Confidential: For Review Only - BMJ · 2016. 1. 28. · Confidential: For Review Only 1 1 The 6-PACK program to decrease fall injuries in acute hospitals: A cluster randomised 2 controlled

Confidential: For Review O

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The 6-PACK program to decrease fall injuries in acute

hospitals: A cluster randomised controlled trial

Journal: BMJ

Manuscript ID: BMJ.2015.025801

Article Type: Research

BMJ Journal: BMJ

Date Submitted by the Author: 08-Mar-2015

Complete List of Authors: Barker, Anna; Monash University, Epidemiology and Preventive Medicine Morello, Renata; Monash University, Wolfe, Rory; Monash University, Department of Epidemiology and Preventive Medicine Brand, Caroline; Monash University, Centre for Research Excellence in

Patient Safety Haines, T; Monash University, Hill, Keith; Curtin University, Brauer, Sandra; The University of Queensland, Physiotherapy Botti, Mari; Epworth Health Care, Centre for Clinical Nursing Research Cumming, Robert; University of Sydney, School of Public Health Livingston, Patricia; Deakin University, Sherrington, Catherine; The George Institute for Global Health, University of Sydney Zavarsek, Silva; Monash University, Centre for Health Economics Lindley, Richard; University of Sydney, Discipline of Medicine Kamar, Jeannette; The Northern Hospital,

Keywords: Accidental falls, Injury, Randomised controlled trial, Acute care

https://mc.manuscriptcentral.com/bmj

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The 6-PACK program to decrease fall injuries in acute hospitals: A cluster randomised 1

controlled trial 2

3

Anna L Barker1, Renata T Morello1, Rory Wolfe1, Caroline A Brand1, Terry P Haines2, Keith D Hill3, 4

Sandra G Brauer4, Mari Botti5, Robert G Cumming6, Patricia M Livingston5, Catherine Sherrington7, 5

Silva Zavarsek8, Richard I Lindley7,, and Jeannette Kamar10 6

7

1Department of Epidemiology and Preventive Medicine, Monash University, 99 Commercial Road 8

Melbourne Victoria 3004, Australia 9

Anna L Barker, Associate Professor, Renata T Morello, Research Manager, Rory Wolfe, Biostatistician, 10

Caroline A Brand, Adjunct Associate Professor 11

2Physiotherapy Department, Monash University, Allied Health Research Unit, Monash Health, 12

Kingston Centre, Kingston Road Cheltenham , Victoria 3195, Australia 13

Terry P Haines, Professor 14

3School of Physiotherapy and Exercise Science, Curtin University, Kent Street Perth, Western Australia 15

6102, Australia 16

Keith D Hill, Professor 17

4Division of Physiotherapy, School of Health and Rehabilitation Sciences, The University of 18

Queensland Brisbane Queensland 4072, Australia 19

Sandra G Brauer, Professor 20

5School of Nursing and Midwifery, Deakin University, 221 Burwood Highway Burwood Victoria 3125, 21

Australia 22

Mari Botti, Professor 23

Patricia M Livingston, Professor; Associate Dean (Research) 24

6School of Public Health, The University of Sydney, New South Wales 2006, Australia 25

Robert G Cumming, Professor 26

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7The George Institute for Global Health, Sydney Medical School, The University of Sydney, New South 27

Wales 2006, Australia 28

Catherine Sherrington, Professorial Research Fellow, Richard I Lindley, Professor 29

8Centre for Health Economics, Monash Business School, Monash University, Clayton, Victoria 3800, 30

Australia 31

Silva Zavarsek, Associate Professor 32

9The Northern Hospital, Northern Health, 185 Cooper Street, Epping, Victoria 3076, Australia 33

Jeannette Kamar, Policy and procedure coordinator 34

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Correspondence to: 35

Anna Barker 36

Monash University, DEPM 37

The Alfred Centre 38

99 Commercial Road 39

Melbourne Vic 3004 40

Email [email protected] 41

Phone +61 3 9903 0946 42

Fax +61 3 9903 0556 43

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ABSTRACT 44

Objective 45

Evaluate the effect of the 6-PACK program on falls and fall injuries in acute wards. 46

Design 47

Cluster randomised controlled trial. 48

Setting 49

Six Australian hospitals. 50

Participants 51

All patients admitted to 24 acute wards during the trial period were included. 52

Interventions 53

Participating wards were randomly assigned to receive either the nurse-led 6-PACK program or usual 54

care over 12-months. The 6-PACK program included a validated fall-risk tool and individualised use of 55

one or more of six interventions: ‘falls alert’ sign; supervision of patients in the bathroom; ensuring 56

patients’ walking aids are within reach; a toileting regime; use of a low-low bed; and use of a bed/chair 57

alarm. 58

Primary and secondary outcome measures 59

The co-primary outcomes were falls and fall injuries per 1,000 occupied bed days. 60

Results 61

During the trial there were 46,245 admissions to 16 medical and 8 surgical wards. As many people were 62

admitted more than once, this represented 31,411 individuals. Patient characteristics and length of stay 63

were similar for intervention and control wards. Use of 6-PACK program components was higher on 64

intervention compared to control wards (incidence rate ratio [IRR] = 3�05, 95% confidence interval 65

[CI], 2�14 to 4.34; P<0�001). There were 1,831 falls and 613 fall injuries, and the rate of falls (IRR = 66

