Improving Outcomes Among Urgent Care Clinic Patients With Inflammatory Bowel Disease

NCT03239704 | Unknown

• 1 other identifier: URGENT-IBD
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammatory Bowel Disease; Ulcerative Colitis; Crohn Disease

Keywords

Inflammatory Bowel Disease; Ulcerative Colitis; Crohn Disease; Quality Improvement; Telemedicine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Post-Appointment IBD related Surgery

  Within 30 days of study enrolment

• Patient Satisfaction with Health Care in IBD

  At 30 days following study enrolment

• IBD related Quality of Life

  At 30 days following study enrolment

• Disease Activity

  At 30 days following study enrolment

Study Arms (2)

Telemedicine Follow-Up and Telemedicine Monitoring

EXPERIMENTAL

Behavioral: Telemedicine Follow-Up; Other: Telemedicine Monitoring; Behavioral: 30 Day Comprehensive Questionnaire

Minimal Intervention

ACTIVE COMPARATOR

Behavioral: 30 Day Comprehensive Questionnaire

Interventions

Telemedicine Follow-Up BEHAVIORAL

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.

Telemedicine Follow-Up and Telemedicine Monitoring

Telemedicine Monitoring OTHER

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.

Telemedicine Follow-Up and Telemedicine Monitoring

30 Day Comprehensive Questionnaire BEHAVIORAL

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.

Minimal Intervention; Telemedicine Follow-Up and Telemedicine Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Crohn's and Colitis Canada: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

Location

Related Publications (7)

• 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.

  PMID: 23166905 BACKGROUND

• 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.

  PMID: 25279267 BACKGROUND

• 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.

  PMID: 24040629 BACKGROUND

• 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.

  PMID: 16779459 BACKGROUND

• 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.

  PMID: 20186353 BACKGROUND

• 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.

  PMID: 27989663 BACKGROUND

• 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.

  PMID: 23541150 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Colitis, Ulcerative; Crohn Disease

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Geoffrey C Nguyen

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoffrey C Nguyen, MD, PhD

CONTACT

416-586-4800; geoff.nguyen@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 4, 2017
• Study Start: December 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)