Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000581561
Ethics application status
Approved
Date submitted
5/04/2024
Date registered
7/05/2024
Date last updated
7/05/2024
Date data sharing statement initially provided
7/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Optimising person-centred care and rehabilitation experience for adults with spinal cord injury (SCI) through implementation of psychosocial guidelines in rehabilitation units – Phase 2.
Scientific title
Implementation of psychosocial guidelines in spinal cord injury (SCI) rehabilitation units: What is the impact on person-centred health care delivery and rehabilitation experience in adults with SCI? – Phase 2
Secondary ID [1] 311891 0
None
Universal Trial Number (UTN)
U1111-1306-4726
Trial acronym
Linked study record
The current study is a follow-up study linked to the study undertaken in ACTRN12619001702101.

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 333470 0
Cognitive impairment 333471 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330148 330148 0 0
Other physical medicine / rehabilitation
Injuries and Accidents 330149 330149 0 0
Other injuries and accidents
Neurological 330150 330150 0 0
Other neurological disorders
Mental Health 330151 330151 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a mixed methods study consisting of 3 stages. The intervention will be conducted in Stage 2, informed by Stage 1, and evaluated in Stage 3. In Stage 1, we will assess the context for implementation through surveying and interviewing a range of healthcare professionals in three SCI Units (Royal North Shore Hospital [RNSH], Prince of Wales Hospital [PoWH], and Royal Rehab [RR]) in NSW Australia. In Stage 2 we will integrate the 2023 version of the Psychosocial Guidelines that promote psychological adjustment, including guidelines for cognitive impairment, into the SCI Units in Sydney, NSW, Australia. The duration of the intervention will be guided by the findings from Stage 1. In Stage 3 we will monitor the efficacy of the implementation and translation process, evaluate facilitators and barriers to successful implementation of these guidelines, explore health care professionals’ perceptions towards the implementation of these guidelines, and explore the rehabilitation experience of people with a SCI.
Stage 1 will be completed over approximately 6 months, with Stage 2 commencing directly after data collection has been completed. Stage 3 will commence directly after Stage 2 has been completed and will be conducted over approximately 6 months.
Stage 2: Implementation
Stage 2 consists of a multi-dimensional intervention that will be conducted over a period of 18 months (beginning mid-2024) and delivered by the multidisciplinary research team who have a background in psychology. The intervention will be delivered through a mixture of face-to-face and online strategies to groups of healthcare professionals, the content based on their discipline and the context of their workplace (i.e., RNSH, PoWH, RR).
Sites may trial up to 3 interventions during the same time period. The interventions will all be based on the 2023 version of the Psychosocial Guidelines but may be tailored for different health disciplines within the SCI Units (e.g., nurses, physiotherapists, dieticians), taking into account specific contexts and unique challenges identified during the Stage 1 survey and focus group processes.
A variety of “time sensitive” interventions will be trialled, such as education sessions designed for each discipline (e.g., regular team/discipline-based seminars, employee onboarding education sessions, discussions of team cultures), and training skills-based workshops designed to encourage the use of psychosocial skills in accord with the guidelines (e.g., master classes or basic level of training, audit and feedback, and active choice through prompts). Regular training sessions for Unit staff as well as training for new staff that embeds the psychosocial guidelines into practice will be needed. Further to this, interventions may include in-service training on psychosocial topics delivered on a regular basis, development of checklist of competencies for delivering person-centred care for people with SCI and providing feedback of the experience of people living with SCI at team meetings. The interventions will be designed to educate and familiarise all healthcare professionals working in the SCI Units about psychosocial care. The purpose is to optimise the implementation of the psychosocial guidelines into the practice of the SCI Units.
The training materials provided to health care professionals will be based on the 2023 version of the Psychosocial Guidelines and will be designed specifically for this study incorporating feedback from the baseline qualitative and quantitative analysis of the healthcare professionals’ views on psychosocial care and the current practices in the SCI Units.
The duration of the intervention will be guided by the findings from Stage 1. The anticipated frequency and duration of the education sessions and skills-based workshops is two 1-hour sessions at each site over a 6-month period. If we incorporate online education sessions, we anticipate one 10-minute module to be completed in the participants own time over the same 6-month period. The frequency and duration of these education sessions and workshops may vary and be tailored based on the qualitative and quantitative findings from Stage 1 (survey and focus groups).
The strategies used to monitor adherence to the interventions will depend on the mode of intervention used. This is yet to be determined as we have not progressed to this stage of the study yet. However, session attendance checklists and an online feedback survey will be used for face-to-face sessions and website analytics to determine website usage will be used if online training is implemented along with an online feedback survey.
The implementation program will involve only healthcare professionals. The interventions are intended to improve rehabilitation outcomes for future SCI patients who are receiving in-patient rehabilitation. The participants with SCI involved in this study may benefit from the outcomes of the intervention if they are still in-patients after the intervention has been implemented. The SCI participants interviewed in Stage 3 will be in-patients and potentially benefiting from the intervention as healthcare professionals will have received training in the delivery of person-centred health care during this period. However, it is likely that the SCI participants interviewed in Stage 1 will be discharged before the intervention is implemented. Although SCI out-patients will not participate in the study, future SCI out-patients may indirectly benefit from the intervention as result of improved knowledge and delivery of person-centred care within SCI units.


Intervention code [1] 328358 0
Treatment: Other
Intervention code [2] 328440 0
Behaviour
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337901 0
The effectiveness of the implementation for integrating for the 2023 version of the Psychosocial Guidelines (including guidelines for cognitive impairment) into practice in the SCI Units in Sydney, NSW.

These primary outcomes will be reviewed against data collected from Stages 1 and 3 and Consolidated Framework for Implementation Research (CFIR) implementation determinants (i.e., adoption, implementation, sustainability); as rated by healthcare professionals involved in the implementation through online surveys, interviews, and focus groups.
Timepoint [1] 337901 0
1. Baseline: pre-intervention
2. Follow-up: post-intervention

Within one month following the completion of the interventions at each site we will begin to conduct follow-up online surveys, interviews with key informants (e.g., Unit Director, Rehabilitation Medicine Physician, CNC, Social Worker, Psychologist), and focus groups.

Primary outcome [2] 338018 0
The effectiveness of the translation process for integrating for the 2023 version of the Psychosocial Guidelines (including guidelines for cognitive impairment) into practice in the SCI Units in Sydney, NSW.
Timepoint [2] 338018 0
1. Baseline: pre-intervention
2. Follow-up: 1 month post-intervention completion

Within one month following the completion of the interventions at each site we will begin to conduct follow-up online surveys, interviews with key informants, and focus groups.
Secondary outcome [1] 433625 0
To determine important factors that may impede or facilitate (i.e., barriers and facilitators) the uptake of the 2023 version of the Guidelines among multi-disciplinary healthcare professionals (HCP) involved in the rehabilitation of adults with SCI.
Timepoint [1] 433625 0
1. Baseline: pre-intervention
2. Follow-up: post-intervention

Within one month following the completion of the interventions at each site we will begin to conduct follow-up online surveys, interviews with key informants, and focus groups.
Secondary outcome [2] 433627 0
To monitor any change in Guideline uptake by healthcare professionals over time.
Timepoint [2] 433627 0
1. Baseline: pre-intervention
2. Follow-up: post-intervention

Within one month following the completion of the interventions at each site we will begin to conduct follow-up online surveys, interviews with key informants, and focus groups.
Secondary outcome [3] 433628 0
To determine the experience of patients with SCI following the introduction of the new psychosocial guidelines.
Timepoint [3] 433628 0
1. Baseline: pre-intervention
2. Follow-up: post-intervention

Within one month following the completion of the interventions at each site we will begin to conduct follow-up online surveys, interviews with key informants, and focus groups.
Secondary outcome [4] 434132 0
To monitor any change in Guideline adherence by healthcare professionals over time.
Timepoint [4] 434132 0
1. Baseline: pre-intervention
2. Follow-up: post-intervention

Within one month following the completion of the interventions at each site we will begin to conduct follow-up online surveys, interviews with key informants, and focus groups.
Secondary outcome [5] 434133 0
To determine the level of satisfaction of care of patients with SCI following the introduction of the new psychosocial guidelines.
Timepoint [5] 434133 0
1. Baseline: pre-intervention
2. Follow-up: 1 month post-intervention completion
Within one month following the completion of the interventions at each site we will begin to conduct follow-up online surveys, interviews with key informants, and focus groups.

