JMIR Publications

ABSTRACT

Background:

Musculoskeletal conditions account for 16% of global disability, resulting in a negative effect on millions of patients and increasing demand for healthcare utilization. Introduction of digital technologies to improve health care outcomes and efficiency have been prioritized . We have developed a musculoskeletal Digital Assessment Routing Tool (DART), enabling patients to self-assess and be directed to the right care which requires validation prior to implementation. Such innovations are rarely rigorously tested in clinical trials - considered the gold standard for evaluating safety and efficacy. This pilot study is a precursor to a trial assessing DART performance with a physiotherapist-led triage assessment.

Objective:

To evaluate trial design, assess procedures and collect exploratory data to assess feasibility of delivering an adequately powered, definitive randomized trial, assessing DART safety and efficacy in an NHS primary care setting.

Methods:

This 8-week crossover, non-inferiority pilot trial utilizing an Integrated Knowledge Translation approach, took place in an NHS England primary care practice. Participants were patients over 18 years, registered with the practice and seeking assessment for a musculoskeletal condition. All participants completed a DART assessment and the history-taking element of a face-to-face physio-led triage in a randomized order. The primary outcome was the agreement between DART and physiotherapist triage recommendation to condition management pathway. Data were collected allowing analysis of participant recruitment and retention, randomization, blinding, study burden and potential barriers to intervention delivery. Participant satisfaction with using DART was measured using the System Usability Scale.

Results:

129 patients were invited to participate, with 60% (78/129) meeting the inclusion criteria and being randomized into each intervention arm (39/39). There were no dropouts and data were analyzed for all 78 participants. Agreement between physiotherapist and DART across all participants and all primary triage outcome was 32/78, 41% (95% CI 22 to 45), ICC=0.37 (95% CI = 0.16-0.55), indicating that the reliability of DART was poor to moderate. Feedback from the clinical service team led to adjusted analysis yielding 61/78, 78% (CI 47 to 78), ICC=0.57 with a 95% confidence interval = 0.40-0.70. Participant satisfaction was measured quantitively using amalgamated System Usability Scale scores (n=78, mean score = 84.0, 90% CI = ±2.94), equating to a “Excellent” system. There were no study incidents, and trial burden was acceptable.

Conclusions:

This pilot highlighted the well documented complexity of assessing safety and effectiveness of a digital triage system. In response to this, amendments to the study protocol are proposed to improve validity of the main trial. Completion of a consensus study is recommended to inform what constitutes an acceptable noninferiority margin and subsequent calculation of the full trial sample size. It is concluded an adequately powered definitive noninferiority randomized controlled trial is feasible. Clinical Trial: Clinicaltrials.gov NCT04904029, http://clinicaltrials.gov/ct2/show/NCT04904029