Patients and Families Improving Safety in Hospitals by Actively Reporting Experiences (I-SHARE)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 656
- 试验地点
- 1
- 主要终点
- Medical errors
研究概览
简要总结
Hospitals ineffectively examine the safety of their processes by relying on voluntary incident reporting (VIR) by clinical staff who are overworked and afraid to report. VIR captures only 1-10% of events, excludes patients and families, and underdetects events in vulnerable groups like patients with language barriers. Patients and families are vigilant partners in care who are adept at identifying errors and AEs. Failing to actively include patients and families in safety reporting and instead relying on flawed VIR presents an important missed opportunity to improve safety. To improve hospital safety, there is a critical need to coproduce (create in partnership with families) effective systems to identify uncaptured errors. Without this information, hospitals are impeded in their ability to improve patient safety. In partnership with diverse families, nurses, physicians, and hospital leaders, investigators created a multicomponent communication intervention to engage families of hospitalized children in safety reporting. The intervention includes 3 elements: (1) a multilingual mobile (email, text, and QR-code) reporting tool prompting families to share concerns and suggestions about safety, (2) family/staff education, and (3) a process for sharing family reports with the unit and hospital so systemic issues can be addressed.
详细描述
After piloting the intervention in one inpatient unit, marked improvements in family safety reporting and reductions in disparities in reporting by parent education and language results. The investigators now propose to conduct an RCT of the intervention in 4 geographically, ethnically, and linguistically diverse hospitals. The specific aims are to: (1) evaluate the effectiveness of the intervention in improving error detection and other safety outcomes, (2) assess the impact of the intervention on disparities in reporting, and (3) understand contextual factors contributing to successful implementation of the intervention. If effective, the intervention will contribute by: (1) increasing patient/family engagement in reporting, especially from vulnerable groups, (2) identifying otherwise unrecognized events, and (3) enabling hospitals to better understand safety problems in a 360-degree manner and design more effective, patient-centered solutions. Our application has high potential to reshape paradigms for measuring and improving safety and equity.
Hypothesis 1A: The I-SHARE arm will detect higher rates of errors (via I-SHARE tool + VIR) than usual care (via VIR alone).
Hypothesis 1B: In the I-SHARE arm, rates of errors detected by the I-SHARE tool will exceed rates detected through VIR.
Hypothesis 1C: The I-SHARE arm will have higher safety experience, safety climate, and patient activation scores than usual care.
Hypothesis 2A: Among Spanish-speaking and less educated patients/families, the I-SHARE arm will detect higher rates of errors (via I-SHARE tool + VIR) than usual care (via VIR alone).
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient/Family/Caregiver who has been hospitalized on the study unit during the study period (within the past 24 hours) or hospital employee who works at the study sites
- •Participants speaking all languages are eligible
排除标准
- •Admitted awaiting inpatient psychiatric placement
- •In state custody
- •Admitted for greater than 24 hours
- •Same day discharge
- •Covid positive
- •Previously enrolled in I-SHARE
- •Airborne illness precautions
结局指标
主要结局
Medical errors
时间窗: From date of randomization through hospital discharge (typically about 7 days).
Investigators will evaluate rates and types of errors detected through the mobile tool and through voluntary incident reporting (VIR). Errors will be validated by physician and chart review in real time using an established process the study team has used in prior studies.
次要结局
- Hospital experience(From date of randomization through hospital discharge (typically about 7 days).)
- Hospital safety climate(From date of randomization through hospital discharge (typically about 7 days).)
- Patient/family reported safety concerns concerns(From date of randomization through hospital discharge (typically about 7 days).)
- Patient/parent patient activation(From date of randomization through hospital discharge (typically about 7 days).)
研究者
Alisa Khan
Pediatric Hospitalist/Assistant Professor of Pediatrics
Boston Children's Hospital