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Trial registered on ANZCTR
Registration number
ACTRN12617001618347
Ethics application status
Approved
Date submitted
3/11/2017
Date registered
11/12/2017
Date last updated
11/12/2017
Type of registration
Retrospectively registered
Titles & IDs
Public title
Educational program for nursing staff on management of resident-to-resident elder mistreatment (R-REM)
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Scientific title
Implementation and evaluation of an education program for nursing staff on recognizing, reporting, managing and preventing resident-to-resident elder mistreatment (R-REM) in residential aged care
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Secondary ID [1]
293269
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None
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Universal Trial Number (UTN)
U1111-1204-6095
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Trial acronym
R-REM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Resident-to-resident elder mistreatment (R-REM)
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Condition category
Condition code
Public Health
304622
304622
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0
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Health promotion/education
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The principal investigator will deliver the educational sessions. She has extensive experience teaching at La Trobe University and working in the research area of ageing and aged care.
The educational sessions consist of i) session 1; recognising resident to resident elder mistreatment (R-REM), ii) session 2: management R-REM by using the SEARCH (Support, Evaluate, Act, Report, Care Plan, Help to Avoid) approach and iii) session 3: implementation of R-REM guidelines. The materials (power point presentations and videos) and data collection tools (questionnaires, evaluation form and note pads) have been developed, validated and implemented in previous studies with the participation/collaboration of the principal investigator (Teresi, J. A., Ramirez, M., Ellis, J., et al. (2013). A staff intervention targeting resident-to-resident elder mistreatment (R-REM) in long-term care increased staff knowledge, recognition and reporting: results from a cluster randomized trial. International Journal of Nursing Studies, 50(5), 644-656. doi:10.1016/j.ijnurstu.2012.10.010; Teresi, J. A., OcepekWelikson, K., Ramirez, M., et al. (2014). Development of an instrument to measure staff-reported resident-to-resident elder mistreatment (R-REM) using item response theory and other latent variable models. Gerontologist, 54(3), 460-472. doi:10.1093/geront/gnt001; Ellis, J. M., Teresi, J. A., Ramirez, , et al. (2014). Managing resident-to-resident elder mistreatment in nursing homes: the SEARCH approach. J Contin Educ Nurs, 45(3), 112-121; quiz 122-113. doi:10.3928/00220124-20140223-01).
These educational sessions will be delivered face to face, in small groups of nurses in the Educational Building at Bundoora Extended Care Centre (BECC). Power point presentations, videos and data collection tools will be used during the sessions. Participants will report the incidents of R-REM by using note pads.
Below is a brief description of the procedures/activities of this project:
1. All nurse participants (the control and intervention group) will record the incidents of R-REM for a period of 4 weeks by using the notepads.
2. For the intervention group:
2.1 Following this 4 weeks, there will be three educational sessions. These three sessions will be delivered face to face for approximately 45 minutes in a single class. It could be also possible to divide these three sessions into two classes, taking approximately 30 minutes for the first part (session 1 and 2) and 15 minutes for the second part (session 3) and they will be delivered within 1 week. The latter possibility can be done considering the availability of time of the nursing staff.
2.2 Participants will fill out questionnaires before and after the educational sessions, and an evaluation of the education program after the last educational session.
2.3 After the last educational program, the participants will record again incidents of R-REM for a period of 4 weeks by using the notepads
3. For the control group
3.1 The educational sessions will be delivered at the end of the research project.
4. All participants (the control and intervention group) will be asked to complete an evaluation of the implementation of the R-REM activities at 1 months and 3 months after the last educational session.
The intervention adherence or fidelity will be maintain/encourage by the following strategies:
i) A general email from the Operations Director and Deputy Director of Nursing, of Bundoora Extended Care Centre (Northern Health) to all staff (those who participate and those who do not) working at BECC telling about this research. She will be also sending weekly emails to the nurse unit managers to remind them about the research, and to mention it during the hand-over.
ii) Friendly reminder messages about the research from the nurse unit managers (of each ward) to the nursing staff (of each ward). This will be mainly performed in the hand-over or in other meetings (if possible) during the study period.
iii) The principal investigator and/or the research officer will be coming to the setting every fortnight. They will speak about the research during the afternoon hand-over. This will remind all staff, including the nurse unit managers about the research.
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Intervention code [1]
299527
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Behaviour
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Intervention code [2]
299683
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Prevention
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Comparator / control treatment
This is a cluster clinical trial and the wards were randomized. The intervention group consists of participants who consent to participate and work in the wards (BECC), which were randomly selected to receive the intervention.
The control group consists of participants who consent to participate and work in the wards (BECC), which were randomly selected to not receive the intervention (educational sessions). They will continue with the standard care as usual. The control group will receive the educational sessions after the end of the project (approximately 4-week after the intervention period).
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Control group
Active
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Outcomes
Primary outcome [1]
303854
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Knowledge of recognizing R-REM assessed by pre-test and post-test questionnaires.
The name of the questionnaire is "Knowledge of recognizing R-REM".
This questionnaire was validated and used in a previous study (Teresi, J. A., Ramirez, M., Ellis, J., et al. (2013). A staff intervention targeting resident-to-resident elder mistreatment (R-REM) in long-term care increased staff knowledge, recognition and reporting: results from a cluster randomized trial. International Journal of Nursing Studies, 50(5), 644-656. doi:10.1016/j.ijnurstu.2012.10.010 )
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Assessment method [1]
303854
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Timepoint [1]
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Before and after (immediately at completion) the educational session 1 of recognising resident to resident elder mistreatment (R-REM).
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Primary outcome [2]
303937
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Knowledge of the SEARCH approach to managing R-REM assessed by pre-test and post-test questionnaires.
The name of the questionnaire is "Knowledge of the SEARCH approach to managing R-REM".
This questionnaire was validated and used in a previous study (Teresi, J. A., Ramirez, M., Ellis, J., et al. (2013). A staff intervention targeting resident-to-resident elder mistreatment (R-REM) in long-term care increased staff knowledge, recognition and reporting: results from a cluster randomized trial. International Journal of Nursing Studies, 50(5), 644-656. doi:10.1016/j.ijnurstu.2012.10.010
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Assessment method [2]
303937
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Timepoint [2]
303937
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Before and after (immediately at completion) the educational session 2 of management R-REM by using the SEARCH (Support, Evaluate, Act, Report, Care Plan, Help to Avoid) approach.
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Secondary outcome [1]
340278
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Implementation of the SEARCH approach to managing R-REM by recording R-REM incidents using the note pads.
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Assessment method [1]
340278
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Timepoint [1]
340278
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Four weeks prior to the education session and for 4 weeks after the education session.
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Eligibility
Key inclusion criteria
1. Participants will be RNs and ENs working at a residential aged care
2. Staff working during day, evening and night shifts.
3. They can be working part-time or full time.
4. Written informed consent
5. Age greater than or equal to 18 years old.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
1. Other health care professionals working at the residential aged care, such as doctors, therapists, personal care workers, etc.
2. RNs and ENs who do not provide written informed consent.
3. Students.
4. Older residents and/or their relatives.
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Study design
Purpose of the study
Educational / counselling / training
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
Regarding enhanced staff knowledge related to R-REM, data from pre and post education programs will be analysed using descriptive statistics, including frequencies and Chi-squared for individual items and paired t-tests of mean scores. Analysis will include testing for normality of assumptions.
Regarding enhanced R-REM recognition and reporting implementation: data will be examined by evaluating the differences between baseline staff reports of R-REM collected and follow-up R-REM. Chi-square analysis will be used to compare if there is any difference in R-REM behaviour between pre and post session. ANOVA will be used to identify the difference in the number of reported R-REM incidents. Analysis will include testing for normality of assumptions. Analysis of data will be undertaken using IBM SPSS 23.
Information from the open-ended questions on the Evaluation forms will be analysed using content analysis approach to classify the participants’ responses into codes, lists of categories and groups (main categories). These main categories will be quantified for descriptive data analysis.
