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Trial registered on ANZCTR


Registration number
ACTRN12611000332921
Ethics application status
Approved
Date submitted
21/03/2011
Date registered
29/03/2011
Date last updated
11/01/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
The 6-PACK program to decrease fall-related injuries in acute hospitals - measuring effectiveness, potential cost savings and capacity to be a long term solution.
Scientific title
Falls prevention in the acute hospital setting: a multi-centre cluster randomised controlled trial of efficacy, cost effectiveness and sustainability of the 6-PACK program.
Secondary ID [1] 253445 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
In hospital falls and fall-related injuries 260993 0
Condition category
Condition code
Injuries and Accidents 259125 259125 0 0
Fractures
Injuries and Accidents 259126 259126 0 0
Other injuries and accidents
Public Health 259395 259395 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 257886 0
Prevention
Intervention code [2] 258109 0
Behaviour
Comparator / control treatment
Usual patient care.

Usual care practice will be defined as any standard hospital practice provided by wards as part of existing hospital policy relating to falls prevention. Commonly used ‘usual care’ falls prevention practice involves the promotion of a targeted and multifactorial falls prevention model, which is supported by best practice guidelines. These models promote a risk assessment on admission and more than 20 interventions.
Control group
Active

Outcomes
Primary outcome [1] 261979 0
Rate of fall-related injuries per 1000 occupied bed days

Data for this primary outcome will include daily medical record audit and nurse verbal report, audit of hospital administrative and incident reporting databases. Data from these sources will be triangulated to ensure optimum capture of fall events.
Timepoint [1] 261979 0
During the 12 month period following 6-PACK implementation
Primary outcome [2] 261980 0
Rate of falls per 1000 occupied bed days

Data for this primary outcome will include daily medical record audit and nurse verbal report, audit of hospital administrative and incident reporting databases. Data from these sources will be triangulated to ensure optimum capture of fall events.
Timepoint [2] 261980 0
During the 12 month period following 6-PACK implementation
Secondary outcome [1] 268910 0
Cost or saving per fall-related injury prevented, using a hospital perspective

This will be measured by calculating the differences in the mean costs and effects in the intervention and control groups to generate an incremental cost-effectiveness ratio
Timepoint [1] 268910 0
During the 12 month period following 6-PACK implementation
Secondary outcome [2] 268911 0
Cost or saving per fall prevented, using a hospital perspective

This will be measured by calculating the differences in the mean costs and effects in the intervention and control groups to generate an incremental cost-effectiveness ratio
Timepoint [2] 268911 0
During the 12 month period following 6-PACK implementation
Secondary outcome [3] 273011 0
Rate of fall-related injuries per 1000 occupied bed day

Data for this secondary outcome will be collected in two stages:
1. As above for the primary outcome 1 for the period of 0-12 months
2. Audit of hospital administrative database and incident reporting database.
Timepoint [3] 273011 0
During the 24 month period following 6-PACK implementation
Secondary outcome [4] 273223 0
Rate of falls per 1000 occupied bed day

Data for this secondary outcome will be collected in two stages:
1. As above for the primary outcome 1 for the period of 0-12 months
2. Audit of hospital administrative database and incident reporting database.
Timepoint [4] 273223 0
During the 24 month period following 6-PACK implementation
Secondary outcome [5] 273224 0
Intervention compliance, to measure if the program was implemented as planned

(proportion of high falls risk patients that received one or more falls prevention interventions)

Methods used for assessment of this outcome will include daily medical record audit and structured observation.
Timepoint [5] 273224 0
During the 12 month period following 6-PACK implementation
Secondary outcome [6] 273225 0
Patient safety culture as measured by the Safety Attitudes Questionnaire (SAQ)
Timepoint [6] 273225 0
Baseline, 12 months post 6-PACK implementation
Secondary outcome [7] 273335 0
Knowledge, attitudes and beliefs of hospital staff to fall prevention

Methods used for assessment of this outcome will include a structured and pre-piloted staff survey, and semi-structured focus groups and key informant interviews.
Timepoint [7] 273335 0
Baseline, 6 months and 12 months post 6-PACK implementation
Secondary outcome [8] 273336 0
Staff satisfaction with 6-PACK falls prevention program

Methods used for assessment of this outcome will include a structured and pre-piloted staff survey.
Timepoint [8] 273336 0
12 months post 6-PACK implementation

Eligibility
Key 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.
Minimum age
0 Years
Maximum age
125 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any detail contradicting the above inclusion criteria.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Hospitals will be identified via: 1. State based falls prevention networks, 2. Hospitals where members of the investigator team hold conjoint appointments, and 3. Expressions of interests logged with the project team. Following informal discussions and interest in participating in the study have been established, hospitals will be invited to participate in the study. We expect to formally recruit six to eight hospitals from which a total of 24 wards will be randomised. Hospitals that agree to participate in this project will be required to provide extract reports from hospital administrative databases and ensure access to 6-PACK equipment and staffing.

