Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000831684
Ethics application status
Approved
Date submitted
22/03/2023
Date registered
3/08/2023
Date last updated
21/07/2024
Date data sharing statement initially provided
3/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Time to get moving: Evaluation of an evidence-based, multicomponent tailored intervention on hospital mobility.
Scientific title
Evaluation of an evidence-based, multicomponent tailored intervention on hospital mobility.
Secondary ID [1] 309270 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Medical inpatients 329423 0
patients at risk of functional decline 329424 0
Condition category
Condition code
Public Health 326370 326370 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a prospective, multisite pre-post hybrid study which will evaluate the implementation and effectiveness of a co-designed mobility improvement strategy.

The mobility improvement strategy will be co-designed by a health service Multi-professional Mobility Improvement Collaborative. Consumers, clinicians (nurses, medical staff, physiotherapists, occupational therapists), managers and support staff from across 4 hospitals in the health service will be invited to join this collaborative. Three meetings will be scheduled to present the background to the project and information regarding the consequences of hospital associated functional decline. The group will be asked to nominate priorities for improvement after which time working groups will be formed to pursue this work. These smaller worker groups will then meet monthly to co-design and seek agreement about specific strategies pertaining to the working group's purpose. It is anticipated that 4 months will be required to develop these strategies.

Once agreed, strategies will be implemented across the 10 participating wards. Examples of potential strategies may include: development of a policy to facilitate inpatient mobility, modifications to documentation and communication processes, interprofessional education and training. Whilst many strategies will be relevant across all participating wards, local ward level strategies may also be encouraged. Examples of these include education and local support to improve storage and equipment maintenance.

The implementation phase will be overseen and supported by the project team and co-ordinated by the Project Officer. Successful uptake of the mobility strategy will be facilitated through broad multi-professional engagement which has been undertaken at all sites, use of key management stakeholders as champions, through existing facilitators already embedded within clinical settings as part of a delirium prevention program (Eat Walk Engage Program), and through the established professional networks of our investigator group. Champions and existing facilitators will assist by developing educational resources, contributing to policy development and through dissemination of marketing strategies to promote mobility practices. As these champions are positioned within the work unit, they will have local influence to disseminate information to colleagues on respective wards.
We anticipate evaluating the effectiveness of the intervention 12 months post implementation.
Data will be collected pre and post implementation to determine effectiveness of the intervention.
Intervention code [1] 325702 0
Behaviour
Intervention code [2] 326542 0
Treatment: Other
Comparator / control treatment
Patients on participating wards will receive usual care by their treating teams during the pre-implementation phase. This includes medical, allied health and nursing cares as required for their acute admission to a medical ward.

Pre-implementation data will be collected July 2023 - Oct 2023.
Post implementation data will be collected Jan - Apr 2025.

No control group
Control group
Active

Outcomes
Primary outcome [1] 334221 0
The primary outcome is daytime mobility.
This will be reported as the average proportion of patient observations spent standing and/or walking for each ward.
A member of the research team will systematically observe patients at regular intervals over an 8 hour period (8am to 4pm) recording the highest level of (eg. lying, sitting in bed, sitting in a chair, standing, walking).
Timepoint [1] 334221 0
Time point 1 : 3 months prior to implementation
Time point 2 : 6 months post implementation
Time point 3 : 18 months post implementation
Secondary outcome [1] 419880 0
Functional decline, measured as change in function using the Katz Index of Independence in activities of daily living between 2 weeks prior to admission and discharge
Timepoint [1] 419880 0
Baseline - 3 months prior to implementation
Post implementation - 12 mths post implementation
Secondary outcome [2] 419881 0
Hospital length of stay - measured by extraction of information from medical records
Timepoint [2] 419881 0
Pre and post intervention
Data will be collected for a 12 week period on each ward at baseline and 12 months following initial implementation of the intervention.
Secondary outcome [3] 419882 0
Discharge destination - information for this outcome will be extracted from medical records
Timepoint [3] 419882 0
Pre and post intervention
Data will be collected for a 12 week period on each ward at baseline and 12 months following initial implementation of the intervention.
Secondary outcome [4] 419883 0
30 day readmission - information for this outcome will be extracted from medical records
Timepoint [4] 419883 0
Pre and post intervention
Data will be collected for a 12 week period on each ward at baseline and 12 months following initial implementation of the intervention.
Secondary outcome [5] 419884 0
Adoption of the intervention will be measured by describing which elements of the multi-component intervention are adopted and sustained at each of the 4 participating hospitals.

This will be ascertained by regular meetings with Eat Walk Engage staff embedded within the participating wards. These meetings already occur as part of the Eat Walk Engage Program on a monthly basis.
Timepoint [5] 419884 0
18 months following initial implementation of the intervention
Secondary outcome [6] 419885 0
Acceptability of the intervention will be measured qualitatively through focus groups with members of the Multi-professional Mobility Improvement Collaborative.