1�04, 95% CI, 0�78 to 1�37; P=0�796) and fall injuries (IRR, 0�96; 95% CI, 0�72 to 1�27; P=0�766) 67

were similar in intervention and control wards. 68

Conclusions 69

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Positive changes in falls prevention practice occurred following the introduction of the 6-PACK 70

program. However, there was no difference in falls or fall injuries between groups. There remains an 71

absence of high-quality evidence showing the effectiveness of falls prevention strategies in acute wards. 72

Novel solutions to the issue of in-hospital falls are urgently required. 73

74

Trial Registration This study is registered with the Australian New Zealand Clinical Trials Registry, 75

number ACTRN12611000332921. 76

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INTRODUCTION 77

Patient falls remain a common cause of harm in acute hospitals worldwide. In the United Kingdom 78

(U.K.) as many as 250,000 falls and more than 1,000 fractures are recorded each year. [1] Recent 79

epidemiological studies provide evidence that the harm from in-hospital falls is increasing. A Danish 80

study that included national hospital data revealed the rate of falls-related major injuries increased more 81

than 3% each year between 2000 and 2012, and more than 11% over the most recent period between 82

2007 and 2012.[2] The operational costs for fallers experiencing serious injury during their hospital stay 83

are higher than for non-fallers, and their length of stay more than six days longer.[3] Consequently, falls 84

prevention best practice guidelines have been developed2,3,20 and in-hospital falls has been adopted as a 85

quality indicator.[4 5] In the U.K. falls are reported under the NHS Patient Safety Thermometer [6]—a 86

local improvement tool for measuring, monitoring and analysing patient harms and 'harm free' care. In 87

the United States (U.S.), there is a financial incentive to prevent falls as hospitals do not receive 88

reimbursement for management of serious injuries resulting from inpatient falls.[7] A recent report on 89

data from 1,381 U.S. hospitals revealed that there has been no significant change in injurious falls 90

following the implementation of the non-payment initiative. This is in contrast to rates of other ‘never 91

events’ such as hospital acquired infections, for which significant declines were reported.[8] 92

Commentary around reasons for the reduction in hospital acquired infections but not falls have 93

highlighted that there is more robust evidence on how to prevent infections.[9] 94

95

There is limited high-quality evidence for effective falls prevention programs in acute hospitals. The 96

most recent Cochrane systematic review concluded that, despite a number of trials, there was limited 97

evidence to support any one intervention and that more trials are needed to confirm the effectiveness 98

of multifactorial interventions in the hospital setting.[10] There is some evidence for effectiveness of 99

prevention programs in rehabilitation hospitals but differences in length of stay, case-mix, care models, 100

staff mix, and environments suggest results may not be generalisable to the acute setting. 101

102

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The 6-PACK program is a targeted nurse-led multifactorial falls prevention program designed 103

specifically for acute wards. It includes a validated nine-item fall-risk tool[11] and six interventions that 104

are reflective of those included in Australian best practice guidelines.[12] A 9-year observational study 105

involving 271,095 patients from one hospital indicated that fall injuries reduced following the 106

implementation of the program.[13] The apparent success of the program may be due to the 107

interventions not being dependent on multidisciplinary input. Nurses are the primary care providers for 108

hospital patients, so are optimally positioned to implement falls prevention activities. Having a single 109

discipline responsible for falls prevention activities may improve accountability for implementation. 110

The ‘FallSafe’ program is another multifactorial nurse-led falls prevention program developed for acute 111

wards. A non-randomised controlled evaluation of FallSafe involving 16 hospitals in the U.K. reported 112

a reduction in falls in the wards that implemented FallSafe and no change in the control wards.[14] 113

114

Whilst these observational studies provide proof of concept for the effectiveness of nurse-led 115

multifactorial programs in acute wards, large-scale randomised trials are needed to provide robust 116

estimates of effect. We therefore conducted a cluster randomised controlled trial (RCT) to evaluate the 117

effect of the 6-PACK program on fall and fall injuries in acute wards. A ward-based approach was 118

undertaken to reduce contamination between groups. Randomisation at the ward level was appropriate 119

as key aspects of the intervention were ward based. 120

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METHODS 121

Design 122

This cluster RCT recruited 24 acute wards from six Australian hospitals. Wards were eligible to 123

participate if they i) were nominated by participating hospitals as being wards where falls commonly 124

occurred, ii) had an average patient length of stay of <10 days, iii) had one or fewer low-low beds to 125

each six standard beds on medical wards and one or fewer low-low beds to each 29 standard beds on 126

surgical wards, and iv) did not include a fall-risk tool and/or intervention checklist on the daily patient 127

care plan documentation. A waiver of individual patient consent was provided by hospital ethics 128

committees enabling all patients on participating wards to be included as trial participants. There were 129

no patient-level exclusion criteria. A detailed description of the study methods is available in the 130

published protocol[15] and trial registration (www.anzctr.org.aunumber ACTRN12611000332921). 131

132

Intervention 133

The 12 intervention wards implemented the 6-PACK program (Appendix 1) over a 12-month period. 134

