Impact of the Mobile HealthPROMISE Platform on the Quality of Care and Quality of Life in Patients With Inflammatory Bowel Disease: Study Protocol of a Pragmatic Randomized Controlled Trial

Ashish Atreja, Sameer Khan, Jason D Rogers, Emamuzo Otobo, Nishant P Patel, Thomas Ullman, Jean Fred Colombel, Shirley Moore, Bruce E Sands, HealthPROMISE Consortium Group, Ashish Atreja, Sameer Khan, Jason D Rogers, Emamuzo Otobo, Nishant P Patel, Thomas Ullman, Jean Fred Colombel, Shirley Moore, Bruce E Sands, HealthPROMISE Consortium Group

Abstract

Background: Inflammatory 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.

Objective: The 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.

Methods: Participants 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).

Results: Enrollment 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.

Conclusions: HealthPROMISE 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. Using pragmatic trial design, we hope to show that IBD patients who participate in their own care and share in decision making have appreciably improved outcomes when compared to patients who do not.

Trial registration: ClinicalTrials.gov NCT02322307; https://ichgcp.net/clinical-trials-registry/NCT02322307 (Archived by WebCite at http://www.webcitation.org/6W8PoYThr).

Keywords: engagement; mHealth; medical informatics; patient reported outcome.

Conflict of interest statement

Conflicts of Interest: The app was developed in-house at Sinai AppLab.

Figures

Figure 1
Figure 1
Quality of life measure.
Figure 2
Figure 2
Short Inflammatory Bowel Disease Questionnaire.
Figure 3
Figure 3
Quality of care.
Figure 4
Figure 4
Point of care recruitment and randomization.
Figure 5
Figure 5
Shows initial mock-up of app.
Figure 6
Figure 6
Shows completed app.
Figure 7
Figure 7
Provider workflow on app dashboard.

