Pilot Testing Post-Intensive Care Transitions Using Rehabilitation and Engagement To Heal ICU Survivors and Families (PICTURE-THIS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Enrollment
研究概览
简要总结
This is a single-center pilot study examining the feasibility and acceptability of a transitional rehabilitation intervention, PICTURE-THIS, among critical illness survivors and their families. The intervention activities include transitional care coordination and activity-based rehabilitation delivered by a specialist team and integrated into usual care. There are three components to the assessment of feasibility and acceptability in this study:
- User testing the PICTURE-THIS protocol to work out basic challenges to feasibility and acceptability.
- Assessing the feasibility and acceptability of the user-tested PICTURE-THIS protocol.
- Assessing the feasibility and acceptability of research activities required to test the clinical efficacy of PICTURE-THIS to improve outcomes among critical illness survivors and their family caregivers.
详细描述
Purpose: PICTURE-THIS is a transitional rehabilitation intervention for critical illness survivors and their family caregivers. It has 2 phases: (1) A Run-In Phase in the hospital; (2) A post-discharge phase. The purpose of this study is to user- and pilot-test the protocols for PICTURE-THIS.
Aim 1: To test, troubleshoot, and revise study procedures and protocols for PICTURE-THIS with a convenience sample of critical illness survivors and their family caregivers.
The investigators will: 1) ensure that dyads reliably adhere to PICTURE-THIS protocols; 2) troubleshoot assessments at enrollment and 3 and 6 month follow-up; 3) refine data collection and management procedures.
Aim 2: To pilot test PICTURE-THIS for feasibility and acceptability among a convenience sample of critical illness survivors and their family caregivers.
Feasibility will be demonstrated by: 1) >80% completion of clinical assessments; 2) >80% retention rate (enrolled patients attending ≥ 2 outpatient transitional care visits and 8 rehabilitation sessions); 2) >80% completion rate for surveys assessing outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Enrollment
时间窗: Up to 6 months
Achieving an enrollment rate of 80% of eligible participants. Enrollment Rate (%) = (Number of Enrolled Participants / Number of Eligible Participants) x 100
Retention
时间窗: Up to 6 months
Maintaining an active engagement and complete participation rate of 80% throughout the study. Retention Rate (%) = (Number of Retained Participants / Number of Enrolled Participants) x 100
次要结局
- PROPr(Up to 6 months)
研究者
Leslie Scheunemann
Assistant Professor
University of Pittsburgh
