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临床试验/NCT06203509
NCT06203509招募中不适用

An Equity-focused Intervention to Improve Care Transitions for Medicaid Insured Individuals With Co-occurring Chronic Medical Conditions and Serious Mental Illness

University of Pennsylvania1 个研究点 分布在 1 个国家目标入组 267 人开始时间: 2024年4月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
267
试验地点
1
主要终点
Rates of Emergency Department Visit

研究概览

简要总结

This study aims to evaluate the THRIVE clinical pathway at HUP, focusing on supporting Medicaid-insured individuals, including those with serious mental illness, following hospitalization. The study will assess clinician/administrator perspectives on the pathway's feasibility, appropriateness, and acceptability and analyze referral patterns and post-discharge outcomes.

The objectives are:

  1. To conduct a qualitative study evaluating the implementation of THRIVE, particularly its adaptation to include patients with serious mental illness.
  2. To examine referral patterns, 30-day readmission rates, and ED utilization for THRIVE participants, comparing them with those receiving standard care.

Participants will be referred to home care services during hospitalization and seen by a home care nurse within 48 hours post-discharge. A discharging physician or Advanced Practice Provider will oversee care for 30 days or until a primary care or specialist visit. The Care Coordination Team will hold weekly case conferences for 30 days post-discharge to address both health and mental health needs. The study will compare outcomes of Medicaid-insured patients, including those with serious mental illness, to those receiving usual care.

详细描述

Detailed Description:

This study is a single-site Type 1 hybrid effectiveness-implementation parallel mixed methods (quantitative + qualitative) quasi-experimental study at HUP, focusing on the THRIVE clinical pathway. It integrates simultaneous quantitative and qualitative data collection and analysis, with a stronger emphasis on quantitative data to evaluate referrals, outcomes, and program fidelity. The qualitative aspect will explore the implementation process, delving into the barriers and facilitators encountered by healthcare providers. It will also assess stakeholder perspectives on the intervention's impact on health inequities among Medicaid-insured individuals in both acute and home care settings. By nesting qualitative interviews within a quasi-experimental framework, the study aims to examine the intervention's effect on primary outcomes (homecare referrals, 30-day readmission, ED utilization, connection to PCP) and to identify professional and organizational barriers to its implementation. The combination of effectiveness data with contextual insights will inform understanding of factors critical to THRIVE's implementation and outcomes.

Qualitative Study:

The recruitment process is meticulously managed to track each participant's journey. Recruitment begins in early January, with participants contacted via email, providing study details and interview scheduling links. Follow-up reminders ensure participant engagement. Interviews, conducted virtually and recorded with consent, focus on maintaining confidentiality and privacy. Non-consented sessions are captured through detailed notes. Post-interview, recordings are transcribed for analysis, enabling categorization into codes and themes for a deeper understanding of participant perspectives.

Quantitative Study:

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 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

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

Usual Care

No Intervention

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

THRIVE Intervention

Experimental

THRIVE Intervention

1-month intensive post discharge case management and care coordination

干预措施: Thrive Intervention (Behavioral)

结局指标

主要结局

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.

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

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 (1)

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