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Improving Outcomes Among Urgent Care Clinic Patients With Inflammatory Bowel Disease

Primary Purpose

Inflammatory Bowel Disease, Ulcerative Colitis, Crohn Disease

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Telemedicine Follow-Up
Telemedicine Monitoring
30 Day Comprehensive Questionnaire
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Inflammatory Bowel Disease focused on measuring Inflammatory Bowel Disease, Ulcerative Colitis, Crohn Disease, Quality Improvement, Telemedicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Telemedicine Follow-Up and Telemedicine Monitoring

Minimal Intervention

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
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.
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.

Full Information

First Posted
August 2, 2017
Last Updated
September 6, 2018
Sponsor
Mount Sinai Hospital, Canada
Collaborators
Crohn's and Colitis Canada
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1. Study Identification

Unique Protocol Identification Number
NCT03239704
Brief Title
Improving Outcomes Among Urgent Care Clinic Patients With Inflammatory Bowel Disease
Official Title
Improving Outcomes Among Urgent Care Clinic Patients With Inflammatory Bowel Disease (URGENT-IBD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada
Collaborators
Crohn's and Colitis Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Ulcerative Colitis, Crohn Disease
Keywords
Inflammatory Bowel Disease, Ulcerative Colitis, Crohn Disease, Quality Improvement, Telemedicine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Telemedicine Follow-Up and Telemedicine Monitoring
Arm Type
Experimental
Arm Title
Minimal Intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Telemedicine Follow-Up
Intervention Description
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
Other
Intervention Name(s)
Telemedicine Monitoring
Intervention Description
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
Behavioral
Intervention Name(s)
30 Day Comprehensive Questionnaire
Intervention Description
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.
Primary Outcome Measure Information:
Title
Post-Appointment IBD related Hospital Admission
Description
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.
Time Frame
Within 30 days of study enrolment
Secondary Outcome Measure Information:
Title
Post-Appointment IBD related Surgery
Description
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
Time Frame
Within 30 days of study enrolment
Title
Patient Satisfaction with Health Care in IBD
Description
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.
Time Frame
At 30 days following study enrolment
Title
IBD related Quality of Life
Description
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.
Time Frame
At 30 days following study enrolment
Title
Disease Activity
Description
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.
Time Frame
At 30 days following study enrolment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geoffrey C Nguyen, MD, PhD
Phone
416-586-4800
Ext
2819
Email
geoff.nguyen@utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey C Nguyen
Organizational Affiliation
MOUNT SINAI HOSPITAL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Geoffrey C Nguyen, MD, PhD
Phone
416-586-4800
Ext
2819
Email
geoff.nguyen@utoronto.ca

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23166905
Citation
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.
Results Reference
background
PubMed Identifier
25279267
Citation
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.
Results Reference
background
PubMed Identifier
24040629
Citation
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.
Results Reference
background
PubMed Identifier
16779459
Citation
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.
Results Reference
background
PubMed Identifier
20186353
Citation
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.
Results Reference
background
PubMed Identifier
27989663
Citation
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.
Results Reference
background
PubMed Identifier
23541150
Citation
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.
Results Reference
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Improving Outcomes Among Urgent Care Clinic Patients With Inflammatory Bowel Disease

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