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Trial registered on ANZCTR

Registration number

ACTRN12624001268538

Ethics application status

Approved

Date submitted

4/09/2024

Date registered

18/10/2024

Date last updated

18/10/2024

Date data sharing statement initially provided

18/10/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

Implementing integrated psychological and physical care in routine physiotherapy practice for patients with musculoskeletal road traffic injury (PICOT): a hybrid implementation-effectiveness type III cluster randomised controlled trial.

Scientific title

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

PICOT Trial

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Musculoskeletal spinal (neck and/or back) pain following a road traffic injury

Condition category

Condition code

Musculoskeletal

Other muscular and skeletal disorders

Injuries and Accidents

Other injuries and accidents

Physical Medicine / Rehabilitation

Physiotherapy

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

As this is a hybrid implementation-effectiveness type III cluster RCT, the intervention is an implementation strategy designed to upskill physiotherapists in the delivery of integrated psychological and physical care (StressModex) for patients with musculoskeletal spinal pain following road traffic injury: PICOT (Physiotherapists bIopsyChosocial On-line Training).

PICOT comprises a blended learning approach over 6 weeks, including 1) online self-paced modules, 2) real-time zoom sessions co-facilitated by a clinical psychologist and expert physiotherapist, and 3) practice feedback.
Online self-paced modules: The physiotherapists will complete 6 online self-paced modules weekly over 6 weeks, with each module taking 20-30 minutes to complete. The modules reflect the content of the StressModex treatment manual and include: (1) pain education and the influence of stress on pain, (2) stress-management strategies, e.g., relaxed breathing, muscle relaxation, (3) problem solving skills, (4) use of positive coping statements, (5) real-world practice of skills, and (6) relapse prevention. These online modules will be presented via an engaging format that includes quizzes, short videos of experts delivering StressModex, Q&A video session, and downloadable written resources. All modules are integrated with guideline recommended exercise.
Real time zoom sessions: The weekly group online sessions (each 1 hour), co-facilitated by a clinical psychologist and expert physiotherapist, will include skills role play in small break-out groups, case studies and general discussion/questions. Following the 6-week program, online facilitated discussion sessions (each 1 hour) will be held fortnightly for a further 6 weeks, to support physiotherapist training through discussion of issues that may arise as they implement StressModex into practice.
Practice feedback: After each training session delivered through online platforms, the physiotherapist will be asked to videotape the relevant practice session with a patient or colleague. The clinical psychologist will provide feedback on each of the 6 sessions to the physiotherapists.
Adherence to the online training platform modules will be monitored using analytics from the training platform. Attendance at the zoom sessions will be monitored by the research assistant recording attendance at each session.

After the physiotherapists have completed the training, the physiotherapists will recruit eligible patients from their respective clinics and deliver 6 individual sessions of StressModex over 8 weeks (StressModex is a 6-week intervention, but we will allow an additional 2 weeks for delivery to account for interruptions such as patient/physiotherapist illness, holidays, rescheduling of appointments etc.). Duration of each session will be as per standard physiotherapy consultation session with both being up to 50 minutes duration. Please see an overall outline of the week-to-week delivery of StressModex below:
Week 1: Patient education about stress and pain, relaxation techniques of abdominal breathing and exercise;
Week 2: Relaxation techniques of progressive muscle relaxation (body scans) and Exercise
Week 3: Problem Solving techniques (the physiotherapist will teach the patient problem solving techniques of identifying a problem, brainstorming solutions and weighing up options) and Exercise
Week 4: Positive coping statements (the physiotherapist will teach the patient about the effect of unhelpful thoughts on pain and stress and how these can be replaced with more helpful thoughts) and Exercise
Week 5: Developing a coping plan (the physiotherapist will teach the patient how to develop a plan to deal with individual like stressors using the skills they have learnt in the first 4 sessions) and Exercise
Week 6: Maintenance/relapse prevention (the physiotherapist will teach the patient about how to prevent relapses in their stress and pain) and Exercise.

