Clinical trial NCT04904029: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: Optima Health
First posted: 2021-05-27
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Pilot study to inform a pilot randomised, double-blinded, crossover, non-inferiority trial with two arms (to account for order effects).
Primary purpose: OTHER

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;

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.

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

Primary outcomes:
measure: The agreement rate between triage outcomes with management pathways from physiotherapy-led and DART triage assessments.
timeFrame: Immediately after the intervention.
Secondary outcomes:
Other outcomes:
measure: Proportion of participants identified, shown interest to participate, and recruited to the study.
timeFrame: Through study completion, an average of 3 months.
measure: The number of errors reported in randomisation, allocation concealment, blinding or data collection.
timeFrame: Immediately after the intervention.
measure: Time burden (in minutes) of interventions.
timeFrame: Immediately after the intervention.
Locations:
city: St Helens
country: United Kingdom
facility: Haydock Medical Centre
state: Herts
Study officials:
affiliation: Queen Mary University of London
name: Dylan Morissey, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.