Eligibility
Key inclusion criteria
Healthcare professionals:
a) health care professionals from each of the three SCI Units in NSW Australia who volunteer to participate in the study;
b) a minimum of 12-months experience in SCI rehabilitation;
c) representation of all disciplines working in SCI rehabilitation, and
d) being able to communicate effectively in English.

Participants with SCI:
a) patients with a SCI from each of the three SCI Units in NSW Australia who volunteer to participate in the study;
b) being able to communicate effectively in English.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Purposive sampling methods will be used to recruit representative participants. Qualitative analysis from interviews/focus group data will involve thematic analysis and directed content analysis to determine the most important themes that emerged from discussions with rehabilitation staff or people with SCI. In addition, a problem-solving technique will be used to rank ideas that emerged from focus group discussions to aid guideline implementation.

Quantitative data analysis will involve generating descriptive statistics to provide summary details of the participants’ demographics profile and to report quantitative data (e.g., frequency) regarding healthcare professionals attitudes toward psychosocial guidelines and perceived barriers and facilitators to guideline adherence. Comparative analyses using parametric (e.g., t-tests) and non-parametric (e.g., chi-square tests) will assess differences in the above outcomes according to HCP characteristics.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
21/08/2023
Date of last participant enrolment
Anticipated
31/03/2025
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
70
Accrual to date
55
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 26375 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 26376 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 26377 0
Royal Rehab - Ryde - Ryde
Recruitment postcode(s) [1] 42347 0
2065 - St Leonards
Recruitment postcode(s) [2] 42348 0
2031 - Randwick
Recruitment postcode(s) [3] 42349 0
2112 - Ryde

Funding & Sponsors
Funding source category [1] 316240 0
Government body
Name [1] 316240 0
icare
Country [1] 316240 0
Australia
Primary sponsor type
Government body
Name
Northern Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 318426 0
University
Name [1] 318426 0
The University of Sydney
Address [1] 318426 0
Country [1] 318426 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315061 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 315061 0
Ethics committee country [1] 315061 0
Australia
Date submitted for ethics approval [1] 315061 0
07/12/2022
Approval date [1] 315061 0
20/02/2023
Ethics approval number [1] 315061 0
2022/ETH02224

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

Contacts
Principal investigator
Name 133546 0
Prof Ashley Craig
Address 133546 0
John Walsh Centre for Rehabilitation Research School of Health Sciences, Faculty of Medicine and Health, The University of Sydney Level 12, The Kolling Institute, Royal North Shore Hospital, 10 Westbourne Street, St Leonards, NSW, Australia, 2065
Country 133546 0
Australia
Phone 133546 0
+61 417 290 521
Fax 133546 0
Email 133546 0
[email protected]
Contact person for public queries
Name 133547 0
Candice McBain
Address 133547 0
John Walsh Centre for Rehabilitation Research School of Health Sciences, Faculty of Medicine and Health, The University of Sydney Level 12, The Kolling Institute, Royal North Shore Hospital, 10 Westbourne Street, St Leonards, NSW, Australia, 2065
Country 133547 0
Australia
Phone 133547 0
+61 438 469 279
Fax 133547 0
Email 133547 0
[email protected]
Contact person for scientific queries
Name 133548 0
Candice McBain
Address 133548 0
John Walsh Centre for Rehabilitation Research School of Health Sciences, Faculty of Medicine and Health, The University of Sydney Level 12, The Kolling Institute, Royal North Shore Hospital, 10 Westbourne Street, St Leonards, NSW, Australia, 2065
Country 133548 0
Australia
Phone 133548 0
+61 438 469 279
Fax 133548 0
Email 133548 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Non-identifiable quantitative or qualitative data for published results only.
When will data be available (start and end dates)?
At the end of the study (anticipated date: February 2026) until data retained by a journal (as per their data retention policy), where the results of the study will be published for 5-years after the publication.
Available to whom?
Collaborators and independent researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of the Primary Sponsor and the research team.
Available for what types of analyses?
For future meta-analyses and educational purposes only.
How or where can data be obtained?
From the repository of journals where the results of the study will be published. Please note, part of this project also comprises pare of a PhD thesis and may be obtained from The University of Sydney repository.

Method of contact for data requests in the interim
Name: Candice McBain
Email: [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22104Other https://aci.health.nsw.gov.au/networks/spinal-cord-injury/resources/psychosocial-care  NSW Agency for Clinical Innovation website: https:... [More Details]



Results publications and other study-related documents

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