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CompletedNCT02569333PATIENT-UCUpdated Feb 28, 2020

Patient Centered Algorithms to Optimize the Inpatient Experience and Treatment of Ulcerative Colitis

An interventional study of Educational video in Colitis, Ulcerative, Inflammatory Bowel Diseases and Colitis, sponsored by Mount Sinai Hospital, Canada. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-28.

Sponsored by Mount Sinai Hospital, Canada · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
91
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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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Conditions studied

  • Colitis, Ulcerative
  • Inflammatory Bowel Diseases
  • Colitis
  • Intestinal Disease

Keywords

  • ulcerative colitis
  • inflammatory bowel disease
  • education
  • patient-reported outcomes
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In context

Colitis

1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.

This study's enrollment of 91 is above the median of 60 across 771 interventional studies indexed under Colitis.

Browse Colitis studies →

Lead sponsor

Mount Sinai Hospital, Canada is the lead sponsor of 157 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diagnosis of ulcerative colitis
  • able to provide informed consent
  • admission to hospital with flare of underlying ulcerative colitis

Exclusion criteria

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)
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
91 participants (actual)

Study arms

  • Experimental
    Educational Video

    Subjects to have access to educational video during hospital stay

    Other: Educational video

  • No intervention
    Usual Care

    Patients to receive usual care and will not have access to educational video.

Interventions

  • OtherEducational video

    iPad with educational video highlighting current guidelines for the management of hospitalized patients with ulcerative colitis.

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What researchers measure

Primary outcomes

  1. Overall length of stay

    Time frame: 1 year

  2. Percentage of patients undergoing colectomy

    Time frame: 1 year

Other outcomes

  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

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Study locations

1 site
  • Mount Sinai Hospital
    Toronto, Ontario M5G1X5, Canada
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References and documents

Publications

  • 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. doi: 10.1093/jcag/gwaa029. PubMed 34061122 ↗

Individual participant data

Plan to share: Yes

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02569333
Lead 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
Responsible party
Sponsor
First posted
Oct 6, 2015
Start date
Jan 2016
Primary completion
Jan 2019
Completion
Jan 2020
Last update
Feb 28, 2020

Study contacts

Adam V. Weizman, MD, MSc
principal investigator · MOUNT SINAI HOSPITAL

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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