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Trial registered on ANZCTR


Registration number
ACTRN12618000695202
Ethics application status
Approved
Date submitted
20/04/2018
Date registered
27/04/2018
Date last updated
16/04/2020
Date data sharing statement initially provided
26/04/2019
Date results provided
16/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Video versus written materials for research implementation
Scientific title
The success of video and written-based implementation strategy modes for knowledge translation in nursing and allied health: a novel helix crossover randomised study
Secondary ID [1] 294634 0
None
Universal Trial Number (UTN)
U1111-1212-5775
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Evidence Informed Decision Making 307483 0
Condition category
Condition code
Public Health 306564 306564 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Data will be collected from three study groups examining the success of two research implementation strategies: ‘video-based’ evidence summary (a) and ‘written-based’ evidence summary (b), compared with ‘usual-care’ control conditions (c). These research implementation strategies will aim to align self-reported benefit ratings with the current evidence-base for the use of bedside pressure sensor alarms to prevent falls (S1), written falls prevention patient education materials (S2), and physical activity after diagnosis of deep vein thrombosis (S3). This study will be conducted as a 3-level helical model as follows: S1a S2b S3c / S1b S2c S3a / S1c S2a S3b.

The study will be open to participants until data saturation (at least 30 participants in each group have been recruited). This is anticipated to take one month. Recruitment/intervention/data collection all occur within one period (online survey). Therefore, time to completion is determined by each participant. The video-based evidence-summary will be delivered as a 3-minute video. The written-based evidence-summary will be delivered as a full-text research article that may take between 10-30 minutes to read. Completion of the survey questions will take approximately 20 minutes. The video-based evidence-summary was created for the purposes of this study using animation software to summarise the same content presented in the written-based evidence-summary for that health context.

Potential participants will be contacted via their staff email and invited to take part in this study. The email will have an access link to the online survey software tool, where they will be provided with information regarding the study. Participants will then be randomised to Group 1, Group 2, or Group 3 on commencement of the survey using an inbuilt randomisation feature within the online survey software tool to receive the different research implementation strategies in each health context area. The video-based, written-based evidence summary and no intervention will be delivered as a one-off intervention in each context area within the online survey. Participants will receive both the video-based intervention and the written-based intervention at the same time using two embedded links within the survey. Participants can select the order they access the interventions and the time between interventions, as there is no washout period between conditions. After implementation strategy provision, participants will be prompted to complete the survey for data collection purposes. There is no planned washout period in this study, as the helix crossover randomised trial design allows the implementation strategies to be delivered simultaneously in different health contexts, minimising the risk of potential "carry-over" or "contamination" effects. No additional measures will be used to monitor adherence to watching the video-based evidence-summary or reading the written-based evidence-summary.

Group 1
The S1a S2b S3c study group receives the video-based evidence summary implementation strategy (a) in bedside pressure sensor alarms to prevent falls (S1), the written-based evidence summary implementation strategy (b) in written falls prevention patient education materials (S2), and the no intervention control (c) for physical activity after diagnosis of deep vein thrombosis (S3).

Group 2
The S1b S2c S3a study group receives the written-based evidence summary implementation strategy (b) in bedside pressure sensor alarms to prevent falls (S1), the no intervention control (c) for written falls prevention patient education materials (S2), and the video-based evidence summary implementation strategy (a) for physical activity after diagnosis of deep vein thrombosis (S3).

Group 3
The S1c S2a S3b study group receives the no intervention control (c) in bedside pressure sensor alarms to prevent falls (S1), the video-based evidence summary implementation strategy (a) in written falls prevention patient education materials (S2), and the written-based evidence summary implementation strategy (b) for physical activity after diagnosis of deep vein thrombosis (S3).
Intervention code [1] 300939 0
Behaviour
Comparator / control treatment
No intervention, usual practice control, as described in the intervention/exposure section.
Control group
Active

Outcomes
Primary outcome [1] 305562 0
Primary outcome: alignment between self reported rating of treatment benefit and current research evidence. Participants will be asked: “How beneficial do you think bed/chair alarms are for preventing falls in hospital?”, “How beneficial do you think written patient educational materials are for preventing falls in hospital?”, and “How beneficial do you think exercise is as an adjunct treatment for deep vein thrombosis (DVT)?”. Participants will be able to choose the options of “beneficial”, “not beneficial but not harmful”, or “harmful”.
Timepoint [1] 305562 0
Immediately following Implementation Strategy delivery
Secondary outcome [1] 345775 0
Secondary outcome 1: self reported confidence of judgement of treatment benefit. Participants will be asked: “How certain are you that this judgement of benefit is correct?” and will be able to choose the options of “very certain”, “somewhat certain”, and “uncertain”.
Timepoint [1] 345775 0
Immediately following Implementation Strategy delivery
Secondary outcome [2] 345776 0
Secondary outcome 2: self reported perception of whether practice should be implemented or de-implemented. Participants will be asked: “Do you think this strategy should be used to prevent falls in hospital?”, and will be bale to choose the options of “yes”, “no”, or “unsure”.
Timepoint [2] 345776 0
Immediately following Implementation Strategy delivery
Secondary outcome [3] 345777 0
Secondary outcome 3: self reported perception of the value of dissemination mode. An open-ended question will asked: “Do you have any comments regarding the video or written-based evidence summaries provided?”
Timepoint [3] 345777 0
Immediately following Implementation Strategy delivery

Eligibility
Key inclusion criteria
Registered nurses (RN) and enrolled nurses (EN) from all inpatient wards, as well as allied health professionals (physiotherapy, occupational therapy, speech pathology, dietetics, social work, psychology, podiatry, and exercise physiology) and allied health assistants at each study hospital will be eligible for inclusion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nursing staff working in aged care, outpatient, or community services, and assistant in nursing (AIN) staff working in any setting will be excluded

