The 6-PACK programme to decrease fall-related injuries in acute hospitals: protocol for a cluster randomised controlled trial

Background and aims In-hospital fall-related injuries are a source of personal harm, preventable hospitalisation costs, and access block through increased length of stay. Despite increased fall prevention awareness and activity over the last decade, rates of reported fall-related fractures in hospitals appear not to have decreased. This cluster randomised controlled trial (RCT) aims to determine the efficacy of the 6-PACK programme for preventing fall-related injuries, and its generalisability to other acute hospitals.

Methods 24 acute medical and surgical wards from six to eight hospitals throughout Australia will be recruited for the study. Wards will be matched by type and fall-related injury rates, then randomly allocated to the 6-PACK intervention (12 wards) or usual care control group (12 wards). The 6-PACK programme includes a nine-item fall risk assessment and six nursing interventions: ‘falls alert’ sign; supervision of patients in the bathroom; ensuring patient’s walking aids are within reach; establishment of a toileting regime; use of a low-low bed; and use of bed/chair alarm. Intervention wards will be supported by a structured implementation strategy. The primary outcomes are fall and fall-related injury rates 12 months following 6-PACK implementation.

Discussion This study will involve approximately 16 000 patients, and as such is planned to be the largest hospital fall prevention RCT to be undertaken and the first to be powered for the important outcome of fall-related injuries. If effective, there is potential to implement the programme widely as part of daily patient care in acute hospital wards where fall-related injuries are a problem.

The 6-PACK programme to decrease falls and fall-related injuries in acute hospitals : protocol for an economic evaluation alongside a cluster randomised controlled trial

Background Falls are a common hospital occurrence complicating the care of patients. From an economic perspective, the impact of in-hospital falls and related injuries is substantial. However, few studies have examined the economic implications of falls prevention interventions in an acute care setting. The 6-PACK programme is a targeted nurse delivered falls prevention programme designed specifically for acute hospital wards. It includes a risk assessment tool and six simple strategies that nurses apply to patients classified as high-risk by the tool.
Objective To examine the incremental cost-effectiveness of the 6-PACK programme for the prevention of falls and fall-related injuries, compared with usual care practice, from an acute hospital perspective.
Methods and design The 6-PACK project is a multicentre cluster randomised controlled trial (RCT) that includes 24 acute medical and surgical wards from six hospitals in Australia to investigate the efficacy of the 6-PACK programme. This economic evaluation will be conducted alongside the 6-PACK cluster RCT. Outcome and hospitalisation cost data will be prospectively collected on approximately 16 000 patients admitted to the participating wards during the 12-month trial period. The results of the economic evaluation will be expressed as ‘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 (ICER).
Discussion This economic evaluation will provide an opportunity to explore the cost-effectiveness of a targeted nurse delivered falls prevention programme for reducing in-hospital falls and fall-related injuries. This protocol provides a detailed statement of a planned economic evaluation conducted alongside a cluster RCT to investigate the efficacy of the 6-PACK programme to prevent falls and fall-related injuries.

In-hospital falls and fall-related injuries: a protocol for a cost of fall study

Background:
In-hospital falls are common and pose significant economic burden on the healthcare system. To date, few studies have quantified the additional cost of hospitalisation associated with an in-hospital fall or fall-related injury. The aim of this study is to determine  the additional length of stay and hospitalisation costs associated with in-hospital falls and fall-related injuries, from the acute hospital perspective.

Methods and design: 
A multisite prospective study will be conducted as part of a larger falls-prevention clinical trial—the 6-PACK project. This study will involve 12 acute medical and surgical wards from six hospitals across Australia. Patient and admission characteristics, outcome and hospitalisation cost data will be prospectively collected on approximately 15 000 patients during the 15-month study period. A review of all inhospital fall events will be conducted using a multimodal method (medical record review and daily verbal report from the nurse unit manager, triangulated with falls recorded in the hospital incident reporting and administrative database), to ensure complete case ascertainment. Hospital clinical costing data will be used to calculate patient-level hospitalisation costs incurred by a patient during their inpatient stay. Additional hospital and hospital resource utilisation costs attributable to inhospital falls and fall-related injuries will be calculated using linear regression modelling, adjusting for a prioridefined potential confounding factors.

Discussion:
This protocol provides the detailed statement of the planned analysis. The results from this study will be used to support healthcare planning, policy making and allocation of funding relating to falls prevention within acute hospitals.