The 6-PACK program included a validated nine-item fall-risk tool[11] and six interventions: ‘falls alert’ 135

sign; supervision of patients in the bathroom; ensuring patients’ walking aids are within reach; 136

establishment of a toileting regime; use of a low-low bed; and use of a bed/chair alarm. Nurses were 137

asked to update the fall-risk tool for each of their patients each shift and to apply a ‘falls alert’ sign and 138

one or more of the remaining 6-PACK interventions to patients classified as high risk. Selection of 139

interventions for each patient was based on their clinical judgment. Implementation of the program 140

was supported by project change management and program facilitators, a standardised implementation 141

guide, a hospital based site clinical leader and ward champions who conducted staff education and 142

audits, and provided reminders and feedback on the use of program components during the trial period. 143

144

Comparator 145

Control wards were asked to continue with usual care throughout the trial period. Usual care involved 146

falls prevention practices provided by wards as part of existing hospital policy, which may have 147

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included some components of the 6-PACK program and other strategies such as non-slip socks, 148

constant patient observers and falls alert wrist bands. 149

150

Outcome measures 151

Co-primary outcomes were falls and fall injuries per 1,000 occupied bed days (OBD). A fall was 152

defined as ‘an event resulting in a person coming to rest inadvertently on the ground, floor, or other 153

lower level’.[16] A fall injury was defined as any reported physical harm resulting from a fall (including 154

bruising, abrasions, lacerations and fractures).[15] 155

156

Data collection 157

Fall, falls prevention practice and patient demographic data were recorded for a 3 month period prior 158

to the RCT to inform the implementation of the 6-PACK program and provide a baseline reference 159

period to which sample characteristics and outcomes for the 12-month RCT period could be compared. 160

Admitted patients’ demographic characteristics and diagnoses were obtained from hospital 161

administrative datasets. Diagnoses were recorded using the International Classification of Diseases, 162

10th Revision, Australian Modification (ICD-10-AM). Published algorithms were applied to generate 163

Charlson comorbidities from ICD-10-AM diagnoses.[17] Falls data were prospectively collected via 164

daily patient medical record audit and verbal reports from the ward Nurse Unit Manager about falls 165

known to have occurred within the previous 24 hours as well as monthly audit of hospital incident 166

reporting and administrative databases. Radiological investigation reports were reviewed to verify 167

fractures. All recorded falls were reviewed and re-coded (ward, injuries sustained, fall location, time, 168

and activity) by a second independent assessor and disagreements resolved by a third. Process data on 169

risk tool completion and use of the 6-PACK program components was recorded by daily medical 170

record audit and structured bedside observation by trained assessors using a standardised tool during 171

the baseline and RCT period. 172

173

Sample size 174

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The sample size estimate assumed a control ward fall injury rate of 2�8 per 1,000 OBD, an average of 175

8,500 OBD per ward in 12-months and an average cluster (ward) size of 1,000 patient ward admissions, 176

using an intra-class correlation coefficient of 0�001.[18] For 80% power to detect a rate ratio of 0�7 177

between intervention and control wards at the 5% significance level, 12 intervention and 12 control 178

wards were required, assuming a total of 510 fall injuries, from approximately 16,000 patient ward 179

admissions and 212,000 OBD during the trial period.[15] 180

181

Randomisation 182

Wards were paired within hospitals based on type (surgical or medical). One ward from each pair was 183

randomised to receive the intervention or to continue with usual care (control). Where more than two 184

acute wards of the same type (medical or surgical) were available at a hospital (4 wards each at two 185

hospitals), pairing was additionally based on comparable fall injury rates in the 3-months prior to 186

randomisation. The randomisation schedule was developed using a random sequence in blocks of two 187

generated by the study statistician using the RALLOC command in Stata.[19] Allocation concealment 188

was ensured as the schedule was only accessible by the study statistician who was not involved in ward 189

recruitment. 190

191

Blinding 192

As the intervention was nurse-led, blinding of ward nurses and patients was not possible. It was also 193

not possible to blind the assessors collecting the fall and falls prevention practice data. Secondary 194

coding of fall characteristics and injuries was performed by assessors blinded to group allocation and 195

the coding completed by the primary assessor. A statistician blinded to group allocation (RW) 196

performed the data analysis. 197

198

Statistical methods 199

Hospital administrative datasets that contained demographic and diagnosis data were linked to fall data 200

(linking variables: patient identifier, date of hospital admission, and ward name). Descriptive statistics 201

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were used to profile the sample, fall and fall injury rates, and process data on the use of 6-PACK 202

program components (program adherence). To evaluate program efficacy and implementation rates of 203

falls, fall injuries and use of 6-PACK components were compared between the intervention and control 204

groups using mixed effect negative binomial models, with the at-risk time being each ward admission’s 205

length of stay. Primary analyses allowed for pairing of wards by inclusion of a fixed effect for ward type 206

(surgical or medical) and clustering of a ward’s admissions by including a random effect for ward. 207

Secondary analyses included adjustment in the same model framework for the pre-specified variables 208

age and cognitive impairment[15]. Subgroup analysis by ward type was undertaken by including an 209

interaction term between ward type and randomised group in each of the fall and fall injury models. 210

Potential contamination was investigated by examining changes in the use of 6-PACK program 211

components from the baseline to RCT period in the control wards. A significance level of P<0�05 was 212

used to indicate statistical significance and all analysis applied intention to treat principles. Stata MP v13 213

statistical software was used for all analyses. 214

215

Role of the funding source 216

The funders of the study had no role in study design, data collection, data analysis, data interpretation, 217

or writing of the manuscript. A Barker, R Morello and R Wolfe had full access to all the data in the 218

study, and the corresponding author had final responsibility for the decision to submit for publication. 219

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RESULTS 220

No major protocol deviations or unexpected adverse events occurred during the study period. 221

222

Characteristics of the wards and participants 223

This study involved 46,245 ward admissions, from 16 medical and 8 surgical wards. Characteristics of 224

admitted patients and length of stay were similar for intervention and control groups and across 225

baseline and RCT periods (Table 1). There were 31,411 unique patients admitted to the wards including 226

3,853 patients (12�3%) admitted to both an intervention and control ward at different times during the 227

trial period. 228

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Table 1: Characteristics of intervention and control wards and patients 229

Ward admissions

Baseline

n=11,223

Intervention

n=22,670

Control

n=23,575

Ward characteristics

Number of unique admitted patients

8,877

17,698

17,566

Number of medical wards 16 8 8

Number of surgical wards 8 4 4

Ward length of stay in days —median (IQR)

All wards

Medical wards

Surgical wards

4 (2, 6)

4 (2, 7)

3 (2, 6)

4 (2, 7)

4 (2, 7)

3 (2, 6)

4 (2, 6)

4 (2, 7)

3 (2, 5)

Patient characteristics

Age*, y; mean (SD)

63.5 (19�8)

63.9 (20�0)

63.5 (19�7)

Female, n (%) 5,448 (48�5) 11,476 (50�6) 11,424 (48�5)

Emergency admissions, n (%) 8,686 (77�4) 18,415 (81�2) 17,263 (73�2)

Same day hospital admissions, n (%) 229 (2�0) 417 (1�8) 527 (2�2)

Cognitive impairment†, n (%) 756 (6�7) 1,816 (8�0) 1,730 (7�3)

IQR: Interquartile range 230

*Four ward admissions in new-born infants omitted 231

†ICD-10 codes for delirium and dementia: F050, F051, F058, F059, F104, F106, F114, F124, F134, 232

F144, F154, F164, F174, F184, F194, F430, F00-F03, G30, G311, G309 233

234

Eighteen of the 24 wards had a trial period of 12-months (Figure 1). Three ward pairs had an 11-month 235

trial period due to ward closures. 236

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237

*Note, three ward pairs ceased observation at 11 months due to ward closure. 238

Figure 1: Flow of wards and patients through trial 239

24 acute wards in six hospital were

recruited

Cluster randomisation

(n=24 wards, n=46,245

patient ward admissions)

Intervention

(n=12 wards, n=22,670


Control

(n=12 wards,

n=23,575 patient ward

admissions)

6-PACK falls

prevention

program

Loss to follow-up

(n=0)

Total of 141 months*

Baseline data collection

Falls & fall injuries

(3 months)

Usual care

falls

prevention

practices

Excluded (n=0)

Analysed

(n=12 wards, n=22,670


Analysed

(n=12 wards, n=23,575


Allocation

Analysis

Follow-Up Loss to follow-up

(n=0)

Total of 141 months*

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The use of all 6-PACK program components (fall-risk tool and six interventions) was 3-fold higher on 240

intervention compared to control wards (incidence rate ratio [IRR] = 3�05, 95% confidence interval 241

[CI], 2�14 to 4.34; P<0�001). Use of 6-PACK program components increased rapidly on the 242

intervention wards following introduction of the program at the start of the RCT period. No change 243

was observed on the control wards suggesting contamination was unlikely. The higher use of 6-PACK 244

program components was sustained for the 8 months of the RCT period for which implementation 245

data were collected (Figure 2). Budget constraints prevented collection of these data for the last 4 246

months of the RCT period. Use of individual components of the 6-PACK program was higher on the 247

intervention compared to the control wards during the RCT period (Figure 3). 248

249

250

Figure 2: Rate of use of all 6-PACK program components (fall-risk tool and 6 interventions) by 251

month and group 252

0

200

400

600

800

1000

1200

1400

1600

1800

2000

-3 -2 -1 1 2 3 4 5 6 7 8

Baseline RCT

Rate

of

use

of

6-P

AC

K p

rog

ram

co

mp

on

ets

/

1,0

00 o

ccu

pie

d b

ed

days

Month of observation

Control Intervention

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253 Figure 3: Use of 6-PACK program components during RCT period by group 254

255

During the baseline period there were 393 falls and 144 fall injuries recorded for 273 individuals 256

contributing 284 admissions. The rates of falls and fall injuries were 6.45 and 2.36 per 1,000 OBD 257

respectively. 258

259

During the RCT period there were 1,831 falls and 613 fall injuries recorded for 1,247 individuals 260

contributing 1,333 admissions. The fall rate in intervention wards was 7�46 per 1,000 OBD compared 261

with 7�03 per 1,000 OBD in control wards, and the rate of fall injuries was 2�33 and 2�53 per 1,000 262

OBD, respectively. The fall and fall injury rates varied across wards and ward types (Appendix 2). Rates 263

of falls, fall injuries and injurious falls remained stable across the baseline and RCT period for both 264

groups (Figure 4). 265

16

20

5

63

24

106

142

57

171

8

95

165

344

665

0 100 200 300 400 500 600 700

Toileting schedule documented

Need for bathroom supervision documented

Bed/chair alarm observed

Gait aid observed to be in reach

Low-low bed observed

"Falls alert" sign observed

Risk score completed

Rate / 1,000 occupied bed days

Intervention Control

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266

Figure 4: Fall outcomes by month and group 267

268

The rate of falls (IRR = 1�04; 95% confidence interval [CI], 0�78 to 1�37; P=0�796) and fall injuries 269