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)
Group allocation will be concealed to investigators and participants using the online survey’s inbuilt randomisation feature, as neither will be actively involved in the process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomised to Group 1, Group 2, or Group 3 on commencement of the survey using an inbuilt randomisation feature within the online survey software tool.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative data from questioners will be analysed using Stata (StataCorp, 2013. Stata Statistical Software: Release 13. College Station; TX: StataCorp LP). Descriptive statistics will be used to summarise demographic data. Continuous data will be presented as mean and standard deviation (SD). Categorical data will be presented as median and interquartile range (IGR), and nominal data as percentage. All quantitative analysis results will be deemed significant when p<0.05.

A mixed effects, general linear model analysis will be used to determine differences between implementation strategies (video versus written) for the proportion of participants who correctly identify the rating of benefit of each intervention. The investigators, based on their review of the evidence base, will classify responses of “not beneficial but not harmful” for the bed alarm context and the written falls prevention patient education contexts as being correct, and “beneficial” for the exercise for deep vein thrombosis prevention context as being correct. The implementation strategy will be entered into this model as a fixed effect, along with the intervention context (bed alarms for falls prevention, written falls prevention education, exercise for deep vein thrombosis). We will also include an implementation strategy*intervention context interaction effect. Individual participant identifiers will be entered as a random effect. A Bernouli family and logit link function will be employed.

We will examine participant responses to the rating of their certainty in their judgment of benefit separately for participant responses where the rating of benefit was deemed as being correct or incorrect. For those who are correct, we will compare the level of certainty in their judgment using ordered logit regression with data clustered by participant. We will include main effects for each implementation strategy and intervention context along with an implementation strategy*intervention context interaction effect. We will conduct similar analyses separately for those responses where the corresponding classification of benefit is not correct.

We will examine participant responses to whether a particular intervention should be used or not separately for each intervention context (bed alarm, written education material for falls prevention, exercise for deep vein thrombosis prevention) as the evidence of benefit differs between these contexts. We will use ordered logit regression with data clustered by participant to examine difference between the effects of each implementation strategy on this outcome.

Qualitative data will be analysed thematically by two investigators. Responses will be coded and collated into themes using a framework approach. Disagreements between these investigators will be resolved via discussion or, failing this engagement of a third investigator to resolve the dispute.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/05/2018
Actual
8/05/2018
Date of last participant enrolment
Anticipated
31/08/2018
Actual
31/07/2018
Date of last data collection
Anticipated
31/08/2018
Actual
31/07/2018
Sample size
Target
90
Accrual to date
Final
119
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10741 0
Kingston Centre - Cheltenham
Recruitment hospital [2] 11581 0
Dandenong Hospital - Dandenong
Recruitment hospital [3] 11582 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment hospital [4] 11583 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [5] 11584 0
Casey Hospital - Berwick
Recruitment postcode(s) [1] 22465 0
3192 - Cheltenham
Recruitment postcode(s) [2] 23624 0
3175 - Dandenong
Recruitment postcode(s) [3] 23625 0
3168 - Clayton
Recruitment postcode(s) [4] 23626 0
3165 - East Bentleigh
Recruitment postcode(s) [5] 23627 0
3806 - Berwick

Funding & Sponsors
Funding source category [1] 299253 0
University
Name [1] 299253 0
Monash University
Country [1] 299253 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Room 304, Building G, Peninsula Campus, McMahons Road
FRANKSTON VIC 3199
Country
Australia
Secondary sponsor category [1] 298524 0
None
Name [1] 298524 0
Address [1] 298524 0
Country [1] 298524 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300171 0
Monash Health Human Research Ethics Low Risk Review Panel
Ethics committee address [1] 300171 0
Ethics committee country [1] 300171 0
Australia
Date submitted for ethics approval [1] 300171 0
11/04/2018
Approval date [1] 300171 0
18/04/2018
Ethics approval number [1] 300171 0
LNR/18/MonH/155

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

Contacts
Principal investigator
Name 82778 0
Mr Mitchell Sarkies
Address 82778 0
Allied Health Research Unit, Kingston Centre, Monash Health, 400 Warrigal Road
CHELTENHAM, VIC, 3192
Country 82778 0
Australia
Phone 82778 0
+61 (0) 433337491
Fax 82778 0
Email 82778 0
mitchell.sarkies@monash.edu
Contact person for public queries
Name 82779 0
Mitchell Sarkies
Address 82779 0
Allied Health Research Unit, Kingston Centre, Monash Health, 400 Warrigal Road
CHELTENHAM, VIC, 3192
Country 82779 0
Australia
Phone 82779 0
+61 (0) 433337491
Fax 82779 0
Email 82779 0
mitchell.sarkies@monash.edu
Contact person for scientific queries
Name 82780 0
Mitchell Sarkies
Address 82780 0
Allied Health Research Unit, Kingston Centre, Monash Health, 400 Warrigal Road
CHELTENHAM, VIC, 3192
Country 82780 0
Australia
Phone 82780 0
+61 (0) 433337491
Fax 82780 0
Email 82780 0
mitchell.sarkies@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified quantitative data can be shared
When will data be available (start and end dates)?
31/07/2018 - 31/07/2025
Available to whom?
Researchers who provide a methodologically sound proposal may be provided de-identified data on a case-by-case basis at the discretion of the principal investigator.
Available for what types of analyses?
Meta analysis
How or where can data be obtained?
Electronic


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.