Patient Safety Clinical Trial
Official title:
A Cluster Randomized Controlled Trial Comparing the Safety Action Feedback and Engagement (SAFE) Loop With an Established Incident Reporting System
Verified date | November 2023 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This trial will test whether a new intervention, the Safety Action Feedback and Engagement (SAFE) Loop, enhances nurse incident reporting practices, improves nurses' perceptions of incident reporting, and lowers rates of high-priority medication events, as compared with using an existing incident reporting system. The trial will be performed in 20 acute care nursing units at Cedars-Sinai Medical Center.
Status | Enrolling by invitation |
Enrollment | 5163 |
Est. completion date | July 31, 2025 |
Est. primary completion date | July 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Nurses: Inclusion Criteria: 1. Intervention (SAFE Loop): - All 1,980 nurses on the nursing units will be eligible to participate. 2. Aim 1 (review of incident reports): - All 1,980 nurses on the nursing units will be eligible to participate. 3. Aim 2 (survey of nurses): - Nurses will be eligible if they worked >50% time on one study nursing unit during a 6-month study period. 4. Aim 3 (review of medical records): - All 1,980 nurses on the nursing units will be eligible to participate. 5. Qualitative interviews: - Nurses and nurse managers will be eligible to participate if they worked at least 50% time on the study nursing units for the entire duration of a SAFE Loop implementation period. - We will enroll 32 participants out of a pool of approximately 800 eligible nurses. Exclusion Criteria: 1. All study procedures: - Provided care ONLY in outpatient clinics, operating/ procedure rooms, post-anesthesia care, and diagnostic and therapeutic services. 2. Aim 3: - Provided care ONLY in the emergency department. Patients: Inclusion Criteria: 1. Intervention (SAFE Loop): - All patients admitted to the study nursing units during a 6-month study period will be eligible to participate. 2. Aim 1 (review of incident reports): - Patients will be cared for on the study nursing units during a 6-month study period. - Patients will also have an incident report that addresses one of the high-priority medication events. 3. Aim 2 (survey of nurses): - Not applicable. 4. Aim 3 (review of medical records): - Patients will be admitted to the study nursing units during a 6-month study period. - We will randomly sample 1,520 hospitalizations divided equally between the four study groups and the baseline and follow-on periods. 5. Qualitative interviews: - Not applicable. Exclusion Criteria: 1. All study procedures: - Received care ONLY in outpatient clinics, operating/ procedure rooms, post-anesthesia care, and diagnostic and therapeutic services. 2. Aim 3: - Received care ONLY in the emergency department. |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center | Agency for Healthcare Research and Quality (AHRQ) |
United States,
Cohen TN, Francis SE, Wiegmann DA, Shappell SA, Gewertz BL. Using HFACS-Healthcare to Identify Systemic Vulnerabilities During Surgery. Am J Med Qual. 2018 Nov/Dec;33(6):614-622. doi: 10.1177/1062860618764316. Epub 2018 Mar 21. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Nurses' incident reporting practices | Number of work-system factors identifiable in the narrative section of each incident report. Two researchers with expertise in human factors methods will identify (and classify) the work-system factors described in each incident report, with a third researcher available to adjudicate ties. Work-system factors will be based on HFACS Healthcare taxonomy. | 48 weeks | |
Primary | Nurses' attitudes regarding communication about error | Performance on composite measure on "Communication About Error," from AHRQ Hospital Survey on Patient Safety Cultureā¢ version 2.0, based on surveys of nurses. | 24 weeks | |
Primary | Rate of high-priority medication events | Rate per 1,000 patient-days of medication events identified as high priorities for prevention by the 10 nursing units in the intervention group. Medication events include preventable adverse drug events and potential adverse drug events. Medication events will be detected via the IHI Trigger Tool method of medical record review, with screening by trained nurse reviewers and confirmation by trained physician reviewers. | 48 weeks | |
Secondary | Rate of reporting high-priority medication events | Rate (%) per 1000 patient-days of incident reports addressing one of the medication events identified as high priorities for prevention by the 10 nursing units in the intervention group. Medication events include preventable adverse drug events and potential adverse drug events. | 48 weeks | |
Secondary | Nurses' attitudes regarding reporting of patient safety events | Performance on composite measure on "Reporting Patient Safety Events," from AHRQ Hospital Survey on Patient Safety Cultureā¢ version 2.0, based on surveys of nurses. | 24 weeks | |
Secondary | Rate of high-priority medication events that involved patient harm | Rate per 1,000 patient-days of medication events (1) identified as high priorities for prevention by the 10 nursing units in the intervention group, and (2) involving harm (NCC MERP severity categories E-I). These medication events will include only preventable adverse drug events (NOT potential adverse drug events). Medication events will be detected via the IHI Trigger Tool method of medical record review, with screening by trained nurse reviewers and confirmation and classification (severity rating) by trained physician reviewers. | 48 weeks |
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