Trials / Unknown
UnknownNCT02931799
Prevention of Readmissions at IBD Centres of Excellence
Prevention of Readmissions at Inflammatory Bowel Disease Centres of Excellence
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 400 (estimated)
- Sponsor
- Mount Sinai Hospital, Canada · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Nurse Follow-Up | 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. |
| OTHER | Electronic Monitoring | 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. |
| OTHER | Post-Discharge Questionnaire | 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. |
| OTHER | Post-Discharge Questionnaire | 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. |
| OTHER | Standard of Care | Discharge summary detailing inpatient IBD admission; in addition to outpatient follow-up with a Gastroenterologist post-discharge |
Timeline
- Start date
- 2018-10-01
- Primary completion
- 2021-09-01
- Completion
- 2021-12-01
- First posted
- 2016-10-13
- Last updated
- 2018-09-10
Locations
1 site across 1 country: Canada
Source: ClinicalTrials.gov record NCT02931799. Inclusion in this directory is not an endorsement.