Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000608662
Ethics application status
Approved
Date submitted
20/05/2023
Date registered
2/06/2023
Date last updated
2/06/2023
Date data sharing statement initially provided
2/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
A Cluster-Randomised Implementation Trial to Promote Evidence Use by Occupational Therapists and Physiotherapists working in Stroke Rehabilitation: The Promote Trial.
Scientific title
Effect of the implementation of PROMOTE into inpatient stroke rehabilitation on adherence to clinical practice guidelines and patient outcomes – a cluster randomised trial
Secondary ID [1] 309702 0
None
Universal Trial Number (UTN)
U1111-1292-8705
Trial acronym
PROMOTE Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 330082 0
Condition category
Condition code
Stroke 326978 326978 0 0
Haemorrhagic
Stroke 326979 326979 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Promote experimental intervention aims to increase the therapy team’s delivery of recommended upper limb therapies to stroke inpatients, specifically task-specific motor training, mirror box therapy, electrical stimulation, constraint-induced movement therapy and/or mental imagery.
To increase delivery of these therapies, the Promote experimental intervention includes:
• Providing a copy of the NHMRC / Stroke Foundation ‘Clinical guidelines for stroke management’. These are available free online at https://informme.org.au/Guidelines
• Online Education modules (specifically developed for this trial) which explain the NHMRC/Stroke Foundation clinical practice guideline recommendations. Total time to complete will depend on each individual clinician, but ranges between 30 minutes to 3 hours.
• Specialist Education tailored to each site, provided as in-services, point-of-care demonstration videos, and written manuals to train clinicians in the skills related to the clinical guideline recommendations. This will augment (not replace) the online modules. Education provided by an experienced occupational therapist or physiotherapist with a minimum of 10y experience in stroke rehabilitation. The education will be delivered by a member of the core-research team, and supported locally at the site by a Guideline Champion. Education slides have been developed by the core research team to support the specialist education
• Guideline Champion: an experienced clinician (Occupational Therapist or Physiotherapist with a minimum of 3 years in stroke rehabilitation) who advocates, encourages, coaches, mentors, educates, trains, persuades and motivates other clinicians. The Champion will be a clinician already employed at the Centre, who is provided with additional training at least 3 weeks prior to anticipated delivery of the Promote package. The Champion will support to mentor, coach and deliver the PROMOTE package.
• Resources: electrical stimulation machines, GRASP kits, constraint-induced movement therapy mitts, treatment tables. Training in set-up and use of these resources will be provided by the core research team in the first weeks of delivery of the PROMOTE package.
• Feedback from file-audits about current practice: medical records from a consecutive sample of the 5 most-recently discharged stroke patients from each centre team will be audited monthly. Feedback will address the number of people with stroke receiving recommended guidelines, the number of sessions per person, stroke severity, and team challenges. Audit-and-Feedback completed by the Guideline Champion (see above).
Mode of delivery will be primarily face-to-face, but will include online meetings and education. Intervention is a mix of individually provided (such as the mentoring, joint-therapy sessions) and group (such as skills workshops and audit-and-feedback sessions; group size is anticipated to be approximately 10 clinicians however a maximum number will not be enforced). Wherever possible, these sessions will be provided by the Guideline Champion.
All support and education will be logged during the trial.
A six-month intervention period is delivered to each site.

A minimum of 24 sessions are planned (education, skills, feedback) but total number of sessions delivered will be tailored to each site by their "Guideline Champion" who will work with their team to plan sessions. There are weekly education presentations (45min) and fortnightly audit-and-feedback sessions (30mins).

Location of delivery is an inpatient rehabilitation hospital (clinician workplace).
Intervention code [1] 326139 0
Behaviour
Intervention code [2] 326214 0
Treatment: Other
Comparator / control treatment
Online Education modules to explain the NHMRC/Stroke Foundation clinical practice guideline recommendations.. These are self-directed, online. Total time to complete will depend on each individual clinician, but ranges between 30 minutes to 3 hours.
Clinicians will be provided with access to the education module for 6months.
Control group
Active

Outcomes
Primary outcome [1] 334815 0
Clinical adherence to Stroke Foundation Clinical Guideline Recommendations of newly admitted patients with stroke.
Timepoint [1] 334815 0
Change in adherence to guideline adherence from baseline to 6- and 12-months post-Promote intervention commencement, as measured using the medical record audit in the PROMOTE versus control group clusters.
Secondary outcome [1] 422167 0
Clinician beliefs as measured by the Theoretical Domains Framework Questionnaire.
Timepoint [1] 422167 0
Change in clinician TDFQ scores from baseline to 6- and 12-months post-intervention commencement in the PROMOTE versus control group clusters.
Secondary outcome [2] 422168 0
Measurement of upper limb ability of each patient participant on the Box and Block Test,
Timepoint [2] 422168 0
Change in patient upper limb ability scores from admission (pre-therapy) to 4-weeks post-therapy in the PROMOTE versus control group clusters.
Secondary outcome [3] 422169 0
Measurement of change in upper limb ability of each patient participant on the Action Research Arm Test
Timepoint [3] 422169 0
Change in patient upper limb ability scores from admission (pre-therapy) to 4-weeks post-therapy in the PROMOTE versus control group clusters.
Secondary outcome [4] 422170 0
Measurement of change in upper limb ability of each patient participant on the REACH scale,
Timepoint [4] 422170 0
Change in patient upper limb ability scores from admission (pre-therapy) to 4-weeks post-therapy in the PROMOTE versus control group clusters.
Secondary outcome [5] 422171 0
Cost-estimation of the PROMOTE package costs as estimated for hospital financial records, and estimated from trial data collated at each site for the intervention period (6mo) and for a further 6mo following the intervention period.
Timepoint [5] 422171 0
Collected across the intervention period from hospital financial records, and estimated from trial data collated at each site for the intervention period (6mo) and for a further 6mo following the intervention period.
Secondary outcome [6] 422172 0
Measurement of change in health-related quality of life using the EQ5D-5L which will be administered to each patient participant.
Timepoint [6] 422172 0
Change in patient HRQoL scores from admission (pre-therapy) to 4-weeks post-therapy in the PROMOTE versus control group clusters.

