Digital Assessment Routing Tool (DART): Pilot Study

January 18, 2023 updated by: Queen Mary University of London

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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;

  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

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 Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Herts
      • St Helens, Herts, United Kingdom, WA11 0NA
        • Haydock Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1. Digital Assessment Routing Tool (DART) 2. Physiotherapy-led remote triage
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]

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

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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Immediately after the intervention.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants identified, shown interest to participate, and recruited to the study.
Time Frame: Through study completion, an average of 3 months.
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.
The number of errors reported in randomisation, allocation concealment, blinding or data collection.
Time Frame: Immediately after the intervention.
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.
Time Frame: Immediately after the intervention.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Mary University of London

Collaborators

Optima Health

Investigators

  • Principal Investigator: Dylan Morissey, PhD, Queen Mary University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 30, 2022

Primary Completion (Actual)

July 25, 2022

Study Completion (Actual)

July 25, 2022

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

May 21, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Actual)

January 23, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OH_QMUL_DART-Pilotstudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Musculoskeletal Diseases or Conditions

Clinical Trials on Digital Assessment Routing Tool [DART]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe