Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001863224
Ethics application status
Approved
Date submitted
6/06/2018
Date registered
15/11/2018
Date last updated
15/11/2018
Date data sharing statement initially provided
15/11/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Development and evaluation of a nursing risk assessment manual handling training program for moving patients with a stroke and other conditions affecting mobility: The Risk Assessment for Moving Patients (RAMP) program
Scientific title
Does the Risk Assessment for Moving Patients (RAMP) manual handling program for nurses change clinical manual handling practice?
Secondary ID [1] 294170 0
Nil known
Universal Trial Number (UTN)
U1111-1212-1180
Trial acronym
RAMP: Risk Assessment for Moving Patients
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Workplace musculo-skeletal injuries 307087 0
Stroke 307088 0
Condition category
Condition code
Injuries and Accidents 306195 306195 0 0
Other injuries and accidents
Stroke 306196 306196 0 0
Haemorrhagic
Stroke 306197 306197 0 0
Ischaemic
Public Health 306198 306198 0 0
Health promotion/education
Musculoskeletal 306199 306199 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 306200 306200 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention (Risk Assessment for Moving Patients; RAMP) is a single, 4 hour, face-to-face manual handling training package for nursing staff. The training focuses on the moving and transferring of patients and will consist of a 30 minute introductory digital presentation followed by 2.5 hours practical time and 1 hour of concurrent practical assessments and case study practise. During the practical time, the trainer will select a patient transfer, guide participants through the relevant pages of the training manual and demonstrates the risk assessment relating to that transfer with one of the participating nurses acting as a patient model. Time will then be allowed for participants to immediately practise the demonstrated skills in small groups with reference to the training manual and roving feedback from the trainer. This process will be repeated for all groups of transfers presented in the training manual. In the final hour of the session, the trainer will observe each participant as they perform a mock patient scenario with another participant acting as the patient. During this scenario, the trainer will use the ‘Competency Tool – Trainee’ designed and piloted for this study to assess each participant’s ability to verbalise key concepts in risk assessment and to demonstrate appropriate manual handling techniques. While this is taking place, the rest of the participants will be divided into groups of 3-4 and will practise complex clinical scenarios which require risk assessment, clinical problem solving and practical completion of that scenario.
The afternoon RAMP session will be delivered on the same day as a 3.5 hour morning organisational Work, Health and Safety (WHS) training session aimed at teaching practical skills for the use of common manual handling equipment such as hoists and standing machines. The equipment used in the RAMP session will be those commonly found in patients' rooms such as a hospital bed and chair and specific manual handling equipment such as slide sheets and leg lifters. Both sessions will be delivered in the hospital's simulation laboratory and staff attendance will be documented for each RAMP and WHS session. A WHS employee will deliver the morning WHS session and the RAMP session is delivered by a physiotherapist who is at least 4 years post graduation and has experience in neurological physiotherapy.
During and after the training, staff will have access to a paper RAMP training manual detailing the risk assessment procedures and patient transfers learnt. Prior to and following the training, staff will have access to the RAMP course via an online education portal. The online course includes the RAMP training manual, purpose-filmed training videos and the post-training quiz. While completing the quiz, participants have access to the training manual and the intent therefore is that the quiz highlights and consolidates key areas of learning.
The strategy for intervention adherence and sustainability is to have two nurses designated as 'clinical implementation leads' on each of the pilot wards. These nurses will be involved in the creation of the program and training manual, attend two RAMP training sessions rather than one (aimed to consolidate learning and confidence) and serve as a resource and encouragement to nursing staff on each of the pilot wards.
Intervention code [1] 300665 0
Behaviour
Intervention code [2] 300666 0
Prevention
Comparator / control treatment
Translation of learning into the workplace: control data collected from both pilot wards in the month preceding the training, October 2017. Historical controls for number and severity of patient falls were collected from both pilot wards from April 2017 - October 2017 and staff musculoskeletal injury data collected from 3 years and 6 months preceding training .
Control group
Historical