(IRR = 0�96; 95% CI, 0�72 to 1�27; P=0�766) were similar in intervention and control wards during the 270

RCT period. Consistent results were observed in analyses by ward type (medical or surgical) both in 271

primary unadjusted analyses and secondary analyses adjusted for age and cognitive impairment 272

(Appendix 3). 273

0.00

2.00

4.00

6.00

8.00

10.00

12.00

-3 -2 -1 1 2 3 4 5 6 7 8 9 10 11 12

Baseline RCT

Rate

/ 1

,000 o

ccu

pie

d b

ed

days

Month of observation

Control falls Control fall injuries Control injurious falls

Intervention falls Intervention fall injuries Intervention injurious falls

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DISCUSSION 274

Falls remain a frequent and substantial source of personal harm for older people admitted to acute 275

wards. This study, involving 24 wards from 6 hospitals across Australia, is the largest falls prevention 276

RCT to have been undertaken to date. A rigorous, cluster randomised design was employed with 277

allocation concealment, falls data collection from multiple sources, implementation data collection, 278

blinded outcome assessment and intention to treat analysis. Rates for some wards in this trial 279

approached 18 per 1,000 OBD for falls and 4 per 1,000 OBD for fall injuries. The overall rates for falls 280

and fall injures recorded in this trial are comparable with rates reported in other multi-centre trials[14 281

18]. 282

283

Whilst introduction of the 6-PACK program improved fall-risk tool completion and use of fall 284

prevention strategies recommended by best practice guidelines, no effect on falls or fall injuries was 285

observed. This finding of no effect is consistent with other similar quality studies. The mainstay model 286

of falls prevention practice in acute hospitals is targeted—those most at risk of falling are identified—287

and multifactorial; that is, multiple strategies are implemented to mitigate the risk. This approach is 288

supported by best practice guidelines.[12 20] Yet targeted, multifactorial falls prevention programs have 289

demonstrated little benefit for preventing injuries in RCTs, whether delivered by nurses[21 22] or 290

multidisciplinary teams.[18] Our trial and one other[18] also identified no effect on falls whereas two 291

studies reported falls reduced but not fall injuries.[21 22] Interestingly, studies that used multiple 292

sources to capture falls found null effects[18], whereas those that reported a reduction, relied upon 293

incident reports alone[21 22] suggesting a risk of measurement bias. A recent review that included eight 294

randomised and non-randomised comparative studies in U.S. acute hospitals reported multifactorial 295

interventions had no effect on falls and concluded that further research is required to provide evidence 296

on how hospitals can successfully prevent falls.[23] The findings of this trial support recent 297

recommendations relating to the U.S. non-payment for serious in-hospital fall injuries—policy makers 298

should only implement outcome metrics that have robust evidence on how to improve them. [9] 299

300

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Possible explanations for our finding of no effect include implementation failure, contamination, 301

confounding, and ineffectiveness of the intervention. The results presented provide evidence that the 302

6-PACK implementation strategy was effective at achieving meaningful changes in falls prevention 303

practice and that there was a low risk of contamination. While further exploration of the quality of the 304

program implementation, including appropriateness of intervention delivery is planned, the current 305

analysis indicates implementation was effective. The groups were comparable in key measured factors 306

known to affect falls risk, including age and cognitive impairment, suggesting that confounding due to 307

case-mix variation was also unlikely. While it is possible that confounding due to factors not measured 308

(including staff skill mix, availability of mobility aids, use of benzodiazepines, and complexity of illness) 309

occurred, we had no evidence of this. 310

311

In the absence of evidence of implementation failure, contamination or confounding we conclude that 312

the 6-PACK program was not effective at preventing falls or fall injuries. Reasons for lack of effect 313

may relate to the interventions included in the 6-PACK program. Bathroom supervision and toileting 314

regimes were included as many falls occur in relation to toileting.[24] Positioning patients’ walking aids 315

within reach was intended to improve mobility safety as impaired mobility is a common falls risk 316

factor.[24] Cognitive impairment is another important falls risk factor.[24] Bed/chair alarms were 317

included to reduce the likelihood of patients with cognitive impairment moving from a bed or chair 318

without staff assistance, and low-low beds were believed to be an effective strategy for reducing the 319

likelihood of injury in patients with cognitive impairment who may attempt to get out of bed 320

independently. Whilst an observational study indicated low-low beds may reduce fall injuries[25], a 321

larger RCT reported no effect.[26] Recent trials have also cast doubt on the effectiveness of bed/chair 322

alarms.[27 28] Falls prevention programs may need a greater focus on preventing delirium, which was 323

not specifically addressed in the 6-PACK program. The successful FallSafe program included urinalysis 324

screening and reducing night-time sedation to address delirium.[14] 325

326

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Whilst the interventions included in the 6-PACK hold face validity, they may lack potency to effectively 327

mitigate risk of falls and injury. The findings of a recent meta-analysis support the concept of a lack of 328

potency of multifactorial falls prevention approaches—assuming a rate of 8 falls per 1,000 OBD, the 329

number needed to treat to prevent a single inpatient fall is 1,250 patient days[29]. This represents one 330

fall prevented every 6 weeks in a standard 30 bed ward and assumes a small treatment effect of 0.9 331

(odds ratio) generated from pooled effects of 5 non-randomised clinical trials and 1 RCT. Potency may 332

be limited by a reliance on behaviour change both from the nurses and the patients. 333

334

Strategies such as providing assistance in the bathroom to those who require it, toileting schedules, and 335

ensuring a gait aid is in reach represent basic care for older patients and should not be discontinued. 336

However, there is an absence of evidence that these strategies prevent falls or associated harm. There is 337

no evidence to support use of low-low beds, bed/chair alarms, “falls alert” signs or fall-risk tools, so 338

the use of these strategies must be questioned in an environment that is time and resource poor with 339

many competing priorities. Innovative approaches, such as ward redesign or intelligent sensor 340

systems[30] to improve observation of high falls risk patients, floor coverings to decrease injury risk, or 341

a whole of system approach to patient safety and care of older vulnerable people that are acutely unwell 342

may offer new solutions. 343

344

Study limitations warrant consideration. Importantly, ward sampling was done at convenience. The 345

participating wards may therefore not be representative of the broader population of acute wards in 346

Australia or internationally. The assessment of cognitive impairment was based on ICD-10 codes 347

recorded in routine hospital datasets, which may have been under-coded. Whilst we used multiple data 348

sources to identify primary outcomes, it may be possible that falls and fall injuries were reported more 349

on intervention wards due to increased awareness of falls with 6-PACK implementation. However, 350

there was no significant change in falls outcome reporting between baseline and intervention periods. 351

Similarly, although process data on the use of 6-PACK strategies was recorded by assessors who were 352

aware of group allocation, rates of 6-PACK component use in control wards were comparable across 353

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the baseline period prior to wards being randomised, and group allocation being revealed, and the RCT 354

period where ward allocation was known. Therefore, we consider that there was a low risk of reporting 355

or detection bias in this study. All fall events were also double coded (event meets fall definition, 356

injuries sustained, ward and fall characteristics) by a second assessor who was blind to the ward 357

allocation and the codes assigned by the first assessor to minimise reporting bias. 358

359

Falls are complex; they are unfortunate events that result from myriad interactions between 360

physiological, behavioural and environmental factors. Indeed, each individual has unique risk factors, 361

risk profile, and responsiveness to prevention strategies. People at risk of falling in the acute setting are 362

no exception. They are usually acutely unwell, with multiple comorbidities, and taking a number of 363

medications. For some, their hospitalisation may represent a cascading deterioration in health and 364

function and a point along the pathway to residential aged care. Safe and effective patient care is 365

dependent not only on the knowledge, skills and behaviours of clinical staff, but also the cultural and 366

physical environment, availability of resources, and the policies, incentives and penalties that govern 367

and drive practice. In-hospital falls therefore represent a complex problem, affecting individuals with 368

complex care needs in the environment of a complex system. 369

370

In conclusion, use of the 6-PACK falls prevention program had no effect on falls or fall injuries in the 371

12 acute intervention wards that participated in this trial. Whilst the substantial harm and negative 372

sequelae of inpatient falls is unquestionable, there remains an absence of high-quality evidence showing 373

the effectiveness of preventative strategies for falls in acute wards. There is no RCT evidence to 374

support the effectiveness of any single falls prevention strategy either currently being used in practice in 375

acute wards or recommended by practice guidelines or accreditation standards. There is also an absence 376

of epidemiological data to support that the increased focus on falls prevention in hospitals via 377

introduction of guidelines, accreditation standards and quality improvement initiatives has had any 378

impact on falls or their sequelae. System level and/or environmental interventions may offer improved 379

potency and effectiveness and warrant further investigation. 380

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381

Data sharing statement 382

A full dataset that includes patient level data, technical appendix and statistical code are available on 383

reasonable request from the corresponding author. Individual patient consent was not obtained but the 384

presented data are anonymised and risk of identification is low. 385

386

Transparency statement 387

The lead author (AB) affirms that the manuscript is an honest, accurate, and transparent account of the 388

study being reported; no important aspects of the study have been omitted; and that any discrepancies 389

from the study as planned (and, if relevant, registered) have been explained. 390

391

Contributors 392

AB led the conception, design and application for funding of the project in conjunction with CB, TH, 393

KH, SB, MB, RC, PL, CS and SZ. AB, RM, JK, CB, TH, KH, SB, MB, RC, PL, CS and SZ participated 394

in the steering committee and project governance. RL was a study site investigator. AB led the drafting 395

all sections of this manuscript except the results in consultation with all of the co-authors. RM managed 396

the collection and verification of data and led the drafting of the results section of this manuscript. RW 397

was responsible for the analysis and interpretation of data. All authors reviewed and revised the 398

manuscript critically for important intellectual content. 399

400

Competing interest statement 401

We declare that we have no competing interests or conflicts of interest with this research. 402

403

Acknowledgements 404

We acknowledge the contribution of Sheral Rifat and Darshini Ayton in the preparation of this article, 405

the Injury Prevention Unit, The Northern Hospital, Northern Health, Melbourne, Australia who 406

developed the 6-PACK Program and the late Damien Jolley who provided substantial input to the 407

