- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01396044
Daily Checklists and Outcome in the Intensive Care Unit
Medical errors account for tens of thousands of deaths and tens of billions of dollars in healthcare costs in the United States every year. One field that has seen the strongest push toward quality improvement has been critical care medicine, likely because its particularly high degree of medical complexity makes it a practice area prone to high error rates with serious consequences. One of the most commonly used interventions used to help reduce errors in the intensive care unit (ICU) has been the implementation of checklists.
The investigators propose a clinical trial in a University critical care setting to determine whether an electronic checklist versus verbal prompting to use a written checklist improves clinical practice and patient outcomes. The investigators also plan to compare these data with a time period prior to the study to determine if the electronic checklist or verbal prompting are better than usual care. The investigators hypothesize that both the electronic checklist and verbal prompting to use a written checklist will be better for clinical practice and patient outcomes than usual care, and that verbal prompting will lead to better outcomes compared to the electronic checklist.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University
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Chicago, Illinois, 미국, 60611
- Northwestern Memorial Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Admission to a medical intensive care unit (MICU) team during the study timeframe
Exclusion Criteria:
- Transfer from MICU team to a separate ICU team within 12 hours of admission
- Transfer to MICU team from a separate ICU team after more than 72 hours on the separate ICU team
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Electronic checklist
|
Electronic checklist for process of care issues implemented in our institution.
Training on a regular basis of the electronic checklist arm to use the electronic checklist.
Process of care issues on the electronic checklist include several that are under investigation: antibiotics and mechanical ventilation.
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|
실험적: Verbal prompting
Verbal prompting with written checklist
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Prompting by study investigators of physicians on the verbal prompting arm.
Prompting will include questions related to antibiotic utilization and mechanical ventilation weaning.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Empiric Antibiotic Duration
기간: During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)
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During intensive care unit admission, an average of 5 days per patient (although individual patients may vary)
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|
|
Proportion of Empiric Antibiotics
기간: ICU admission
|
The difference between the electronic checklist and prompted groups' proportion of all antibiotics that were administered empirically (empiric/total antibiotics).
|
ICU admission
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Hospital Mortality
기간: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
|
During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
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|
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Length of Stay
기간: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
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During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
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Ventilator-free Days
기간: During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
|
Number of days within the first 28 days after ICU admission that a patient does not require mechanical ventilation.
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During hospitalization, an average of 2 weeks per patient (although individual patients may vary)
|
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Proportion of Successful Prompts
기간: During ICU admission, an average of 5 days (although individual patients may vary)
|
Prompting group: number of patient-days that prompting led to empirical antibiotics being discontinued or narrowed/number of patient-days prompting occurred Electronic checklist group: number of patient-days that electronic checklist led to empirical antibiotics being discontinued or narrowed/number of patient-days electronic checklist was completed |
During ICU admission, an average of 5 days (although individual patients may vary)
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Proportion of Patients-days on Which Empirical Antibiotics Were Used
기간: ICU admission
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Proportion of patients-days on which empirical antibiotics were used
|
ICU admission
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Standardized Mortality Ratio
기간: Hospital admission
|
Hospital admission
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Curtis H Weiss, MD, Northwestern University
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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