Improving Outcomes Among Urgent Care Clinic Patients With Inflammatory Bowel Disease

NCT ID: NCT03239704

Last Updated: 2018-09-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2020-12-01

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.

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.

Conditions

Inflammatory Bowel Disease; Ulcerative Colitis; Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Telemedicine Follow-Up and Telemedicine Monitoring

Group Type: EXPERIMENTAL

Telemedicine Follow-Up

Intervention Type: 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 Monitoring

Intervention Type: 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.

30 Day Comprehensive Questionnaire

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

30 Day Comprehensive Questionnaire

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Crohn's and Colitis Canada

OTHER

Sponsor Role: collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Geoffrey C Nguyen

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

Countries

Canada

Central Contacts

Geoffrey C Nguyen, MD, PhD

Role: CONTACT

geoff.nguyen@utoronto.ca

416-586-4800 ext. 2819

Facility Contacts

Geoffrey C Nguyen, MD, PhD

Role: primary

geoff.nguyen@utoronto.ca

416-586-4800 ext. 2819

References

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.

Reference Type: BACKGROUND

PMID: 23166905 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25279267 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24040629 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16779459 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20186353 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27989663 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23541150 (View on PubMed)

Other Identifiers

URGENT-IBD

Identifier Type: -

Identifier Source: org_study_id