Patient Centered Algorithms to Optimize the Inpatient Experience and Treatment of Ulcerative Colitis (PATIENT-UC)
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|ClinicalTrials.gov Identifier: NCT02569333|
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : February 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|Colitis, Ulcerative Inflammatory Bowel Diseases Colitis Intestinal Disease||Other: Educational video||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||91 participants|
|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|
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.
- Overall length of stay [ Time Frame: 1 year ]
- Percentage of patients undergoing colectomy [ Time Frame: 1 year ]
- Proportion of patient undergoing testing of C difficile within 48 hours of admission [ Time Frame: 1 year ]
- Time from initiation of IV steroids to salvage therapy or surgery. [ Time Frame: 1 year ]
- Proportion of patients receiving VTE prophylaxis [ Time Frame: 1 year ]
- Trust in physician as measured by TIPS [ Time Frame: 6 months ]
- Patient Satisfaction as measured by CACHE [ Time Frame: 6 months ]
- Anxiety and Depression as measured by HADS. [ Time Frame: 6 months ]
- Adherence to Medication as measured by Morisky scale [ Time Frame: 6 months ]
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
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G1X5|
|Principal Investigator:||Adam V. Weizman, MD, MSc||MOUNT SINAI HOSPITAL|