Implementation fidelity of a nurse-led falls prevention program in acute hospitals during the 6-PACK trial.

BACKGROUND: When tested in a randomized controlled trial (RCT) of 31,411 patients, the nurse-led 6-PACK falls prevention program did not reduce falls. Poor implementation fidelity (i.e., program not implemented as intended) may explain this result. Despite repeated calls for the examination of implementation fidelity as an essential component of evaluating interventions designed to improve the delivery of care, it has been neglected in prior falls prevention studies. This study examined implementation fidelity of the 6-PACK program during a large multi-site RCT. METHODS: Based on the 6-PACK implementation framework and intervention description, implementation fidelity was examined by quantifying adherence to program components and organizational support. Adherence indicators were: 1) falls-risk tool completion; and for patients classified as high-risk, provision of 2) a 'Falls alert' sign; and 3) at least one additional 6-PACK intervention. Organizational support indicators were: 1) provision of resources (executive sponsorship, site clinical leaders and equipment); 2) implementation activities (modification of patient care plans; training; implementation tailoring; audits, reminders and feedback; and provision of data); and 3) program acceptability. Data were collected from daily bedside observation, medical records, resource utilization diaries and nurse surveys. RESULTS: All seven intervention components were delivered on the 12 intervention wards. Program adherence data were collected from 103,398 observations and medical record audits. The falls-risk tool was completed each day for 75% of patients. Of the 38% of patients classified as high-risk, 79% had a 'Falls alert' sign and 63% were provided with at least one additional 6-PACK intervention, as recommended. All hospitals provided the recommended resources and undertook the nine outlined program implementation activities. Most of the nurses surveyed considered program components important for falls prevention. CONCLUSIONS: While implementation fidelity was variable across wards, overall it was found to be acceptable during the RCT. Implementation failure is unlikely to be a key factor for the observed lack of program effectiveness in the 6-PACK trial. TRIAL REGISTRATION: The 6-PACK cluster RCT is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12611000332921 (29 March 2011).

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.

Reducing serious fall-related injuries in acute hospitals: are low-low beds a critical success factor?

AIM: This article is a report of a study of associations between occurrence of serious fall-related injuries and implementation of low-low beds at The Northern Hospital, Victoria, Australia. BACKGROUND: A 9-year evaluation at The Northern Hospital found an important reduction in fall-related injuries after the 6-PACK falls prevention program was implemented. Low-low beds are a key component of the 6-PACK that aims to decrease fall-related injuries. DESIGN: A retrospective cohort study. METHODS: Retrospective audit of The Northern Hospital inpatients admitted between 1999-2009. Changes in serious fall-related injuries throughout the period and associations with available low-low beds were analysed using Poisson regression. RESULTS: During the observation of 356,158 inpatients, there were 3946 falls and 1005 fall-related injuries of which 60 (5·9%) were serious (55 fractures and five subdural haematomas). Serious fall-related injuries declined significantly throughout the period. When there was one low-low bed to nine or more standard beds there was no statistically significant decrease in serious fall-related injuries. An important reduction only occurred when there was one low-low bed to three standard beds. CONCLUSION: The 6-PACK program has been in place since 2002 at The Northern Hospital. Throughout this time serious fall-related injuries have decreased. There appears to be an association between serious fall-related injuries and the number of available low-low beds. Threshold numbers of these beds may be required to achieve optimal usability and effectiveness. A randomized controlled trial is required to give additional evidence for use of low-low beds for injury prevention in hospitals.

Implementation of pressure ulcer prevention best practice recommendations in acute care: an observational study.

Pressure ulcers are a common but preventable problem in hospitals. Implementation of best practice guideline recommendations can prevent ulcers from occurring. This 9-year cohort study reports prevalence data from point prevalence surveys during the observation period, and three practice metrics to assess implementation of best practice guideline recommendations: (i) nurse compliance with use of a validated pressure ulcer risk assessment and intervention checklist; (ii) accuracy of risk assessment scoring in usual-care nurses and experienced injury prevention nurses; and (iii) use of pressure ulcer prevention strategies. The prevalence of hospital-acquired pressure ulcers decreased following implementation of an evidence-based prevention programme from 12·6% (2 years preprogramme implementation) to 2·6% (6 years postprogramme implementation) (P < 0·001). Audits between 2003 and 2011 of 4368 patient medical records identified compliance with pressure ulcer prevention documentation according to best practice guidelines was high (>84%). A sample of 270 patients formed the sample for the study of risk assessment scoring accuracy and use of prevention strategies. It was found usual-care nurses under-estimated patients' risk of pressure ulcer development and under-utilised prevention strategies compared with experienced injury prevention nurses. Despite a significant reduction in prevalence of hospital-acquired pressure ulcers and high documentation compliance, use of prevention strategies could further be improved to achieve better patient outcomes. Barriers to the use of prevention strategies by nurses in the acute hospital setting require further examination. This study provides important insights into the knowledge translation of pressure ulcer prevention best practice guideline recommendations at The Northern Hospital.

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.

Adding value to the STRATIFY falls risk assessment in acute hospitals.

AIM: This paper is a report of a study conducted to compare the predictive accuracy for fallers of The Northern Hospital Modified St Thomas's Risk Assessment Tool and St Thomas's Risk Assessment Tool, and to determine the inter-rater agreement of each tool. BACKGROUND: Falls risk assessment is a key component of fall prevention. Investigation of clinimetric properties of a tool should be completed before it are used in clinical practice. METHODS: Local falls data were used to inform modification of the St Thomas's Risk Assessment Tool to improve faller prediction. Clinimetric properties of the St Thomas's Risk Assessment Tool and The Northern Hospital Modified St Thomas's Risk Assessment Tool were examined in a prospective cross-sectional study with acute hospital patients. Phase I involved assessment of predictive accuracy using sensitivity, specificity and the Youden Index (J) with 263 patients. Phase II of the evaluation involved assessment of inter-rater agreement using the Kappa statistic (κ) with 52 patients. Data were collected in 2008. RESULTS: Impaired balance, age 80 years and older and drug and alcohol problems were identified as additional falls risk factors in The Northern Hospital population and added to the St Thomas's Risk Assessment Tool. The Northern Hospital Modified St Thomas's Risk Assessment Tool had higher sensitivity (0·65 vs. 0·35, P = 0·016). The St Thomas's Risk Assessment Tool had higher specificity (0·93 vs. 0·79, P = 0·000). The Northern Hospital Modified St Thomas's Risk Assessment Tool had the greater overall accuracy (J) (0·44 vs. 0·28, P = 0·006). Inter-rater agreement of The Northern Hospital Modified St Thomas's Risk Assessment Tool was fair (κ = 0·34) and low for the St Thomas's Risk Assessment Tool (κ = 0·19). CONCLUSION: The Northern Hospital Modified St Thomas's Risk Assessment Tool and St Thomas's Risk Assessment Tool accurately identified patients at risk of falling. The Northern Hospital Modified St Thomas's Risk Assessment Tool was more accurate. Tools which have unknown validity and reliability should not be used. Future research is needed to provide evidence that use of falls risk assessments has a positive impact on reducing patient falls.

Development and validation of a pressure ulcer risk assessment tool for acute hospital patients.

The purpose of this study was to develop and validate a pressure ulcer risk assessment for acute hospitals. This tool was developed in a cohort of 342 patients with a mean age 63 years (SD 19.82) and validated in a second cohort of 165 patients with a mean age 68 years (SD 18.40). Risk factors for inclusion on The Northern Hospital Pressure Ulcer Prevention Plan (TNH-PUPP) were identified from the literature then examined and weighted using logistic regression. Risk factors included on the TNH-PUPP were requires assistance to move in bed (odds ratio [OR] 5.15; 95% confidence interval [CI]: 2.49-10.65), admission to intensive care during current admission (OR 2.98; 95% CI: 1.33-6.67), aged ≥ 65 years (OR 2.81; 95% CI: 1.24-6.36), reduced sensation (OR 2.29; 95% CI: 1.19-4.42), and cognitive impairment (OR 2.26; 95% CI: 1.09-4.67). The TNH-PUPP was validated in a prospective sample. The new tool had high diagnostic validity (area under the receiver operating curve=0.86), consistent in the validation sample (area under the receiver operating curve=0.90). The TNH-PUPP has a moderate positive predictive value (development=0.50; validation=0.13), and a high negative predictive value (development=0.94; validation=0.99) enabling low-risk patients to be screened out, as noncandidates for pressure ulcer prevention interventions. An accurate pressure ulcer risk assessment has been developed and validated, which identifies a high-risk group to whom limited pressure ulcer prevention resources should be directed. The TNH-PUPP facilitates effective resource allocation and is likely to reduce unnecessary patient harm and costs from pressure ulcers in acute hospitals.