Sepsis survivors Monitoring and coordination in Outpatient Health care - Smooth
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 290
研究概览
简要总结
The mean age of the 291 patients was 61.6 years (SD, 14.4); 66.2% (n = 192) were men, and 84.4% (n = 244) required mechanical ventilation during their ICU stay (median duration of ventilation, 12 days [range, 0-134]). At 6 and 12 months after ICU discharge, 75.3% (n = 219 [112 intervention, 107 control]) and 69.4% (n = 202 [107 intervention, 95 control]), respectively, completed follow-up. Overall mortality was 13.7% at 6 months (40 deaths [21 intervention, 19 control]) and 18.2% at 12 months (53 deaths [27 intervention, 26 control]). Among patients in the intervention group, 104 (70.3%) received the intervention at high levels of integrity. There was no significant difference in change of mean MCS scores (intervention group mean at baseline, 49.1; at 6 months, 52.9; change, 3.79 score points [95% CI, 1.05 to 6.54] vs control group mean at baseline, 49.3; at 6 months, 51.0; change, 1.64 score points [95% CI, -1.22 to 4.51]; mean treatment effect, 2.15 [95% CI, -1.79 to 6.09]; P = .28). Conclusions and Relevance : Among survivors of sepsis and septic shock, the use of a primary care–focused team-based intervention, compared with usual care, did not improve mental health–related quality of life 6 months after ICU discharge. Further research is needed to determine if modified approaches to primary care management may be more effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one(—)
- 性别
- All
入选标准
- •Survivors of severe sepsis or septic shock (ICD-10: A41)
- •- at least two SIRS criteria
- •- at least one organ dysfunction
- •- sufficient German language skills
- •- Patients have primary care provider
排除标准
- •- Dementia (TICSM < 27)
- •- guardianship before sepsis
- •- nursing home residents
- •- severe language/speech disorder
- •- deaf or blind patients
- •- insufficiant German language skills
