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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)
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
Secondary ID [1] 293269 0
None
Universal Trial Number (UTN)
U1111-1204-6095
Trial acronym
R-REM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Resident-to-resident elder mistreatment (R-REM) 305329 0
Condition category
Condition code
Public Health 304622 304622 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
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.

Intervention code [1] 299527 0
Behaviour
Intervention code [2] 299683 0
Prevention
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).

Control group
Active

Outcomes
Primary outcome [1] 303854 0
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 )
Timepoint [1] 303854 0
Before and after (immediately at completion) the educational session 1 of recognising resident to resident elder mistreatment (R-REM).
Primary outcome [2] 303937 0
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
Timepoint [2] 303937 0
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.
Secondary outcome [1] 340278 0
Implementation of the SEARCH approach to managing R-REM by recording R-REM incidents using the note pads.
Timepoint [1] 340278 0
Four weeks prior to the education session and for 4 weeks after the education session.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
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.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
18/09/2017
Date of last participant enrolment
Anticipated
Actual
29/09/2017
Date of last data collection
Anticipated
15/12/2017
Actual
Sample size
Target
65
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9335 0
Bundoora Extended Care Centre - Bundoora
Recruitment postcode(s) [1] 18005 0
3083 - Bundoora

Funding & Sponsors
Funding source category [1] 297897 0
Charities/Societies/Foundations
Name [1] 297897 0
The Nurses Board Victoria Legacy Limited
Country [1] 297897 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Plenty Road & Kingsbury Drive, Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 296950 0
Hospital
Name [1] 296950 0
Northern Health (Bundoora Extebded Care Centre)
Address [1] 296950 0
1231 Plenty Road Bundoora, 3083
Melbourne
Victoria
Country [1] 296950 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298946 0
Austin Health Human Research Ethics
Ethics committee address [1] 298946 0
Ethics committee country [1] 298946 0
Australia
Date submitted for ethics approval [1] 298946 0
30/05/2017
Approval date [1] 298946 0
17/08/2017
Ethics approval number [1] 298946 0
LNR/17/Austin/174

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78746 0
Dr Julie Ellis
Address 78746 0
College of Science, Health and Engineering, School of Nursing and Midwifery, La Trobe University.
Plenty Road & Kingsbury Drive, Melbourne VIC 3086, Victoria,
Country 78746 0
Australia
Phone 78746 0
+61 03 94795805
Fax 78746 0
Email 78746 0
j.ellis@latrobe.edu.au
Contact person for public queries
Name 78747 0
Julie Ellis
Address 78747 0
College of Science, Health and Engineering, School of Nursing and Midwifery, La Trobe University.
Plenty Road & Kingsbury Drive, Melbourne VIC 3086, Victoria,
Country 78747 0
Australia
Phone 78747 0
+61 03 94795805
Fax 78747 0
Email 78747 0
j.ellis@latrobe.edu.au
Contact person for scientific queries
Name 78748 0
Julie Ellis
Address 78748 0
College of Science, Health and Engineering, School of Nursing and Midwifery, La Trobe University.
Plenty Road & Kingsbury Drive, Melbourne VIC 3086, Victoria,
Country 78748 0
Australia
Phone 78748 0
+61 03 94795805
Fax 78748 0
Email 78748 0
j.ellis@latrobe.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseImplementation and evaluation of an education programme for nursing staff on recognising, reporting and managing resident-to-resident elder mistreatment in aged care facilities.2019https://dx.doi.org/10.1111/jan.13819
N.B. These documents automatically identified may not have been verified by the study sponsor.