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临床试验/NCT05714605
NCT05714605Enrolling By Invitation不适用

Implementation and Evaluation of THRIVE: A Health Innovation to Support Care Transitions for Medicaid-Insured Individuals Following Hospitalization

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2023年3月27日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
267
试验地点
2
主要终点
Rates of Referrals to Homecare

研究概览

简要总结

The goal of this stepped wedge pragmatic trial is to compare referral patterns and post discharge outcomes in Medicaid insured individuals discharge following a hospitalization]. The aims are to 1) evaluate the implementation of the THRIVE clinical pathway, including feasibility, appropriateness, and acceptability and 2) examine referral patterns, 30- day readmission and Emergency Department (ED) utilization patterns for participants who receive THRIVE support services. During hospitalization participants will receive a referral to home care services and will be seen by a home care nurse within 48 hours following discharge. A discharging physician or Advanced Practice Provider will maintain clinical oversight for 30 days or until the patient sees primary care provider or specialist. A Care Coordination Team conducts weekly case conferences to ensure social and health needs are being addressed for 30 days post-discharge. Researchers will compare Medicaid insured patients discharged during the study, to those receiving usual care to determine if there are differences in post-acute utilization outcomes.

详细描述

This is a prospective single site Type 1 hybrid effectiveness-implementation parallel mixed methods (QUANT + qual) quasi-experimental study. This study design involves simultaneous collection and analysis of quantitative and qualitative data, giving priority weight to the quantitative data to evaluate program referrals, outcomes, and program fidelity, while qualitative data will evaluate process through detailed descriptions of perspectives of barriers and facilitators faced by health care providers in implementing the THRIVE intervention. Qualitative interviews will also assess stakeholder perspectives of the value of the intervention in addressing health inequities among Medicaid insured individuals cared for in the acute and home care settings. Nesting the qualitative interview within a single-site randomized trial of a the THRIVE intervention will allow us to determine whether the intervention improved primary outcomes (referrals to homecare, 30-day readmission, ED utilization, connection to PCP) and to identify professional and organizational barriers to implementation. Combining these insights with that of effectiveness outcome date will allow consideration for meaningful contextual factors that are viewed as critical to the implementation of THRIVE and subsequent outcomes. Our stepped wedge design with include a randomized roll-out to case managers at Pennsylvania Hospital and the study will be carried out over 18 months. To begin, 5 case managers will be randomized to receive training on the THRIVE clinical pathway. Following training they will be invited to begin offering referrals to the THRIVE clinical pathway. After 2 months the remaining 4 case managers will be trained on the THRIVE intervention and will be able to begin submitting referrals.

研究设计

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

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Medicaid insured
  • Residing in the state of Pennsylvania
  • Experienced a hospitalization at study hospital
  • Agrees to home care at partner home care setting.

排除标准

  • Individuals under age 18

研究组 & 干预措施

THRIVE Intervention

Experimental

1 month intensive post discharge case management and care coordination.

干预措施: THRIVE Intervention (Behavioral)

Usual Care

No Intervention

Discharge to home without intensive post acute case management or care coordination.

结局指标

主要结局

Rates of Referrals to Homecare

时间窗: Through study completion, an average of 18 months

We will evaluate changes in home care referrals between case managers exposed to the intervention compared to those who were not.

Rates of Readmissions

时间窗: 30 days following hospital discharge

We will evaluate the rate of readmissions over the course of the study for THRIVE participants compared to those receiving usual care.

Rates of Emergency Department Visit

时间窗: 30 days following hospital discharge

We will evaluate the rate of ED visits over the course of the study for THRIVE participants compared to those receiving usual care.

Primary Care or Specialist Visit

时间窗: 30 Days following hospital discharge

We will compare the rates of primary care provider and specialist visits within 30 days following discharge compared to those receiving usual care.

次要结局

  • Feasibility, Acceptability, Appropriateness, Workload(Through study completion, an average of 18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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