Digital Health Co-Design
Non-randomised pilot trial
Non-randomised Pilot Trial
A non-randomised trial is a study design in which participants are assigned to intervention or control groups without random allocation. In co-design studies, it is often used in the Deliver phase to pilot-test digital health interventions in real-world settings, providing early evidence of feasibility, acceptability, and potential effectiveness before larger randomised trials are conducted.
Application Example
In a study developing MyPath, a web-based decision support tool to help women Veterans clarify reproductive goals and make informed contraceptive choices, researchers conducted a non-randomised pilot trial in two primary care clinics to test the acceptability and feasibility of the intervention. A control group (n=28) was recruited prior to the introduction of MyPath, and an intervention group (n=30) was recruited after the tool was implemented. Patients in the intervention phase used MyPath on an iPad in the waiting room before their consultation. Findings showed that MyPath was highly acceptable to participants, with 97% reporting they learned new information and 93% recommending it to others. Compared to controls, a greater proportion of intervention participants reported discussions about reproductive needs during their visits (93% vs 68%). They also demonstrated higher knowledge, greater communication self-efficacy, and reduced decision conflict, without adding to providers’ workload. (Callegari et al., 2021)