Musculoskeletal Diseases or ConditionsNCT04904029
Digital Assessment Routing Tool (DART): Pilot Study
A study testing Digital Assessment Routing Tool [DART] in people with Musculoskeletal Diseases or Conditions, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Diseases or Conditions
- What is being tested?
- Digital Assessment Routing Tool [DART]
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 May 2022to 25 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A current musculoskeletal injury for which they are seeking treatment
- Over 18 years old
- Able to read and speak English
- Live in the UK
- Able to access the internet
Who cannot join
- Cognitive impairments or learning disabilities that limits the participants to follow study- related procedures
- Unwillingness or inability to follow protocol-related procedures
- Optima Health employees
- Has an assessment from a health care professional for the same condition within the last 7 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation and Implementation of a Digital Assessment Routing Tool (DART) as an Alternative to Physiotherapy-led Remote Triage for Musculoskeletal Disorders: Protocol for a Pilot Randomised Crossover Non-inferiority Trial
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.
Read the detailed description
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
- A\&E referral
- Urgent GP
- Routine GP
- Consultant review
- Physiotherapy care
- Post-fracture or surgery physiotherapy
- Physiotherapy referral
- Physiotherapy referral plus psychosocial support
- Self-management
- Self-management with SOS
- Continue self-management advice
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;
- Physiotherapy care or self-management when it should have been urgent medical care (A\&E referral or urgent GP).
- Self-management when it should have been either physiotherapy care or medical care and harm could result.
- Routine care when it should have been urgent care and harm could result.
In addition, random samples of triage outcomes will be assessed to decide whether they were the most appropriate outcome.
- Conditions
- Musculoskeletal Diseases or Conditions
- Being tested
- Digital Assessment Routing Tool [DART], Physiotherapy-led remote triage (usual care)
- Keywords
- Musculoskeletal disorders, Physiotherapy, Web-based tool, Telehealth, Musculoskeletal, DART, Digital tool, Triage, Remote triage, Musculoskeletal management, Musculoskeletal triage, Clinical algorithm, Digital assessment routing tool, MSK, MSD, Telephone triage
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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;
- Medical care
- A\&E referral
- Urgent GP
- Routine GP
- Consultant review
- Physiotherapy care
- Post-fracture or surgery physiotherapy
- Physiotherapy referral
- Physiotherapy referral plus psychosocial support
- Self-management
- Self-management with SOS
- Continue self-management advice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Digital Assessment Routing Tool [DART]; Other: Physiotherapy-led remote triage (usual care) |
| 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. Receives: Other: Digital Assessment Routing Tool [DART]; Other: Physiotherapy-led remote triage (usual care) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- Medical care
- A\&E referral
- Urgent GP
- Routine GP
- Consultant review
- Physiotherapy care
- Post-fracture or surgery physiotherapy
- Physiotherapy referral
- Physiotherapy referral plus psychosocial support
- Self-management
- Self-management
- Self-management with SOS
- Continue self-management advice
Measured: Immediately after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start30 May 2022
- Primary completion25 Jul 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal Diseases or ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Pilot study to inform a pilot randomised, double-blinded, crossover, non-inferiority trial with two arms (to account for order effects).
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Optima Health
- Responsible party
- Sponsor
- Investigators
- Dylan Morissey, PhD, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04904029
- Sponsor's protocol ID
- OH_QMUL_DART-Pilotstudy
- Status last verified
- May 2021
- First submitted
- 19 Mar 2021
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39078682Lowe 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.
PubMed 34898461
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Implementation of a Digital Assessment Routing Tool (DART) as an Alternative to Physiotherapy-led Remote Triage for Musculoskeletal Disorders: Protocol for a Pilot Randomised Crossover Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04904029
- Acronym / sponsor ID
- OH_QMUL_DART-Pilotstudy
- Conditions
- Musculoskeletal Diseases or Conditions
- Keywords
- Musculoskeletal disorders, Physiotherapy, Web-based tool, Telehealth, Musculoskeletal, DART, Digital tool, Triage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Optima Health
- Study start
- 30 May 2022 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
- A\&E referral
- Urgent GP
- Routine GP
- Consultant review
- Physiotherapy care
- Post-fracture or surgery physiotherapy
- Physiotherapy referral
- Physiotherapy referral plus psychosocial support
- Self-management
- Self-management with SOS
- Continue self-management advice
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;
- Physiotherapy care or self-management when it should have been urgent medical care (A\&E referral or urgent GP).
- Self-management when it should have been either physiotherapy care or medical care and harm could result.
- Routine care when it should have been urgent care and harm could result.
In addition, random samples of triage outcomes will be assessed to decide whether they were the most appropriate outcome.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Pilot study to inform a pilot randomised, double-blinded, crossover, non-inferiority trial with two arms (to account for order effects).
| Arm | Type | Receives |
|---|---|---|
| 1. Digital Assessment Routing Tool (DART) 2. Physiotherapy-led remote triage | Experimental | Other: Digital Assessment Routing Tool [DART], Other: Physiotherapy-led remote triage (usual care)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 | Other: Digital Assessment Routing Tool [DART], Other: Physiotherapy-led remote triage (usual care)Participants complete their physiotherapy-led remote triage with the usual care clinician, which is followed by the Digital Assessment Routing Tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A current musculoskeletal injury for which they are seeking treatment
- Over 18 years old
- Able to read and speak English
- Live in the UK
- Able to access the internet
Key exclusion criteria (4 listed)
- Cognitive impairments or learning disabilities that limits the participants to follow study- related procedures
- Unwillingness or inability to follow protocol-related procedures
- Optima Health employees
- Has an assessment from a health care professional for the same condition within the last 7 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital Assessment Routing Tool [DART]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; 1. Medical care * A\&E referral * Urgent GP * Routine GP * Consultant review 2. Physiotherapy care * Post-fracture or surgery physiotherapy * Physiotherapy referral * Physiotherapy referral plus psychosocial support 3. Self-management * Self-management with SOS * Continue self-management advice | Other | 1. Digital Assessment Routing Tool (DART) 2. Physiotherapy-led remote triage, 1. Physiotherapy-led remote triage 2. Digital Assessment Routing Tool (DART) |
| Physiotherapy-led remote triage (usual care)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 | Other | 1. Digital Assessment Routing Tool (DART) 2. Physiotherapy-led remote triage, 1. Physiotherapy-led remote triage 2. Digital Assessment Routing Tool (DART) |
Primary outcome
The agreement rate between triage outcomes with management pathways from physiotherapy-led and DART triage assessments.
Time frame: Immediately after the intervention.
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. 1. Medical care * A\&E referral * Urgent GP * Routine GP * Consultant review * Physiotherapy care 2. Post-fracture or surgery physiotherapy * Physiotherapy referral * Physiotherapy referral plus psychosocial support * Self-management 3. Self-management * Self-management with SOS * Continue self-management advice
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Derived from this study: PubMed 39078682Lowe 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.
- Derived from this study: PubMed 34898461Lowe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dylan Morissey, PhD principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Assessment Routing Tool [DART] in people with Musculoskeletal Diseases or Conditions, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The agreement rate between triage outcomes with management pathways from physiotherapy-led and DART triage assessments. (time frame: Immediately after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04904029, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.