None listed
Conditions
Brief summary
This cluster randomised controlled trial (RCT) aims to provide evidence of the efficacy and sustainability of the 6-PACK program for preventing fall-related injuries in acute hospitals. Twenty-four acute medical and surgical wards from six to eight hospitals throughout Australia will be recruited. Wards will be matched by type and baseline fall-related injury rates then randomly allocated to either the 6-PACK intervention (12 wards) or the usual care control group (12 wards).The 6-PACK program includes completion of a nine-item falls risk assessment and six nursing interventions: ‘‘falls alert’’ sign above the patient’s bed; supervision of patients while in the bathroom; ensuring that the patient’s walking aid is within reach; establishment of a toileting regime; use of a low-low bed and use of bed/chair alarm. Intervention wards will receive 6-PACK equipment (falls alert signs, low-low beds and bed/chair alarms) and there will be a supported implementation (small group training and assignment of clinical leaders) and review strategy (audit, feedback and reminders). A cost effectiveness study of the 6-PACK program will also be conducted. The effectiveness of the 6-PACK implementation will also be examined using a structured mixed methods evaluation. Sustainability will be assessed in the year after the RCT when there will be a staged withdrawal of the research staff from the sites. The primary outcome measures are fall and fall-related injury rates in the 12 months after the 6-PACK is implemented. The cost-effectiveness outcome is “cost or saving per fall prevented” and “cost or saving per fall-related injury prevented” calculated from differences in mean costs and effects in the intervention and control groups to generate an incremental cost-effectiveness ratio. Outcome analyses will be undertaken on an intention to treat basis. Differences in fall and fall-related injury rates will be compared between groups using negative binomial regression where data are adjusted for clustering and pairing of wards. Primary analysis will be unadjusted. Secondary analyisis that adjusts for age and cognitive impairment will also be conducted. This study is planned to be the largest hospital falls prevention RCT to be undertaken and is the first to be powered to the important primary outcome of falls injuries.
Interventions
Completion of a nine-item falls risk assessment and delivery of one or more of the following six interventions to high risk falls patients:
1. Placement of a "falls alert" sign above the patient's bed. 2. Supervision of patients while in bathroom.
3. Use of a low-low bed. Where a low-low bed is a standard hospital bed that has the additional feature of being able to be lowered to 250mm from the floor level or lower. These beds are designed to reduce the risk of bed fall-related injuries.
4. E
Completion of a nine-item falls risk assessment and delivery of one or more of the following six interventions to high risk falls patients: 1. Placement of a "falls alert" sign above the patient's bed. 2. Supervision of patients while in bathroom. 3. Use of a low-low bed. Where a low-low bed is a standard hospital bed that has the additional feature of being able to be lowered to 250mm from the floor level or lower. These beds are designed to reduce the risk of bed fall-related injuries. 4. Ensuring that the patient's walking aid is within reach at all times. 5. Establishment of a toileting regime. 6. Use of bed/chair alarm when the patient is positioned in the bed/chair. The 6-PACK interventions will be applied to high falls risk patients at the discretion of the patient’s treating nurse. The frequency and duration of the interventions used will not be prescribed by the research project but will be measured as part of the cluster RCT. Site clinical leaders will be trained in the 6-PACK program and implementation by the research team. The site clinical leaders will then deliver small interactive group training sessions to intervention ward nursing staff. Intervention ward staff will also be provided with access to an online training package. This will ensure intervention ward staff delivering the 6-PACK interventions will be trained to take part in the study and deliver the 6-PACK interventions. The overall duration of this trial will be: 1. Baseline data collection - 6 months 2. Cluster RCT - 12 months 3. Sustainability of the 6-PACK program - 24 months (including the 12 months of data obtained from the cluster RCT) In summary data collection will span a total of 30 months.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
0 to 125 Years
Healthy volunteers
No
Inclusion criteria
The hypotheses will be explored using a multicentre single blinded cluster RCT. Hospitals will be asked to identify wards where fall-related injuries are a problem as potential wards to participate in the study. For wards to be eligible to participate in the project the following criteria must be met: Acute medical and surgical wards (primarily adult wards); Average patient length of stay <10 days; Wards to have one or less low-low bed to six standard beds on medical wards and one or less low-low bed to 29 standard beds on surgical wards; and No falls risk assessment and/or intervention checklist on the DAILY patient care plan documentation. Wards that have a policy to complete a falls risk assessment tool on admission and / or as status changes will not be excluded from the study. All patients admitted to participating wards during the study observation period will be included in the study.
Exclusion criteria
Any detail contradicting the above inclusion criteria.
Outcome results
None listed