Simple versus informed choice invitations to screening

ISRCTN	ISRCTN73125647
DOI	https://doi.org/10.1186/ISRCTN73125647
Protocol serial number	076838
Sponsor	King's College London (UK)
Funder	The Wellcome Trust (UK) (ref: 076838)

Submission date: 23/12/2005
Registration date: 09/01/2006
Last edited: 21/12/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Theresa Marteau
Scientific

Psychology Dept. (at Guy's)
Health Psychology Section
Psychology & Genetics Research Group
5th Floor Thomas Guy House
Guy's Campus
London Bridge
London
SE1 9RT
United Kingdom

Phone	+44 (0)20 7188 0192
Email	theresa.marteau@kcl.ac.uk

Study information

Primary study design	Interventional
Study design	Multicentre single-blind randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Didactic versus informed choice invitations to screening: balancing public health benefits and individual choice
Study acronym	DICISION
Study objectives	We propose to develop a feasible and effective informed choice strategy and to evaluate its impact on attendance at screening and motivation to follow subsequent advice, both overall and stratified by social deprivation. The work is set within the important public health context of screening for type two diabetes. We will test two hypotheses: 1. Uptake of screening for diabetes is higher following a traditional, didactic invitation compared with an informed choice invitation. 2. Amongst those who attend for screening, intentions to change behaviour to reduce risks are stronger following an informed choice invitation compared with a traditional invitation.
Ethics approval(s)	Cambridgeshire 1 Research Ethics Committee gave approval on the 5th May 2006 (ref: 06/Q0104/17)
Health condition(s) or problem(s) studied	Informed choice for screening for type two diabetes
Intervention	1. Traditional invitation: This will be a brief letter based on previous invitations for screening tests, including diabetes and coronary heart disease. It will include: a. name of the condition i.e. type two diabetes b. aims of screening i.e. to reduce risks of diabetes and associated cardiovascular disease c. procedure i.e. review of risk including blood tests and clinical measures, advice and treatment as indicated 2. Informed choice invitation: This will comprise the same brief letter but with additional detailed information based on General Medical Council (GMC) guidelines, and linked to a self-administered informed choice aid based on similar tools successfully used to facilitate personal decisions in other health care contexts.
Intervention type	Other
Primary outcome measure(s)	Uptake of screening, which will be recorded by the practice nurses conducting the screening.
Key secondary outcome measure(s)	1. Intention to change behaviour to reduce risks of diabetes: behavioural intentions are good predictors of behaviour change. Three core behavioural intentions will be assessed in those attending: a. increasing physical activity b. restricting calories by eating low fat foods c. taking preventive medication, if indicated d. stopping smoking will also be assessed, when relevant 2. Self-reported behaviour assessed using standard questionnaires: a. physical activity b. diet c. smoking and use of medication to reduce risk of diabetes 3. Attendance for post screening blood tests and subsequent practice nurse advice will be recorded 4. Social deprivation: area (post code) and individual level measures (education, home ownership and access to car) will be used. Age, gender, and ethnic group and risk factors known before screening will also be recorded. 5. Risk stratification: all those attending will be given a risk score to indicate their risks of developing diabetes and experiencing a cardiovascular event over the next ten years. Those with confirmed diabetes, expected to be about 30 individuals, will also receive their Coronary Heart Disease (CHD) risk scores 6. Informed choice: choices to participate in screening will be classified as informed to the extent that they are based on understanding diabetes screening and reflect the decision-makers values, using a standardised method we have developed and validated in other screening contexts
Completion date	31/12/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1200
Key inclusion criteria	1. 1200 men and women aged 40 to 69 years 2. In the top 20% of risk of undiagnosed diabetes on practice registers, defined by a validated risk score applied to routine data on general practice population registers. The Cambridge Diabetes Risk Score includes the following risk variables: a. age b. gender c. family history of diabetes d. smoking status e. prescription of steroid or anti-hypertensive medication f. body mass index
Key exclusion criteria	Patients considered by the practice nurse or General Practitioner to be unsuitable for the project, for example, people who are severely ill, will be excluded from the study.
Date of first enrolment	01/01/2006
Date of final enrolment	31/12/2007

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Psychology Dept. (at Guy's)

London
SE1 9RT
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	13/05/2010		Yes	No
Results article	results	01/09/2011		Yes	No
Protocol article	protocol	20/02/2009		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes