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Improving Outcomes Among Urgent Care Clinic Patients With Inflammatory Bowel Disease

Mount Sinai Hospital, Canada logo

Mount Sinai Hospital, Canada

Status

Unknown

Conditions

Inflammatory Bowel Disease
Ulcerative Colitis
Crohn Disease

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT03239704
URGENT-IBD

Details and patient eligibility

About

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.

Full 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.

Enrollment

450 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

450 participants in 2 patient groups

Telemedicine Follow-Up and Telemedicine Monitoring
Experimental group
Treatment:
Other: Telemedicine Monitoring
Behavioral: Telemedicine Follow-Up
Behavioral: 30 Day Comprehensive Questionnaire
Minimal Intervention
Active Comparator group
Treatment:
Behavioral: 30 Day Comprehensive Questionnaire

Trial contacts and locations

1

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Central trial contact

Geoffrey C Nguyen, MD, PhD

Data sourced from clinicaltrials.gov

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