Title: Does slip resistant footwear reduce slips among healthcare workers? A randomised controlled trial.
Funder: Department of Health and Social Care

Abstract: Design: A randomised controlled trial with an economic evaluation, a qualitative study and an internal pilot. Setting: NHS Hospitals in the United Kingdom. In this case the NHS is a place of work. Participants: 4,400 NHS trust hospital staff. Inclusion criteria. We will include all members of hospital staff who adhere to a dress code policy and work in clinical, catering or general areas. This will include doctors, nurses, ward clerks, as well as porters and cleaning and catering staff. A clinical area is defined as a hospital ward, outpatient clinic, and service users'/patients' homes where clinical activity takes place. Exclusion criteria: We will exclude staff who: either do not have a mobile phone or are unwilling/unable to receive/send text messages; are required to wear protective footwear provided by their employer, as part of their job; are require to wear prescribed orthopaedic footwear or footwear that requires modification by an orthotist; are office based; are temporary or agency staff, or staff who have less than 6 months remaining on their employment contract. Health technologies being assessed: Intervention - slip resistant footwear. Participants will be provided with one pair of slip resistant shoes, provided by 'Shoes for Crews'. Control (the comparator) - participants will wear their usual footwear for 12 weeks after which time they will be offered a free pair of trial slip resistant shoes. Baseline data collection: Data will be collected on: age; gender; profession; average number of hours worked per week; history of slipping; ethnicity and education. Primary outcome: The incidence rate of slips, not necessarily resulting in injury, in the workplace over 12 weeks. A slip is defined as 'a loss of traction of your foot - you can slip without falling.' Data on number of slips, falls from a slip and whether they result in an injury, will be collected by weekly text messages. If a participant reports a fall as a result of a slip or an injury, then additional information including the location of fall/injury, type of flooring, if the flooring was wet or dry; severity of fall and severity of resulting injury (if any) will be collected from the participant via a follow-up telephone call. Secondary outcomes: Proportion of participants who report a slip and fall in the workplace over 12 weeks; incidence rate of falls over 12 weeks; time to first slip; time to first fall; reason for slip/fall; consequence of slip/fall i.e. superficial wound (bruising, sprain, cut, abrasions) or fractures and type of fracture, footwear worn at time of slip/fall, hospital admissions; time off work; number of days in hospital; compliance and reasons for non-compliance; assessment of wear on the sole of the footwear; cost effectiveness. We will assess the acceptability of the footwear and reasons for compliance/ noncompliance in qualitative interviews. Sample size: To detect a relative reduction of 30% in the number of participants reporting at least one slip from 10% to 7%, with 90% power, using 2 sided 5% significance and assuming 20% attrition, 4,400 participants need to be recruited and randomised (2,200 to intervention and 2,200 control). The study will also have 80% power to show a reduction in the number of participants who fall from 5.5% to 3.5%. Project timetable: The trial duration is 30 months. Start date is 01/10/2016; recruitment, randomisation and provision of footwear would start 01/04/2017 and last until 30/04/2018. Follow-up of the participants would end in 31/07/2018. Data cleaning, analysis and report writing would be completed by 31/03/2019. The team: This includes health and safety experts; statisticians, health economists; trial managers; podiatrists; and trial methodologists.

Lay abstract: Slips, trips and falls are the main cause of accidents in the workplace. Last year, over 100,000 people hurt themselves as a result of a having a slip, trip or fall at work. This was the cause of about 40% of all of the injuries which had to be reported to the Health and Safety Executive. These injuries can have a major effect on the individual as well as the people who employ them. It has been estimated that one million days were taken off work in 2012/13 due to injuries caused by slips, trips or falls. People working in health and social care, report the highest numbers of slips and trips where they work. Hospital staff are more likely to slip because of the type of flooring they have to walk on. The floors are often smooth as this makes them easier to keep clean and reduces the spread of diseases; however, these types of floors become very slippery when they are wet or dirty. Some staff visiting patients at home will have no control over the type or condition of the flooring they walk on. One possible way of reducing the number of slips and falls people have could be for them to wear slip resistant shoes. The aim of this study is to find out if slip resistant shoes can stop hospital staff from slipping, falling or hurting themselves. We will recruit participants from staff working in NHS trusts who have to follow a workplace dress code policy and who have a mobile phone. These will include doctors, nurses, ward clerks and cleaning and catering staff working both in the hospital and those who visit patients at their homes. Staff will be sent an information sheet about the study and details of the trial coordinator to ring for further information. Volunteers will be asked to sign a consent form and fill in a questionnaire. We will recruit at least 4,400 participants and they will have a 4 to 6 week run-in period where they will return weekly text messages to the team. Those who complete the texts will be randomly allocated to one of two groups using a computer program. Participants will either receive one free pair of slip resistant shoes to wear at work or asked to wear their own work shoes, but will be given a free pair of slip resistant shoes when they have finished the study. We will text everyone once a week, for 12 weeks, asking if they have had a slip or a fall and if so how many and if they were injured. If they report a fall or an injury we will ring them to find out further information. Participants will also be given a weekly paper diary in which to record details of any falls or injuries. Once a month we will ask the people wearing the shoes how often they are wearing them. We will ask some participants to return their shoes so that we can test how worn the soles are. Our sample size is large enough to give us 80% power to show a reduction in the number of particiants who fall from 5.5% in the control group down to 3.5% in the intervention group (36% reduction). The sample size will also give us 90% power to show a 30% relative reduction in the number of people who slip. Our team is experienced in running this type of study. It includes experts in slip and trip prevention, clinical trial methodology and conduct, statistics and health economics. The Cheshire and Wirral Partnership NHS Foundation Trust's Ward Management Task and Finish Group have agreed to act as lay advisors for the study. We will send a summary of our findings to all of the trial participants and NHS Trusts managers where the study was run. We will also publish our findings scientific journals, conferences and websites.

Research activity codes: 3.2 INTERVENTIONS TO ALTER PHYSICAL AND BIOLOGICAL ENVIRONMENTAL RISKS
Health categories: INJURIES AND ACCIDENTS