Improved Quality of Care for IBD Patients Using HealthPROMISE App: A Randomized, Control Trial

Abstract

BACKGROUND: Inflammatory bowel disease (“IBD”) is a chronic condition affecting over one million people in the United States (1). The recurrent and potentially debilitating nature of IBD elevates patients' risk for adverse health outcomes. IBD patients and providers report rushed visits, impersonal communications, and constrained resources as barriers to quality care (2). IBD patients are an ideal population to assess the therapeutic potential of a digital intervention used in conjunction with clinical methods for long-term IBD management. HealthPROMISE is an innovative software platform, developed by Sinai AppLab, comprising a patient mobile application linked to a cloud-based decision support dashboard designed to improve health outcomes and enhance quality of care (“QOC”) by increasing patient engagement, self-management skills, and communication transparency (3,4). METHODS: Recruited patients provided informed consent during in-person office visits and were randomized into intervention (HealthPROMISE) or control. Patients completed an intake questionnaire assessing health literacy, disease severity, general health status, and demographic information. The primary endpoint is QOC data based on American Gastroenterological Association's QOC indicator checklist, which was verified against and conformed to EPIC records. Secondary endpoints include decrease in IBD-related emergency visits and hospitalizations, change in quality of life (“QOL”) score from baseline, and proportion of patients reporting controlled disease status per group. In the app, HealthPROMISE patients update their information and receive a disease summary of QOC metrics and IBD-specific QOL trends. A population health coordinator monitored patient data in real-time on the HealthPROMISE dashboard and communicated with the care team and patients as needed. Ongoing collection of follow-up exit survey data captures overall medication adherence, system usability scale (SUS), SIBDQ, patient activation measures (PAM-13), and general health status (EQ-5D). (https://clinicaltrials.gov/;ct2/show/NCT02322307) RESULTS: 320 patients were enrolled in the study. 162 were randomized to intervention group and 158 to control group (Females 49.1%; White 82.2%; Black 5.3%; Hispanics 9.1%; English as primary language 96.3%; Everyday Computer Usage 93.4%) (Figure 1). IBD-QOL continued to improve among HealthPROMISE patients over a follow-up of 575 days (25.2±11.3 vs. 30.3±11.3 baseline, P<0.001) (Figure 2). Patients reported that uncontrolled anxiety (89.4%) and uncontrolled fatigue (80.9%) were major drivers of poor QOL and disproportionately contributed to disease burden (Figure 3). After an average follow-up of 495±135 days, QOC improved among all patients (78% vs. 59% control), with a more significant increase since baseline observed among HealthPROMISE users (+28 ppt vs. +9 ppt, P<0.01). After a second follow-up of 575±135 days, QOC continued improving (84% vs. 65% control) with a more significant change from baseline observed among HealthPROMISE users (+34 ppt vs. +15 ppt, P<0.01) (Figure 4). After 575 days, Screening Colonoscopy was the most met QOC indicator (92% met) while Smoking Cessation Screening with the least documented QOC indicator (7% met) (Figure 5). CONCLUSION(S): A significant improvement in QOC was observed among patients using HealthPROMISE. IBD patients engaging with HealthPROMISE reported more equitable participation in their care decision-making process, and showed improved health outcomes compared to patients not using HealthPROMISE. Digital health interventions and IBD remote monitoring can address gaps in QOC, increase patient engagement, and improve health outcomes.