The exercise component will include low load exercises to encourage movement, progressing to strengthening exercise as tolerated, exercises to improve eye head co-ordination, balance exercises and will advise the patient on returning to aerobic exercise (e.g. walking) and relevant daily activities. The exercises will be tailored and then progressed in individual patients as deemed appropriate by the physiotherapist. They are guideline recommended exercises of which physiotherapists are very familiar with. Some examples of the exercises include: range of movement exercises for the neck, lifting the head off the treatment bed commencing with pillows under the head progressing to lying flat, overhead press exercise with light weights progressing weight as tolerated, following a laser pointer on the wall with head and eyes, standing on one leg progressing from eyes open to eyes closed.

Focus groups will be held with physiotherapists from both training groups and champion physiotherapists at each site at the end of the patient recruitment phase (one focus group for each trial arm). Each focus group will last ~1.5 hours. To ensure a range of experiences in the focus groups, up to 10 physiotherapists from each trial arm will be purposively selected from those who opt in for the additional focus group. Selection will be based on factors such as gender, years of practice, seniority level, clinic roles (e.g., manager), geographic location, and patient volumes. A qualitative researcher in the team will conduct the focus group to gather information about the clinical setting (e.g., organisation and interpersonal dynamics, care practice) and explore physiotherapists’ experiences and barriers/facilitators to delivering StressModex within the trial. For example, questions will include physiotherapists’ experience participating in this trial, and receiving training either online or in person, recruiting and identifying eligible patient-participants, experience in delivering StressModex, considering what factors made it easy or difficult to deliver StressModex in their clinical practice, and what contextual factors or resources helped or hindered such delivery.

Intervention code [1]

Rehabilitation

Intervention code [2]

Behaviour

Comparator / control treatment

A 2-day in-person training workshop delivered to physiotherapists facilitated by a clinical psychologist and expert physiotherapist. The duration of the workshop is 14 hours (7 hours each day). The same material will be covered as in the PICOT implementation strategy (the physiotherapist on-line training). Attendance will be monitored by the research assistant recording attendance the commencement of each day.

Focus groups will be held with physiotherapists from both training groups and champion physiotherapists at each site at the end of the patient recruitment phase (one focus group for each trial arm). Each focus group will last ~1.5 hours. To ensure a range of experiences in the focus groups, up to 10 physiotherapists from each trial arm will be purposively selected from those who opt in for the additional focus group. Selection will be based on factors such as gender, years of practice, seniority level, clinic roles (e.g., manager), geographic location, and patient volumes. A qualitative researcher in the team will conduct the focus group to gather information about the clinical setting (e.g., organisation and interpersonal dynamics, care practice) and explore physiotherapists’ experiences and barriers/facilitators to delivering StressModex within the trial. For example, questions will include physiotherapists’ experience participating in this trial, and receiving training either online or in person, recruiting and identifying eligible patient-participants, experience in delivering StressModex, considering what factors made it easy or difficult to deliver StressModex in their clinical practice, and what contextual factors or resources helped or hindered such delivery.

Similar to those in the PICOT implementation strategy, physiotherapists in the comparator arm will recruit eligible patients from their clinics after completing in-person training. They will then deliver 6 individual sessions of StressModex over an 8-week period.

Control group

Active

Outcomes

Primary outcome [1]

Reach of StressModex to physiotherapy clinic patients per trial arm

Assessment method [1]

Proportion of all eligible new patients who receive at least four out of six StressModex sessions, measured by a blinded audit of anonymised medical record audit from physiotherapy sessions of all new patients treated by the physiotherapist-participants.

Timepoint [1]

At 8 months following the 6-week implementation strategies (physiotherapist training).

Secondary outcome [1]

Sustainable reach of StressModex to physiotherapy clinic patients per trial arm

Assessment method [1]

Timepoint [1]

At 12 months following the 6-week implementation strategies (physiotherapist training).

