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Patient Centered Algorithms to Optimize the Inpatient Experience and Treatment of Ulcerative Colitis (PATIENT-UC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02569333
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : February 28, 2020
Sponsor:
Collaborators:
University of British Columbia
University of Calgary
University of Manitoba
University of Ottawa
McGill University
University of Alberta
Dalhousie University
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

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.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Inflammatory Bowel Diseases Colitis Intestinal Disease Other: Educational video Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 91 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Patient Centered Algorithms to Optimize the Inpatient Experience and Treatment of Ulcerative Colitis: PATIENT-UC
Study Start Date : January 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Educational Video
Subjects to have access to educational video during hospital stay
Other: Educational video
iPad with educational video highlighting current guidelines for the management of hospitalized patients with ulcerative colitis.

No Intervention: Usual Care
Patients to receive usual care and will not have access to educational video.



Primary Outcome Measures :
  1. Overall length of stay [ Time Frame: 1 year ]
  2. Percentage of patients undergoing colectomy [ Time Frame: 1 year ]

Other Outcome Measures:
  1. Proportion of patient undergoing testing of C difficile within 48 hours of admission [ Time Frame: 1 year ]
  2. Time from initiation of IV steroids to salvage therapy or surgery. [ Time Frame: 1 year ]
  3. Proportion of patients receiving VTE prophylaxis [ Time Frame: 1 year ]
  4. Trust in physician as measured by TIPS [ Time Frame: 6 months ]
  5. Patient Satisfaction as measured by CACHE [ Time Frame: 6 months ]
  6. Anxiety and Depression as measured by HADS. [ Time Frame: 6 months ]
  7. Adherence to Medication as measured by Morisky scale [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02569333


Locations
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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G1X5
Sponsors and Collaborators
Mount Sinai Hospital, Canada
University of British Columbia
University of Calgary
University of Manitoba
University of Ottawa
McGill University
University of Alberta
Dalhousie University
Investigators
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Principal Investigator: Adam V. Weizman, MD, MSc MOUNT SINAI HOSPITAL
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Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT02569333    
Other Study ID Numbers: Abbvie-PATIENT-UC
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Mount Sinai Hospital, Canada:
ulcerative colitis
inflammatory bowel disease
education
patient-reported outcomes
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Intestinal Diseases
Inflammatory Bowel Diseases
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Pathologic Processes