RecruitingACTRN12614000615684

A night-lighting intervention to reduce inpatient falls: A stepped-wedge cluster randomised controlled trial

A single site, stepped-wedge cluster randomised controlled trial among hospitalised patients to determine the effect of a novel night lighting solution compared to usual care on ward level rates of patient falls.

Sponsor

Royal Brisbane and Women's Hospital, Queensland Health, Australia

Enrollment

7,500 participants

Start Date

Jun 12, 2014

Study Type

Interventional

Conditions

Accidental Falls

Summary

BACKGROUND Falls among older hospital patients are a concerning and costly problem. While most falls occur during the day, nearly 40% happen outside normal hours; potentially while patients attempt to mobilise to and from the toilet in poorly lit environments. A practical solution for these problems is the installation of targeted low-intensity lighting around key room features without disrupting the dark sleep environment. Previous laboratory research has demonstrated improved postural stability and gait among older people with such lighting. Subsequent evaluations in aged care facilities have confirmed high levels of acceptance among staff and residents. In order to test the clinical acceptability of this solution the investigative team recently completed a multi-site user acceptance study (unpublished). Formal patient and staff feedback after ward demonstrations of the novel lighting confirmed both acceptability and the likelihood of sleep and safety improvements. User feedback has been incorporated into the final intervention design for the present trial. AIM We aim to test the effect of the night lighting intervention on ward level patient fall rates. METHODS The effect of our intervention on the primary outcome will be evaluated through a stepped-wedge cluster randomised controlled trial (RCT) across six inpatient wards at the Royal Brisbane and Women's Hospital over fourteen months. A stepped-wedge cluster RCT design describes a staggered roll-out of the intervention across participating wards such that the order of roll-out is randomly generated. Therefore, participating wards provide control data prior to implementation and intervention data after implementation.

Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

Falls in hospital are a serious problem, especially for older patients who may get up at night to use the bathroom in poorly lit rooms. This study is testing whether installing low-intensity, targeted night lighting around key areas in hospital patient rooms (like the bed and bathroom) reduces the number of falls on hospital wards. The lighting is designed to improve visibility without disturbing sleep. Six wards at Royal Brisbane and Women's Hospital will gradually adopt the new lighting in a staggered rollout over 14 months. You may be eligible if: - You are admitted to one of the six study wards at the Royal Brisbane and Women's Hospital during the 14-month trial period You may NOT be eligible if: - There are no patient-level exclusion criteria — all patients admitted to study wards during the trial are included Talk to your doctor about whether this trial might be right for you.

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Interventions

The intervention in this study is a modified night-lighting solution that will be installed in all patient rooms (both shared rooms and single rooms) across trial wards. We will use low-output LED strip lighting with an output wavelength of 670 nm (orange colour), which will be housed in aluminium tracks with diffuser cover strips. The spectral characteristics of the light have been determined in line with prior research on relationships between blue wavelength lighting and alertness (an unwanted effect for night lighting) [1]. The lights will be installed in multiple locations within each patient environment; the orientation and illumination characteristics are based on prior published research and on findings of a preliminary clinical acceptability study conducted by this team. LED luminaires will be installed in the following three locations: i. Around the exterior ensuite door-frame: To provide a visual reference point for patients attempting to mobilise to the toilet at night, we will install a continuous length of strip lighting around the exterior perimeter of the toilet door-frame. ii. Above the washbasin in the ensuite toilet: In a horizontal section below the mirror and above the wash basin. iii. Behind the toilet and adjacent to the toilet: To facilitate easy visualisation of the immediate area around the toilet we will install one section of lighting behind to the toilet (above the cistern) and in a second section over the grab rail (where a wall-mounted grab rail is installed along the closest adjacent wall). Due to known inter-ward variability in location of toilets, type and location of grab-rails within ensuite bathrooms, it might not be feasible to install grab rail lighting in all locations (such as when the toilet is located equidistance from both adjacent walls and bilateral fold-back grab-rails are installed on the posterior wall on either side of the toilet). In such instances, we will make pragmatic decisions on implementation feasibility and variation, which will be comprehensively catalogued by the PI in a study journal. The lighting will be installed by hospital building and engineering service electricians such that 12 volt power-supply units and all wiring will be housed behind wall panels. While 24 hour operation of the lights is acceptable, we intend to automate the lights to gradually turn on at 5 PM and fade out at 7 AM by linking them with the hospital central timer. This will help maximise service life, reduce power consumption and eliminate the need for staff input. The on/off times have been selected to ensure that seasonal variations of sunrise and sunset times in Brisbane, Queensland are accounted for. Importantly, none of the existing lighting will be altered in any way, and staff and patients will have full use of existing lightings in patient rooms and toilets if the installed night lighting was considered inadequate or required supplementation, for example if additional light is required for patients with severe visual impairment, or if a medical emergency occurs. The duration of the intervention period is 14 months from commencement. However, participating wards will be given the option to retain the modified night lighting at the end of the trial. I wards chose to retain the lighting, it will become part of ward infrastructure. If requested for removal, the lights will be deactivated upon trial completion and removed by RBWH building and engineering services subsequently. 1. Cajochen, C (2007). "Alerting effects of light." Sleep medicine reviews 11.6: 453-464.