Secondary outcome [2]

Adoption of StressModex by physiotherapists per trial arm

Assessment method [2]

1) Objective measure of percentage of physiotherapist-participants who have made any attempt to deliver StressModex, measured by physiotherapy medical record audit. 2) Subjective measure through self-rated intention to deliver StressModex using a single item: ‘I intend to use the StressModex program when appropriate to treat my patients with non-catastrophic musculoskeletal road traffic injury’ (with response options ranged from “1” = “strongly disagree” to “5” = “strongly agree”).

Timepoint [2]

1) At 8 and 12 months following the 6-week implementation strategies (physiotherapist training). 2) Immediately after the 6-week implementation strategies.

Secondary outcome [3]

Dose of StressModex delivered per trial arm

Assessment method [3]

Number of StressModex sessions delivered to each patient-participant by the physiotherapist-participants measured by physiotherapy medical record audit.

Timepoint [3]

At 8 and 12 months following the 6-week implementation strategies (physiotherapist training).

Secondary outcome [4]

Fidelity 1 - Physiotherapists' adherence to StressModex treatment manual per trial arm

Assessment method [4]

1) Objective measure of physiotherapy medical record audit; 2) Evaluation of randomly selected 50% of video recordings of physiotherapist-participants delivering StressModex to patient-participants against criteria checklist.

Timepoint [4]

At 8 and 12 months following the 6-week implementation strategies (physiotherapist training).

Secondary outcome [5]

Fidelity 2 – Physiotherapists’ confidence and competency to deliver StressModex per trial arm

Assessment method [5]

1) Physiotherapist-participants self-rated confidence in delivering StressModex measured using a purpose-built 12-item questionnaire with a rating scale from 1 to 5 (1=not confident at all; 5=extremely confident); 2) Physiotherapist-participants self-rated competency in delivering StressModex measured using a purpose-built 12-item questionnaire with a rating scale from 1 to 5 (1 = beginner; 3 = competent, 5 = specialist level); 3) Evaluation of randomly selected 50% of video recordings of physiotherapist-participants delivering StressModex to patient-participants against the Therapist Quality Scale by psychologist/expert physiotherapist.

Timepoint [5]

At 8 and 12 months following the 6-week implementation strategies (physiotherapist training).

Secondary outcome [6]

Reach of the implementation strategies to physiotherapy clinics per trial arm

Assessment method [6]

Proportion of invited physiotherapy clinics that agree to undertake training following randomisation, measured by study specific log.

Timepoint [6]

Following randomisation and prior to commencement of the 6-week implementation strategies (physiotherapist training).

Secondary outcome [7]

Adoption of the implementation strategies by physiotherapists per trial arm

Assessment method [7]

Proportion of physiotherapist-participants who complete the training in full, measured by study specific log. For the PICOT arm (on-line training group): proportion of physiotherapist-participants who complete all on-line modules/provide audiotapes /attend all zoom group sessions; and proportion of clinics with a champion.

Timepoint [7]

Following completion of the 6-week implementation strategies (physiotherapist training).

Secondary outcome [8]

Dose delivered of implementation strategies per trial arm

Assessment method [8]

Number of sessions attended by the physiotherapist-participants and number of hours of training undertaken measured by study specific log. For the PICOT arm (on-line training group): the number of on-line modules completed/audiotapes provided/zoom sessions attended.

Timepoint [8]

Following completion of the 6-week implementation strategies (physiotherapist training).

Secondary outcome [9]

Fidelity of the implementation strategies by training facilitators per trial arm

Assessment method [9]

The extent to which the implementation strategies are delivered as intended measured by study specific log.

Timepoint [9]

For the PICOT arm (on-line training group), assessments will be conducted weekly during the 6-week implementation strategy period (physiotherapist training). For the in-person training arm, assessments will be conducted daily throughout 2-day in-person training scheduled towards the end of the 6-week implementation strategy period (physiotherapist training).

