Assisting decision making in menorrhagia in primary care: a randomised controlled trial to compare computerised decision analysis with patient information leaflet. MENTIP study: Menorrhagia Treatment Information and Preferences
| ISRCTN | ISRCTN72253427 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN72253427 |
| Secondary identifying numbers | G106/1048 |
- Submission date
- 19/02/2003
- Registration date
- 19/02/2003
- Last edited
- 03/03/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Joanne Protheroe
Scientific
Scientific
NPCRDC
5th Floor Williamson Building
The University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom
| Phone | +44 (0)161 2757601 |
|---|---|
| j.protheroe@man.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Scientific title | |
| Study acronym | MENTIP |
| Study objectives | Aims: Since patient information leaflets are highly accessible and relatively cheap, they may be considered the standard against which more complex decision aids must be evaluated. The purpose of this study is to evaluate whether the addition of decision analysis to written information improves the process of decision-making in women consulting their doctor with heavy periods, compared with written information alone. Objectives: To answer the following question: Is the addition of decision analysis to written information significantly more effective at reducing decisional conflict compared with written information alone. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Menorrhagia |
| Intervention | 1. Control group: Patient Information Leaflet (PIL) 2. Intervention group: PIL and Clinical Guidance Tree (computerised Decision Analysis) |
| Intervention type | Other |
| Primary outcome measure | The primary outcome measure will be the Decisional Conflict Scale (DCS), a questionnaire developed by O'Connor (1999) for use in studies of decision-making processes. This instrument measures a person's perception of: personal uncertainty in making a choice about health care options, the modifiable factors (such as feeling uninformed, unsupported and unclear about personal values) and the quality of the decision made (in terms of satisfaction with the choice and expectation to maintain). |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/02/2003 |
| Completion date | 09/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 300 |
| Key inclusion criteria | Women aged 30-49 years presenting to GP with heavy periods |
| Key exclusion criteria | 1. Women with confirmed or provisional diagnoses of physical pathology (including cancer, endometriosis, fibroids, prolapse and cysts). 2. Women considered by their GP to be unsuitable due to physical or psychological impairment. 3. Women unable to understand English. Because of the nature of the intervention (i.e. a written computer programme), some proficiency in English is required. |
| Date of first enrolment | 01/02/2003 |
| Date of final enrolment | 09/09/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
NPCRDC
Manchester
M13 9PL
United Kingdom
M13 9PL
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) Special Training Fellowship (UK) (ref: G106/1048)
No information available
National Primary Care Research And Development Centre (NPCRDC) (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/09/2007 | Yes | No |
