A study investigating patient decision making in the light of 'evidence'
| ISRCTN | ISRCTN26423417 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN26423417 |
| Protocol serial number | N0116149179 |
| Sponsor | Department of Health |
| Funders | Kings College Hospital NHS Trust R&D Consortium (UK), NHS R&D support funding (UK) |
- 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
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 |
|---|---|
| tim.newton@kcl.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | A study investigating patient decision making in the light of 'evidence' |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
The outcome variable will be the proportion of patients to undergo the treatment described in the vignette. |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 30/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | 1. Patients from the waiting areas of King's College Dental Hospital 2. Gave consent |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 15/06/2004 |
| Date of final enrolment | 30/09/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Guy's Hospital
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/07/2016: No publications found, verifying study status with principal investigator.