Secondary outcome [10]

Sustainability of implementation strategies per trial arm

Assessment method [10]

The percentage of physiotherapist-participants who are interested in training additional physiotherapists measured using a self-reported question: ‘I am interested in training physiotherapists to use the StressModex program’ (with response options ranged from “1” = “strongly disagree” to “5” = “strongly agree”).

Timepoint [10]

At the 12-months following the 6-week implementation strategies (physiotherapist training).

Secondary outcome [11]

Patient outcome 1 - Difference in pain-related function between the two arms of the trial

Assessment method [11]

Brief Pain Inventory (BPI) Interference Scale.

Timepoint [11]

Patient baseline (recruitment to the trial after the 6-week implementation strategies), and at 8 weeks, 6- and 12-months post patient baseline assessment.

Secondary outcome [12]

Patient outcome 2 - Difference in pain severity between the two arms of the trial

Assessment method [12]

Pain severity score of the BPI.

Timepoint [12]

Patient baseline (recruitment to the trial after the 6-week implementation strategies), and at 8 weeks, 6- and 12-months post patient baseline assessment.

Secondary outcome [13]

Patient outcome 3 - Difference in pain self-efficacy between the two arms of the trial

Assessment method [13]

Pain Self-Efficacy Questionnaire.

Timepoint [13]

Patient baseline (recruitment to the trial after the 6-week implementation strategies), and at 8 weeks, 6- and 12-months post patient baseline assessment.

Secondary outcome [14]

Patient outcome 4 - Difference in depression, anxiety, and stress symptoms between the two arms of the trial

Assessment method [14]

Depression, Anxiety and Stress Scale-21.

Timepoint [14]

Patient baseline (recruitment to the trial after the 6-week implementation strategies), and at 8 weeks, 6- and 12-months post patient baseline assessment.

Secondary outcome [15]

Patient outcome 5 - Difference in posttraumatic stress symptoms between the two arms of the trial

Assessment method [15]

The Posttraumatic Stress Disorder (PTSD) Checklist for the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM–5; PCL–5)

Timepoint [15]

Patient baseline (recruitment to the trial after the 6-week implementation strategies), and at 8 weeks, 6- and 12-months post patient baseline assessment

Secondary outcome [16]

Patient outcome 6 - Difference in health-related quality of life between the two arms of the trial

Assessment method [16]

EQ5D-5L

Timepoint [16]

Patient baseline (recruitment to the trial after the 6-week implementation strategies), and at 8 weeks, 6- and 12-months post patient baseline assessment

Secondary outcome [17]

Patient outcome 7 - Difference in therapeutic alliance between the two arms of the trial

Assessment method [17]

Evaluation of the last session of StressModex using the Session Rating Scale.

Timepoint [17]

After physiotherapist-participants deliver the last session of the StressModex treatment (8 weeks post patient baseline assessment).

Secondary outcome [18]

Cost-effectiveness of the two implementation strategies.

Assessment method [18]

1) Implementation package costs: the total cost of delivering the implementation strategies, including education training materials, time of psychologist and expert physiotherapist, champions time, travel and accommodation costs for physiotherapists to attend in-person training, opportunity costs of clinicians’ time, will be measured by trial-specific data; 2) Treatment (StressModex) costs: The number of treatment sessions delivered to each patient-participant measured from clinical files audits. Costs will be determined based on participating clinic data.

Timepoint [18]

Following completion of the 6-week implementation strategies, at the 8-month and 12-month periods following the 6-week implementation strategies (physiotherapist training).

Secondary outcome [19]

Implementation determinant 1: Physiotherapists’ self-rated confidence to deliver StressModex

Assessment method [19]

Physiotherapist-participants self-rated confidence in delivering StressModex measured using a purpose-built 12-item questionnaire with a rating scale from 1 to 5 (1=not confident at all; 5=extremely confident)

Timepoint [19]

Before and after the 6-week implementation strategies (physiotherapy training).

