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Completed

NCT Number: NCT04904029

Digital Assessment Routing Tool (DART): Pilot Study

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.

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Key information

Conditions

Musculoskeletal Diseases or Conditions Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haydock Medical Centre

St Helens, Herts, WA11 0NA, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.

    • 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

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Queen Mary University of London

Other

Collaborators

  • Optima Health

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
May 27, 2021
Registry last updated
Jan 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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