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design of the 6-PACK project. The study could not have been completed without the collaboration and 408

support from the participating hospitals, site clinical leaders and nursing staff. This project was funded 409

by the National Health and Medical Research Council (NHMRC), Australia (APP 1007627). A Barker’s 410

salary was funded by a Career Development Fellowship from the NHMRC (APP1067236). R Morello’s 411

salary was supported by a post graduate scholarship from the NHMRC (APP1055604). T Haines’ salary 412

was funded by a Career Development Fellowship from the NHMRC (APP1069758).C Sherrington’s 413

salary was funded by a Career Development Fellowship from the NHMRC (APP632929). 414

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Appendix 1: Intervention description (as per CONSORT extension Template for Intervention 504

Description and Replication guidelines)† 505

Item 1: Brief Name

The nurse-led 6-PACK program for reducing falls and fall related injuries in acute hospitals.

Item 2: Why?

Rationale, theory, or goal of the elements essential to the intervention

There is limited high-level evidence to support the effectiveness of multifactorial falls prevention

programs in the acute hospital setting. This RCT aimed to provide robust information on the

effectiveness of a targeted, multifactorial, nurse-led falls prevention program. Best practice guidelines

recommend the use of targeted multifactorial programs. Nurse-led program as nurses are the primary

care providers for hospital patients so are optimally positioned to implement falls prevention activities.

Having a single discipline responsible for the primary delivery of a falls prevention program may

improve accountability for implementation. The program components were added to the existing

patient care plan to ensure the program activities were integrated into nurse workflow.

Item 2: What (materials)?

Physical and informational materials used in the intervention

The 6-PACK program includes a validated nine-item fall-risk tool (TNH-STRATIFY)[11] and options

for six 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. Hospitals provided intervention wards with ‘falls alert’ signs, low-low beds (a

minimum of 1 low-low to 3 standard beds on medical wards and 1 low-low to 10 standard beds on

surgical wards), and bed/chair alarms (three on medical wards and one on surgical wards). A low-low

bed was defined as a standard hospital bed that could be lowered to 250mm from the floor or lower.

Risk scores and interventions applied to patients were recorded on a 6-PACK patient care plan and

reviewed and updated each shift.

Item 4. What (procedures)?

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Procedures, activities, and/or processes used in the intervention, including any enabling or

support activities

The 6-PACK program was implemented by nurses on the intervention wards. A hospital-nominated

site clinical leader and ward-nominated champions oversaw the implementation of the 6-PACK

program on intervention wards. Champions and site clinical leaders met regularly to discuss the

assimilation of the 6-PACK on their ward, undertake ‘ward walk-rounds’ that included practice audits

and reminders, and review fall and implementation data provided by the research team. Site clinical

leaders were supported by a change management and program facilitator employed by the project via

telephone, email and site visits on a needs basis. Monthly meetings with the site clinical leaders from

each hospital, change management and program facilitators and the research lead also occurred.

Item 5. Who provided?

Expertise, background and any specific training given to each category of intervention

provider

Site clinical leaders were registered nurses with varying levels of experience in education and falls

prevention. They participated in a one day training session delivered by the change management and

program facilitator, and the research lead. Site clincal leaders trained the champions and intervention

ward nurses using a standardised 6-PACK implementation guide. Ward nurses included registered

nurses (bachelor degree qualified) and assistants in nursing (technical college training). The change

management facilitator was a health professional experienced in health service evaluation, project

management and communication. The program facilitator was a registered nurse who designed,

implemented and maintained the 6-PACK program at The Northern Hospital over a 10 year period

prior to commencement of this study.

Item 6. How?

Modes of delivery (such as face to face or by some other mechanism, such as internet or

telephone) of the intervention and whether it was provided individually or in a group

The 6-PACKprogram was integrated into daily care activities and delivered to individual patients by

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their treating nurse without provision of additional staffing resources.

Item 7. Where?

The type(s) of location(s) where the intervention occurred, including any necessary

infrastructure or relevant features

The 6-PACK programwas delivered on the 12 participating intervention acute wards, in six public

hospitals. Hospital 1 was a regional teaching hospital with 221 acute beds, hospital 2 was a metropolitan

University teaching hospital with 420 beds, hospitals 3, 5 and 6 were metropolitan teaching hospitals of

moderate size (200-500 beds) and hospital 4 was a metropolitan University teaching and major referral

centre (>500 beds).

Item 8. When and how much?

The number of times the intervention was delivered and over what period of time including the

number of sessions, their schedule, and their duration, intensity or dose

The 6-PACK program was delivered over the 12-month trial period. The patients’ treating nurse

completed/updated the fall-risk tool for each patient each shift. For patients classified as high risk,

nurses were required to select, record and apply a ‘falls alert’ sign and a minimum of one additional 6-

PACK intervention as they deemed appropriate during the patient ward admission.

Item 9. Tailoring

If the intervention was planned to be personalized, titrated or adapted, then describe what,

why, when, and how

The 6-PACK interventions applied to each patient were personalized based on the fall-risk tool

findings and clinical judgment of their treating nurse.

Item 10. Modifications

If the intervention was modified during the course of the study, describe the changes (what,

why, when, and how)

Due to local hospital policies and equipment purchasing procedures different models of low-low beds

and bed/chair alarms were used across intervention wards.

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Item 11. How well (planned)?

