NCT04904029

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 27, 2021

Completed
1 year until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2022

Completed
Last Updated

January 23, 2023

Status Verified

May 1, 2021

Enrollment Period

2 months

First QC Date

March 19, 2021

Last Update Submit

January 18, 2023

Conditions

Keywords

Musculoskeletal disordersPhysiotherapyWeb-based toolTelehealthMusculoskeletalDARTDigital toolTriageRemote triageMusculoskeletal managementMusculoskeletal triageClinical algorithmDigital assessment routing toolMSKMSDTelephone triage

Outcome Measures

Primary Outcomes (1)

  • 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. 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

    Immediately after the intervention.

Other Outcomes (3)

  • Proportion of participants identified, shown interest to participate, and recruited to the study.

    Through study completion, an average of 3 months.

  • The number of errors reported in randomisation, allocation concealment, blinding or data collection.

    Immediately after the intervention.

  • Time burden (in minutes) of interventions.

    Immediately after the intervention.

Study Arms (2)

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.

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.

Other: Digital Assessment Routing Tool [DART]Other: Physiotherapy-led remote triage (usual care)

Interventions

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

1. Digital Assessment Routing Tool (DART) 2. Physiotherapy-led remote triage1. Physiotherapy-led remote triage 2. Digital Assessment Routing Tool (DART)

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

1. Digital Assessment Routing Tool (DART) 2. Physiotherapy-led remote triage1. Physiotherapy-led remote triage 2. Digital Assessment Routing Tool (DART)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haydock Medical Centre

St Helens, Herts, WA11 0NA, United Kingdom

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Dylan Morissey, PhD

    Queen Mary University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigator will be blinded for group intervention and outcomes data-analysis.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Pilot study to inform a pilot randomised, double-blinded, crossover, non-inferiority trial with two arms (to account for order effects).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2021

First Posted

May 27, 2021

Study Start

May 30, 2022

Primary Completion

July 25, 2022

Study Completion

July 25, 2022

Last Updated

January 23, 2023

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations