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Trial registered on ANZCTR


Registration number
ACTRN12617001284358
Ethics application status
Approved
Date submitted
30/08/2017
Date registered
6/09/2017
Date last updated
22/12/2021
Date data sharing statement initially provided
13/11/2019
Date results information initially provided
22/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Can an allied health and nursing expanded scope Treatment Access Pathway (TAP) improve health outcomes for people with persistent pain? A pragmatic randomised controlled trial
Scientific title
Can an allied health and nursing expanded scope Treatment Access Pathway (TAP) improve health outcomes for people with persistent pain? A pragmatic randomised controlled trial
Secondary ID [1] 292463 0
None
Universal Trial Number (UTN)
U1111-1199-4668
Trial acronym
TAP RCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Persistent Pain 304080 0
Condition category
Condition code
Public Health 303416 303416 0 0
Health service research
Physical Medicine / Rehabilitation 303417 303417 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A pragmatic randomised controlled trial design will be employed - analysis and comparison of cross over waitlist group outcomes. The proposed study has two separate study areas. The first part of the project will compare treatment from day 1 of referral (TAP without wait) to a waitlist control (Waitlist). This will provide data on clinical outcomes of treatment versus no treatment. Participants who are allocated to the treatment group (TAP without wait) will enter the TAP pathway and receive treatment. At six months, participants in the treatment group will attend an appointment with a research assistant to re-collect the measures that were administered at time 1.. This study will not directly address the question of whether TAP is effective if delivered, as it will be in routine practice, after several months of waiting for treatment (i.e., following the decline in functioning and increased pain that occurs after 6 months of waiting for treatment). This study limitation, and associated critique that RCT TAP outcomes may be inflated due to earlier treatment than can be achieved in routine service delivery, may impede implementation of TAP, should it be demonstrated to exhibit positive clinical and cost-effectiveness outcomes. Therefore, the second part of the study proposes to evaluate the clinical and cost-effectiveness of TAP in regards to likely real-world delivery (i.e., after waiting 6 months for treatment) (TAP with wait).

The treatment access pathway (TAP) TAP utilises existing allied health and nursing staffing, within the context of a GP shared care model, to provide a multidisciplinary pain centre entry point for non-urgent patients that is not contingent on receipt of a Pain Specialist assessment. TAP is an allied health and nursing expanded scope of practice model of care with full-scope (first-contact, referring to other professionals, criteria-led discharge) and extended-scope (trans-disciplinary skill sharing assessment and discharge) clinics. Components of TAP in order are Pain Services Introduction, Choose your Path (group or individual assessment) and then a combination of group only, group and individual allied health or individual allied health only interventions depending on what the patient chooses. Further explanation of the interventions on offer are below:

Pain Service Introduction:
A 90-minute large group introduction to the IPPC including service aims and expectations; an introduction to pain physiology; and further information about IPPC treatment components. At the end of this session patients elect to continue with IPPC assessment and treatment, or can elect to self-discharge if they do not require the service.

Choose Your Path Assessment:
A 5 hour small group session to assess and identify areas that may be contributing to ongoing pain. Education provided from psychology, occupational therapy, physiotherapy, nursing and pharmacy on pain physiology, thoughts and emotions, daily activities, physical health, lifestyle and medications. A modified 90 minute session is available for patients unsuitable for a group setting due to hearing, vision, cognitive, emotional or language barriers. Patients are guided to develop an individual pain management plan that provides the basis for their treatment pathway through the IPPC.

Treatment interventions
Patients then complete a combination of multidisciplinary group and individual allied health treatments, tailored to their individual pain management plan established at the Choose Your Path group assessment.

PACE (Pain Activity Coping Education) - group:
An intensive multidisciplinary program involving 8 sessions run two days per week over 4 weeks (44 hours total). Includes education and practical sessions about understanding pain; movement (QiGong, aquatic physiotherapy, strength, stretch sessions), graded walking programs, activity pacing, managing daily activities, acceptance and commitment therapy, relaxation, mindfulness, healthy lifestyles, medication and community resources.

Bounce Back - group:
Specific to neck and back pain, this small group runs 2 hours per week for 4 weeks with both pre- and post-assessment sessions (10 hours total), and provides education on pain, anatomy, muscles and nerves of the back. Includes creation of walking and exercise programs, postures for daily activities, and managing flare ups.

Mindfulness - group:
2 hours per week for 6 weeks (12 hours total), this is a modified Mindfulness Stress Based Reduction Program. Introduces the principles and practices of mindfulness, as a strategy to cope with stress, pain, and improve quality of life.

Aquatic Physiotherapy - group:
1 hour per week for 4 weeks (4 hours total) to develop and practice an individual water-based movement program.

Individual allied health sessions:
• Psychology: Assessment and formulation of biological, psychological and social factors that predispose precipitate and perpetuate an individual’s experience of persistent pain. Treatment provided with the view to foster greater quality of life and improved mental health and well-being.
• Physiotherapy: Aims to improve quality of life by increasing level of activity and participation. Assessment and treatment can focus on pathology, movement patterns or function, with education and self-empowerment to facilitate active management of persistent pain.
• Occupational Therapy: Aims for people to participate in the activities of everyday life. Assessment focuses on the impact of pain on daily life and quality of life. Treatment provided to optimise occupational performance and engagement, develop self- efficacy and pain self-management skills.
• Pharmacy: Assessment of current and past medication, adherence and appropriateness. Education provided on safe and effective use of medications, appropriate medication-taking behaviours. Recommendations provided to optimise all treatment options including management of relevant concurrent disease processes, and review following commencement of new medication.
Intervention code [1] 298645 0
Treatment: Other
Intervention code [2] 298691 0
Rehabilitation
Comparator / control treatment
Participants allocated to the waitlist control will remain on the waitlist for six months. Nil treatment will be provided by the IPPC during that time.
Control group
Active

Outcomes
Primary outcome [1] 302845 0
BPI - Interference
Timepoint [1] 302845 0
TAP treatment group: T1 (day 1) and T2 (6 months post day 1)
TAP with wait group : T1 (day 1), T2 (6 months post day 1) and T3 (12 months post day 1)
Secondary outcome [1] 337227 0
BPI - Pain scale
Timepoint [1] 337227 0
TAP treatment group: T1 (day 1) and T2 (6 months post day 1) TAP with wait group : T1 (day 1), T2 (6 months post day 1)
Secondary outcome [2] 337230 0
DASS - Depression
Timepoint [2] 337230 0
TAP treatment group: T1 (day 1) and T2 (6 months post day 1) TAP with wait group : T1 (day 1), T2 (6 months post day 1)
Secondary outcome [3] 337232 0
Patient Global Impression of Change
Timepoint [3] 337232 0
TAP treatment group: T1 (day 1) and T2 (6 months post day 1) TAP with wait group : T1 (day 1), T2 (6 months post day 1)
Secondary outcome [4] 337233 0
NIH toolbox - Motor - 2MWT (2 minute walk test)
Timepoint [4] 337233 0
TAP treatment group: T1 (day 1) and T2 (6 months post day 1) TAP with wait group : T1 (day 1), T2 (6 months post day 1)
Secondary outcome [5] 337234 0
CPAQ - Pain Willingness domain
Timepoint [5] 337234 0
TAP treatment group: T1 (day 1) and T2 (6 months post day 1) TAP with wait group : T1 (day 1), T2 (6 months post day 1)
Secondary outcome [6] 337235 0
CPAQ - Activity Engagement domain
Timepoint [6] 337235 0
TAP treatment group: T1 (day 1) and T2 (6 months post day 1) TAP with wait group : T1 (day 1), T2 (6 months post day 1)
Secondary outcome [7] 337237 0
DASS - Anxiety
Timepoint [7] 337237 0
TAP treatment group: T1 (day 1) and T2 (6 months post day 1) TAP with wait group : T1 (day 1), T2 (6 months post day 1)
Secondary outcome [8] 338346 0
DASS -Stress
Timepoint [8] 338346 0
TAP treatment group: T1 (day 1) and T2 (6 months post day 1) TAP with wait group : T1 (day 1), T2 (6 months post day 1)
Secondary outcome [9] 338347 0
Pain Self Efficacy Questionnaire (PSEQ)
Timepoint [9] 338347 0
TAP treatment group: T1 (day 1) and T2 (6 months post day 1) TAP with wait group : T1 (day 1), T2 (6 months post day 1)
Secondary outcome [10] 338348 0
Pain Catastrophising Scale (PCS)
Timepoint [10] 338348 0
TAP treatment group: T1 (day 1) and T2 (6 months post day 1) TAP with wait group : T1 (day 1), T2 (6 months post day 1)
Secondary outcome [11] 338350 0
Tampa Scale of Kinesiophobia (TSK)
Timepoint [11] 338350 0
TAP treatment group: T1 (day 1) and T2 (6 months post day 1) TAP with wait group : T1 (day 1), T2 (6 months post day 1)

