Feasibility of delivering and evaluating stratified care integrated with telehealth (‘Rapid Stratified Telehealth’) for patients with low back pain: protocol for a feasibility and pilot randomised controlled trial

Abstract

IntroductionLong waiting time is an important barrier to accessing recommended care for low back pain (LBP) in Australia’s public health system. This study describes the protocol for a randomised controlled trial (RCT) that aims to establish the feasibility of delivering and evaluating stratified care integrated with telehealth (‘Rapid Stratified Telehealth’), which aims to reduce waiting times for LBP.Methods and analysisWe will conduct a single-centre feasibility and pilot RCT with nested qualitative interviews. Sixty participants with LBP newly referred to a hospital outpatient clinic will be randomised to receive Rapid Stratified Telehealth or usual care. Rapid Stratified Telehealth involves matching the mode and type of care to participants’ risk of persistent disabling pain (using the Keele STarT MSK Tool) and presence of potential radiculopathy. ‘Low risk’ patients are matched to one session of advice over the telephone, ‘medium risk’ to telehealth physiotherapy plus App-based exercises, ‘high risk’ to telehealth physiotherapy, App-based exercises, and an online pain education programme, and ‘potential radiculopathy’ fast tracked to usual in-person care. Primary outcomes include the feasibility of delivering Rapid Stratified Telehealth (ie, acceptability assessed through interviews with clinicians and patients, intervention fidelity, appointment duration, App useability and online pain education programme usage) and evaluating Rapid Stratified Telehealth in a future trial (ie, recruitment rates, consent rates, lost to follow-up and missing data). Secondary outcomes include waiting times, number of appointments, intervention and healthcare costs, clinical outcomes (pain, function, quality of life, satisfaction), healthcare use and adverse events (AEs). Quantitative analyses will be descriptive and inform a future adequately-powered RCT. Interview data will be analysed using thematic analysis.Ethics and disseminationThis study has received approval from the Ethics Review Committee (RPAH Zone: X21-0221). Results will be published in peer-reviewed journals and presented at conferences.Trial registration numberACTRN12621001104842.

If You Build It, Will They Come? Patient and Provider Use of a Novel Hybrid Telehealth Care Pathway for Low Back Pain

“…To date, most hybrid care models described in the literature are conceptual, 16 , 26 , 27 delivered in the context of tightly controlled randomized controlled trials, 28–32 or “blended models” 33 that involve only a single provider type delivering care through telehealth or alongside a digital resource (eg, an app). 6 , 11 , 32 , 34–37 Therefore, existing examples provide little guidance on how to integrate interdisciplinary hybrid care models into “real world” health systems.…”

The relevance of research in clinical practice

“…The impact of COVID-19 has been a catalyst for innovations in clinical practice that are promoted through research, such as the feasibility and value of telehealth (Zadro, 2022). Embedding clinical research placements across healthcare settings is a possible way of further reducing the gap between evidence and practice within physiotherapy (Dario & Simic, 2021).…”