Outcomes
Primary outcome [1] 305208 0
The extent to which learning from the RAMP program is translated back into the workplace. This is to be assessed through the observation of nursing staff performing patient transfers as part of usual practice on the ward. An independent researcher will spend a total of 9 hours on each ward at each timepoint to observe and assess patient transfers using the ‘Competency Tool - Point Prevalence Study Record Sheet’ developed and piloted for this study and based upon the within-training assessment tool: ‘Competency Tool – Trainee’.
Timepoint [1] 305208 0
Data collected points: immediately preceding training (October 2017), 1 month post-training (December 2017 – Primary endpoint) and 6 months post-training (June 2018).
Secondary outcome [1] 344507 0
The number of patient falls on the pilot wards collected from the hospital's risk management system, Riskman,
Timepoint [1] 344507 0
Baseline data will be collected in the 6 months preceding the implementation of the training and post-training data will be collected in the 6 months following the completion of the final training session (Dec 17 - Jun 18).
Secondary outcome [2] 344508 0
Staff attitudes towards the manual handling training program via surveys developed and piloted for this study. The ‘Post education staff survey – Fundamentals’ to be completed by participants before the RAMP training and the ‘Post education staff survey - Stroke Safe Moves’ to be completed at the conclusion of the RAMP session. A very small number of questions from the ‘Post education staff survey – Fundamentals' are also asked pre-Fundamentals.
Timepoint [2] 344508 0
All data points to be collected on the day of training: at the beginning of the Work, Health and Safety training sessions; at the beginning of the RAMP training session and; at the conclusion of the RAMP training session.
Secondary outcome [3] 344758 0
The rate of patient related acute musculoskeletal staff injuries as assessed by data collected from the health service RiskMan database.
Timepoint [3] 344758 0
Baseline data will be collected in the 3 years and 6 months preceding the implementation of the training (Apr 14 - Oct 17) and post-training data will be collected in the 6 months following the completion of the final training session (Dec 17 - Jun 18).
Secondary outcome [4] 345476 0
Staff perceptions of barriers to implementation of RAMP on the ward, to be investigated by focus groups and thematic analysis undertaken.
Timepoint [4] 345476 0
Focus groups to be conducted at 4 months following training.
Secondary outcome [5] 345477 0
Level of learning achieved as assessed by the training competency assessment tool developed for the study, ‘Competency Tool – Trainee’ and the online post-training quiz developed for the study with the assistance of the Cabrini Health Education Department and piloted for usability prior.
Timepoint [5] 345477 0
Competency Assessment completed by each individual at the end of the training session.
Participants invited to complete a post-training quiz following the RAMP training. Participants are encouraged to complete this within weeks of completing their training session, with an end date of four months post training.
Secondary outcome [6] 348396 0
The severity of patient falls on the pilot wards collected from the hospital's risk management system, Riskman,
Timepoint [6] 348396 0
Baseline data will be collected in the 6 months preceding the implementation of the training and post-training data will be collected in the 6 months following the completion of the final training session (Dec 17 - Jun 18).
Secondary outcome [7] 348398 0
Staff perceptions of facilitators to implementation of RAMP on the ward, to be investigated by focus groups and thematic analysis undertaken.
Timepoint [7] 348398 0
Focus groups to be conducted at 4 months following training.

Eligibility
Key inclusion criteria
Cabrini Health full-time, permanent part-time and regular casual (average at least once per fortnight) registered nurses, enrolled nurses and qualified ward assistants working at either the Malvern Ward 3 South or Glenhuntly Road inpatient rehabilitation setting.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cabrini Health casual nurses who work infrequently (average less than once per fortnight) (Registered nurses, enrolled nurses and qualified ward assistants) or nurses from nursing agencies. Nurses not on the target wards.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
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
Single group
Other design features
Pre-post design with historical controls
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Qualitative data - focus group data analysed by coding and thematic analysis
- nonparametric survey data analysed using Mann-Whitney U Test, including a measure of variance.
Quantitative data - parametric data analysed and reported as a mean value for the pre and post score, with a mean difference also presented where appropriate using t-.Tests.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/10/2017
Date of last participant enrolment
Anticipated
Actual
5/12/2017
Date of last data collection
Anticipated
Actual
6/06/2018
Sample size
Target
78
Accrual to date
Final
72
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10403 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [2] 10404 0
Cabrini Health Elsternwick Rehabilition Service - Elsternwick
Recruitment postcode(s) [1] 22088 0
3144 - Malvern
Recruitment postcode(s) [2] 22089 0
3185 - Elsternwick

Funding & Sponsors
Funding source category [1] 298805 0
Charities/Societies/Foundations
Name [1] 298805 0
Cabrini Foundation
Country [1] 298805 0
Australia
Primary sponsor type
Individual
Name
Helen Kugler
Address
Cabrini Institute
154 Wattletree Road
Malvern VICTORIA 3144
Country
Australia
Secondary sponsor category [1] 298603 0
None
Name [1] 298603 0
Address [1] 298603 0
Country [1] 298603 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299751 0
Cabrini Human Research Ethics Committee
Ethics committee address [1] 299751 0
Ethics committee country [1] 299751 0
Australia
Date submitted for ethics approval [1] 299751 0
30/03/2016
Approval date [1] 299751 0
26/05/2016
Ethics approval number [1] 299751 0
08-21-08-17

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

Contacts
Principal investigator
Name 81458 0
Ms Helen Kugler
Address 81458 0
Cabrini Institute
154 Wattletree Road
Malvern VICTORIA 3144
Country 81458 0
Australia
Phone 81458 0
+61 3 9508 5225
Fax 81458 0
Email 81458 0
[email protected]
Contact person for public queries
Name 81459 0
Helen Kugler
Address 81459 0
Cabrini Institute
154 Wattletree Road
Malvern VICTORIA 3144
Country 81459 0
Australia
Phone 81459 0
+61 3 9508 5225
Fax 81459 0
Email 81459 0
[email protected]
Contact person for scientific queries
Name 81460 0
Helen Kugler
Address 81460 0
Cabrini Institute
154 Wattletree Road
Malvern VICTORIA 3144
Country 81460 0
Australia
Phone 81460 0
+61 3 9508 5225
Fax 81460 0
Email 81460 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to the sensitive nature of the qualitative data (i.e. potentially identifiable) it is not appropriate to share the individual participant data


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
No additional documents have been identified.