Eligibility
Key inclusion criteria
Centres will be Australian rehabilitation services who treat adults with stroke who present with upper limb impairments. All centres will receive >20 stroke referrals annually.
Clinician participants will be occupational therapists, physiotherapists and/or allied health assistants who work at participating centres and deliver upper limb rehabilitation;
Patient Participants will be aged 18 years or older, have sustained a stroke in the previous 6 months that has led to upper limb impairments. Be able to read and understand spoken English to a level where they can participate in the motor training program, and be eligible for upper limb rehabilitation as per the guidelines (i.e. have a minimum of 5-degree active wrist extension) and have a maximum ability to move 30 blocks on the Box and Block Test).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinician participants who will not be working in the Centre for a minimum of 4 weeks of the PROMOTE period will be excluded.
Patient participants who do not receive a minimum of 1 week of upper limb rehabilitation will be excluded.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be maintained through our site allocation protocol which involves
contacting the holder of the allocation schedule, who is "off-site" at Biostatistics Unit at Melbourne Medical School.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be conducted by trial statistician (Prof Leonid Churilov) at the centre level:, stratified on baseline level of adherence to guidelines, and rurality.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics will be summarised using means and standard deviations (where continuous data is normally distributed), medians and interquartile ranges (where continuous data is non-normally distributed) and frequencies and percentages for proportions including 95% confidence intervals, as appropriate.

Preliminary logistic regressions will be undertaken to check for differences on demographic, primary and secondary outcomes between PROMOTE and controle group clusters. Any significant differences will be reported and controlled for wherever possible, to control for sampling bias.

Primary outcome: PROMOTE and control group clusters will be compared to determine whether there has been an increase in adherence to guideline recommendations from baseline to 6 months (end of implementation period).

Secondary outcomes: PROMOTE and control group clusters will be compared across all measures and all timepoints with change as an outcome, group as a factor and baseline value of adherence as a covariate.

Secondary outcomes: Linear mixed effects models will be used to determine if there are i) changes over time in substance use and mental health outcomes between exposed (First Step) and unexposed (standard care) clusters at one-month and three-month follow up. Substance use and mental health at each time-point will be treated as a fixed effect and we will include random effects for cluster, treatment centre, and time to account for clustering of data within the RCT rollout clusters, treatment centres, and individuals, respectively.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
26/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
238
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC

Funding & Sponsors
Funding source category [1] 313895 0
Government body
Name [1] 313895 0
Medical Research Futures Fund, Department of Industry, Science and Resources
Country [1] 313895 0
Australia
Primary sponsor type
University
Name
Monash University
Address
The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 315748 0
None
Name [1] 315748 0
Address [1] 315748 0
Country [1] 315748 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313042 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 313042 0
The Alfred Centre, 99 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 313042 0
Australia
Date submitted for ethics approval [1] 313042 0
Approval date [1] 313042 0
29/11/2022
Ethics approval number [1] 313042 0
89725 [NMA]

Summary
Brief summary
The trial will test the clinical benefit and cost effectiveness of an implementation package to increase clinician use of arm and stroke rehabilitation evidence in practice. We hypothesise that providing support (education, mentorship) alongside resources (such as equipment and processes) will increase clinician use of the evidence. We will recruit 14 hospitals across 3 Australian states to deliver arm rehabilitation to 238 patients after stroke. The primary outcome is clinician adherence to guidelines, with secondary outcomes of patient arm and hand movement, health-related quality of life and cost. To understand the challenges faced during the PROMOTE trial, we will conduct a process evaluation alongside the main trial. Then, in partnership with the Stroke Foundation, we will employ implementation science methods to work with consumers and clinicians to develop an implementation strategy. Together these will allow rapid translation of findings into routine stroke care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126786 0
Prof Natasha A. Lannin
Address 126786 0
Department of Neuroscience
The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 126786 0
Australia
Phone 126786 0
+61 3 9903 4840
Fax 126786 0
Email 126786 0
natasha.lannin@monash.edu
Contact person for public queries
Name 126787 0
Prof Natasha Lannin
Address 126787 0
Department of Neuroscience
The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 126787 0
Australia
Phone 126787 0
+61 3 9903 4840
Fax 126787 0
Email 126787 0
natasha.lannin@monash.edu
Contact person for scientific queries
Name 126788 0
Prof Natasha Lannin
Address 126788 0
Department of Neuroscience
The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 126788 0
Australia
Phone 126788 0
+61 3 9903 4840
Fax 126788 0
Email 126788 0
natasha.lannin@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not approved in ethical review.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19194Ethical approval  natasha.lannin@monash.edu
19195Informed consent form  natasha.lannin@monash.edu



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.