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临床试验/NCT02931799
NCT02931799Unknown不适用

Prevention of Readmissions at Inflammatory Bowel Disease Centres of Excellence

Mount Sinai Hospital, Canada2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
400
试验地点
2
主要终点
Post-Discharge Readmission

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Nurse Follow-Up and Electronic Monitoring

Experimental

干预措施: Nurse Follow-Up (Behavioral)

Nurse Follow-Up and Electronic Monitoring

Experimental

干预措施: Electronic Monitoring (Other)

Nurse Follow-Up and Electronic Monitoring

Experimental

干预措施: Post-Discharge Questionnaire (Other)

Nurse Follow-Up and Electronic Monitoring

Experimental

干预措施: Standard of Care (Other)

Minimal Intervention

Active Comparator

干预措施: Post-Discharge Questionnaire (Other)

Minimal Intervention

Active Comparator

干预措施: Standard of Care (Other)

结局指标

主要结局

Post-Discharge Readmission

时间窗: Within 30 days of initial hospital discharge

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.

次要结局

  • Patient Satisfaction with Health Care in IBD(30 days post-discharge)
  • IBD related Quality of Life(30 days post-discharge)
  • Post-Discharge Occurrence of Venous Thromboembolism(Within 30 days of initial hospital discharge)
  • Disease Activity(30 days post-discharge)
  • Patient Satisfaction with 'Health Promise'(30 days post-discharge)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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