The design, implementation, and impact of an automated patient-reported outcome data collection and adverse event surveillance tool: a randomized trial

Background Incorporating patient-reported outcome measures into routine clinical care can improve the patient experience, increase engagement, and establish a structured method for gathering adverse event (AE) data. Systematically collecting this information on a large scale can also inform new solutions for removing treatment barriers like medication nonadherence. This study evaluated whether implementing a patient-reported outcome data collection and adverse event surveillance tool would result in greater treatment continuation for patients receiving care on a telehealth platform. Methods We used iterative plan-study-do-act cycles to evaluate how this data collection and surveillance tool--a short prompt for patients to provide information on treatment satisfaction and side effects--impacted treatment continuation, the outcome of interest. We tested two cycles in n = 2,000 patients receiving care for erectile dysfunction on a telehealth platform as a randomized controlled trial, and accounted for incidents where true randomization was not possible during implementation. The first cycle tested the tool alone, while the second cycle tested the tool in conjunction with a messaging template system that provided standardized side effect counseling. Results Compared to patients in the control group, patients in the intervention group were more likely to refill their prescription over the duration of the study period (75% vs. 71%, Kaplan Meier log-rank test, p = 0.04). Receiving standardized counseling as part of the AE response system was positively associated with treatment continuation (p = 0.0005). Conclusions Prompting patients to report side effects and outcomes outside of routine clinical visits has the potential to improve quality of care in virtual treatment. Trial registration This trial has been retrospectively registered as a clinical trial (ClinicalTrials.gov Identifier: NCT05895539, registered June 8, 2023). Keywords: Patient-reported outcomes, Patient-reported experience measures, Healthcare quality improvement, Adverse events, Side effects, Telemedicine