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| Name | Class |
|---|---|
| Optima Health | UNKNOWN |
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In the pilot study, we aim to explore trial design, assess procedures, and collect exploratory data to inform the design of a future Randomised Controlled Trial.
The intervention involves a Digital Assessment Routing Tool (DART) that provides triage outcomes with recommended management pathways for participants with musculoskeletal problems. Participants complete DART either before or after their consultation with usual care clinicians (Physiotherapy-led remote triage). The triage outcome dispositions between DART and usual care clinicians will be compared.
A panel will be formed to provide consensus on disagreements that may result in adverse triage outcomes, as well as on a sample of agreements between DART and usual care clinicians.
The Digital Assessment Routing Tool (DART) is a first-contact web-based and mobile health system that uses clinical algorithms to triage patients with musculoskeletal disorders and recommend management pathways. This is achieved by completing an online web-based questionnaire that follows a clinical reasoning process commonly observed in face-to-face physiotherapy consultations. Based on the participant's answers, the clinical algorithm will generate sets of questions, leading up to a final triage disposition with a recommended management pathway. The triage outcomes with recommended management pathways are classified as follows;
Medical care
Physiotherapy care
Self-management
The usual care clinician, providing physiotherapy-led remote triage, will follow their clinical reasoning and proceed with the consultation as usual. The participants will receive both the DART assessment and usual care remote triage (crossover design). Patient care will not change (except time taken to reach a decision) as its a crossover design and only the clinician assessment will count. Note, participants will be randomised in two arms (DART, PT-remote triage or reversed) to account for order effects.
Outcomes will be collected at a single time point (Visit 1).
Post data collection, a panel consisting of researchers, physiotherapists and clinical leaders with a minimum of 5 years' experience in musculoskeletal health will provide consensus on all the disagreements between DART and physiotherapy-led remote triage that can result in adverse triage outcomes;
In addition, random samples of triage outcomes will be assessed to decide whether they were the most appropriate outcome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1. Digital Assessment Routing Tool (DART) 2. Physiotherapy-led remote triage | Experimental | Participants complete the Digital Assessment Routing Tool (DART), which is followed by physiotherapy-led remote triage with the usual care clinician. |
|
| 1. Physiotherapy-led remote triage 2. Digital Assessment Routing Tool (DART) | Experimental | Participants complete their physiotherapy-led remote triage with the usual care clinician, which is followed by the Digital Assessment Routing Tool. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Assessment Routing Tool [DART] | Other | DART is a first contact web-based and mobile health system that uses clinical algorithms to triage patients and recommend management pathways. Participants complete an online web-based questionnaire that follows a clinical reasoning process commonly observed in face-to-face physiotherapy consultations. Based on the participant's answers, the clinical algorithm generates sets of questions, leading up to a triage disposition with recommended management pathway. The triage outcomes with management pathways are classified;
|
| Measure | Description | Time Frame |
|---|---|---|
| The agreement rate between triage outcomes with management pathways from physiotherapy-led and DART triage assessments. | The primary outcome measure will be the agreement rate of triage decisions made by both the clinician and the Digital Assessment Routing Tool (DART). The possible triage outcomes with management pathways are classified in three categories, namely 1) Medical care, 2) Physiotherapy care, and 3) Self-management.
| Immediately after the intervention. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants identified, shown interest to participate, and recruited to the study. | Participants drop-out rates at each stage of the trial (and where possible reasons for dropping out) will be collected. A pre-defined criterion of 50% and 95% will be considered satisfactory for the proportion of identified participants recruited and retained, respectively. | Through study completion, an average of 3 months. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dylan Morissey, PhD | Queen Mary University of London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haydock Medical Centre | St Helens | Herts | WA11 0NA | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39078682 | Derived | Lowe C, Sephton R, Marsh W, Morrissey D. Evaluation of a Musculoskeletal Digital Assessment Routing Tool (DART): Crossover Noninferiority Randomized Pilot Trial. JMIR Form Res. 2024 Jul 30;8:e56715. doi: 10.2196/56715. | |
| 34898461 | Derived | Lowe C, Hanuman Sing H, Marsh W, Morrissey D. Validation of a Musculoskeletal Digital Assessment Routing Tool: Protocol for a Pilot Randomized Crossover Noninferiority Trial. JMIR Res Protoc. 2021 Dec 13;10(12):e31541. doi: 10.2196/31541. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 4, 2024 | |
| Reset | Sep 26, 2024 | |
| Release | Mar 7, 2025 | |
| Reset | Mar 20, 2025 | |
| Release | Mar 31, 2025 | |
| Reset | Apr 17, 2025 | |
| Release | May 9, 2025 | |
| Reset | May 28, 2025 | |
| Release | Jun 20, 2025 | |
| Reset | Jul 9, 2025 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 27, 2021 | Mar 18, 2021 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 4, 2024 | Sep 26, 2024 | |||
| Mar 7, 2025 |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
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Pilot study to inform a pilot randomised, double-blinded, crossover, non-inferiority trial with two arms (to account for order effects).
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The investigator will be blinded for group intervention and outcomes data-analysis.
|
| Physiotherapy-led remote triage (usual care) | Other | Participants will receive usual physiotherapy-led remote triage services by a registered health care professional. This service is either a telephone or video consult and includes any diagnostic procedure (e.g. patient history, remote assessments) and treatment, such as management advise or home-based exercise therapy. Participants may seek help elsewhere or opt-out the study at any point, which will not affect their usual physiotherapy-led remote care |
|
| The number of errors reported in randomisation, allocation concealment, blinding or data collection. | System process outcomes include errors reported in randomisation, allocation concealment, blinding or data collection. Any evidence for selection bias or other sources of bias will be explored. | Immediately after the intervention. |
| Time burden (in minutes) of interventions. | The overall time burden (in minutes) will be estimated from initial participant contact to first treatment, along with any treatment delay due to the additional time required to perform research procedures. | Immediately after the intervention. |
| Mar 20, 2025 |
| Mar 31, 2025 | Apr 17, 2025 |
| May 9, 2025 | May 28, 2025 |
| Jun 20, 2025 | Jul 9, 2025 |