A Cluster Randomized Controlled Trial Comparing the Safety Action Feedback and Engagement (SAFE) Loop With an Established Incident Reporting System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Cedars-Sinai Medical Center
- Enrollment
- 5,163
- Locations
- 1
- Primary Endpoint
- Rate of high-priority medication events
Study Overview
Brief Summary
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.
Detailed Description
This cluster randomized controlled trial will test whether a novel intervention, the Safety Action Feedback and Engagement (SAFE) Loop, enhances hospital incident reporting practices, improves nurses' perceptions of incident reporting, and lowers rates of high-priority medication events, as compared with Cedars-Sinai Medical Center's (CSMC's) existing incident reporting system.
The specific aims are to determine whether SAFE Loop:
- Aim 1: improves incident reporting practices by increasing the rate at which nurses report high-priority medication incidents (H1.1) and the number of contributing factors described per report (H1.2).
- Aim 2: improves nurses' attitudes toward incident reporting, including perceptions of feedback and communication about error (H2.1) and of the frequency with which events are reported (H2.2).
- Aim 3: reduces rates of high-priority medication events (H3.1) and high-priority medication events involving harm (H3.2).
Setting and Subject Population: 20 acute care nursing units at Cedars-Sinai Medical Center in Los Angeles, where about 1980 nurses provide over 294,000 patient-days of care per year (about 115,000 hospital visits).
Quality Improvement (QI) Activities: (1) Safe Loop Activities, including obtaining input from nurses, educational activities training them in how to focus on target events and write high-quality reports, stimulated time-limited reporting, integration of information from reports and other QI data sources from within the hospital and other information, designing changes to improve medication safety, and providing feedback to nurses. (2) Randomization of nursing units to intervention or control and early vs. later implementation. The will assure that the implementation occurs in a uniform and manageable fashion. (3) Implementation activities: planning, engaging, executing, reflecting/evaluating.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
Nurses and nursing units will not be masked to study arm. Patients cared for on nursing units will be masked to study arm (and will not be consented for participation). Outcome assessors will be blinded to study arm.
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion Criteria:
- •Intervention (SAFE Loop):
- •All 1,980 nurses on the nursing units will be eligible to participate.
- •Aim 1 (review of incident reports):
- •All 1,980 nurses on the nursing units will be eligible to participate.
- •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.
- •Aim 3 (review of medical records):
- •All 1,980 nurses on the nursing units will be eligible to participate.
- •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
- •All study procedures:
- •Provided care ONLY in outpatient clinics, operating/ procedure rooms, post-anesthesia care, and diagnostic and therapeutic services.
- •Provided care ONLY in the emergency department.
- •Inclusion Criteria:
- •Intervention (SAFE Loop):
- •All patients admitted to the study nursing units during a 6-month study period will be eligible to participate.
- •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.
- •Aim 2 (survey of nurses):
- •Not applicable.
- •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.
- •Qualitative interviews:
- •Not applicable.
- •Exclusion Criteria:
- •All study procedures:
- •Received care ONLY in outpatient clinics, operating/ procedure rooms, post-anesthesia care, and diagnostic and therapeutic services.
- •Received care ONLY in the emergency department.
Arms & Interventions
SAFE Loop Arm
Nursing units involved in the intervention arm will participate in an iterative educational and quality improvement process that encourages improved reporting of medication safety events deemed important to their individual nursing units.
Intervention: Safety Action Feedback and Engagement (SAFE) Loop (Behavioral)
Control Arm
Nurses in this study will continue standard practice protocol.
Outcomes
Primary Outcomes
Rate of high-priority medication events
Time Frame: 48 weeks
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.
Nurses' attitudes regarding communication about error
Time Frame: 24 weeks
Performance on composite measure on "Communication About Error," from AHRQ Hospital Survey on Patient Safety Culture™ version 2.0, based on surveys of nurses.
Nurses' incident reporting practices
Time Frame: 48 weeks
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.
Secondary Outcomes
- Rate of high-priority medication events that involved patient harm(48 weeks)
- Rate of reporting high-priority medication events(48 weeks)
- Nurses' attitudes regarding reporting of patient safety events(24 weeks)
Investigators
Teryl K. Nuckols
Vice Chair for Clinical Research, Director of Division of General Internal Medicine
Cedars-Sinai Medical Center