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Completed

NCT Number: NCT02569333

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Educational Video

Other

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

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

Sponsors and collaborators

Lead sponsor

Mount Sinai Hospital, Canada

Other

Collaborators

  • Dalhousie University
  • McGill University
  • University of Alberta
  • University of British Columbia
  • University of Calgary
  • University of Manitoba
  • University of Ottawa

Registry information

Official study title

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

Acronym: PATIENT-UC

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Oct 6, 2015
Registry last updated
Feb 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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