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

ISRCTN ISRCTN26423417
DOI https://doi.org/10.1186/ISRCTN26423417
Secondary identifying numbers N0116149179
Submission date
30/09/2005
Registration date
30/09/2005
Last edited
05/07/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof T Newton
Scientific

Department of Dental Public Health
18th Floor Guy's Tower
Guy's Hospital
London
SE5 9RS
United Kingdom

Phone +44 (0)20 7955 4031
Email tim.newton@kcl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleA study investigating patient decision making in the light of 'evidence'
Study objectivesIn 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedOral Health
InterventionThe 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 typeOther
Primary outcome measureThe 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 measuresNo secondary outcome measures
Overall study start date15/06/2004
Completion date30/09/2004

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Patients from the waiting areas of King's College Dental Hospital
2. Gave consent
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment15/06/2004
Date of final enrolment30/09/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Guy's Hospital
London
SE5 9RS
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

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

No information available

NHS R&D support funding (UK)

No information available

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

Editorial Notes

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