Evaluation of the Multisite Replication of the Transitional Care Model
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 962
- 试验地点
- 1
- 主要终点
- Number of hospital admissions
研究概览
简要总结
The study is a randomized controlled trial to estimate the effects of the transitional care model (TCM) on hospital admissions and patients' experience during the year following the patient's qualifying discharge. The University of Pennsylvania, where TCM was developed, will be the coordinating center for the implementation. The study will be conducted in three large health systems spread throughout the U.S., drawing patients from seven hospitals in those systems. Eligible patients are older adults (age 65 and older) admitted to a participating hospital with symptoms of heart failure (HF), chronic obstructive pulmonary disease (COPD), or pneumonia (PNA). The evaluation will be conducted by Mathematica.
详细描述
The Transitional Care Model (TCM) is an advanced practice registered nurse (APRN) led, team-based, care management strategy designed to improve the care and outcomes of high-risk older adults transitioning from hospital to home. Eligible patients who agree to participate in the study will be randomly assigned to either the intervention group, which receives the TCM intervention, or the control group, which receives usual care (standard hospital discharge planning and post-hospital follow up services). The target sample size for the study is close to 1000, evenly divided into intervention and control groups, with 250 to 270 patients derived from each of UCSF and Trinity health systems, and another 450 recruited from the two VHA hospitals combined. Data will be collected at intake, prior to randomization, by enrollment coordinators at each of the participating hospitals. Followup data will be collected in a survey of patients conducted 90 days after discharge, and from claims data obtained from Medicare, Medicare Advantage plans, and the VHA.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 65 years and older
- •Admitted from home with Pneumonia OR with a history of HF or COPD with symptoms of HF or COPD exacerbation or whose symptoms suggest a new HF or COPD diagnosis
- •English and non-English speaking, able to respond to questions
- •Reachable by telephone after discharge
- •Resides within the geographic service area
- •Consent to participation
排除标准
- •Enrolled in Medicare's Hospice or End-Stage Renal Disease programs
- •Presence of active and untreated psychiatric conditions (ICD10: F10-F29)
- •Long-term care resident
- •Undergoing active cancer treatment
- •Currently enrolled in another RCT
研究组 & 干预措施
Treatment group
The treatment group receives the TCM intervention while in the hospital and during the first 90 days after returning to the community.
干预措施: Transitional care model (TCM) (Behavioral)
Control group
The control group receives usual discharge planning and post-discharge care.
干预措施: Usual care (Behavioral)
结局指标
主要结局
Number of hospital admissions
时间窗: 12 months
number of times admitted to the hospital during 12 months after initial discharge
Costs
时间窗: 12 months
Costs of medical care paid for by Medicare, Medicare Advantage plan, or Veterans Health Administration
次要结局
- length of time to death or hospital admission(12 months after initial discharge)
- Skilled nursing facility days(12 months after initial discharge)
- 30-day readmission(30 days)
- Patient-Reported Outcomes Measurement Information System Physical Functioning (SF10a)(90 days after initial discharge)
- Patient Health Questionnaire for Depression and Anxiety (PHQ-4)(90 days after initial discharge)
- emergency department visits(12 months)
- Mortality(12 months after initial discharge)
- Edmonton Symptom Assessment Scale(90 days after initial discharge)
研究者
Randy Brown
Principal investigator
Mathematica Policy Research, Inc.