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
18/09/2017
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Date of last participant enrolment
Anticipated
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Actual
29/09/2017
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Date of last data collection
Anticipated
15/12/2017
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Actual
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Sample size
Target
65
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Accrual to date
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Final
66
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
9335
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Bundoora Extended Care Centre - Bundoora
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Recruitment postcode(s) [1]
18005
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3083 - Bundoora
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Funding & Sponsors
Funding source category [1]
297897
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Charities/Societies/Foundations
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Name [1]
297897
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The Nurses Board Victoria Legacy Limited
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Address [1]
297897
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NBVLL Secretariat
PO Box 327
Wendouree VIC 3355
Melbourne, Australia
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Country [1]
297897
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Australia
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Primary sponsor type
University
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Name
La Trobe University
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Address
Plenty Road & Kingsbury Drive, Bundoora VIC 3086
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Country
Australia
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Secondary sponsor category [1]
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Hospital
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Name [1]
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Northern Health (Bundoora Extebded Care Centre)
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Address [1]
296950
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1231 Plenty Road Bundoora, 3083
Melbourne
Victoria
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Country [1]
296950
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
298946
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Austin Health Human Research Ethics
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Ethics committee address [1]
298946
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Research Ethics
Office for Research
Level 8, Harold Stokes Building
Austin Health
PO Box 5555
Heidelberg
Victoria 3084
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Ethics committee country [1]
298946
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Australia
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Date submitted for ethics approval [1]
298946
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30/05/2017
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Approval date [1]
298946
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17/08/2017
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Ethics approval number [1]
298946
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LNR/17/Austin/174
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Summary
Brief summary
Although previous studies on aggressive and disruptive behaviours in residential aged care homes (RACHs) suggests that these types of incidents are common, aggressive interactions between residents has received little attention in the research literature. These incidents between residents are referred to as resident-to-resident elder mistreatment (R-REM). RACHs house the frailest of older people, and even small injuries can have major negative consequences. Therefore, it is important to protect older residents from R-REM and nurses should play an essential role in identifying and managing R-REM to prevent serious harm. However, many nurses may not recognise these behaviours as forms of abuse. Thus, the aim of this study is to implement and evaluate an education program for nursing staff caring for older people on recognizing, reporting, managing and preventing R-REM.
This is a Cluster Controlled Trial. There will be a control group and an intervention group. Firstly, participants will document, on small note pads provided, incidents of R-REM that occur during all shifts worked for a four-week period. After that, the intervention group will attend three educational sessions of approximately 45 minutes duration that will be held in the Education building at BECC. They will also complete a short questionnaire before and after each educational session and an evaluation after the last educational session. Following the educational sessions, the intervention group will again document, on small note pads provided, all incidents of R-REM for a four-week period. The educational sessions for the control group will be delivered at the end of the research project. In addition, both groups will document, at 1 and 3 months later, an evaluation of the implementation of the R-REM activities to prevent or reduce these types of incidents between older residents.
This educational program will improve health and well-being of older resident living in RACHs and it will assist nursing staff in preventing and reducing R-REM by protecting vulnerable older people experiencing R-REM in RACHs.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Julie Ellis
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Address
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College of Science, Health and Engineering, School of Nursing and Midwifery, La Trobe University.
Plenty Road & Kingsbury Drive, Melbourne VIC 3086, Victoria,
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Country
78746
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Australia
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Phone
78746
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+61 03 94795805
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Fax
78746
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Email
78746
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[email protected]
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Contact person for public queries
Name
78747
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Dr Julie Ellis
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Address
78747
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College of Science, Health and Engineering, School of Nursing and Midwifery, La Trobe University.
Plenty Road & Kingsbury Drive, Melbourne VIC 3086, Victoria,
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Country
78747
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Australia
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Phone
78747
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+61 03 94795805
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Fax
78747
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Email
78747
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[email protected]
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Contact person for scientific queries
Name
78748
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Dr Julie Ellis
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Address
78748
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College of Science, Health and Engineering, School of Nursing and Midwifery, La Trobe University.
Plenty Road & Kingsbury Drive, Melbourne VIC 3086, Victoria,
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Country
78748
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Australia
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Phone
78748
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+61 03 94795805
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Fax
78748
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Email
78748
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Implementation and evaluation of an education programme for nursing staff on recognising, reporting and managing resident-to-resident elder mistreatment in aged care facilities.
2019
https://dx.doi.org/10.1111/jan.13819
N.B. These documents automatically identified may not have been verified by the study sponsor.
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