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ISRCTN
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ISRCTN70398358
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ClinicalTrials.gov identifier
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Public title
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Out of Hours Study: the effect of weekend and out-of-hours appointments on attendance rates at breast screening
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Scientific title
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A multicentre randomised controlled study of the effect of weekend and out-of-hours appointments on attendance rates at breast screening
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Acronym
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OOHS
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Serial number at source
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N/A
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Study hypothesis
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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.
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Ethics approval
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Outer North East London Research Ethics Committee (REC) approved on the 15th March 2009 (ref: 09/H0701/96)
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Study design
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Multicentre randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Breast cancer screening and prevention
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/01/2010
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Anticipated end date
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01/01/2011
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Status of trial
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Ongoing |
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Patient information material
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Target number of participants
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18,000
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Interventions
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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.
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Primary outcome measure(s)
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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).
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Secondary outcome measure(s)
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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.
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Sources of funding
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NHS Breast Screening Programme National Office (UK)
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Trial website
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http://www.cptu.co.uk/outofhours
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Publications
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Contact name
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Prof
Stephen
Duffy
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Address
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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
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City/town
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London
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Zip/Postcode
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EC1M 6BQ
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Country
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United Kingdom
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Tel
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+44 (0)20 7882 3535
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Email
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s.w.duffy@qmul.ac.uk
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Sponsor
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Queen Mary University of London (UK)
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Address
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Research & Development Office
Queen Mary Innovations Centre
Lower Ground Floor
5 Walden Street
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City/town
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London
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Zip/Postcode
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E1 2AN
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Country
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United Kingdom
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Tel
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+44 (0)20 7882 7260
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Email
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gerry.leonard@bartsandthelondon.nhs.uk
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Sponsor website:
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http://www.qmul.ac.uk/
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Date applied
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20/10/2009
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Last edited
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27/10/2009
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Date ISRCTN assigned
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27/10/2009
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