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

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

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.

Study Overview

• Status: Completed
• Conditions: Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Intestinal Disease
• Intervention / Treatment: Other: Educational video

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.

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall length of stay	1 year
Percentage of patients undergoing colectomy	1 year

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Collaborators: University of Manitoba; University of British Columbia; McGill University; University of Alberta; University of Calgary; University of Ottawa; Dalhousie University
• Investigators: Principal Investigator: Adam V. Weizman, MD, MSc, Mount Sinai Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2020

Study Registration Dates

• First Submitted: September 29, 2015
• First Submitted That Met QC Criteria: October 5, 2015
• First Posted (Estimate): October 6, 2015

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: education; ulcerative colitis; patient-reported outcomes; inflammatory bowel disease
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Ulcer; Inflammatory Bowel Diseases; Intestinal Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: Abbvie-PATIENT-UC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES