Sepsis survivors Monitoring and coordination in Outpatient Health care

Not Applicable

• Conditions: A41; Other sepsis

• Registration Number: DRKS00000741
• Lead Sponsor: Center for Sepsis Control & Care, Universitätsklinikum Jena

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-02
• Study Completion: 2015-12-31
• Results First Posted: 2016-06-28
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

Survivors of severe sepsis or septic shock (ICD-10: A41)
- at least two SIRS criteria
- at least one organ dysfunction
- Adults
- sufficient German language skills
- Patients have primary care provider

Exclusion Criteria

- Dementia (TICSM < 27)
- guardianship before sepsis
- nursing home residents
- severe language/speech disorder
- deaf or blind patients
- insufficiant German language skills

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health related quality of life / Physical Health Summary Scale (SF-36 – Patient survey) after 6 months