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 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
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