Improving Outcomes Among Urgent Care Clinic Patients With Inflammatory Bowel Disease

Improving Outcomes Among Urgent Care Clinic Patients With Inflammatory Bowel Disease (URGENT-IBD)

Inflammatory Bowel Diseases (IBD) refers to a category of disorders, consisting of Crohn's Disease (CD) and Ulcerative Colitis (UC), where segments of the gastrointestinal tract become inflamed and ulcerated. Canada has among the highest incidence rates of IBD in the world - 16.3 and 12.3 per 100,000 for CD and UC respectively. In the absence of a cure, the current goal of treatment is to manage patients in a milder state of remission. However, maintaining (or even achieving) remission is dependent on timely access to specialist IBD care; which in light of rising incidence rates have proven to be challenging. Moreover, patients often experience flare-ups of their gastrointestinal symptoms, while awaiting access to specialist care. In recent years, there has been increased integration of telemedicine services in gastroenterology practice. This change has been driven by a desire among IBD patients to have more flexible follow-up care, where 'virtual' care is provided as an adjunct to in-person consultations. Within the context of IBD, telemedicine might be effective in delivering routine and timely follow-up care to high-risk patients. The purpose of this study to determine whether telemedicine-based follow-up care can effectively manage the gastrointestinal symptoms of high-risk IBD patients and reduce their need for preventive health care services.

Study Overview

• Status: Unknown
• Conditions: Crohn Disease; Ulcerative Colitis; Inflammatory Bowel Disease
• Intervention / Treatment: Behavioral: Telemedicine Follow-Up; Other: Telemedicine Monitoring; Behavioral: 30 Day Comprehensive Questionnaire

Detailed Description

Inflammatory Bowel Diseases (IBD) refers to a category of disorders, consisting of Crohn's Disease (CD) and Ulcerative Colitis (UC), where segments of the gastrointestinal tract become inflamed and ulcerated. Canada has among the highest incidence rates of IBD in the world - 16.3 and 12.3 per 100,000 for CD and UC respectively. Moreover, IBD care spans a broad range of inpatient, outpatient, and emergency services; which vary across populations due to the heterogeneous nature of these conditions. The economic burden of IBD in Canada is estimated to be $2.8 billion per anum, where direct health care costs (i.e. medications, hospitalizations, physician visits) alone exceed $1.2 billion.

In the absence of a cure, the current goal of treatment is to manage patients in a milder state of remission. However, maintaining (or even achieving) remission is dependent on timely access to specialist IBD care; which in light of rising incidence rates have proven to be challenging. Wait times for gastroenterology care are currently in excess of guidelines outlined by the Canadian Association of Gastroenterology - Wait Times Consensus Group. Moreover, patients often experience flare-ups of their gastrointestinal symptoms, while awaiting access to specialist care.

In recent years, there has been increased integration of telemedicine services in gastroenterology practice. This change has been driven by a desire among IBD patients to have more flexible follow-up care, where 'virtual' care is provided as an adjunct to in-person consultations. Telemedicine is the process by which medical information is transferred between providers and patients through an electronic interface (i.e. two-way video, smartphone applications and secure messaging). Within the context of IBD, telemedicine might be effective in delivering routine and timely follow-up care to high-risk patients. It's also enticing to speculate that if telemedicine follow-up care can adequately manage the gastrointestinal symptoms of high-risk patients, then it may also reduce their need for preventive health care services and alleviate some of the economic burden associated with these conditions.

Therefore, the purpose of this study to determine whether telemedicine-based follow-up care can effectively manage the gastrointestinal symptoms of high-risk IBD patients and reduce their need for preventive health care services. As part of this study, we will attempt to recruit all IBD outpatients, who were seen at the Mount Sinai Hospital urgent care clinic. These are a subset of high-risk IBD patients, who often have moderate to severe exacerbations of their medical condition.

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geoffrey C Nguyen, MD, PhD; Phone Number: 2819 416-586-4800; Email: geoff.nguyen@utoronto.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital
      • Contact: Geoffrey C Nguyen, MD, PhD; Phone Number: 2819 416-586-4800; Email: geoff.nguyen@utoronto.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ability to provide informed consent
• Confirmed diagnosis of Crohn's Disease or Ulcerative Colitis
• Recruited from an IBD urgent care clinic

Exclusion Criteria:

• Subjects who can't communicate in English
• Subjects who are read or write in English
• Subjects who lack internet access
• Subjects who lack access to a personal smartphone

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telemedicine Follow-Up and Telemedicine Monitoring	Behavioral: Telemedicine Follow-Up; Organized follow-up with an IBD advanced practice nurse at 24-48 hours, 7 days, and 30 days post-urgent care clinic appointment; to monitor the health status of patients with respect to their IBD.; Other: Telemedicine Monitoring; Patients will be provided access to a smartphone application entitled: 'Health Promise'. The application will generate short questionnaires every 3 days, where patients can self-report their Crohn's disease activity as measured by the PRO-2 score or Ulcerative Colitis activity as measured by the 6-Point Mayo score, and medication adherence as measured by the MMAS-8 scale. The survey responses will be monitored by an IBD advanced practice nurse, to arrange for additional telemedicine follow-up sessions or to triage patients for an expedited appointment with a gastroenterologist.; Behavioral: 30 Day Comprehensive Questionnaire; Patients will complete a web-based questionnaire at 30 days following the urgent care clinic visit when they were enrolled in the study. The questionnaire will query the following: Patient Demographics; Patient Satisfaction as measured by the CACHE Questionnaire; IBD related Quality of Life as measured by the IBDQ questionnaire; and Crohn's Disease activity as measured by the PRO-2 score or Ulcerative Colitis Activity as measured by the 6-Point Mayo score.
Active Comparator: Minimal Intervention	Behavioral: 30 Day Comprehensive Questionnaire; Patients will complete a web-based questionnaire at 30 days following the urgent care clinic visit when they were enrolled in the study. The questionnaire will query the following: Patient Demographics; Patient Satisfaction as measured by the CACHE Questionnaire; IBD related Quality of Life as measured by the IBDQ questionnaire; and Crohn's Disease activity as measured by the PRO-2 score or Ulcerative Colitis Activity as measured by the 6-Point Mayo score.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Appointment IBD related Hospital Admission	Incidence of post-appointment IBD related hospital admission will be recorded for all patients enrolled in the study. Post-appointment hospital admissions will be defined as any IBD related hospital admission following the initial urgent care clinic appointment when the patient was enrolled in the study. Post-appointment IBD related hospital admission rates will will be compared between study groups.	Within 30 days of study enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Appointment IBD related Surgery	Incidence of post-appointment IBD related surgery will be recorded for all patients enrolled in the study. Post-appointment IBD related surgery will be defined as any IBD related surgery following the initial urgent care clinic appointment when the patient was enrolled in the study. Post-appointment IBD related surgery rates will be compared between compared study groups	Within 30 days of study enrolment
Patient Satisfaction with Health Care in IBD	Patient satisfaction with health care in IBD as measured by CACHE will be collected from all patients, through a web-based questionnaire administered at 30 days following the initial urgent care clinic appointment, where the patient was enrolled in the study. Mean scores for Patient Satisfaction with Health Care in IBD will be compared between study groups.	At 30 days following study enrolment
IBD related Quality of Life	IBD related Quality of Life as measured by IBDQ will be collected from all patients, through a web-based questionnaire administered at 30 days following the initial urgent care clinic appointment, where the patient was enrolled in the study. Mean scores for IBD related Quality of Life will be be compared between study groups.	At 30 days following study enrolment
Disease Activity	Disease Activity as measured by PRO-2 score for Crohn's Disease or the 6-Point Mayo score for Ulcerative Colitis will be collected from all patients, through a web-based questionnaire administered at 30 days following the initial urgent care clinic appointment where the patient was enrolled in the study. Mean scores for disease activity will be compared between study groups.	At 30 days following study enrolment

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Collaborators: Crohn's and Colitis Canada
• Investigators: Principal Investigator: Geoffrey C Nguyen, Mount Sinai Hospital

Publications and helpful links

General Publications

• Rocchi A, Benchimol EI, Bernstein CN, Bitton A, Feagan B, Panaccione R, Glasgow KW, Fernandes A, Ghosh S. Inflammatory bowel disease: a Canadian burden of illness review. Can J Gastroenterol. 2012 Nov;26(11):811-7. doi: 10.1155/2012/984575.
• Park MD, Bhattacharya J, Park K. Differences in healthcare expenditures for inflammatory bowel disease by insurance status, income, and clinical care setting. PeerJ. 2014 Sep 23;2:e587. doi: 10.7717/peerj.587. eCollection 2014.
• Novak K, Veldhuyzen Van Zanten S, Pendharkar SR. Improving access in gastroenterology: the single point of entry model for referrals. Can J Gastroenterol. 2013 Nov;27(11):633-5. doi: 10.1155/2013/519342. Epub 2013 Sep 13.
• Paterson WG, Depew WT, Pare P, Petrunia D, Switzer C, Veldhuyzen van Zanten SJ, Daniels S; Canadian Association of Gastroenterology Wait Time Consensus Group. Canadian consensus on medically acceptable wait times for digestive health care. Can J Gastroenterol. 2006 Jun;20(6):411-23. doi: 10.1155/2006/343686.
• Paterson WG, Barkun AN, Hopman WM, Leddin DJ, Pare P, Petrunia DM, Sewitch MJ, Switzer C, van Zanten SV. Wait times for gastroenterology consultation in Canada: the patients' perspective. Can J Gastroenterol. 2010 Jan;24(1):28-32. doi: 10.1155/2010/912970.
• Cross RK, Kane S. Integration of Telemedicine Into Clinical Gastroenterology and Hepatology Practice. Clin Gastroenterol Hepatol. 2017 Feb;15(2):175-181. doi: 10.1016/j.cgh.2016.09.011. Epub 2016 Dec 16. No abstract available.
• Kemp K, Griffiths J, Campbell S, Lovell K. An exploration of the follow-up up needs of patients with inflammatory bowel disease. J Crohns Colitis. 2013 Oct;7(9):e386-95. doi: 10.1016/j.crohns.2013.03.001. Epub 2013 Mar 27.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: August 2, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 4, 2017

Study Record Updates

• Last Update Posted (Actual): September 10, 2018
• Last Update Submitted That Met QC Criteria: September 6, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Telemedicine; Ulcerative Colitis; Inflammatory Bowel Disease; Crohn Disease; Quality Improvement
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Ulcer; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: URGENT-IBD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No