PMID- 35017255
OWN - NLM
STAT- MEDLINE
DCOM- 20220321
LR  - 20220430
IS  - 2044-6055 (Electronic)
IS  - 2044-6055 (Linking)
VI  - 12
IP  - 1
DP  - 2022 Jan 11
TI  - 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.
PG  - e056339
LID - 10.1136/bmjopen-2021-056339 [doi]
LID - e056339
AB  - INTRODUCTION: Long 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 ANALYSIS: We 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 
      DISSEMINATION: This 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 NUMBER: ACTRN12621001104842.
CI  - (c) Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No 
      commercial re-use. See rights and permissions. Published by BMJ.
FAU - Zadro, Joshua R
AU  - Zadro JR
AUID- ORCID: 0000-0001-8981-2125
AD  - Institute for Musculoskeletal Health, School of Public Health, Faculty of 
      Medicine and Health, The University of Sydney, Camperdown, New South Wales, 
      Australia joshua.zadro@sydney.edu.au.
FAU - Needs, Christopher
AU  - Needs C
AD  - Royal Prince Alfred Hospital, Sydney Local Health District, Camperdown, New South 
      Wales, Australia.
FAU - Foster, Nadine E
AU  - Foster NE
AD  - Surgical, Treatment and Rehabilitation Service (STARS) Research and Education 
      Alliance, The University of Queensland, Herston, Queensland, Australia.
FAU - Martens, David
AU  - Martens D
AD  - Royal Prince Alfred Hospital, Sydney Local Health District, Camperdown, New South 
      Wales, Australia.
FAU - Coombs, Danielle M
AU  - Coombs DM
AUID- ORCID: 0000-0003-0005-7851
AD  - Institute for Musculoskeletal Health, School of Public Health, Faculty of 
      Medicine and Health, The University of Sydney, Camperdown, New South Wales, 
      Australia.
FAU - Machado, Gustavo C
AU  - Machado GC
AUID- ORCID: 0000-0002-8544-0448
AD  - Institute for Musculoskeletal Health, School of Public Health, Faculty of 
      Medicine and Health, The University of Sydney, Camperdown, New South Wales, 
      Australia.
FAU - Adams, Cameron
AU  - Adams C
AD  - Royal Prince Alfred Hospital, Sydney Local Health District, Camperdown, New South 
      Wales, Australia.
FAU - Han, Christopher S
AU  - Han CS
AD  - Institute for Musculoskeletal Health, School of Public Health, Faculty of 
      Medicine and Health, The University of Sydney, Camperdown, New South Wales, 
      Australia.
FAU - Maher, Christopher G
AU  - Maher CG
AD  - Institute for Musculoskeletal Health, School of Public Health, Faculty of 
      Medicine and Health, The University of Sydney, Camperdown, New South Wales, 
      Australia.
LA  - eng
SI  - ANZCTR/ACTRN12621001104842
PT  - Clinical Trial Protocol
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20220111
PL  - England
TA  - BMJ Open
JT  - BMJ open
JID - 101552874
SB  - IM
MH  - Feasibility Studies
MH  - Humans
MH  - *Low Back Pain/therapy
MH  - Physical Therapy Modalities
MH  - Pilot Projects
MH  - Randomized Controlled Trials as Topic
MH  - *Telemedicine
PMC - PMC8753403
OTO - NOTNLM
OT  - *back pain
OT  - *primary care
OT  - *protocols & guidelines
OT  - *rehabilitation medicine
OT  - *rheumatology
COIS- Competing interests: None declared.
EDAT- 2022/01/13 06:00
MHDA- 2022/03/22 06:00
PMCR- 2022/01/11
CRDT- 2022/01/12 06:12
PHST- 2022/01/12 06:12 [entrez]
PHST- 2022/01/13 06:00 [pubmed]
PHST- 2022/03/22 06:00 [medline]
PHST- 2022/01/11 00:00 [pmc-release]
AID - bmjopen-2021-056339 [pii]
AID - 10.1136/bmjopen-2021-056339 [doi]
PST - epublish
SO  - BMJ Open. 2022 Jan 11;12(1):e056339. doi: 10.1136/bmjopen-2021-056339.