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

Inflammatory Bowel Diseases Clinical Trial

— PATIENT-UC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02569333
• Other study ID #: Abbvie-PATIENT-UC
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2020

Study information

• Verified date: February 2020
• Source: Mount Sinai Hospital, Canada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (8)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	Dalhousie University, McGill University, University of Alberta, University of British Columbia, University of Calgary, University of Manitoba, University of Ottawa

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of patient undergoing testing of C difficile within 48 hours of admission		1 year
Other	Time from initiation of IV steroids to salvage therapy or surgery.		1 year
Other	Proportion of patients receiving VTE prophylaxis		1 year
Other	Trust in physician as measured by TIPS		6 months
Other	Patient Satisfaction as measured by CACHE		6 months
Other	Anxiety and Depression as measured by HADS.		6 months
Other	Adherence to Medication as measured by Morisky scale		6 months
Primary	Overall length of stay		1 year
Primary	Percentage of patients undergoing colectomy		1 year