Prevention of Readmissions at IBD Centres of Excellence

NCT02931799 | Unknown

• 1 other identifier: PRICE
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with Inflammatory Bowel Disease (IBD) are frequently hospitalized, with an increased risk of repeat hospitalizations within the same calendar year. Given that hospital readmissions represent a significant burden to patients and the health care system, a standardised pathway for IBD patients discharged from the hospital can have a significant impact on reducing readmission rates, healthcare utilization and patient satisfaction. The primary aim of this study is to evaluate the effectiveness of an IBD post-discharge pathway, involving post-discharge nurse follow-up and electronic monitoring, in reducing IBD readmission rates.

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Keywords

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases; Gastroenterology; Quality Improvement; Post-Discharge

Outcome Measures

Primary Outcomes (1)

• Post-Discharge Readmission

  Occurrence of post-discharge readmissions will be recorded for all patients enrolled in the study. Post-discharge readmissions will be defined as any IBD readmission subsequent to the initial hospital admission where the patient was enrolled in the study. Post-discharge readmission rates will be compared between study arms.

  Within 30 days of initial hospital discharge

Secondary Outcomes (5)

• Post-Discharge Occurrence of Venous Thromboembolism

  Within 30 days of initial hospital discharge

• Patient Satisfaction with Health Care in IBD

  30 days post-discharge

• IBD related Quality of Life

  30 days post-discharge

• Disease Activity

  30 days post-discharge

• Patient Satisfaction with 'Health Promise'

  30 days post-discharge

Study Arms (2)

Nurse Follow-Up and Electronic Monitoring

EXPERIMENTAL

Behavioral: Nurse Follow-Up; Other: Electronic Monitoring; Other: Post-Discharge Questionnaire; Other: Standard of Care

Minimal Intervention

ACTIVE COMPARATOR

Other: Post-Discharge Questionnaire; Other: Standard of Care

Interventions

Nurse Follow-Up BEHAVIORAL

Organized follow-up with an IBD advanced practice nurse at 24-48 hours, 7 days, and 30 days post-discharge; to monitor patients' health status with respect to their IBD.

Nurse Follow-Up and Electronic Monitoring

Electronic Monitoring OTHER

Patients will be provided access to a web-based application entitled: 'Health Promise'. The application will generate surveys every 3 days, where patients will self-report their IBD symptoms, quality of life and medication adherence on three separate scales: * PRO-2 Scale for patients with Crohn's Disease * 6-Point Mayo Score for patients with Ulcerative Colitis * Morisky Medication Adherence Scale (MMAS-4) The survey responses will be monitored by an IBD advanced practice nurse, to triage patients for outpatient follow-up.

Nurse Follow-Up and Electronic Monitoring

Post-Discharge Questionnaire OTHER

Patients will complete a web-based questionnaire at 30 days post-discharge. The questionnaire will capture information related to: Demographics, Patient Satisfaction as measured by the CACHE questionnaire; IBD related quality of life as measured by the IBDQ questionnaire; Disease activity as measured by PRO-2 scale for Crohn's Disease or 6-Point Mayo Score for Ulcerative Colitis; and Patient Satisfaction with the 'Health Promise' application.

Nurse Follow-Up and Electronic Monitoring

Standard of Care OTHER

Discharge summary detailing inpatient IBD admission; in addition to outpatient follow-up with a Gastroenterologist post-discharge

Minimal Intervention; Nurse Follow-Up and Electronic Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years of age
• IBD diagnosis of UC or CD
• Hospitalization for diagnosis or exacerbation of IBD

You may not qualify if:

• Inability to provide informed consent
• No internet access
• Death during hospitalization
• History of surgical management for IBD

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Crohn's and Colitis Canada: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (10)

• Casellas F, Ginard D, Vera I, Torrejon A; GETECCU. Development and testing of a new instrument to measure patient satisfaction with health care in inflammatory bowel disease: the CACHE questionnaire. Inflamm Bowel Dis. 2013 Mar;19(3):559-68. doi: 10.1097/MIB.0b013e31827febd1.

  PMID: 23429448 BACKGROUND

• Pallis AG, Mouzas IA, Vlachonikolis IG. The inflammatory bowel disease questionnaire: a review of its national validation studies. Inflamm Bowel Dis. 2004 May;10(3):261-9. doi: 10.1097/00054725-200405000-00014.

  PMID: 15290922 BACKGROUND

• Hazratjee N, Agito M, Lopez R, Lashner B, Rizk MK. Hospital readmissions in patients with inflammatory bowel disease. Am J Gastroenterol. 2013 Jul;108(7):1024-32. doi: 10.1038/ajg.2012.343.

  PMID: 23820989 BACKGROUND

• Vest JR, Gamm LD, Oxford BA, Gonzalez MI, Slawson KM. Determinants of preventable readmissions in the United States: a systematic review. Implement Sci. 2010 Nov 17;5:88. doi: 10.1186/1748-5908-5-88.

  PMID: 21083908 BACKGROUND

• Makaryus AN, Friedman EA. Patients' understanding of their treatment plans and diagnosis at discharge. Mayo Clin Proc. 2005 Aug;80(8):991-4. doi: 10.4065/80.8.991.

  PMID: 16092576 BACKGROUND

• Moore C, Wisnivesky J, Williams S, McGinn T. Medical errors related to discontinuity of care from an inpatient to an outpatient setting. J Gen Intern Med. 2003 Aug;18(8):646-51. doi: 10.1046/j.1525-1497.2003.20722.x.

  PMID: 12911647 BACKGROUND

• Nguyen GC, Bollegala N, Chong CA. Factors associated with readmissions and outcomes of patients hospitalized for inflammatory bowel disease. Clin Gastroenterol Hepatol. 2014 Nov;12(11):1897-1904.e1. doi: 10.1016/j.cgh.2014.02.042. Epub 2014 Mar 26.

  PMID: 24681074 BACKGROUND

• Bernstein CN, Nabalamba A. Hospitalization, surgery, and readmission rates of IBD in Canada: a population-based study. Am J Gastroenterol. 2006 Jan;101(1):110-8. doi: 10.1111/j.1572-0241.2006.00330.x.

  PMID: 16405542 BACKGROUND

• Nguyen GC, Sam J. Rising prevalence of venous thromboembolism and its impact on mortality among hospitalized inflammatory bowel disease patients. Am J Gastroenterol. 2008 Sep;103(9):2272-80. doi: 10.1111/j.1572-0241.2008.02052.x. Epub 2008 Aug 5.

  PMID: 18684186 BACKGROUND

• Nguyen GC, Kaplan GG, Harris ML, Brant SR. A national survey of the prevalence and impact of Clostridium difficile infection among hospitalized inflammatory bowel disease patients. Am J Gastroenterol. 2008 Jun;103(6):1443-50. doi: 10.1111/j.1572-0241.2007.01780.x. Epub 2008 May 29.

  PMID: 18513271 BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Inflammatory Bowel Diseases

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Geoffrey Nguyen, MD, PhD

  Mount Sinai Hospital, Canada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geoffrey Nguyen, MD, PhD

CONTACT

416-586-4800; geoff.nguyen@utoronto.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2016
• First Posted: October 13, 2016
• Study Start: October 1, 2018
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: September 10, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)