NCT07584252尚未招募不适用
The Healing and Empowerment Actions for Recovery From Trauma (HEART) Trial
Stephanie Di Stasi7 个研究点 分布在 1 个国家目标入组 804 人开始时间: 2026年7月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 804
- 试验地点
- 7
研究概览
简要总结
The HEART Trial aimed to determine if wrap-around psychosocial support for patients who sustain moderate to severe trauma requiring orthopedic surgery intervention improves outcomes for patients (Aim 1), care-partners (Aim 2), and healthcare workers (Aim 3) as well as explore implementation strategies to improve health systems' capabilities and capacity to integrate psychosocial support services. The comparators represent real healthcare options for patients, caregivers, and healthcare workers. The HEART Trial is a multicenter pragmatic, stepped-wedge cluster randomized, hybrid type I comparative effectiveness-implementation superiority trial. The study intervention (C-TRP) is a trauma-focused psychosocial intervention, with each site serving as its own control (TRP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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
- 否
入选标准
- •Inclusion Criteria:
- •Age >= 18 years
- •Anticipated hospital length of stay > 72 hours
- •Moderate to severe orthopaedic trauma treated surgically for 1 or more injuries
- •GCS >= 13 at the time of enrollment
- •Willing and able to meet with Evellere coach while hospitalized or via the telephone within 72 hours of discharge (intervention cohort only)
排除标准
- •Non-english speaking (must be sufficiently fluent in English to consent and complete surveys without interpretive services)
- •Prior to index hospitalization, patient must not be receiving home services or be independent in daily tasks
- •Any penetrating brain injury
- •Patients with significant burn injury
- •Prior cognitive impairment
- •Hospital death or imminent death
- •Hospice care at time of trauma or selection for hospice during initial hospital admission or do not resuscitate or comfort care only before index visit
- •Prisoner/ inmate or police/ security intervention during hospitalization
- •No reliable internet access at baseline
- •Trauma presentation is a result of suicide attempt/ self-harm
- •Care Partners
- •Inclusion criteria:
- •Identified by the enrolled patient as a primary source of support during their recovery. A care partner can be in person or supporting remotely.
- •Age >= 18 years
- •Willing and able to meet with an Evellere coach during patient hospitalization or via telephone within 72 hours of discharge (intervention cohort only)
- •Exclusion criteria:
- •Non-english speaking (must be sufficiently fluent in English to consent and complete surveys without interpretive services)
- •Paid professionals or home healthcare providers whose support is provided as part of employment (e.g., nurses, aides, case managers)
- •Already enrolled as a care partner for another participant in the HEART Trial
- •Hospitalized at time of patient enrollment
- •No reliable internet access at baseline
- •Healthcare Workers
- •Inclusion criteria:
- •Age > 18 years
- •Currently employed (full-time, part-time) at a participating trauma center in a role type associated with trauma care (e.g., engaged in clinical care navigation, behavioral health, rehabilitation, recovery coordination, etc.)
- •Provides or supports care for orthopedic trauma patients for ≥20% of their clinical time
- •Expected to remain employed at the trauma center for >12 months after enrollment
- •Exclusion criteria:
- •Are contracted staff or traveling temporary staff
- •Are students or trainees
- •No reliable internet access at baseline
研究者
Stephanie Di Stasi
Associate Professor, Health and Rehabilitation Sciences
Ohio State University
研究点 (7)
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