References

    1. Cohen RD. The quality of life in patients with Crohn's disease. Aliment Pharmacol Ther. 2002 Sep;16(9):1603–1609.
    1. Irvine EJ. Quality of life issues in patients with inflammatory bowel disease. Am J Gastroenterol. 1997 Dec;92(12 Suppl):18S–24S.
    1. Atreja A, Bahuva R, Achkar JP, Brzezinski A, Shen B, Kandiel A, Lashner B. Can patients reliably report quality indicators and disease phenotype? Proceedings of the 11th Advances in Inflammatory Bowel Diseases, Crohn’s & Colitis Foundation’s Clinical and Research Conference; 2011 Dec 1-3; Hollywood Florida. Advances in Inflammatory Bowel Diseases, Crohn's & Colitis Foundation's Clinical and Research Conference; 2011; Hollywood, FL. 2011. Dec,
    1. De Feo J, Barnard W. Juran Institute's Six Sigma Breakthrough and Beyond: Quality Performance Breakthrough Methods. New York: McGraw-Hill; 2004.
    1. McGlynn EA, Asch SM, Adams J, Keesey J, Hicks J, DeCristofaro A, Kerr EA. The quality of health care delivered to adults in the United States. N Engl J Med. 2003 Jun 26;348(26):2635–2645. doi: 10.1056/NEJMsa022615.
    1. Centers for Medicare & Medicaid Services (CMS)‚ HHS. Medicare program; payment policies under the physician fee schedule, five-year review of work relative value units, clinical laboratory fee schedule: signature on requisition, and other revisions to part B for CY 2012. Final rule with comment period. Fed Regist. 2011 Nov 28;76(228):73026–73474.
    1. Kappelman MD, Dorn SD, Peterson E, Runge T, Allen JI. Quality of care for gastrointestinal conditions: a primer for gastroenterologists. Am J Gastroenterol. 2011 Jul;106(7):1182–1187. doi: 10.1038/ajg.2011.118.
    1. Wu SY, Green A. Projection of chronic illness prevalence and cost inflation. Santa Monica, CA: RAND Health. 2000
    1. DeVol R, Bedroussian A, Charuworn A, Chatterjee A, Kim IK, Kim S, Klowden K. Santa Monica, CA; Milken Institute. 2007. [2015-01-24]. An unhealthy America: the economic burden of chronic disease—charting a new course to save lives and increase productivity and economic growth .
    1. Kappelman MD, Palmer L, Boyle BM, Rubin DT. Quality of care in inflammatory bowel disease: a review and discussion. Inflamm Bowel Dis. 2010 Jan;16(1):125–133. doi: 10.1002/ibd.21028.
    1. Reddy SI, Friedman S, Telford JJ, Strate L, Ookubo R, Banks PA. Are patients with inflammatory bowel disease receiving optimal care? Am J Gastroenterol. 2005 Jun;100(6):1357–61. doi: 10.1111/j.1572-0241.2005.40849.x.
    1. HealthPROMISE. [2015-01-23].
    1. Sinai AppLab. [2015-01-24].
    1. Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med. 1993 Apr 15;118(8):622–629.
    1. Patient Reported Outcomes Measurement Information System. [2015-01-29]. .
    1. Project HealthDesign. [2015-01-29].
    1. Cretin S, Shortell SM, Keeler EB. An evaluation of collaborative interventions to improve chronic illness care. Framework and study design. Eval Rev. 2004 Feb;28(1):28–51. doi: 10.1177/0193841X03256298.
    1. Chen LM, Rein MS, Bates DW. Costs of quality improvement: a survey of four acute care hospitals. Jt Comm J Qual Patient Saf. 2009 Nov;35(11):544–550.
    1. Wagner EH. Chronic disease management: what will it take to improve care for chronic illness? Eff Clin Pract. 1998;1(1):2–4.
    1. Irvine EJ, Zhou Q, Thompson AK. The Short Inflammatory Bowel Disease Questionnaire: a quality of life instrument for community physicians managing inflammatory bowel disease. CCRPT Investigators. Canadian Crohn's Relapse Prevention Trial. Am J Gastroenterol. 1996 Aug;91(8):1571–1578.
    1. Rabin R, de Charro F. EQ-5D: a measure of health status from the EuroQol Group. Ann Med. 2001 Jul;33(5):337–43.
    1. Norman CD, Skinner HA. eHEALS: The eHealth Literacy Scale. J Med Internet Res. 2006;8(4):e27. doi: 10.2196/jmir.8.4.e27.
    1. Hibbard JH, Mahoney ER, Stockard J, Tusler M. Development and testing of a short form of the patient activation measure. Health Serv Res. 2005 Dec;40(6 Pt 1):1918–1930. doi: 10.1111/j.1475-6773.2005.00438.x.
    1. Allen. JI. Dassopoulos T. American Gastroenterology Association. [2014-12-17]. Adult inflammatory bowel disease physician performance measures set .
    1. The physician quality reporting system. [2014-12-17]. American Gastroenterology Association .
    1. Cebul RD, Love TE, Jain AK, Hebert CJ. Electronic health records and quality of diabetes care. N Engl J Med. 2011 Sep 1;365(9):825–833. doi: 10.1056/NEJMsa1102519.
    1. Kanwal F, Schnitzler MS, Bacon BR, Hoang T, Buchanan PM, Asch SM. Quality of care in patients with chronic hepatitis C virus infection: a cohort study. Ann Intern Med. 2010 Aug 17;153(4):231–239. doi: 10.7326/0003-4819-153-4-201008170-00005.
    1. Riippa I, Linna M, Rönkkö I. The effect of a patient portal with electronic messaging on patient activation among chronically ill patients: controlled before-and-after study. J Med Internet Res. 2014;16(11):e257. doi: 10.2196/jmir.3462.
    1. Kuijpers W, Groen WG, Aaronson NK, van Harten WH. A systematic review of web-based interventions for patient empowerment and physical activity in chronic diseases: relevance for cancer survivors. J Med Internet Res. 2013;15(2):e37. doi: 10.2196/jmir.2281.
    1. Eysenbach G, CONSORT-EHEALTH Group CONSORT-EHEALTH: improving and standardizing evaluation reports of Web-based and mobile health interventions. J Med Internet Res. 2011;13(4):e126. doi: 10.2196/jmir.1923.

Source: PubMed

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever