ANZCTR - Registration

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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 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]

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

Condition category

Condition code

Public Health

Health service research

Physical Medicine / Rehabilitation

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]

Treatment: Other

Intervention code [2]

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]

BPI - Interference

Timepoint [1]

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]

BPI - Pain scale

Timepoint [1]