Eligibility
Key inclusion criteria
Greater than or equal to 18 years of age;
Have experienced chronic non-cancer pain for more than 3 months;
Be proficient in written and spoken English;
Have a referral triaged as a category 3 (routine); and
Be deemed suitable for TAP by their GP.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have a medical/psychiatric condition that would prevent TAP engagement;
Be scheduled for surgical or interventional treatment related to their pain condition within next 6 months;
Have been engaged with IPPC within the last 12 months.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Study 1: TAP no wait group is parallel with waitlist
Study 2: One arm crossover - waitlist group crosses over and becomes TAP with wait group and receives treatment.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A-priori power analysis was completed to determine the necessary sample size N of the study, given a desired alpha level, a desired power level (1-B), and the size of the effect to be detected. The G*Power statistical package was used (Faul, F. 2007). Preliminary clinical data (unpublished) of the outcome measures shows a range of effect size between 0.3 (Depression) and 0.68 (Pain Acceptance).
Using a one tail t-test of independent groups at a significance level of p < 0.05 and a power of 80% with an effect size of 0.4 (moderate range) a sample size of N = 156 (78 in each group) will be required to reject the null hypothesis. If the groups are not of a normal distribution an increase in sample size of 28 (14 in each group) will be required. Attrition of 20% between commencement and 6 months is expected and will be accounted for with an additional 40 recruits (20 in each group) i.e. 196 participants will be recruited in total.. It is expected that 78 participants will be crossed over from waitlist to TAP (i.e., ‘TAP with wait’ group), and data for 78 participants will be available from the ‘TAP without wait’ group.

Data analyst will be masked to group allocation. Comparisons will be made between pre-post changes in outcomes for the two groups (i.e., ‘TAP without wait’ vs ‘TAP with wait’). Measures at 6 months will be analysed using a linear mixed model 45 (choice based on Akaike Information Criteria),46 with group, subjects and baseline measures as fixed factors, a random effect and covariate, respectively. SPSS (v22) will be used to analyse by intention to treat with two-tailed alpha set at 0.05. A t-test (alpha=0.05) will be used to test whether mean pre-post changes in outcome variables are different between groups (i.e., TAP without wait’ vs ‘TAP with wait’).

A t-test of independent groups will be used to examine whether the mean TAP costs/QALY gained is significantly different to $73,000 (inflation adjusted value).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/09/2017
Actual
11/09/2017
Date of last participant enrolment
Anticipated
25/06/2018
Actual
3/05/2019
Date of last data collection
Anticipated
8/05/2020
Actual
8/05/2020
Sample size
Target
196
Accrual to date
Final
181
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8587 0
Gold Coast University Hospital - Southport
Recruitment postcode(s) [1] 16694 0
4215 - Southport

Funding & Sponsors
Funding source category [1] 297031 0
Government body
Name [1] 297031 0
Health Practitioner Research Scheme, Queensland Health
Country [1] 297031 0
Australia
Funding source category [2] 297414 0
Hospital
Name [2] 297414 0
Gold Coast Hospital and Health Service
Country [2] 297414 0
Australia
Primary sponsor type
Individual
Name
Margaret Vandermost
Address
Interdisciplinary Persistent Pain Centre
2 Investigator Drive, Robina, Queensland 4226
Country
Australia
Secondary sponsor category [1] 296033 0
Hospital
Name [1] 296033 0
Interdisciplinary Persistent Pain Centre
Address [1] 296033 0
2 Investigator Drive, Robina, Queensland4226
Country [1] 296033 0
Australia
Other collaborator category [1] 279695 0
Individual
Name [1] 279695 0
Prof Michele Sterling
Address [1] 279695 0
Griffith University
School of Allied Health,
Menzies Health Institute
Parklands Drive
SOUTHPORT QLD 4222
Country [1] 279695 0
Australia
Other collaborator category [2] 279696 0
Individual
Name [2] 279696 0
Karl Bagraith
Address [2] 279696 0
Interdisciplinary Persistent Pain Centre
2 Investigator Drive, Robina, Queensland 4226
Country [2] 279696 0
Australia
Other collaborator category [3] 279697 0
Individual
Name [3] 279697 0
Hannah Kennedy
Address [3] 279697 0
Interdisciplinary Persistent Pain Centre
2 Investigator Drive, Queensland 4226
Country [3] 279697 0
Australia
Other collaborator category [4] 279698 0
Individual
Name [4] 279698 0
Darren Doherty
Address [4] 279698 0
Interdisciplinary Persistent Pain Centre
2 Investigator Drive, Robina Queensland 4226
Country [4] 279698 0
Australia
Other collaborator category [5] 279699 0
Individual
Name [5] 279699 0
Simon Kilner
Address [5] 279699 0
Interdisciplinary Persistent Pain Centre
2 Investigator Drive, Robina, Queensland 4226
Country [5] 279699 0
Australia
Other collaborator category [6] 281249 0
Individual
Name [6] 281249 0
Associate Professor - Biostatistician Mark Jones
Address [6] 281249 0
Institute for Evidence-Based Healthcare, Faculty of Health Sciences & Medicine, Level 4, Building 5, Faculty of Health Sciences & Medicine, Bond University, 14 University Drive, Robina QLD 4226
Country [6] 281249 0
Australia
Other collaborator category [7] 281250 0
Individual
Name [7] 281250 0
Professor David Henry
Address [7] 281250 0
Professor of Evidence-Based Practice, Institute for Evidence-Based Healthcare Faculty of Health Sciences & Medicine,
Level 4, Building 5, Faculty of Health Sciences & Medicine, Bond University, 14 University Drive, Robina QLD 4226
Country [7] 281250 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298216 0
Gold Coast Hospital and Health Service Human Research Ethics Committee (EC00160)
Ethics committee address [1] 298216 0
Research Directorate
Level 2, Pathology and Education Building
1 Hospital Boulevard
Southport QLD 4215
Ethics committee country [1] 298216 0
Australia
Date submitted for ethics approval [1] 298216 0
25/05/2016
Approval date [1] 298216 0
19/10/2016
Ethics approval number [1] 298216 0
HREC/16/QGC/156

