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

NPCRDC
5th Floor Williamson Building
The University of Manchester
Oxford Road
Manchester
M13 9PL
United Kingdom

Phone +44 (0)161 2757601
Email j.protheroe@man.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)GP practice
Study typeTreatment
Scientific title
Study acronymMENTIP
Study objectivesAims:
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) studiedMenorrhagia
Intervention1. Control group: Patient Information Leaflet (PIL)
2. Intervention group: PIL and Clinical Guidance Tree (computerised Decision Analysis)
Intervention typeOther
Primary outcome measureThe 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 measuresNot provided at time of registration
Overall study start date01/02/2003
Completion date09/09/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants300
Key inclusion criteriaWomen aged 30-49 years presenting to GP with heavy periods
Key exclusion criteria1. 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 enrolment01/02/2003
Date of final enrolment09/09/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

NPCRDC
Manchester
M13 9PL
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email 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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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