Two focus groups consisting of up to 10 people will be scheduled at a time suitable to participants. Participants of the Mobility Collaborative will be invited to attend one of these semi-structured focus groups in person. Discussion will be recorded and transcribed verbatim. The research team will then identify common themes.
Timepoint [6] 419885 0
18 months following initial implementation of the intervention
Secondary outcome [7] 419887 0
Falls frequency will be recorded as the number of falls for each participant during their hospital admission. This will be assessed as self report by patient interview.
Timepoint [7] 419887 0
Data will be measured at baseline (pre-intervention) and 12 months post initial implementation of the intervention
Secondary outcome [8] 424388 0
Hospital associated functional decline measured as change in function using the Katz Index of Independence in activities of daily living, between hospital admission and discharge.
Timepoint [8] 424388 0
Baseline - 3 months prior to implementation
Post implementation - 12 mths post implementation
Secondary outcome [9] 424389 0
Functional decline, measured as change in function using the Katz Index of Independence in activities of daily living between 2 weeks prior to admission and 1 month post discharge
Timepoint [9] 424389 0
Baseline - 3 months prior to implementation
Post implementation : 12 months post implementation

Eligibility
Key inclusion criteria
This study will be conducted on 10 medical wards across across 4 hospitals in the one health service: the Royal Brisbane and Women's Hospital, The Prince Charles Hospital, Redcliffe Hospital and Caboolture Hospital.
For pre-post data, eligible participants will be patients aged 65 years and older admitted to the implementation wards for more than 48 hours (as these are the cohort at most risk of functional decline, and the target of our improvement intervention).

Acceptability of the intervention will be determined by focus groups conducted with key multi-level stakeholders identified through the Multi-professional Mobility Improvement Collaborative (either direct membership or through snowballing techniques).
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients receiving end of life care or who are critically ill, or those who are unable to independently consent due to severe cognitive or psychological impairment or language difficulties that would interfere with their ability to participate in a short interview.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Daytime mobility: The proportion of observations at different levels of activity (lying, sitting, standing or walking) will be described for each ward at each time point in tables or graphs. The change in percentage of patients spending time upright and mobile before and after implementing the mobility strategy will be evaluated using mixed effects modelling accounting for clustering by wards. We estimate that each activity mapping ward sample will provide around 500 observations (5000 observations for each time point), providing >80% power to demonstrate an increase in proportion of patients from 8% to 10%

Participant characteristics of the pre and post implementation cohorts will be summarised across all wards using appropriate descriptive statistics.
The effect to of the intervention on functional decline will be tested using general estimating equations adjusted for clustering, with time point (pre/post) as the main effect, and adjusted for clinically important co-variates. We estimate that a cohort sample size of 400 in each group will provide >80% power to test for a reduction in functional decline from 30% to 20%.

Length of stay, inpatient falls, discharge destination and 30 day readmission will be summarised across all wards before and after the implementation, and the effect of the intervention estimated using appropriate models, to build a comprehensive picture of intended and unintended consequences.


Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/06/2023
Date of last participant enrolment
Anticipated
31/07/2025
Actual
Date of last data collection
Anticipated
31/10/2025
Actual
Sample size
Target
400
Accrual to date
285
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24315 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [2] 24316 0
The Prince Charles Hospital - Chermside
Recruitment hospital [3] 24317 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [4] 24318 0
Caboolture Hospital - Caboolture
Recruitment postcode(s) [1] 39874 0
4029 - Herston
Recruitment postcode(s) [2] 39875 0
4032 - Chermside
Recruitment postcode(s) [3] 39876 0
4020 - Redcliffe
Recruitment postcode(s) [4] 39877 0
4510 - Caboolture

Funding & Sponsors
Funding source category [1] 313464 0
Hospital
Name [1] 313464 0
Metro North Research Fellowship
Country [1] 313464 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital
Address
Royal Brisbane and Women's Hospital
Butterfield St, Herston 4029
Brisbane
Queensland
Country
Australia
Secondary sponsor category [1] 315233 0
None
Name [1] 315233 0
Address [1] 315233 0
Country [1] 315233 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312660 0
Metro North Human Research Ethics Committee A
Ethics committee address [1] 312660 0
Ethics committee country [1] 312660 0
Australia
Date submitted for ethics approval [1] 312660 0
08/03/2023
Approval date [1] 312660 0
16/03/2023
Ethics approval number [1] 312660 0
HREC/2023/MNHA/92176

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

Contacts
Principal investigator
Name 125462 0
Dr Julie Adsett
Address 125462 0
Physiotherapy Department
Level 2, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield ST, Herston 4029
Brisbane
Queensland
Country 125462 0
Australia
Phone 125462 0
+61 7 3646 2280
Fax 125462 0
Email 125462 0
[email protected]
Contact person for public queries
Name 125463 0
Julie Adsett
Address 125463 0
Physiotherapy Department
Level 2, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield ST, Herston 4029
Brisbane
Queensland
Country 125463 0
Australia
Phone 125463 0
+61 7 3646 2280
Fax 125463 0
Email 125463 0
[email protected]
Contact person for scientific queries
Name 125464 0
Julie Adsett
Address 125464 0
Physiotherapy Department
Level 2, Ned Hanlon Building
Royal Brisbane and Women's Hospital
Butterfield ST, Herston 4029
Brisbane
Queensland
Country 125464 0
Australia
Phone 125464 0
+61 7 3646 2280
Fax 125464 0
Email 125464 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
All participant data will be de-identified at the time of data collection and reported as grouped data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18658Study protocol    385601-(Uploaded-22-03-2023-14-11-22)-Study-related document.pdf



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.