Secondary outcome [20]

Implementation determinant 2: Physiotherapists’ self-rated competency to deliver StressModex.

Assessment method [20]

Physiotherapist-participants self-rated competency in delivering StressModex measured using a purpose-built 12-item questionnaire with a rating scale from 1 to 5 (1 = beginner; 3 = competent, 5 = specialist level)

Timepoint [20]

Before and after the 6-week implementation strategies (physiotherapy training).

Secondary outcome [21]

Implementation determinant name 3: Physiotherapists’ Attitudes and Beliefs about pain. This will be assessed as a composite outcome.

Assessment method [21]

The Pain Attitudes and Beliefs Scale for Physiotherapists will be adapted for use in this outcome measure

Timepoint [21]

Before and after the 6-week implementation strategies (physiotherapy training).

Secondary outcome [22]

Implementation determinant 4: Satisfaction with the implementation strategy (physiotherapy training).

Assessment method [22]

A numeric rating scale from 0 to 10 (0: not satisfied; 10: very satisfied).

Timepoint [22]

Immediately after the 6-week implementation strategies (physiotherapy training).

Secondary outcome [23]

Implementation determinant 5: Difficulty involved with the implementation strategy (undertaking the training).

Assessment method [23]

A numeric rating scale from 0 to 10 (0: no difficulty; 10: very difficult).

Timepoint [23]

Immediately after the 6-week implementation strategies (physiotherapy training).

Secondary outcome [24]

Implementation determinant 6: Effort required with the implementation strategy (undertaking the training).

Assessment method [24]

A numeric rating scale from 0 to 10 (0: no effort; 10: very high effort).

Timepoint [24]

Immediately after the 6-week implementation strategies (physiotherapy training).

Secondary outcome [25]

Implementation determinant 7: Experience, barriers, and facilitators to deliver StressModex. This will be assessed as a composite outcome.

Assessment method [25]

Focus groups will be held with physiotherapists from both training groups and champion physiotherapists at each site at the end of the patient recruitment phase (one focus group for each trial arm). Each focus group will last ~1.5 hours. To ensure a range of experiences in the focus groups, up to 10 physiotherapists from each trial arm will be purposively selected from those who opt in for the additional focus group. Selection will be based on factors such as gender, years of practice, seniority level, clinic roles (e.g., manager), geographic location, and patient volumes. A qualitative researcher in the team will conduct the focus group to gather information about the clinical setting (e.g., organisation and interpersonal dynamics, care practice) and explore physiotherapists’ experiences and barriers/facilitators to delivering StressModex within the trial. For example, questions will include physiotherapists’ experience participating in this trial, and receiving training either online or in person, recruiting and identifying eligible patient-participants, experience in delivering StressModex, considering what factors made it easy or difficult to deliver StressModex in their clinical practice, and what contextual factors or resources helped or hindered such delivery.

Timepoint [25]

At 6 months following completion of implementation strategies (the end of the patient recruitment phase)

Eligibility

Key inclusion criteria

Inclusion criteria for the primary care physiotherapy clinics (clusters):
• Employ at least three physiotherapists.
• See approx. 30 patients with spinal musculoskeletal road traffic injury annually.

Inclusion criteria for patient participants:
• Musculoskeletal spinal (neck and/or back) pain following road traffic injury.
• Spinal pain is < /= 12 weeks in duration.
• Screened at medium to high risk of poor recovery on a validated tool appropriate for the clinical presentation (e.g., WhipPredict, Orebro, or StarTBack).
• Aged >/= 18 years.
• Proficient in written and spoken English.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria for patient participants:
• Serious spinal pathology (e.g., metastatic disease, spinal fracture or dislocation).
• Diagnosed inflammatory or neurological conditions.

