Condition category
Oral Health
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
05/07/2016
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

Prof T Newton

ORCID ID

Contact details

Department of Dental Public Health
18th Floor Guy's Tower
Guy's Hospital
London
SE5 9RS
United Kingdom
+44 (0)20 7955 4031
tim.newton@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0116149179

Study information

Scientific title

A study investigating patient decision making in the light of 'evidence'

Acronym

Study hypothesis

In this study we intend to determine, on what basis patients make decisions about whether or not to have dental treatment carried out, when faced with information from two sources. The aim of the study will be to identify the relative effects of research evidence and clinical evidence on patient decision making.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Oral Health

Intervention

The study will take place in the waiting areas of King's College Dental Hospital. All participants will be asked to give their consent to participating in a study examining patient decision making about whether or not to have dental treatment carried out, when faced with information from two sources.

The experimental design will be a two-factor independent group design. The two factors will be the type of information given to patients, informed by the clinician's judgement and the research evidence. Each factor will have two levels: strong evidence for and strong evidence against. The participant will be randomly assigned to one of the four combinations of the two variables. Participants will be given a cover letter explaining the purpose of the study, demographic questions and a case vignette. The participants will be asked to complete the vignettes, making judgements and decisions about treatment and use of information given. Additionally participants' will be asked to rate their oral health using a standardised scale (Atchison and Dolan, 1990)

The scenario will be identical in each vignette. Each vignette will describe a visit to their dentist for treatment of a large hole in one of their back teeth. The nature and purpose of the visit will be identical in each vignette. The first paragraph will describe our study. The second paragraph will describe the context of the visit to the dentist. The next paragraph will describe the strength of research evidence available. The fourth paragraph will describe the dentist's clinical judgement of the possible outcome. The two factors will be manipulated to express two levels of each variable; the evidence strongly supports the intervention, the evidence strongly suggests no effect. The four vignettes will correspond with all four factorial combinations of the two factors. Participants will be asked to read their vignette. After reading their vignette they will be asked to indicate their decision about possible treatment based on the information they will have been given in the vignette and their confidence in the decision.

The vignettes were reviewed as a result of the Research Ethics Committee's comments given on 27th February 2004. In response to these comments, the vignettes were reviewed by three dentists and subsequent modifications were made to encompass the need for clinical reality.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The outcome variable will be the proportion of patients to undergo the treatment described in the vignette.
The outcome measures will be assessed by:
1. Patients' willingness to engage in treatment with the binary of unwilling/willing
2. Patients' confidence

Secondary outcome measures

No secondary outcome measures

Overall trial start date

15/06/2004

Overall trial end date

30/09/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients from the waiting areas of King's College Dental Hospital
2. Gave consent

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

15/06/2004

Recruitment end date

30/09/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's Hospital
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Kings College Hospital NHS Trust R&D Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D support funding (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

05/07/2016: No publications found, verifying study status with principal investigator.