If intervention adherence or fidelity was assessed, describe how and by whom, and if any

strategies were used to maintain or improve fidelity, describe them

Intervention adherence was assessed via daily medical record audit and structured bedside observation

by project-employed data collectors for all patients admitted to the intervention wards during the study

period. A report of these data, including implementation league tables that ranked wards’ level of

adherence to the 6-PACK program components, were provided to the site clinical leaders each month

during the RCT. The site clinical leaders were expected to communicate this information to the

champions, ward nurses and ward Nurse Unit Manager.

506

† Hoffmann TC GP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, 507

Johnston M, Lamb SE, Dixon-Woods M, McCulloch P, Wyatt JC, Chan AW, Michie S. Better 508

reporting of interventions: template for intervention description and replication (TIDieR) checklist and 509

guide. Bmj. 2014;348(Mar 7):g1687.510

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Confidential: For Review Only31

Appendix 2: Supplementary outcome measures by ward for the cluster RCT period 511

Medical wards Surgical wards

Ho

spit

al 1

Ho

spit

al 2

Ho

spit

al 3

Ho

spit

al 3

Ho

spit

al 4

Ho

spit

al 5

Ho

spit

al 6

Ho

spit

al 6

To

tal

Ho

spit

al 1

Ho

spit

al 2

Ho

spit

al 3

Ho

spit

al 4

To

tal

Inte

rven

tio

n

Number of ward admissions 1,833 1,844 2,098 2,265 1,649 1,117 2,429 1,461 14,696 2,018 1,562 3,244 1,150 7,974

Ward LOS; median 4 4 4 4 6 7 3 3 4 3 5 3 6 3

Falls per 1,000 OBD 11�3 5�2 9�1 6.6 3�1 12�6 12.1 17.4 9�2 4•0 4•2 2•4 5•1 3�9

Fall injuries per 1,000 OBD 3�5 2�0 3�7 2�2 2�2 3�0 2�7 2.9 2�9 1•0 1•0 1•3 1•6 1�2

Injurious falls per 1,000 OBD 2�6 1�3 2�2 1�5 1�2 2�2 3.7 2�2 1.9 0•6 0•6 0•8 1•0 0�8

Fractures per 1,000 OBD 0.1 0.1 0.2 0.1 0.2 0.0 0.1 0.1 0.1 0.0 0.0 0.1 0.2 0.1

Co

ntr

ol

Number of ward admissions 1,548 1,398 2,001 3,088 1,547 1,103 1,365 2,000 14,050 2,520 2,348 2,590 2,067 9,525

Ward LOS; median 5 6 4 3 5 6 4 4 4 3 3 3 4 3

Falls per 1,000 OBD 15�1 6�2 7�4 6�3 6�8 11�5 9�3 9.0 8�8 4�8 2�7 3�0 4�2 3�6

Fall injuries per 1,000 OBD 4�8 3�9 2�3 1�5 3�0 5�5 2�8 2�9 3�3 0�6 0�7 0�6 2�1 1�0

Injurious falls per 1,000 OBD 4�2 2�3 1�8 1�0 2�2 3�6 2�2 1�8 2�4 0�5 0�6 0�6 1�2 0�8

Fractures per 1,000 OBD 0.2 0.1 0.1 0.1 0.2 0.4 0.1 0.1 0.2 0.1 0.0 0.0 0.0 0.0

LOS=Length of stay OBD=Occupied bed days 512

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Confidential: For Review Only32

Appendix 3: Incidence rate ratios for falls and fall injuries by ward type‡ 513

Unadjusted Adjusted for age and cognitive impairment

Incidence rate ratio

(Intervention/Control)

P value Interaction P

value†

Incidence rate ratio

(Intervention/Control)

P value Interaction P

value

Falls

All wards 1�04 (0�78 to 1�37) 0�796 1�02 (0�79 to 1�31) 0�888

Medical wards 1�01 (0�70 to 1�48) 0�946 0.98 (0�70 to 1�37) 0�895

Surgical wards 1�08 (0�79 to 1�49) 0�615 0�929 1�11 (0�79 to 1�55) 0�537 0�888

Fall injuries

All wards 0�96 (0�72 to 1�27) 0�766 0�98 (0�70 to 1�39) 0�927

Medical wards 0�89 (0�65 to 1�22) 0�453 0�87 (0�67 to 1�13) 0�286

Surgical wards 1�22 (0�66 to 2�25) 0�533 0�464 1�45 (0�75 to 2�81) 0�269 0�328

Injurious falls

All wards 0�89 (0�66 to 1�18) 0�405 0�86 (0�65 to 1�14) 0�304

Medical wards 0�85 (0�60 to 1�20) 0�358 0�81 (0�59 to 1�11) 0�189

Surgical wards NA 0�321 1�09 (0�63 to 1�89) 0�764 0�177

NA – results not available; non-convergence of model due to limited data for estimating between-ward variability in outcome rate 514

† The interaction p-value tests whether the treatment effect (intervention v control) is different between surgical and medical wards 515

‡The intra-class correlation coefficient (ICC), was 0�007 for rate of falls (95% CI: 0�002-0�011) and 0�002 for rate of fall injuries (95% CI: 0�001-0�004) 516

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Confidential: For Review Only - BMJ · 2016. 1. 28. · Confidential: For Review Only 1 1 The 6-PACK program to decrease fall injuries in acute hospitals: A cluster randomised 2 controlled