injury, educating dental patients about safe drinking is therefore relevant to the government’s health priorities, as well as world-wide initiatives to promote health. The objective of this study therefore is to determine whether it is possible to introduce alcohol misuse screening and treatment in a general dental practice setting.

Who can participate?
All new and routine patients, male and female, aged 18-65 will be eligible to be screened for alcohol misuse and receive a treatment.

What does the study involve?
Patients will be randomly allocated to one of two groups: the control group, who will be treated as usual, and the intervention group, who will be screened for alcohol misuse and will receive advice from a dental healthcare professional. All patients will be contacted after three months to analyse the results.

What are the possible benefits and risks of participating?
The study has the potential to improve dental service. It may also reduce the prevalence of alcohol-related harm and disease in the population. Furthermore, the study could help reduce the burden of alcohol-related illness on dental hospitals. There are no elements in the study that can cause physical or psychological distress to the patients.

Where is the study run from?
The study will take place in Glynneath Dental Centre, Wales, UK.

When is the study starting and how long will it run for?
The study will start in October 2013 and, allowing time to train the members of staff at Glynneath Dental Centre and for the two-month recruitment period, will run for 6 months.

Who is funding the study?
The Royal College of Surgeons of England, UK.

Who is the main contact?
Miss Zairah Roked
RokedZ@cardiff.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Zairah Roked

ORCID ID

Contact details

Cardiff School of Dentistry
Heath Park
Cardiff
CF14 4XY
United Kingdom
rokedz@cf.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 8.0 (protocol approved by REC and R&D)

Study information

Scientific title

A study to explore the feasibility of alcohol misuse screening and treatment interventions in a general dental practice

Acronym

Study hypothesis

1. To conduct an exploratory Randomised Controlled Trial (RCT) with embedded process evaluation that determines the feasibility and barriers to brief alcohol interventions in primary dental care.
2. To assess the acceptability of brief alcohol interventions by patients in primary dental care
3. To determine opportunities to collect informed consent and screen patients in the reception area/waiting room environment
4. To determine appropriate sample size estimates for a larger, definitive implementation RCT
5. To assess time constraints on hygienists and dentists in delivering brief interventions
6. To determine intervention fidelity and selection biases
7. To inform the design of a larger trial

On 12/11/2013 the scientific title was changed from 'A study to explore the feasibility of alcohol screening and treatment in a primary care general dental practice setting' to 'A study to explore the feasibility of alcohol misuse screening and treatment interventions in a general dental practice'.

Ethics approval

Not available at the time of registration

Study design

A randomised controlled trial with an embedded parallel process evaluation

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Prevention

Patient information sheet

Condition

Alcohol misuse prevention

Intervention

Current interventions as of 12/11/2013:
Patients will be sent an invite letter and an information sheet by staff at Glynneath Dental Centre one month before the start of the study and their attendance at the practice in order to give them enough time to decide whether they would like to take part. The study period will then take place within the practice during the following two months.

Patients who decide to take part in the study will be stratified according to their initial appointment (with the dentist or hygienist). Reception staff will administer packs to patients containing a consent form, screening materials (Modified-Single Answer Screening Question or M-SASQ) and a short survey collecting socio-economic information, reasons for attendance and contact details. Packs will be randomly pre-allocated into control and intervention groups by strata and will be administered in opaque, sealed envelopes to conceal allocation from receptionists. Patients will be asked to read and fill out the packs while in the waiting area of the dental practice.

All staff in the practice will be trained on the scoring system of the screening instrument Modified Single Alcohol Screening Question (M-SASQ). Consenting patients identified as having risky alcohol use from the M-SASQ and allocated to the intervention group will then be eligible to receive the intervention from the hygienist or dentist. Staff will be trained in collaboration with Public Health Wales and the Knowledge Transfer Partnership that is currently implementing MIs in maxillofacial clinics across Wales. To ensure competency in delivering the intervention all staff will be audio taped and assessed prior to the start of the trial. A standard intervention (MI) incorporating the FRAMES approach will be used. Patients allocated to the control group will be treated as usual.

Replicating Screening and Intervention Programme for Sensible drinking (SIPS) trial methodology , patients in control and intervention groups will be followed-up at three months by their preferred means of contact.


Previous interventions:
Reception staff will administer packs to patients containing an invitation letter, screening materials (M-SASQ), study information sheets, a consent form and a short survey collecting socio-economic information, reasons for attendance and contact details. Patients will be asked to read and fill out the packs while in the waiting area.

The packs given to patients will be randomly pre-allocated into control and intervention groups by strata and will be administered in sealed envelopes to conceal allocation from receptionists. All staff in the practice will be trained on the scoring system of the screening instrument Modified Single Alcohol Screening Question (M-SASQ). Consenting patients identified as having risky alcohol use from the M-SASQ and allocated to the intervention group will then be eligible to receive the intervention from the hygienist or dentist. Staff will be trained in collaboration with Public Health Wales and the Knowledge Transfer Partnership that is currently implementing MIs in maxillofacial clinics across Wales. To ensure competency in delivering the intervention all staff will be audio taped and assessed prior to the start of the trial. A standard intervention (MI) incorporating the FRAMES approach will be used. Patients allocated to the control group will be treated as usual.

Replicating Screening and Intervention Programme for Sensible drinking (SIPS) trial methodology , patients in control and intervention groups will be followed-up at three months by their preferred means of contact and with standard safeguards to maximise compliance (details of a collateral individual will be noted).

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

A short, valid screening tool, such as the Modified-Single Alcohol Screening Question (M-SASQ) used in identifying patients with risky alcohol consumption

Secondary outcome measures

Additional data will be collected to address secondary outcomes, including drinking and health status (EQ-5D). Patients will also be asked at three months whether they recall receiving a treatment intervention and what this comprised. A process evaluation will therefore be carried out to determine whether this framework of design is feasible to address the research study’s objectives. It will also help identify recruitment biases by practitioner, whether interventions were delivered as instructed, whether there was enough time for patients to complete written material tasks, whether the process of randomisation and recruitment worked and whether trial attrition is related to alcohol use. Professionals will be asked to feed back at three months how they felt the screening and treatment intervention fitted into practice routine.

Overall trial start date

01/10/2013

Overall trial end date

01/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 12/11/2013:
All new and routine patients aged 18-65, male and female and able to read and understand English will be asked to take part in the sudy. Reception staff will identify those patients who fit within the inclusion criteria. Patients will also be identified and stratified according to their appointment with either a dentist or hygienist.

Previous inclusion criteria:
All new, routine and emergency patients, aged 18-65, male and female and able to read and understand English will be asked to take part in the study. Reception staff will identify those patients who fit within the inclusion criteria. Patients will also be identified and stratified according to their appointment with either a dentist or hygienist.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

Participants under the age of 18 years old will not be eligible to participate. Resources are not available for translators and interpreters and so participants who do not speak or cannot understand English and who have learning difficulties will not be invited to participate. There will also be no translators and interpreters for solely Welsh speakers. Participants who cannot provide written informed consent will also not be recruited.

Recruitment start date

01/10/2013

Recruitment end date

01/04/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cardiff School of Dentistry
Cardiff
CF14 4XY
United Kingdom

Sponsor information

Organisation

Cardiff University (UK)

Sponsor details

c/o Helen Falconer
Research Governance Officer
Research
Innovation and Enterprise Services
Cardiff University
7th Floor
30-36 Newport Road
Cardiff
CF24 0DE
United Kingdom
+44 (0) 29 2087 9277
FalconerHE@cf.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Other

Funder name

Faculty of Dental Surgery, Royal College of Surgeons (FDS Research fellowship) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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