A telephone support program to reduce costs and hospital admissions for patients at risk of readmissions: lessons from an evaluation of a complex health intervention

This study aimed to evaluate the effectiveness of a telephone health coaching and support service provided to members of an Australian private health insurance fund-Telephonic Complex Care Program (TCCP)-on hospital use and associated costs. A case-control pre-post study design was employed using propensity score matching. Private health insurance members (n=273) who participated in TCCP between April and December 2012 (cases) were matched (1:1) to members who had not previously been enrolled in the program or any other disease management programs offered by the insurer (n=232). Eligible members were community dwelling, aged ≥65 years, and had 2 or more hospital admissions in the 12 months prior to program enrollment. Preprogram variables that estimated the propensity score included: participant demographics, diagnoses, and hospital use in the 12 months prior to program enrollment. TCCP participants received one-to-one telephone support, personalized care plan, and referral to community-based services. Control participants continued to access usual health care services. Primary outcomes were number of hospital admission claims and total benefits paid for all health care utilizations in the 12 months following program enrollment. Secondary outcomes included change in total benefits paid, hospital benefits paid, ancillary benefits paid, and total hospital bed days over the 12 months post enrollment. Compared with matched controls, TCCP did not appear to reduce health care utilization or benefits paid in the 12 months following program enrollment. However, program characteristics and implementation may have impacted its effectiveness. In addition, challenges related to evaluating complex health interventions such as TCCP are discussed.

The extra resource burden of in-hospital falls: a cost of falls study

OBJECTIVE: To quantify the additional hospital length of stay (LOS) and costs associated with in-hospital falls and fall injuries in acute hospitals in Australia. DESIGN, SETTING AND PARTICIPANTS: A multisite prospective cohort study conducted during 2011-2013 in the control wards of a falls prevention trial (6-PACK). The trial included all admissions to 12 acute medical and surgical wards of six Australian hospitals. In-hospital falls data were collected from medical record reviews, daily verbal reports by ward nurse unit managers, and hospital incident reporting and administrative databases. Clinical costing data were linked for three of the six participating hospitals to calculate patient-level costs. OUTCOME MEASURES: Hospital LOS and costs associated with in-hospital falls and fall injuries for each patient admission. RESULTS: We found that 966 of a total of 27 026 hospital admissions (3.6%) involved at least one fall, and 313 (1.2%) at least one fall injury, a total of 1330 falls and 418 fall injuries. After adjustment for age, sex, cognitive impairment, admission type, comorbidity and clustering by hospital, patients who had an in-hospital fall had a mean increase in LOS of 8 days (95% CI, 5.8-10.4; P < 0.001) compared with non-fallers, and incurred mean additional hospital costs of $6669 (95% CI, $3888-$9450; P < 0.001). Patients with a fall-related injury had a mean increase in LOS of 4 days (95% CI, 1.8-6.6; P = 0.001) compared with those who fell without injury, and there was also a tendency to additional hospital costs (mean, $4727; 95% CI, -$568 to $10 022; P = 0.080). CONCLUSION: Patients who experience an in-hospital fall have significantly longer hospital stays and higher costs. Programs need to target the prevention of all falls, not just the reduction of fall-related injuries.

6-PACK programme to decrease fall injuries in acute hospitals: cluster randomised controlled trial

OBJECTIVE:  To evaluate the effect of the 6-PACK programme on falls and fall injuries in acute wards. DESIGN:  Cluster randomised controlled trial. SETTING:  Six Australian hospitals. PARTICIPANTS:  All patients admitted to 24 acute wards during the trial period. INTERVENTIONS:  Participating wards were randomly assigned to receive either the nurse led 6-PACK programme or usual care over 12 months. The 6-PACK programme included a fall risk tool and individualised use of one or more of six interventions: "falls alert" sign, supervision of patients in the bathroom, ensuring patients' walking aids are within reach, a toileting regimen, use of a low-low bed, and use of a bed/chair alarm. MAIN OUTCOME MEASURES:  The co-primary outcomes were falls and fall injuries per 1000 occupied bed days. RESULTS:  During the trial, 46 245 admissions to 16 medical and eight surgical wards occurred. As many people were admitted more than once, this represented 31 411 individual patients. Patients' characteristics and length of stay were similar for intervention and control wards. Use of 6-PACK programme components was higher on intervention wards than on control wards (incidence rate ratio 3.05, 95% confidence interval 2.14 to 4.34; P<0.001). In all, 1831 falls and 613 fall injuries occurred, and the rates of falls (incidence rate ratio 1.04, 0.78 to 1.37; P=0.796) and fall injuries (0.96, 0.72 to 1.27; P=0.766) were similar in intervention and control wards. CONCLUSIONS:  Positive changes in falls prevention practice occurred following the introduction of the 6-PACK programme. However, no difference was seen in falls or fall injuries between groups. High quality evidence showing the effectiveness of falls prevention interventions in acute wards remains absent. Novel solutions to the problem of in-hospital falls are urgently needed. TRIAL REGISTRATION:  Australian New Zealand Clinical Trials Registry ACTRN12611000332921.