Feasibility of testing the effectiveness of a theory-informed intervention to reduce imaging for low back pain: a pilot cluster randomised controlled trial

Abstract Background General medical practitioner (GP) recruitment and subsequent data collection in clinical practice are challenging and may limit successful completion of a large-scale trial. The aim of this study was to assess the feasibility of undertaking a cluster randomised controlled trial t...

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Main Authors: Hazel J. Jenkins, Simon D. French, Anika Young, Niamh A. Moloney, Chris G. Maher, John S. Magnussen, Blake F. Dear, Mark J. Hancock
Format: Article
Language:English
Published: BMC 2022-12-01
Series:Pilot and Feasibility Studies
Subjects:
Online Access:https://doi.org/10.1186/s40814-022-01216-8
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author Hazel J. Jenkins
Simon D. French
Anika Young
Niamh A. Moloney
Chris G. Maher
John S. Magnussen
Blake F. Dear
Mark J. Hancock
author_facet Hazel J. Jenkins
Simon D. French
Anika Young
Niamh A. Moloney
Chris G. Maher
John S. Magnussen
Blake F. Dear
Mark J. Hancock
author_sort Hazel J. Jenkins
collection DOAJ
description Abstract Background General medical practitioner (GP) recruitment and subsequent data collection in clinical practice are challenging and may limit successful completion of a large-scale trial. The aim of this study was to assess the feasibility of undertaking a cluster randomised controlled trial to test an intervention to reduce non-indicated imaging for low back pain in general medical practice. Methods A pilot cluster randomised controlled trial was performed, with recruitment of GPs and randomisation of GP clinics. All GPs attended a training session and were asked to record low back pain codes in electronic medical records for any low back pain presentations. Intervention group GPs were trained in the use of a patient education booklet to be used during low back pain patient visits. Control group GPs provided usual care. Outcomes for the proposed trial were collected to determine feasibility. GP recruitment was assessed as the proportion of GPs approached who consented to participate. Low back pain imaging outcomes were collected from electronic medical records (counts of patients presenting with low back pain) and from Australian healthcare administrative (Medicare) data (counts of imaging use). GP compliance with study procedures was assessed and qualitative data reported. Results Thirty-four GP clinics were approached, with four participating (12%). At these clinics, 13/19 (68%) GPs consented to participate, and 10/19 (53%) started the study. Outcome data were collected from medical records for all GPs. Three GPs (30%) withdrew consent to access Medicare data, limiting reporting of imaging outcome measures. Three GPs (30%) self-reported low compliance entering low back pain codes. Conclusions This pilot cluster randomised controlled trial demonstrated the feasibility of many aspects of a full-scale effectiveness study, while also identifying a number of challenges that need to be resolved. Recommendations related to GP recruitment, study compliance, data collection, and outcome measures were made to increase the success of a future trial. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR), Trial ID: ACTRN12619000991112; Registered 11 July 2019, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376973
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spelling doaj.art-71308627a8324de2b537f928138e0d5b2022-12-22T02:56:43ZengBMCPilot and Feasibility Studies2055-57842022-12-018111110.1186/s40814-022-01216-8Feasibility of testing the effectiveness of a theory-informed intervention to reduce imaging for low back pain: a pilot cluster randomised controlled trialHazel J. Jenkins0Simon D. French1Anika Young2Niamh A. Moloney3Chris G. Maher4John S. Magnussen5Blake F. Dear6Mark J. Hancock7Faculty of Medicine, Health and Human Sciences, Macquarie UniversityFaculty of Medicine, Health and Human Sciences, Macquarie UniversityFaculty of Medicine, Health and Human Sciences, Macquarie UniversityFaculty of Medicine, Health and Human Sciences, Macquarie UniversityThe University of Sydney, Sydney Musculoskeletal HealthFaculty of Medicine, Health and Human Sciences, Macquarie UniversityFaculty of Medicine, Health and Human Sciences, Macquarie UniversityFaculty of Medicine, Health and Human Sciences, Macquarie UniversityAbstract Background General medical practitioner (GP) recruitment and subsequent data collection in clinical practice are challenging and may limit successful completion of a large-scale trial. The aim of this study was to assess the feasibility of undertaking a cluster randomised controlled trial to test an intervention to reduce non-indicated imaging for low back pain in general medical practice. Methods A pilot cluster randomised controlled trial was performed, with recruitment of GPs and randomisation of GP clinics. All GPs attended a training session and were asked to record low back pain codes in electronic medical records for any low back pain presentations. Intervention group GPs were trained in the use of a patient education booklet to be used during low back pain patient visits. Control group GPs provided usual care. Outcomes for the proposed trial were collected to determine feasibility. GP recruitment was assessed as the proportion of GPs approached who consented to participate. Low back pain imaging outcomes were collected from electronic medical records (counts of patients presenting with low back pain) and from Australian healthcare administrative (Medicare) data (counts of imaging use). GP compliance with study procedures was assessed and qualitative data reported. Results Thirty-four GP clinics were approached, with four participating (12%). At these clinics, 13/19 (68%) GPs consented to participate, and 10/19 (53%) started the study. Outcome data were collected from medical records for all GPs. Three GPs (30%) withdrew consent to access Medicare data, limiting reporting of imaging outcome measures. Three GPs (30%) self-reported low compliance entering low back pain codes. Conclusions This pilot cluster randomised controlled trial demonstrated the feasibility of many aspects of a full-scale effectiveness study, while also identifying a number of challenges that need to be resolved. Recommendations related to GP recruitment, study compliance, data collection, and outcome measures were made to increase the success of a future trial. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR), Trial ID: ACTRN12619000991112; Registered 11 July 2019, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376973https://doi.org/10.1186/s40814-022-01216-8Low back painDiagnostic imagingMedical imagingGeneral medical practicePatient educationPilot study
spellingShingle Hazel J. Jenkins
Simon D. French
Anika Young
Niamh A. Moloney
Chris G. Maher
John S. Magnussen
Blake F. Dear
Mark J. Hancock
Feasibility of testing the effectiveness of a theory-informed intervention to reduce imaging for low back pain: a pilot cluster randomised controlled trial
Pilot and Feasibility Studies
Low back pain
Diagnostic imaging
Medical imaging
General medical practice
Patient education
Pilot study
title Feasibility of testing the effectiveness of a theory-informed intervention to reduce imaging for low back pain: a pilot cluster randomised controlled trial
title_full Feasibility of testing the effectiveness of a theory-informed intervention to reduce imaging for low back pain: a pilot cluster randomised controlled trial
title_fullStr Feasibility of testing the effectiveness of a theory-informed intervention to reduce imaging for low back pain: a pilot cluster randomised controlled trial
title_full_unstemmed Feasibility of testing the effectiveness of a theory-informed intervention to reduce imaging for low back pain: a pilot cluster randomised controlled trial
title_short Feasibility of testing the effectiveness of a theory-informed intervention to reduce imaging for low back pain: a pilot cluster randomised controlled trial
title_sort feasibility of testing the effectiveness of a theory informed intervention to reduce imaging for low back pain a pilot cluster randomised controlled trial
topic Low back pain
Diagnostic imaging
Medical imaging
General medical practice
Patient education
Pilot study
url https://doi.org/10.1186/s40814-022-01216-8
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