search
Back to results

Digital Assessment Routing Tool (DART): Pilot Study

Primary Purpose

Musculoskeletal Diseases or Conditions

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Digital Assessment Routing Tool [DART]
Physiotherapy-led remote triage (usual care)
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Musculoskeletal Diseases or Conditions focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients from outpatient clinics and Optima Health (aged 18 years or older)
  • Presentation of a musculoskeletal disorder
  • Must have a device (e.g. computer, smart phone or tablet) with access to the internet
  • Must have sufficient ability to understand and command English language (may use a translator)

Exclusion Criteria:

  • Cognitive impairments or learning disabilities that limits the participants to follow study- related procedures
  • Unwillingness or inability to follow protocol-related procedures

Sites / Locations

  • Haydock Medical Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1. Digital Assessment Routing Tool (DART) 2. Physiotherapy-led remote triage

1. Physiotherapy-led remote triage 2. Digital Assessment Routing Tool (DART)

Arm Description

Participants complete the Digital Assessment Routing Tool (DART), which is followed by physiotherapy-led remote triage with the usual care clinician.

Participants complete their physiotherapy-led remote triage with the usual care clinician, which is followed by the Digital Assessment Routing Tool.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 19, 2021
Last Updated
January 18, 2023
Sponsor
Queen Mary University of London
Collaborators
Optima Health
search

1. Study Identification

Unique Protocol Identification Number
NCT04904029
Brief Title
Digital Assessment Routing Tool (DART): Pilot 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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
May 30, 2022 (Actual)
Primary Completion Date
July 25, 2022 (Actual)
Study Completion Date
July 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London
Collaborators
Optima Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Musculoskeletal Diseases or Conditions
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Pilot study to inform a pilot randomised, double-blinded, crossover, non-inferiority trial with two arms (to account for order effects).
Masking
Care ProviderInvestigatorOutcomes Assessor
Masking Description
The investigator will be blinded for group intervention and outcomes data-analysis.
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1. Digital Assessment Routing Tool (DART) 2. Physiotherapy-led remote triage
Arm Type
Experimental
Arm Description
Participants complete the Digital Assessment Routing Tool (DART), which is followed by physiotherapy-led remote triage with the usual care clinician.
Arm Title
1. Physiotherapy-led remote triage 2. Digital Assessment Routing Tool (DART)
Arm Type
Experimental
Arm Description
Participants complete their physiotherapy-led remote triage with the usual care clinician, which is followed by the Digital Assessment Routing Tool.
Intervention Type
Other
Intervention Name(s)
Digital Assessment Routing Tool [DART]
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Physiotherapy-led remote triage (usual care)
Intervention Description
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
Primary Outcome Measure Information:
Title
The agreement rate between triage outcomes with management pathways from physiotherapy-led and DART triage assessments.
Description
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
Time Frame
Immediately after the intervention.
Other Pre-specified Outcome Measures:
Title
Proportion of participants identified, shown interest to participate, and recruited to the study.
Description
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.
Time Frame
Through study completion, an average of 3 months.
Title
The number of errors reported in randomisation, allocation concealment, blinding or data collection.
Description
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.
Time Frame
Immediately after the intervention.
Title
Time burden (in minutes) of interventions.
Description
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.
Time Frame
Immediately after the intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dylan Morissey, PhD
Organizational Affiliation
Queen Mary University of London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haydock Medical Centre
City
St Helens
State/Province
Herts
ZIP/Postal Code
WA11 0NA
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34898461
Citation
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.
Results Reference
derived

Learn more about this trial

Digital Assessment Routing Tool (DART): Pilot Study

We'll reach out to this number within 24 hrs