Aims In order to develop an application that addresses the most significant challenges facing IBD patients, this qualitative study explored the major hurdles of living with IBD, the information needs of IBD patients, and how application technology may be used to improve quality of life. Methods 15 IBD patients participated in two focus groups of 120 minutes each. Data collection was achieved by combining focus groups with surveys and direct observation of patients looking at a patient-engaged app (HealthPROMISE) screenshots. The survey elicited information on demographics, health literacy and quality of life through the Short IBD Questionnaire (SIBDQ). Results The needs of IBD patients center around communication as it relates to both patient information needs and navigating the social impacts of IBD on patients’ lives: Communication Challenges regarding Information Needs: Patients cited a doctor-patient communication divide where there is a continued lack of goal setting when discussing treatments and a lack of objectivity in disease control. When objectively compared with the SIBDQ, nearly half of the patients in the focus groups wrongly estimated their IBD control. Communication Challenges regarding Social Impacts of IBD: Patients strongly felt that while IBD disrupts routines, adds significant stress, and contributes to a sense of isolation, the impact of these issues would be significantly alleviated through more conversation and better support. Implication for Mobile Health Solutions: Patients want a tool that improves tracking of symptoms, medication adherence and provides education. Physician feedback to patient input on an application is required for long-term sustainability. Conclusions IBD patients need mobile health technologies that evaluate disease control and the goals of care. Patients feel an objective assessment of their disease control, goal setting and physician feedback will greatly enhance utilization of all mobile health applications.

BackgroundInflammatory bowel disease (IBD) is a chronic condition of the bowel that affects over 1 million people in the United States. The recurring nature of disease makes IBD patients ideal candidates for patient-engaged care that is centered on enhanced self-management and improved doctor-patient communication. In IBD, optimal approaches to management vary for patients with different phenotypes and extent of disease and past surgical history. Hence, a single quality metric cannot define a heterogeneous disease such as IBD, unlike hypertension and diabetes. A more comprehensive assessment may be provided by complementing traditional quality metrics with measures of the patient’s quality of life (QOL) through an application like HealthPROMISE.ObjectiveThe objective of this pragmatic randomized controlled trial is to determine the impact of the HealthPROMISE app in improving outcomes (quality of care [QOC], QOL, patient adherence, disease control, and resource utilization) as compared to a patient education app. Our hypothesis is that a patient-centric self-monitoring and collaborative decision support platform will lead to sustainable improvement in overall QOL for IBD patients.MethodsParticipants will be recruited during face-to-face visits and randomized to either an interventional (ie, HealthPROMISE) or control (ie, education app). Patients in the HealthPROMISE arm will be able to update their information and receive disease summary, quality metrics, and a graph showing the trend of QOL (SIBDQ) scores and resource utilization over time. Providers will use the data for collaborative decision making and quality improvement interventions at the point of care. Patients in the control arm will enter data at baseline, during office visits, and at the end of the study but will not receive any decision support (trend of QOL, alert, or dashboard views).ResultsEnrollment in the trial will be starting in first quarter of 2015. It is intended that up to 300 patients with IBD will be recruited into the study (with 1:1 allocation ratio). The primary endpoint is number of quality indicators met in HealthPROMISE versus control arm. Secondary endpoints include decrease in number of emergency visits due to IBD, decrease in number of hospitalization due to IBD, change in generic QOL score from baseline, proportion of patients in each group who meet all eligible outpatient quality metrics, and proportion of patients in disease control in each group. In addition, we plan to conduct protocol analysis of intervention patients with adequate HealthPROMISE utilization (more than 6 log-ins with data entry from week 0 through week 52) achieving above mentioned primary and secondary endpoints.ConclusionsHealthPROMISE is a unique cloud-based patient-reported outcome (PRO) and decision support tool that empowers both patients and providers. Patients track their QOL and symptoms, and providers can use the visual data in real time (integrated with electronic health records [EHRs]) to provide better care to their entire patient population. U...

S362Poster presentations the time of initial seton placement), intermediate-term (<12 months from the time of initial seton placement), and long-term (>12 months from the time of initial seton placement) outcomes were analyzed. Results: The study cohort included 41 patients. Indication for placement of draining seton alone rather than definitive surgical fistula repair was presence of anal ulceration, stenosis and/or proctitis (n=30; 73%), complex fistulae not amenable to surgical repair (n=8; 26%) or patient preference (n=3; 7%). Concomitant medical therapy using biologics, immunomodulators, and/or steroids was used in 28 (68%), 14 (34%) and 13 (32%) patients, respectively. Median length of follow-up after seton placement was 35 months (range, 8-69). Over the short-term, 16/41 (39%) patients required additional seton placement for new or persistent fistula after median follow-up time of 2.2 months (range, 0.2-5.5 months). Over the intermediateterm, 6/37 (16%) more patients required additional seton placement for new or persistent fistula after a median follow-up time of 7.7 months (range, 7-11.4 months). Over the long-term, 7/35 (20%) more patients required additional seton placement for new or persistent fistula after a median follow-up time of 16.8 months (range, 14.5-29.5 months). Overall, 29 (71%) patients required additional seton placement for new or persistent fistula after a median time of 7 months (range, 0.2-29.5 months) after initial seton placement (Figure 1). The majority of patients requiring additional seton placement also had concomitant medical therapy with a biologic agent (19/29; 66%). Patients who had a family history of CD had a significantly lower incidence of additional seton placement (50%) compared to patients who did not have a family history of CD (90%) (p=0.04). All other clinical factors including concomitant medical therapy were not associated with additional seton placement. Conclusions: Almost 75% of patients with planned long-term seton drainage for PFCD required additional setons. These data suggest that draining setons in PFCD, even in combination with biologic agents, may not have as promising results as previously believed. Progression of PFCD remains high despite biologic therapy and seton drainage. P554 Icahn School of Medicine at Mount Sinai, Department of Medicine, New York City, United StatesBackground: Patients with IBD are ideal candidates for home-based remote monitoring care that is centered on enhanced symptom tracking and improved communication with care teams. The objective of this pragmatic randomized controlled trial is to determine the impact of the HealthPROMISE app in improving outcomes quality of care [QOC] and quality of life [QOL] as compared to a patient education app. Methods: Participants were randomized to either interventional (HealthPROMISE) or control (education app). All patients completed intake questionnaires assessing health literacy, disease severity, general health status, and demographic information. Patients in the HealthPROMISE arm were ...

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