Patient Centered Algorithms to Optimize the Inpatient Experience and Treatment of Ulcerative Colitis (PATIENT-UC)
Primary Purpose
Colitis, Ulcerative, Inflammatory Bowel Diseases, Colitis
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Educational video
Sponsored by
About this trial
This is an interventional health services research trial for Colitis, Ulcerative focused on measuring ulcerative colitis, inflammatory bowel disease, education, patient-reported outcomes
Eligibility Criteria
Inclusion Criteria:
- diagnosis of ulcerative colitis
- able to provide informed consent
- admission to hospital with flare of underlying ulcerative colitis
Exclusion Criteria:
- Crohn's disease
- inability to provide informed consent
- readmission during study period (intervention would only be used on the initial admission during the study period)
Sites / Locations
- Mount Sinai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Educational Video
Usual Care
Arm Description
Subjects to have access to educational video during hospital stay
Patients to receive usual care and will not have access to educational video.
Outcomes
Primary Outcome Measures
Overall length of stay
Percentage of patients undergoing colectomy
Secondary Outcome Measures
Full Information
NCT ID
NCT02569333
First Posted
September 29, 2015
Last Updated
February 26, 2020
Sponsor
Mount Sinai Hospital, Canada
Collaborators
University of British Columbia, University of Calgary, University of Manitoba, University of Ottawa, McGill University, University of Alberta, Dalhousie University
1. Study Identification
Unique Protocol Identification Number
NCT02569333
Brief Title
Patient Centered Algorithms to Optimize the Inpatient Experience and Treatment of Ulcerative Colitis
Acronym
PATIENT-UC
Official Title
Patient Centered Algorithms to Optimize the Inpatient Experience and Treatment of Ulcerative Colitis: PATIENT-UC
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
January 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada
Collaborators
University of British Columbia, University of Calgary, University of Manitoba, University of Ottawa, McGill University, University of Alberta, Dalhousie University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Hospitalized patients with ulcerative colitis (UC) are at increased risk for a variety of complications such as infections, venous thrombosis, and surgery. The literature has revealed significant variation in the quality of care to hospitalized UC patients. As a result, guidelines for the management of these patients have been developed. However, the update of guidelines are variable. Admission to hospital can also have significant impact on quality of life due to interruptions in life commitments and lost sense of control of disease. Maintaining a sense of self-control of disease and active participation in care has been shown to be valuable among individuals with chronic diseases. The investigators propose the development of a multi-site, patient centred initiative aimed at improving clinical and patient-centered outcomes through an educational iPad based tool for patients admitted to hospital with ulcerative colitis.
Detailed Description
Inflammatory bowel disease (IBD) is a chronic gastrointestinal condition with significant morbidity in the form of hospitalizations, surgery, and reductions in quality of life. Most patients with IBD are managed in an ambulatory, outpatient setting. However, to optimally manage severe disease activity, hospitalization may be required. Hospitalized patients are at increased risk for a variety of complications such as infections, venous thrombosis, and surgery. The literature has revealed significant variation in care and disease outcomes among hospitalized IBD patients. The heterogeneous nature of IBD severity, location, and phenotype as well as limited evidence to guide some therapeutic domains make standardization of IBD care delivery difficult. However, hospitalized patients with ulcerative colitis (UC) represent a more homogenous group that may be most amendable to quality improvement initiatives aimed at reducing variation, a known surrogate marker of poor performance. The Canadian Association of Gastroenterology has developed guidelines for hospitalized UC patients. It is well established, however, that update of guidelines are variable.
Admission to hospital can also have significant impact on quality of life due to interruptions in life commitments and lost sense of control of disease. Maintaining a sense of self-control of disease and active participation in care has been shown to be valuable among individuals with chronic diseases such as IBD. The investigators proposed the development of a multi-site, patient centered initiative aimed at improving clinically relevant and patient-centered outcomes through a multi-faceted educational tool for patients admitted to hospital with ulcerative colitis. Participating sites will be randomized to usual care versus administering the educational tool to patients which outlines what to expect during their hospital stay and reviews the current guidelines for hospitalized ulcerative colitis management.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative, Inflammatory Bowel Diseases, Colitis, Intestinal Disease
Keywords
ulcerative colitis, inflammatory bowel disease, education, patient-reported outcomes
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
91 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Educational Video
Arm Type
Experimental
Arm Description
Subjects to have access to educational video during hospital stay
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients to receive usual care and will not have access to educational video.
Intervention Type
Other
Intervention Name(s)
Educational video
Intervention Description
iPad with educational video highlighting current guidelines for the management of hospitalized patients with ulcerative colitis.
Primary Outcome Measure Information:
Title
Overall length of stay
Time Frame
1 year
Title
Percentage of patients undergoing colectomy
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Proportion of patient undergoing testing of C difficile within 48 hours of admission
Time Frame
1 year
Title
Time from initiation of IV steroids to salvage therapy or surgery.
Time Frame
1 year
Title
Proportion of patients receiving VTE prophylaxis
Time Frame
1 year
Title
Trust in physician as measured by TIPS
Time Frame
6 months
Title
Patient Satisfaction as measured by CACHE
Time Frame
6 months
Title
Anxiety and Depression as measured by HADS.
Time Frame
6 months
Title
Adherence to Medication as measured by Morisky scale
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of ulcerative colitis
able to provide informed consent
admission to hospital with flare of underlying ulcerative colitis
Exclusion Criteria:
Crohn's disease
inability to provide informed consent
readmission during study period (intervention would only be used on the initial admission during the study period)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam V. Weizman, MD, MSc
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
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
34061122
Citation
Weizman AV, Bressler B, Seow CH, Afif W, Afzal NM, Targownik L, Nguyen DM, Jones JL, Huang V, Murthy SK, Nguyen GC. Providing Hospitalized Ulcerative Colitis Patients With Practice Guidelines Improves Patient-Reported Outcomes. J Can Assoc Gastroenterol. 2020 Jun 9;4(3):131-136. doi: 10.1093/jcag/gwaa019. eCollection 2021 Jun. Erratum In: J Can Assoc Gastroenterol. 2020 Aug 27;4(4):198.
Results Reference
derived
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Patient Centered Algorithms to Optimize the Inpatient Experience and Treatment of Ulcerative Colitis
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