Prevention of Readmissions at IBD Centres of Excellence

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention of Readmissions at Inflammatory Bowel Disease Centres of Excellence

Conditions
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Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases

Intervention / Treatment
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* Behavioral: Nurse Follow-Up
* Other: Electronic Monitoring
* Other: Post-Discharge Questionnaire
* Other: Post-Discharge Questionnaire
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse Follow-Up and Electronic Monitoring<br> | Behavioral: Nurse Follow-Up<br>* 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.<br>Other: Electronic Monitoring<br>* 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.<br>Other: Post-Discharge Questionnaire<br>* 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.<br>Other: Standard of Care<br>* Discharge summary detailing inpatient IBD admission; in addition to outpatient follow-up with a Gastroenterologist post-discharge<br>|
| Active Comparator: Minimal Intervention<br> | Other: Post-Discharge Questionnaire<br>* 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.<br>Other: Standard of Care<br>* Discharge summary detailing inpatient IBD admission; in addition to outpatient follow-up with a Gastroenterologist post-discharge<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within 30 days of initial hospital discharge | 
| 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. | 30 days post-discharge | 
| 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. | 30 days post-discharge | 
| 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. | 30 days post-discharge | 
| 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. | 30 days post-discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colitis, Ulcerative, Crohn Disease, Inflammatory Bowel Diseases, Gastroenterology, Quality Improvement, Post-Discharge