Web-Based Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care): Multicenter Pragmatic Nonrandomized Trial (Preprint)

Abstract

BACKGROUND Despite acceptability and efficacy of patient reported outcome (PRO) electronic systems, implementation in routine clinical care remains challenging. OBJECTIVE This pragmatic trial implemented the PROMPT-Care web-based system into existing clinical workflows and evaluating its effectiveness among a diverse cancer patient population. METHODS Participants were adult patients with solid tumours receiving active treatment or follow-up care in four cancer centers. The PROMPT-Care intervention supported patient management through a) monthly off-site electronic PRO (ePRO) physical symptom and psychosocial wellbeing assessments, b) automated electronic clinical alerts notifying the care team of unresolved clinical issues following two consecutive assessments, and c) tailored online patient self-management resources. Controls comprised the general cancer patient population (n=1911) seen at participating hospitals during the study period. The primary outcome was reduction in emergency department (ED) presentations. Secondary outcomes were time on chemotherapy and allied health service (AHS) referrals. RESULTS From April 2016-October 2018, 329 patients from four public hospitals received the intervention. Intention-to-treat analysis showed no significant between-group difference in ED presentations (p=0.961). In sub-group analyses, younger patients using PROMPT-Care as intended (completed ≥4 monthly ePROs over 6 months) had significantly fewer ED presentations (p=0.0037) than younger controls. Intervention patients with stage 0/1 disease (RR=5.54; p<0.0001) or in follow-up care (RR=3.42; p<0.0001) had more AHS referrals compared to controls. The majority of clinical feedback reports were reviewed by nursing staff (82%; 729/893), largely in response to the automated clinical alerts (n=877). CONCLUSIONS This study did not demonstrate a significant effect on the primary outcome. However, the results of the sub-group analyses are important for informing future implementation and which patients are likely to benefit most from such an intervention. This study also highlighted the importance of automated triggers for reviewing above-threshold patient reports, rather than passive manual access in patient records; and the instrumental role nurses play in managing alerts. Together these factors will inform the integration of ePRO systems into future models of routine cancer care. CLINICALTRIAL The study is registered with the Australian New Zealand Clinical Trials Registry with registration number ACTRN12616000615482. INTERNATIONAL REGISTERED REPORT RR2-https://doi.org/10.1186/s12885-018-4729-3