Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001106628
Ethics application status
Approved
Date submitted
22/08/2023
Date registered
23/10/2023
Date last updated
23/10/2023
Date data sharing statement initially provided
23/10/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of Clinical Practice Guidelines for the Physiotherapy Management of People with Spinal Cord Injury
Scientific title
Implementation of Clinical Practice Guidelines for the Physiotherapy Management of People with Spinal Cord Injury (SCI): a pre-post study
Secondary ID [1] 310427 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury
 331193 0
Condition category
Condition code
Neurological 327969 327969 0 0
Other neurological disorders
Public Health 328049 328049 0 0
Health service research
Physical Medicine / Rehabilitation 328050 328050 0 0
Physiotherapy
Injuries and Accidents 328051 328051 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physiotherapist adherence to one of the guideline recommendations made in the 'Clinical practice guidelines for the physiotherapy management of people with spinal cord injury' will be assessed by a clinical notes audit before and after an implementation phase. The guideline recommendation chosen will address an evidence to practice gap identified by a retrospective clinical notes audit.
The implementation phase will involve the implementation of targeted strategies (the intervention) that will address the key barriers and facilitators of practice (Implementation phase will be up to 4 months in duration). These implementation strategies will be informed by interviews and surveys of physiotherapists and interviews of people with SCI. It is anticipated that these interviews and surveys will be completed within 3 months of the completion of the initial audit phase and the strategies to be implemented will be confirmed at this time. These may include; audit feedback systems, clinical champions; education sessions etc. The resources and materials used will reflect the chosen implementation strategy(s).
Physiotherapists adherence to the guideline recommendation will be assessed by clinical notes audit conducted pre and post the implementation phase. Fidelity of the guideline recommendation will also be assessed but during the implementation phase via spot clinical notes audit. Implementation strategies will be designed to promote sustainability of adherence and fidelity of the guideline recommendation.
Intervention code [1] 326953 0
Other interventions
Comparator / control treatment
The pre-implementation period (described current practice) is up to one year prior to the commencement of the initial audit. Audits will be conducted at NSW spinal services hospitals: Royal North Shore Hospital, Royal Rehabilitation, Prince of Wales Hospital.
Control group
Historical

Outcomes
Primary outcome [1] 335821 0
Physiotherapy adherence to guideline recommendation: adherence to the guideline recommendation will be measured by pre-post clinical notes audits
Timepoint [1] 335821 0
Baseline 0 months
On completion of the implementation intervention ~up to 7 months following baseline assessment
Follow-up ~ up to 3 months following the implementation phase.
Secondary outcome [1] 425790 0
Acceptability of Intervention Measure; A simple 5-point likert scale (1-5) for four key questions will be used to determine the physiotherapists’ beliefs that the guideline intervention is acceptable,
Timepoint [1] 425790 0
Baseline 0 months
Post implementation phase; up to ~7 months following baseline
Follow-up; up to ~10 months following baseline
Secondary outcome [2] 425791 0
Intervention Appropriateness Measure; A simple 5-point likert scale (1-5) for four key questions will be used to determine the physiotherapists beliefs that the guideline intervention is appropriate,
Timepoint [2] 425791 0
Baseline 0 months
Post implementation phase; up to ~7 months following baseline
Follow-up; up to ~10 months following baseline
Secondary outcome [3] 425792 0
Feasibility of Intervention Measure; A simple 5 point likert scale (1-5) for four key questions will be used to determine the physiotherapists’ feasibility of the intervention,
Timepoint [3] 425792 0
Baseline 0 months
Post implementation phase; up to ~7 months following baseline
Follow-up; up to ~10 months following baseline
Secondary outcome [4] 425793 0
Staff Knowledge of Guideline Recommendations; Participating physiotherapists will be asked to correctly identify the strength and direction of the guideline recommendation via a study specific questionnaire.
Timepoint [4] 425793 0
Baseline 0 months
Post implementation phase; up to ~7 months following baseline
Follow-up; up to ~10 months following baseline
Secondary outcome [5] 425794 0
NoMAD Survey (Implementation measure based on the Normalisation Process Theory); This survey aims to better understand how to implement interventions in the health care setting. The survey has 4 components that gather information regarding the perspectives of the physiotherapist on the specified recommendation.
Timepoint [5] 425794 0
Baseline 0 months
Post implementation phase ~7 months
Follow-up ~10 months
Secondary outcome [6] 425795 0
Physiotherapy Satisfaction with guideline implementation process; A simple 11-point visual analogue scale (0-10) will be used to identify physiotherapist satisfaction with the guideline implementation process,
Timepoint [6] 425795 0
Post implementation phase; up to ~7 months following baseline
Follow-up; up to ~10 months following baseline
Secondary outcome [7] 425796 0
Cost of Implementing the guideline recommendation; Data will be collected to estimate the cost of implementing the guideline recommendation. This will include; therapist time spent planning for the implementation of the guidelines e.g: meetings, interviews / focus groups; cost of strategies implemented e.g: education session, resources, equipment; therapist time to administer. These data will be recorded by participating physiotherapists in a study-specific logbook.
Timepoint [7] 425796 0
collected from baseline up until the completion of the implementation phase of the trial 0- up to 7months post baseline

