Comparative Effectiveness of Readmission Reduction Interventions for Individuals with Sepsis or Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,288
- 试验地点
- 2
- 主要终点
- Post-discharge home days
研究概览
简要总结
An adaptive platform trial to compare effectiveness of different care models to prevent readmissions for patients hospitalized with sepsis or lower respiratory tract infection. The primary outcome is number of days spent at home within 90 days after hospital discharge.
详细描述
This study implements an adaptive platform trial to compare effectiveness of different care models to prevent readmissions for patients hospitalized with sepsis or lower respiratory tract infection and discharged to home (with or without a short stay in a skilled nursing facility prior to going home): structured telephone support (STS); low-intensity remote patient monitoring (RPM-Low); and high-intensity remote patient monitoring (RPM-High). The remote patient monitoring models will be staffed by a physician or a nurse (Standard Team) or by a dedicated nurse-practitioner (NP)-led multidisciplinary team (Enhanced Team). Patients will be randomized to one of five arms: STS, RPM-Low + Standard Team, RPM-Low + Enhanced Team, RPM-High + Standard Team, and RPM-High + Enhanced Team. Using response adaptive randomization (RAR), interim outcome results will be used to modify the random allocation of patients to each study arm. The primary outcome is number of days spent at home within 90 days after hospital discharge. Patient-reported functional status and quality of life data will be collected in addition to electronic health record (EHR) and claims-based data to measure health care utilization. Qualitative interviews with patients and providers will provide insight into the effectiveness of the implementation process.
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
- Double (Investigator, Outcomes Assessor)
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
- •UPMC Health Plan members
- •Medicare Fee-for-Service enrollees
- •Age 21+ -Hospitalized with a primary diagnosis of sepsis or lower respiratory tract infection, --
- •Discharged to home, independent living facility, or skilled nursing facility
- •Readmission risk is moderate or high
排除标准
- •Admitted from hospice;
- •Discharged to hospice, inpatient rehabilitation, or a long term acute care facility;
- •Known to be pregnant;
- •Current enrollment in another remote patient monitoring program;
- •Failure of the Callahan 6 item cognitive screen and do not have a proxy to consent;
- •No access to a technological device required to participate in remote patient monitoring program;
- •Current enrollment in UPMC Advanced Illness Care program;
- •Severe, persistent cognitive impairment;
- •No documented PCP;
- •PCP disapproves of the patient being enrolled in remote patient monitoring;
- •Discharged from hospital to skilled nursing facility and stay at the skilled nursing facility for greater than 28 days
结局指标
主要结局
Post-discharge home days
时间窗: 90 days after discharge to home
days alive and at home
次要结局
- Mortality(measured at 90 days)
- Functional Status (measured by PROMIS Physical Function-for Mobility Aid Users-SF)(baseline, 90 days)
- Transition to Hospice(measured at 90 days after discharge to home)
- Health-related Quality of Life (measured by Quality of Life Enjoyment and Satisfaction Questionnaire-SF)(baseline, 90 days)
- Emergent outpatient utilization(measured at 90 days after discharge to home)
- Hospital readmissions(measured at 90 days)
研究者
Kalpana Char
Associate Vice President
University of Pittsburgh