Clinical trial NCT02569333: Patient Centered Algorithms to Optimize the Inpatient Experience and Treatment of Ulcerative Colitis
Official title: Patient Centered Algorithms to Optimize the Inpatient Experience and Treatment of Ulcerative Colitis: PATIENT-UC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colitis, Ulcerative
Inflammatory Bowel Diseases
Colitis
Intestinal Disease
Keywords: ulcerative colitis
inflammatory bowel disease
education
patient-reported outcomes
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: University of Calgary
name: University of Manitoba
name: University of Ottawa
name: McGill University
name: University of Alberta
name: Dalhousie University
First posted: 2015-10-06
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Overall length of stay
timeFrame: 1 year
measure: Percentage of patients undergoing colectomy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
measure: Proportion of patient undergoing testing of C difficile within 48 hours of admission
timeFrame: 1 year
measure: Time from initiation of IV steroids to salvage therapy or surgery.
timeFrame: 1 year
measure: Proportion of patients receiving VTE prophylaxis
timeFrame: 1 year
measure: Trust in physician as measured by TIPS
timeFrame: 6 months
measure: Patient Satisfaction as measured by CACHE
timeFrame: 6 months
measure: Anxiety and Depression as measured by HADS.
timeFrame: 6 months
measure: Adherence to Medication as measured by Morisky scale
timeFrame: 6 months
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Adam V. Weizman, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.