Summary
Brief summary
The first part of the study aims to investigate whether an innovative allied health expanded scope Treatment Access Pathway (TAP) improves health outcomes compared to a waitlist control. The second part of the study (crossover) will investigate the clinical effectiveness of TAP following 6 months waiting for treatment. Measures of health outcomes will be objective measures of function and patient self-reports of physical function, pain, mood, acceptance, self-efficacy and health related quality of life. A secondary aim of the project is to investigate the cost-effectiveness of TAP utilising a cost-utility ratio, based on delivery cost/quality adjusted life years.

We anticipate 196 participants referred to the Gold Coast Interdisciplinary Persistent Pain Centre (IPPC) will be recruited into the study. Participants will be included if they are over 18 years of age, have non-cancer pain of greater than 3 months duration, and able to read and write adequate English to complete questionnaires. Data will be collected from participants from two cohorts: 1) those receiving standard treatment through TAP (treatment) and 2) those on the waitlist (control).

As part of routine practice, all IPPC patients receiving treatment complete objective measures and a battery of self-report questionnaires about their health-related quality of life at regular time points. Both the waitlist and treatment groups will complete the questionnaires following referral to the service (time 1) and at 6 months post referral (time 2). Additionally, the waitlist group (who will crossover into the “TAP with wait” treatment group at 6 months post referral) will complete the questionnaires at 12 months post referral (time 3).

Study 1
Primary Hypothesis: Treatment Access Pathway (TAP) patients at six months will have clinically important changes in objective physical function and self-report outcome measures (pain, mood, acceptance, self-efficacy, catastrophising and HRQOL) compared with waitlist patients.

Secondary Hypothesis: The TAP delivery cost/quality adjusted life year gained will be less than $73,000/QALY 21,23.

Study 2
Primary Hypothesis: There is no significant difference in clinical outcomes (changes in pain, objective physical function, mood, acceptance, self-efficacy, and HRQOL) between patients that wait (6 months) and do not wait for TAP.

Secondary Hypothesis: There is no significant difference in cost-effectiveness (TAP delivery cost/quality adjusted life year gained) between patients that wait (6 months) and do not wait for TAP.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1904 1904 0 0
/AnzctrAttachments/373328-HREC 16 QGC 156 AM01 approval, dated 31.03.2017.pdf (Ethics approval)
Attachments [2] 1905 1905 0 0
/AnzctrAttachments/373328-Authorisation 16 160, dated 23.02.2017.pdf (Ethics approval)

Contacts
Principal investigator
Name 76370 0
Mrs Margaret Vandermost
Address 76370 0
Interdisciplinary Persistent Pain Centre
2 Investigator Drive, Robina Queensland 4226
Country 76370 0
Australia
Phone 76370 0
+617 5668 6825
Fax 76370 0
+617 5680 9539
Email 76370 0
[email protected]
Contact person for public queries
Name 76371 0
Hannah Kennedy
Address 76371 0
Interdisciplinary Persistent Pain Centre
2 Investigator Drive, Robina Queensland 4226
Country 76371 0
Australia
Phone 76371 0
+617 5668 6825
Fax 76371 0
+617 5680 9539
Email 76371 0
[email protected]
Contact person for scientific queries
Name 76372 0
Margaret Vandermost
Address 76372 0
Interdisciplinary Persistent Pain Centre
2 Investigator Drive, Robina Queensland 4226
Country 76372 0
Australia
Phone 76372 0
+617 5668 6825
Fax 76372 0
+617 5680 9539
Email 76372 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5675Study protocol    373328-(Uploaded-04-11-2019-16-06-25)-Study-related document.docx
5676Ethical approval    373328-(Uploaded-04-11-2019-16-07-06)-Study-related document.pdf
7413Statistical analysis plan    373328-(Uploaded-03-03-2020-09-01-03)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes https://onlinelibrary.wiley.com/doi/10.1002/ejp.18... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseImprovement in pain interference and function by an allied health pain management program: Results of a randomized trial.2021https://dx.doi.org/10.1002/ejp.1836
N.B. These documents automatically identified may not have been verified by the study sponsor.