- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07443098
Front Line Agreement in Diagnosis and Treatment for Musculoskeletal Dysfunctions (DirectPhysio)
The Direct Physio Project Front Line Agreement in Diagnosis and Treatment for Musculoskeletal Dysfunctions. A Prospective, Randomized, Controlled Study
Background: This randomized study, conducted from October to December 2023 in the emergency department of Bethesda Hospital Basel, Switzerland, investigated a new model of care for patients presenting with non-urgent musculoskeletal disorders (MSKDs). It was initiated in response to two major challenges in the Swiss healthcare system: a shortage of general practitioners and a rising number of ED visits for conditions such as back, neck, and shoulder pain, sprains, and other joint or muscle complaints without serious underlying pathology. Internationally, Advanced Physiotherapy Practice (APP) roles, in which specially trained physiotherapists independently assess, diagnose, treat, and discharge patients with appropriate MSKDs, have been successfully implemented in emergency settings, but this model is still novel in Switzerland, and local evidence on safety and comparability to medical care is lacking.
Methods: A total of 102 patients with musculoskeletal complaints and no signs of serious structural or systemic disease were included after informed consent. Patients were randomly assigned either to an intervention group, managed by physiotherapists working in an advanced practice role, or to a control group receiving standard care from resident physicians. Senior physicians, acting as reference standard, reviewed clinical findings, diagnoses, treatment recommendations, and discharge decisions from both groups. Agreement between each provider group and senior physicians was quantified using established measures of inter-rater reliability, specifically Cohen's Kappa (κ) and Gwet's AC1, to determine concordance beyond chance.
Conclusions: This study aims to determine whether advanced practice physiotherapists can provide clinical decision-making comparable to resident physicians for non-urgent MSKDs in the ED. Demonstrating high levels of agreement in diagnosis, management, and discharge planning would support the safe integration of APP roles into Swiss emergency workflows, with potential benefits including reduced waiting times, more efficient use of physician resources, improved patient flow, and maintenance of high standards of care and patient safety, thereby informing workforce planning and task-sharing strategies in acute care.
Study Overview
Status
Conditions
Detailed Description
The study will be conducted between October and December 2023 in the emergency department (ED) of Bethesda Hospital Basel (BSAG), Switzerland, to evaluate a new model of care for patients presenting with non-urgent musculoskeletal conditions (MSKDs). This study was motivated by two major challenges in the Swiss healthcare system: a shortage of general practitioners and an increasing number of ED visits for conditions such as back pain, neck pain, shoulder pain, sprains, and other joint or muscle complaints that do not involve serious structural injury or underlying disease.
Internationally, Advanced Physiotherapy Practice (APP) roles have been successfully implemented in emergency departments. In this model, specially trained physiotherapists assess, diagnose, treat, and discharge patients with appropriate musculoskeletal complaints, working alongside medical staff.
While this approach has been successfully implemented internationally, it remains relatively new in Switzerland, and evidence was needed to determine whether it is safe and comparable to standard medical care in the ED setting.
The aim of this study was to evaluate the level of agreement in diagnosis, treatment decisions, and discharge planning between physiotherapists and resident physicians, using senior physicians as the reference standard. A total of 102 patients presenting with musculoskeletal complaints without signs of serious underlying or structural pathology were included. After providing consent, patients were randomly assigned to one of two groups: the intervention group, in which they were assessed and managed by physiotherapists working in an advanced practice role, or the control group, in which they received standard care from resident physicians.
To ensure patient safety and provide a benchmark for comparison, senior physicians reviewed the clinical findings, diagnoses, treatment recommendations, and discharge decisions from both groups. The degree of agreement between each group and the senior physicians was analyzed using established statistical measures of inter-rater reliability, specifically Cohen's Kappa (κ) and Gwet's AC1. These methods quantify how closely clinical decisions align beyond what would be expected by chance.
This study is highly relevant for patients and families, as it explores whether qualified physiotherapists can safely and effectively manage non-urgent musculoskeletal cases in the emergency department. If agreement levels are high, this would support the safe integration of advanced practice physiotherapists into ED workflows. Potential benefits include reduced waiting times, more efficient use of physician resources, and improved patient flow, while maintaining high standards of care and patient safety.
For healthcare providers and policymakers, the findings contribute important evidence regarding task-sharing and interprofessional collaboration in acute care settings. Demonstrating comparable clinical decision-making between physiotherapists and resident physicians could support workforce innovation, help address physician shortages, and inform future healthcare planning in Switzerland. Overall, the study provides structured and objective data on the feasibility and safety of implementing Advanced Physiotherapy Practice within a Swiss emergency department context.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Basel, Switzerland, 4052
- Bethesda Spital AG - Basel
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18 to 79 years presenting with non-serious musculoskeletal conditions
- report a pain intensity between 3 and 7 on a 0-10 Numeric Rating Scale (NRS).
