Out of Hours Study: the effect of weekend and out-of-hours appointments on attendance rates at breast screening

ISRCTN	ISRCTN70398358
DOI	https://doi.org/10.1186/ISRCTN70398358
Secondary identifying numbers	N/A

Submission date: 20/10/2009
Registration date: 27/10/2009
Last edited: 06/01/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Prof Stephen Duffy
Scientific

Cancer Research UK Centre for Epidemiology, Mathematics and Statistics
Wolfson Institute of Preventive Medicine
Barts and The London School of Medicine and Dentistry
Queen Mary, University of London
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Phone	+44 (0)20 7882 3535
Email	s.w.duffy@qmul.ac.uk

Study information

Study design	Multicentre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	A multicentre randomised controlled study of the effect of weekend and out-of-hours appointments on attendance rates at breast screening
Study acronym	OOHS
Study objectives	The primary purpose of the study is to discover whether the offer of weekend or out of hours screening appointments alters attendance rates, and if so, which is better, working hours appointments, weekday evening appointments or weekend appointments. Women in Manchester and Bristol who are due a routine breast screening appointment will be randomised to trial arms, in which they will receive letters inviting them to an appointment in weekday working hours, an evening, a Saturday, or working hours with the option to change to an evening or Saturday. The measured endpoints for comparison will be overall attendance rates and attendance at first offered appointment.
Ethics approval(s)	Outer North East London Research Ethics Committee (REC) approved on the 15th March 2009 (ref: 09/H0701/96)
Health condition(s) or problem(s) studied	Breast cancer screening and prevention
Intervention	There are no trial drugs or treatments associated with this trial. Women who are due to be invited for breast screening in Manchester and Bristol will be allocated, based on month of birth, to one of 6 groups. These will then be randomised in a ratio of 3:1:1:1 to the following conditions: 1. Usual invitation letter to a routine screening appointment within working hours 2. Invitation letter to a routine screening appointment within working hours, but with the option of changing to an appointment on a weekend or on a weekday evening 3. Invitation letter to a weekday evening screening appointment 4. Invitation letter to a weekend appointment The time taken between sending letters and initial appointment is 5 weeks, if appointments are changed then those within 120 days will be counted. Therefore the maximum length of time the patient could be in the study is 155 days.
Intervention type	Other
Primary outcome measure	Attendance rate. Comparison will be made between the two major arms of the study, those with a working hours appointment offered, and those with an evening or weekend appointment. Attendance is defined as attending a screening appointment either at the time originally offered, or at an alternative appointment time within 120 days of the original. Data capture will include the appointment date and time offered, and the appointment date and time actually attended (if any).
Secondary outcome measures	1. Whether the invitee attended the first appointment offered, measured by whether the radiographer records on the NBSS system database that the patient attended the original appointment (5 weeks after the invitation letter was sent out) 2. Comparison of the attendance rates between the four groups for subsets of the invitees. In particular, we shall evaluate the effect of the non-standard appointments at prevalence screen and by age group, but will also look at effects on incidence screens, previous attenders and previous non-attenders. This will be assessed using the attendance data collected from the primary outcome, and compared between the patient subsets.
Overall study start date	01/01/2010
Completion date	01/01/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	18,000
Key inclusion criteria	All women (aged 47-73 at Manchester, 50-70 at Bristol, the age range which is eligible for the screening programme at these sites) scheduled for invitation in batches to their next breast screening appointment by the participating centres.
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	01/01/2010
Date of final enrolment	01/01/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Cancer Research UK Centre for Epidemiology, Mathematics and Statistics

London
EC1M 6BQ
United Kingdom

Sponsor information

Queen Mary University of London (UK)
University/education

Research & Development Office
Queen Mary Innovations Centre
Lower Ground Floor
5 Walden Street
London
E1 2AN
England
United Kingdom

Phone	+44 (0)20 7882 7260
Email	gerry.leonard@bartsandthelondon.nhs.uk
Website	http://www.qmul.ac.uk/
"ROR"	https://ror.org/026zzn846

Funders

Funder type

Government

NHS Breast Screening Programme National Office (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	06/08/2013		Yes	No