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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]

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

Cognitive impairment

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Injuries and Accidents

Other injuries and accidents

Neurological

Other neurological disorders

Mental Health

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]

Treatment: Other

Intervention code [2]

Behaviour

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

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]

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]

Secondary outcome [2]

To monitor any change in Guideline uptake by healthcare professionals over time.

Timepoint [2]

Secondary outcome [3]

To determine the experience of patients with SCI following the introduction of the new psychosocial guidelines.

Timepoint [3]

Secondary outcome [4]

To monitor any change in Guideline adherence by healthcare professionals over time.

Timepoint [4]

Secondary outcome [5]

To determine the level of satisfaction of care of patients with SCI following the introduction of the new psychosocial guidelines.

Timepoint [5]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Royal North Shore Hospital - St Leonards

Recruitment hospital [2]

Prince of Wales Hospital - Randwick

Recruitment hospital [3]

Royal Rehab - Ryde - Ryde

Recruitment postcode(s) [1]

2065 - St Leonards

Recruitment postcode(s) [2]

2031 - Randwick

Recruitment postcode(s) [3]

2112 - Ryde

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

icare

Address [1]

Country [1]

Australia

Primary sponsor type

Government body

Name

Northern Sydney Local Health District

Address

Country

Australia

Secondary sponsor category [1]

University

Name [1]

The University of Sydney

Address [1]

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

https://www.nslhd.health.nsw.gov.au/Research/ResearchOffice/Pages/HREC.aspx

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/12/2022

Approval date [1]

20/02/2023

Ethics approval number [1]

2022/ETH02224

Summary

Brief summary

Spinal cord injury (SCI) is a life-changing severe injury resulting in substantial physical/psychological impairment. While significant research has investigated adjustment following SCI, very little is known about how co-morbid cognitive impairment impacts adjustment. It is believed around 50% of people with an SCI may have significant levels of cognitive impairment. 

The Project will employ a mixed methods approach (qualitative and quantitative) utilising implementation science to monitor the efficacy of the implementation and translation process for the 2023 version of the Psychosocial Guidelines (https://aci.health.nsw.gov.au/networks/spinal-cord-injury/resources/psychosocial-care), including guidelines for cognitive impairment, into the SCI Units in Sydney, NSW, Australia by exploring health care professionals and SCI patients’ perceptions towards the implementation of these guidelines. It is hypothesised that the intervention will promote the successful adoption, penetration, and sustainment of the 2023 version of the psychosocial guidelines in the SCI Units.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Ashley Craig

Address

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

Australia

Phone

+61 417 290 521

Fax

a.craig@sydney.edu.au

Contact person for public queries

Name

Candice McBain

Address

Country

Australia

Phone

+61 438 469 279

Fax

candice.mcbain@sydney.edu.au

Contact person for scientific queries

Name

Candice McBain

Address

Country

Australia

Phone

+61 438 469 279

Fax

candice.mcbain@sydney.edu.au

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: candice.mcbain@sydney.edu.au

What supporting documents are/will be available?

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

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