Pairs of wards from each hospital will be matched by type and fall-related injury rates using six months baseline observation data. A blinded statistician using computer generated randomisation methods will then allocate pairs of matched wards to either intervention or control group, to ensure allocation concealment.

All patients admitted to the 24 study wards during the cluster RCT study period will be included in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Wards within each pair will be randomly allocated to control or intervention arm using a web-based allocation generated by the program nQuery Advisor (http://www.statistical-solutions-software.com) to generate random numbers and allocations.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
It will not be feasible to blind ward nurses or patients to the intervention. In order to reduce observer bias, randomisation and analysis of the primary outcome will be assessed by a statistician who will be blind to group allocation. In addition an assessor, blinded to group allocation, will classify all fall-related injuries (none, mild, moderate, major) according to the predefined criteria. A mixed methods study will be conducted to examine the barriers and enablers to successful implementation and sustainability of the 6-PACK falls prevention program. This will involve both qualitative and quantitative methods. An incremental cost-effectiveness study will be conducted to determine the cost or savings per fall or fall-related injury prevented.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258366 0
Government body
Name [1] 258366 0
National Health & Medical Research Council
Address [1] 258366 0
PO BOX 1421
Canberra ACT 2601
Country [1] 258366 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Department of Epidemiology & Preventive Medicine
The Alfred Centre
Level 6
99 Commercial Road
Melbourne
Victoria 3000
Country
Australia
Secondary sponsor category [1] 257705 0
None
Name [1] 257705 0
Address [1] 257705 0
Country [1] 257705 0
Other collaborator category [1] 251829 0
Hospital
Name [1] 251829 0
The Northern Hospital
Address [1] 251829 0
185 Cooper St
Epping
Victoria 3076
Country [1] 251829 0
Australia
Other collaborator category [2] 251830 0
University
Name [2] 251830 0
La Trobe University
Address [2] 251830 0
School of Physiotherapy
La Trobe University
Bundoora
Victoria 3086
Country [2] 251830 0
Australia
Other collaborator category [3] 251831 0
University
Name [3] 251831 0
The University of Queensland
Address [3] 251831 0
Division of Physiotherapy, School of Health and Rehabilitation Sciences
The University of Queensland
Brisbane
Queensland 4000
Country [3] 251831 0
Australia
Other collaborator category [4] 251832 0
University
Name [4] 251832 0
Deakin University
Address [4] 251832 0
School of Nursing and Midwifery Deakin University Burwood Victoria 3125
Country [4] 251832 0
Australia
Other collaborator category [5] 251863 0
University
Name [5] 251863 0
The Univeristy of Sydney
Address [5] 251863 0
Sydney Medical School
The University of Sydney
Sydney
NSW 2006
Country [5] 251863 0
Australia
Other collaborator category [6] 251901 0
University
Name [6] 251901 0
Monash University
Address [6] 251901 0
Physiotherapy Department, Monash University & Allied Health Research Unit, Southern Health
Monash University
Frankston
Victoria 3199
Country [6] 251901 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260335 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 260335 0
First Floor, Building 3e
Monash Research Office
Clayton Campus
Monash University VIC 3800
Ethics committee country [1] 260335 0
Australia
Date submitted for ethics approval [1] 260335 0
22/12/2010
Approval date [1] 260335 0
31/03/2011
Ethics approval number [1] 260335 0
CF11/0229 - 2011000072

Summary
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.
Trial website
www.falls6pack.monash.org
Trial related presentations / publications
TBC
Public notes

Contacts
Principal investigator
Name 32112 0
Address 32112 0
Country 32112 0
Phone 32112 0
Fax 32112 0
Email 32112 0
Contact person for public queries
Name 15359 0
Ms Renata Morello
Address 15359 0
Department of Epidemiology & Preventive Medicine
Monash University
Level 6
The Alfred Centre
99 Commerical Road
Melbourne VIC 3000
Country 15359 0
Australia
Phone 15359 0
+61 3 9903 0923
Fax 15359 0
Email 15359 0
Renata.Morello@monash.edu
Contact person for scientific queries
Name 6287 0
Dr Anna Barker
Address 6287 0
Department of Epidemiology & Preventive Medicine
Monash University
Level 6
The Alfred Centre
99 Commerical Road
Melbourne VIC 3000
Country 6287 0
Australia
Phone 6287 0
+61 3 9903 0946
Fax 6287 0
Email 6287 0
Anna.Barker@monash.edu

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary