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

INTERVENTION: 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 PACE (Pain Activity Coping Education) ‐ group: Bounce Back ‐ group: Mindfulness ‐ group: 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 experi CONDITION: Persistent Pain 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. 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. 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. 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. PRIMARY OUTCOME: Brief Pain Inventory (BPI)‐Modified SECONDARY OUTCOME: PROMIS ‐ Satisfaction with Social Roles and Activities Acceptance and Willingness Screener Chronic Pain Acceptance Questionnaire (CPAQ‐8) ; Cognitive Fusion Questionnaire Committed Action Questionnaire (CAQ‐8) Credibility/Expectancy Questionnaire Depression Anxiety Stress Scale (DASS‐21) NIH Toolbox Cognitive Domains: executive function, attention, memory NIH Toolbox Motor domains Pain and Activity Relations Questionnaire (PARQ) Pain Catastrophising Scale (PCS) Pain Self Efficacy Questionnaire (PSEQ) Patient Impression of Change Scales PROMIS ‐ Ability to Participate in Social Roles and Activities PROMIS ‐ Meaning and Purpose PROMIS Anxiety PROMIS Depression PROMIS Global Health Scale ; PROMIS Pain Interference PROMIS Physical Function Tampa Scale for Kinesiophobia The overactivity in chronic pain assessment tool (OCHAT) 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.