跳至主要内容
临床试验/NCT03564626
NCT03564626已完成不适用

Health IT Generated PROs to Improve Outcomes in Cirrhosis

Virginia Commonwealth University3 个研究点 分布在 1 个国家目标入组 232 人开始时间: 2018年6月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
232
试验地点
3
主要终点
Avoidable Readmissions

研究概览

简要总结

SPECIFIC AIM 1: To evaluate in a multi-center, randomized trial the effectiveness of PROs elicited using PatientBuddy and EncephalApp on the prevention of avoidable 30 day readmissions in patients with cirrhosis and their caregivers compared to standard of care.

详细描述

Cirrhosis affects more than 6 million US patients and is a major burden on patients, caregivers and the healthcare system. Patients with cirrhosis are prone to clinical and psycho-social issues that may predict hospitalization, re-hospitalizations and death. Important patient-reported outcomes (PRO) such as impaired daily functioning, sleep, cognition and pain are widely prevalent in patients with cirrhosis. These changes can independently impact hospitalizations, re-hospitalizations and death in cirrhotic patients. The investigators have studied the impact of these PRO using traditional and computerized scales such as PROMIS (Patient-reported outcomes measurement information system). With the increasing spread of health-related electronic devices, the relevance of health IT in the management of chronic diseases such as cirrhosis is paramount. The team has already developed and used several health IT advances to educate patients and their caregivers in inpatient and outpatient settings. These tools are Patient Buddy to define patients regarding factor preventing readmission, and EncephalApp Stroop to detect cognitive dysfunction in cirrhosis. As part of a funded AHRQ R21, PatientBuddy, which has undergone multiple refinements in response to feedback from patients, caregivers and administering staff, is being used by the study team to prevent readmissions to Virginia Commonwealth University Medical Center (VCU). However the evaluation of these tools in a multi-center study that adapts to the status of the patients and their caregivers is an important step towards improvement in cirrhosis-related outcomes. In addition, PROs that are elicited and monitored when the patients are outside the hospital will advance the field by making them integral parts of clinical management.

研究设计

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

入排标准

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

入选标准

  • •Patient Inclusion Criteria:
  • •Cirrhosis patients ≥21 years of age hospitalized for non-elective reasons
  • •Adult caregiver and the patient living in the same house
  • •Able to complete the Patient Buddy training and evaluation
  • •Discharged home from the hospital
  • •Discharge hospital as primary hospital base
  • •Caregiver Inclusion Criteria:
  • •Living in same dwelling as patient for the last ≥1 year
  • •Able to complete the Patient Buddy training and evaluation
  • •Familiar with the patient's routine

排除标准

  • •Elective hospitalization
  • •Lack of an adult caregiver
  • •Active substance abuse within 1 month of the hospitalization (alcohol use is acceptable provided the patient does not have alcoholic hepatitis during this admission or <1 month prior to admission)
  • •Unable to perform training or give consent
  • •Patients discharged to hospice, nursing home or extended care facilities
  • •pregnant women
  • •patients with limited English proficiency
  • •Caregiver Exclusion Criteria
  • •Unable or unwilling to train or adhere to study guidelines
  • •Unfamiliar with the patient routines
  • •Not in the same house as the patient

研究组 & 干预措施

Control Group

No Intervention

Standard of care counseling and discharge instructions per local hospital policy. Standard of care follow up phone calls and visits at baseline and at 30 days. Follow-up will be for 30 days

Health IT +/- Scheduled Follow Up

Experimental

Subjects and caregivers will be given individual phones loaded with the Patient Buddy App and the EncephalApp that will be used to enter medications, issues and orientation questions daily. There will be messages and phone calls as needed per the App and visits will be at baseline, scheduled at 15 days and at 30 days. In addition, scheduled phone calls will be performed at days 7 and 21.Follow-up will be for 30 days

干预措施: Health-IT +/- Scheduled Follow Up (Other)

结局指标

主要结局

Avoidable Readmissions

时间窗: 30 days

Avoidable readmissions within 30 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

Loading locations...

相似试验