Exclusion Criteria:
- major trauma, fracture
- systemic signs (e.g., fever or unexplained profuse sweating)
- progressive neurological deficits (i.e., severe sensory loss or weakness)
- cauda equina syndrome with bladder or bowel dysfunction
- progressive deterioration of the general condition
- severe acute medical distress (e.g., suspected myocardial infarction)
- allergic reaction with or without skin rashes
- acute mental illness (psychological condition)
- Patients who are unwilling or unable to provide informed consent or lacking decision-making capacity.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Arm (Advanced Practice Physiotherapist-Led Care)
All patients in the ED-PT groups (3 subgroups) will undergo a medical history assessment and standardized red flag screening (Boissonnault, 2011; Lüdtke, 2021) to exclude non-musculoskeletal causes. The questionnaire will be signed by both the patient and the ED-PT. Patients with identified red flags will be excluded before randomization. Additionally, all cases will be reviewed by a senior physician to ensure safety. After exclusion of red flags, the ED-PT will perform the clinical assessment, establish a provisional diagnosis, and develop a management and discharge plan. All data will be recorded in a CRF. Before discharge, a senior physician will review and confirm the plan (yes/no) and retain final medical responsibility. A written report to the GP will conclude the ED consultation. |
All patients in the ED-PT groups (3 subgroups) will undergo a medical history assessment and standardized red flag screening (Boissonnault, 2011; Lüdtke, 2021) to exclude non-musculoskeletal causes.
The questionnaire will be signed by both the patient and the ED-PT.
Patients with identified red flags will be excluded before randomization.
Additionally, all cases will be reviewed by a senior physician to ensure safety.
After exclusion of red flags, the ED-PT will perform the clinical assessment, establish a provisional diagnosis, and develop a management and discharge plan.
All data will be recorded in a case report form (CRF). Before discharge, a senior physician will review and confirm the plan (yes/no) and retain final medical responsibility.
A written report to the GP will conclude the ED consultation.
|
|
Active Comparator: Experimental: Control Arm (Resident physician-Led Care)
Resident physicians (RPs) will perform the initial clinical assessment and propose a diagnosis and management plan, which will be reviewed and approved by a senior physician prior to discharge, in accordance with standard emergency department procedures at Bethesda Hospital AG (BSAG).
The same predefined clinical workflow will be applied in both groups (RP and ED-PT).
|
Resident physicians (RPs) will perform the initial clinical assessment and propose a diagnosis and management plan, which will be reviewed and approved by a senior physician prior to discharge, in accordance with standard emergency department procedures at Bethesda Hospital AG (BSAG).
The same predefined clinical workflow will be applied in both groups (RP and ED-PT).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Diagnostic Competence APP
Time Frame: From enrollment to the end of treatment at 13 weeks
|
Cohen's Kappa (κ) and Gwet's AC1 (AC1) with 95% confidence interval (CI) for the review of the diagnosis and follow-up recommendations
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From enrollment to the end of treatment at 13 weeks
|
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Agreement
Time Frame: From enrollment to the end of treatment at 13 weeks.
|
Description:The primary outcome will be the level of agreement, measured using Cohen's Kappa (κ) and Gwet's AC1 (AC1), regarding diagnosis and follow-up recommendations between ED-PTs resp.
residents (control group), and the senior physician.
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From enrollment to the end of treatment at 13 weeks.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Amir Tal, PhD, Bern University of Applied Sciences
Publications and helpful links
General Publications
- Winteler, B., Geese, F., Lehmann, B., & Schmitt, K.-U. (2022). Musculoskeletal Physiotherapy in the Emergency Department - Evaluation of a New Physiotherapy Service in a Swiss University Hospital. Physioscience, 18(02), 69-76. https://doi.org/10.1055/a-1500-1077
- Goodwin, R. W., & Hendrick, P. A. (2016). Physiotherapy as a first point of contact in general prac-tice: A solution to a growing problem? Primary Health Care Research & Development, 17(5), 489-502. https://doi.org/10.1017/S1463423616000189
- Ferreira, G. E., Traeger, A. C., & Maher, C. G. (2019). Review article: A scoping review of physiother-apists in the adult emergency department. Emergency Medicine Australasia, 31(1), 43-57. https://doi.org/10.1111/1742-6723.12987
- Downie, F., McRitchie, C., Monteith, W., & Turner, H. (2019). Physiotherapist as an alternative to a GP for musculoskeletal conditions: A 2-year service evaluation of UK primary care data. Brit-ish Journal of General Practice, 69(682), e314-e320. https://doi.org/10.3399/bjgp19X702245
- de Gruchy, A., Granger, C., & Gorelik, A. (2015). Physical Therapists as Primary Practitioners in the Emergency Department: Six-Month Prospective Practice Analysis. Physical Therapy, 95(9), 1207-1216. https://doi.org/10.2522/ptj.20130552
- Bird, S., Thompson, C., & Williams, K. E. (2016). Primary contact physiotherapy services re-duce waiting and treatment times for patients presenting with musculoskeletal conditions in Australian emergency departments: An observational study. Journal of Physiotherapy, 62(4), 209-214. https://doi.org/10.1016/j.jphys.2016.08.005
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Bern UniversityApplied Science
- 2023-01399 (Other Identifier: EKNZ - Ethikkommission Nordwes)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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