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Prevention of Readmissions at IBD Centres of Excellence (PRICE)

Primary Purpose

Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Nurse Follow-Up
Electronic Monitoring
Post-Discharge Questionnaire
Post-Discharge Questionnaire
Standard of Care
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Colitis, Ulcerative focused on measuring Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases, Gastroenterology, Quality Improvement, Post-Discharge

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nurse Follow-Up and Electronic Monitoring

Minimal Intervention

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Post-Discharge Occurrence of Venous Thromboembolism
Occurrence of post-discharge venous thromboembolism will be recorded for all patients enrolled in the study. Post-discharge occurrence of venous thromboembolism will be defined as any event of venous thromboembolism subsequent to the initial hospital admission where the patient was enrolled in the study. Post-discharge rates of venous thromboembolism will be compared between study arms.
Patient Satisfaction with Health Care in IBD
Patient satisfaction with health care in IBD as measured by CACHE will be collected from all patients, through a web-based questionnaire administered at 30 days post-discharge of initial hospitalization; where patients were enrolled in the study. Mean scores for Patient Satisfaction with Health Care in IBD will be compared between study arms.
IBD related Quality of Life
IBD related Quality of Life as measured by IBDQ will be collected from all patients, through a web-based questionnaire administered at 30 days post-discharge of initial hospitalization; where patients were enrolled in the study. Mean scores for IBD related Quality of Life will be compared between study arms.
Disease Activity
Disease Activity as measured by PRO-2 for Crohn's Disease or 6-Point Mayo Score for Ulcerative Colitis will be collected from all patients, through a web-based questionnaire administered at 30 days post-discharge of initial hospitalization; where patients were enrolled in the study. Mean scores for disease activity will be compared between study arms.
Patient Satisfaction with 'Health Promise'
Patient satisfaction with the 'Heath Promise' application will be collected from patients enrolled in the experimental arm, through a web-based questionnaire administered at 30 days post-discharge of initial hospitalization; where patients were enrolled in the study. Mean score for patient satisfaction the 'Health Promise' application will be interpreted.

Full Information

First Posted
October 11, 2016
Last Updated
September 6, 2018
Sponsor
Mount Sinai Hospital, Canada
Collaborators
Crohn's and Colitis Canada
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1. Study Identification

Unique Protocol Identification Number
NCT02931799
Brief Title
Prevention of Readmissions at IBD Centres of Excellence
Acronym
PRICE
Official Title
Prevention of Readmissions at Inflammatory Bowel Disease Centres of Excellence
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Anticipated)
Primary Completion Date
September 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mount Sinai Hospital, Canada
Collaborators
Crohn's and Colitis Canada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Background: Hospital readmission rates are a key issue in health policy as they place a large burden on the healthcare system. Readmissions are a preventable source of health care expenditure and in some cases, represent an opportunity for quality improvement. Lack of standardization in hospital discharge processes, and deficiencies in the transition of care after discharge, predispose patients to an increased risk of illness, hospital utilization and healthcare costs. Previously identified issues in discharge planning include timely transmission of discharge summaries to primary care providers and lack of communication between providers and patients with respect to discharge medications and follow-up appointments. Rationale: Various post-discharge interventions have been effective in reducing hospital readmission rates and increasing patient satisfaction. However, in patients with flares of Inflammatory Bowel Disease (IBD), there is limited evidence to suggest which processes of care are protective against readmissions. IBD patients are frequently hospitalized, with over 22% of patients hospitalized within the first 2 years of diagnosis. Moreover, readmission rates are high in the IBD population, with over 20% of patients readmitted within the same calendar year of their initial hospitalization. Alongside increased healthcare expenditure, hospitalizations in the IBD population are associated with a number of nosocomial complications including venous thromboembolism and infection. Specific Aim: The primary aim of this study is to determine whether standardized IBD post-discharge pathway, involving regular follow-up with an advanced practice nurse and electronic monitoring through a web-based application, decreases the risk of IBD readmissions when compared to the usual standard of care. Study Design: All IBD inpatients with a diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) will be approached to participate in this parallel group randomized control trial. Patients randomized to the control arm will be discharged with the usual post-discharge standard of care. Patients randomized to the intervention arm will receive the usual post-discharge standard of care, in addition to organised follow-up with an advance practice nurse and electronic monitoring through a web-based application.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases
Keywords
Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases, Gastroenterology, Quality Improvement, Post-Discharge

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nurse Follow-Up and Electronic Monitoring
Arm Type
Experimental
Arm Title
Minimal Intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Nurse Follow-Up
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Electronic Monitoring
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Post-Discharge Questionnaire
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Post-Discharge Questionnaire
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Discharge summary detailing inpatient IBD admission; in addition to outpatient follow-up with a Gastroenterologist post-discharge
Primary Outcome Measure Information:
Title
Post-Discharge Readmission
Description
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.
Time Frame
Within 30 days of initial hospital discharge
Secondary Outcome Measure Information:
Title
Post-Discharge Occurrence of Venous Thromboembolism
Description
Occurrence of post-discharge venous thromboembolism will be recorded for all patients enrolled in the study. Post-discharge occurrence of venous thromboembolism will be defined as any event of venous thromboembolism subsequent to the initial hospital admission where the patient was enrolled in the study. Post-discharge rates of venous thromboembolism will be compared between study arms.
Time Frame
Within 30 days of initial hospital discharge
Title
Patient Satisfaction with Health Care in IBD
Description
Patient satisfaction with health care in IBD as measured by CACHE will be collected from all patients, through a web-based questionnaire administered at 30 days post-discharge of initial hospitalization; where patients were enrolled in the study. Mean scores for Patient Satisfaction with Health Care in IBD will be compared between study arms.
Time Frame
30 days post-discharge
Title
IBD related Quality of Life
Description
IBD related Quality of Life as measured by IBDQ will be collected from all patients, through a web-based questionnaire administered at 30 days post-discharge of initial hospitalization; where patients were enrolled in the study. Mean scores for IBD related Quality of Life will be compared between study arms.
Time Frame
30 days post-discharge
Title
Disease Activity
Description
Disease Activity as measured by PRO-2 for Crohn's Disease or 6-Point Mayo Score for Ulcerative Colitis will be collected from all patients, through a web-based questionnaire administered at 30 days post-discharge of initial hospitalization; where patients were enrolled in the study. Mean scores for disease activity will be compared between study arms.
Time Frame
30 days post-discharge
Title
Patient Satisfaction with 'Health Promise'
Description
Patient satisfaction with the 'Heath Promise' application will be collected from patients enrolled in the experimental arm, through a web-based questionnaire administered at 30 days post-discharge of initial hospitalization; where patients were enrolled in the study. Mean score for patient satisfaction the 'Health Promise' application will be interpreted.
Time Frame
30 days post-discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 18 years of age IBD diagnosis of UC or CD Hospitalization for diagnosis or exacerbation of IBD Exclusion Criteria: Inability to provide informed consent No internet access Death during hospitalization History of surgical management for IBD
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geoffrey Nguyen, MD, PhD
Phone
416-586-4800
Ext
2819
Email
geoff.nguyen@utoronto.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey Nguyen, MD, PhD
Organizational Affiliation
Mount Sinai Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nguyen Geoffrey, MD, PhD
Phone
416-586-4800
Ext
2819
Email
geoff.nguyen@utoronto.ca
First Name & Middle Initial & Last Name & Degree
Geoffrey Nguyen, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23429448
Citation
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.
Results Reference
background
PubMed Identifier
15290922
Citation
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.
Results Reference
background
PubMed Identifier
23820989
Citation
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.
Results Reference
background
PubMed Identifier
21083908
Citation
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.
Results Reference
background
PubMed Identifier
16092576
Citation
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.
Results Reference
background
PubMed Identifier
12911647
Citation
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.
Results Reference
background
PubMed Identifier
24681074
Citation
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.
Results Reference
background
PubMed Identifier
16405542
Citation
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.
Results Reference
background
PubMed Identifier
18684186
Citation
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.
Results Reference
background
PubMed Identifier
18513271
Citation
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.
Results Reference
background

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Prevention of Readmissions at IBD Centres of Excellence

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