Study design

Purpose of the study

Educational / counselling / training

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

To implement the allocation sequence, the trial statistician will generate the allocation sequence and email them to members of the research team organising and delivering the training. The group allocation will be kept by the trial statistician and only be disclosed to members of the research team organising and delivering the training who are not involved in data collection and analysis.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The allocation sequence will be generated using a web-based randomisation service at Griffith University. The randomisation will be conducted at the cluster (physiotherapy clinic) level. Physiotherapy clinics will be stratified by state, location (urban/regional) to ensure balance across these factors. Within each stratum, clinics will be ordered by the volume of patients and paired. The volume of patients will be determined by the estimated total number of annual patients encounters monthly. Within each pair of clinics, one clinic will be randomised to receive the PICOT implementation strategy and one clinic to usual in-person training, in a 1:1 ratio.

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

4/11/2024

Actual

Date of last participant enrolment

Anticipated

3/02/2025

Actual

Date of last data collection

Anticipated

2/02/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

NHMRC Medical Research Future Fund (MRFF) – 2022 Clinician Researchers: Nurses, Midwives and Allied Health

Country [1]

Australia

Primary sponsor type

University

Name

The University of Queensland

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University of Queensland Human Research Ethics Committee A

Ethics committee address [1]

https://www.uq.edu.au/research/research-support/ethics-integrity-and-compliance/human-ethics

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/05/2024

Approval date [1]

14/06/2024

Ethics approval number [1]

Summary

Brief summary

Primary purpose: To compare the effectiveness of the two implementation strategies (PICOT versus in-person training) on the implementation of StressModex in routine physiotherapy practice.

Secondary purpose: To evaluate the effectiveness of the two implementation strategies on patient health outcomes.

Third purpose: To assess the cost-effectiveness of the two implementation strategies

We hypothesise that (1) physiotherapists who receive the PICOT implementation strategy will be more likely to deliver StressModex to their patients with musculoskeletal spinal (neck and/or back) pain following non-catastrophic road traffic crash (measured by reach, adoption, dose, fidelity and sustainability of StressModex) compared to physiotherapists who receive usual in-person training; (2) patients of physiotherapy clinics participating in PICOT will have better health outcomes; and (3) the PICOT implementation strategy will be cost-effective compared to usual in-person training.

Trial website

https://cre-rfrti.centre.uq.edu.au/clinical-trials/picot-clinical-trial

Public notes

Contacts

Principal investigator

Name

Prof Michele Sterling

Address

RECOVER Injury Research Centre, The University of Queensland Level 7, STARS Building 296 Herston Road, HERSTON, QLD, 4029.

Country

Australia

Phone

+61 7 33464793

m.sterling@uq.edu.au

Contact person for public queries

Name

Yanfei Xie

Address

RECOVER Injury Research Centre, The University of Queensland Level 7, STARS Building 296 Herston Road, HERSTON, QLD, 4029.

Country

Australia

Phone

+61 7 3365 5560

yanfei.xie@uq.edu.au

Contact person for scientific queries

Name

Michele Sterling

Address

RECOVER Injury Research Centre, The University of Queensland Level 7, STARS Building 296 Herston Road, HERSTON, QLD, 4029.

Country

Australia

Phone

+61 7 33464793

m.sterling@uq.edu.au

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Access to trial Individual Participant Data can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP), and execution of a Data Sharing Agreement (DSA).

Conditions for requesting access:
• -

What individual participant data might be shared?

• De-identified Individual Participant Data, along with the code books and statistic codes for generating the results will be made available to available to researchers upon reasonable request.

What types of analyses could be done with individual participant data?

• Meta-analysis, individual participant data meta-analysis.

When can requests for individual participant data be made (start and end dates)?

From:
No more than two years after study completion, the data will be available.

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• By contacting the Principal Investigator Professor Michele Sterling through email: m.sterling@uq.edu.au.

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

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