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
Protocol serial number	G106/1048
Sponsor	Medical Research Council (MRC) (UK)
Funders	Medical Research Council (MRC) Special Training Fellowship (UK) (ref: G106/1048), National Primary Care Research And Development Centre (NPCRDC) (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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).
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	09/09/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	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

United Kingdom
England

Study participating centre

NPCRDC

Manchester
M13 9PL
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?
Results article	Results	01/09/2007		Yes	No