Eligibility
Key inclusion criteria
1. Physiotherapists working within a NSW spinal service, or
2. Patient receiving the intervention as recommended by the clinical practice guidelines.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. are unable to provide informed consent.
2. do not speak sufficient English to participate in interviews / focus groups
3. inability to participate in interviews / focus groups due to impaired cognitive function

Study design
Purpose of the study
Treatment
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
Pre-post study
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/10/2023
Actual
Date of last participant enrolment
Anticipated
20/11/2023
Actual
Date of last data collection
Anticipated
9/09/2024
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25416 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment hospital [2] 25417 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [3] 25531 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 41384 0
2031 - Randwick
Recruitment postcode(s) [2] 41383 0
2065 - St Leonards
Recruitment postcode(s) [3] 41158 0
2112 - Ryde

Funding & Sponsors
Funding source category [1] 315027 0
Hospital
Name [1] 315027 0
Prince of Wales Hospital
Country [1] 315027 0
Australia
Funding source category [2] 315028 0
Hospital
Name [2] 315028 0
Royal Rehabilitation
Country [2] 315028 0
Australia
Funding source category [3] 315029 0
Hospital
Name [3] 315029 0
Royal North Shore Hospital
Country [3] 315029 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Kolling Institute, Royal North Shore Hospital, Reserve Rd, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 316597 0
None
Name [1] 316597 0
Address [1] 316597 0
Country [1] 316597 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313656 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 313656 0
NSLHD Research Office, Level 13 Kolling Building, Royal North Shore Hospital, Reserve Road, St Leonards, NSW, 2065
Ethics committee country [1] 313656 0
Australia
Date submitted for ethics approval [1] 313656 0
23/10/2022
Approval date [1] 313656 0
02/11/2022
Ethics approval number [1] 313656 0
ETH00991

Summary
Brief summary
A pragmatic before and after study across NSW spinal services (RNSH, POWH, RR) to identify key evidence to practice gaps and evaluate adherence to one guideline recommendation. The study has 4 distinct phases;
1. Retrospective notes audit of current clinical practice to confirm evidence to practice gap and determine adherence to key recommendations from the ‘Clinical practice guidelines for the physiotherapy management of people with SCI’ (Audit Phase).
2. Interview physiotherapists to identify barriers and facilitators of practice for key guideline recommendations from the ‘Clinical practice guidelines for the physiotherapy management of people with SCI’ (Development of Implementation Intervention Phase).
3. Implementation of tailored intervention(s) using the COM-B model for behaviour change (Implementation Phase).
4. Evaluation of change in adherence to key recommendations from the Guidelines for the physiotherapy management of people with SCI (Evaluation Phase).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128902 0
Ms Keira Tranter
Address 128902 0
John Walsh Centre for Rehabilitation Research The University of Sydney Kolling Institute Royal North Shore Hospital St Leonards NSW 2065
Country 128902 0
Australia
Phone 128902 0
+61 2 99264594
Fax 128902 0
Email 128902 0
kral0000@uni.sydney.edu.au
Contact person for public queries
Name 128903 0
Ms Keira Tranter
Address 128903 0
John Walsh Centre for Rehabilitation Research The University of Sydney Kolling Institute Royal North Shore Hospital St Leonards NSW 2065
Country 128903 0
Australia
Phone 128903 0
+61 2 99264594
Fax 128903 0
Email 128903 0
kral0000@uni.sydney.edu.au
Contact person for scientific queries
Name 128904 0
Ms Keira Tranter
Address 128904 0
John Walsh Centre for Rehabilitation Research The University of Sydney Kolling Institute Royal North Shore Hospital St Leonards NSW 2065
Country 128904 0
Australia
Phone 128904 0
+61 2 99264594
Fax 128904 0
Email 128904 0
kral0000@uni.sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.