Optimizing Research Data Acquisition with Smart Pill Bottles (SPBs), the ORDAS Trial: A Feasibility and Implementation Study Protocol

IntroductionClinical trials are fundamental to advancing all areas of medicine. Despite their importance, trials are often expensive and time-consuming due to the need for extensive human resources, with limitations in cohort sizes and potential biases from loss of follow-up. Smart pill bottles (SPBs) offer a promising innovation by automating data collection, which could reduce costs and improve the granularity and accuracy of data. This technology may provide a more efficient alternative to traditional methods, streamlining data acquisition in clinical research. ObjectivesThis proof-of-concept study aims to assess the feasibility of using smart pill bottles (SPBs) to collect data on opioid consumption in a postoperative setting, comparing their cost- efficiency and data quality to traditional methods. We hypothesize that SPBs will be readily adopted by users and enable the collection of highly granular data with fewer missing data points, while reducing the costs associated with human resource-based data collection. Material and MethodsThis single-center, single-arm trial will enroll 69 patients aged 18 and above undergoing major abdominal surgery via laparotomy. Following recruitment, patients will complete web-based questionnaires assessing pain, comorbidities, and quality of life. Postoperatively, patients will receive an SPB, the Thess Therapy Smart System manufactured by Thess Corporate (France) and provided by AppMed Inc. (Canada) to monitor opioid consumption at home for up to 90 days. At the end of the study period, participants will use the web-based platform to complete the same questionnaires, an opioid compliance checklist and a product satisfaction survey. The primary outcome will be the percentage of patients who successfully use the SPB throughout the study period. Secondary outcomes will include the extent of automated data collection, data granularity, project costs, the incidence of persistent opioid consumption, and patient satisfaction with the SPB. Trial registrationclinicaltrials.gov (July 25th, 2024). Unique protocol ID: 2025-3801. NCT number: NCT06522698.