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A Cluster Randomized Controlled Trial Comparing the Safety Action Feedback and Engagement (SAFE) Loop with an Established Incident Reporting System

Award Number: R01HS027455
ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY
OPDIV: AHRQ
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2020
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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A Cluster Randomized Controlled Trial Comparing the Safety Action Feedback and Engagement (SAFE) Loop with an Established Incident Reporting System - Project Summary Substantial progress has been made in some areas of patient safety, but medication errors and other problems continue to harm many thousands of patients each year. In other high-risk industries, voluntary incident reporting is widely used to improve safety. Incident reporting is also widely used in hospitals, but the reporting systems do not function optimally. Nurses file most reports, but they experience multiple barriers to reporting, including uncertainty about what to report, lack of feedback, and doubt about how hospitals will use the reports. Nurses submit thousands of reports each year, but the reported incidents represent a lower-risk subset of medical errors, the reports impart few actionable insights, and no standardized procedures exist for conducting follow-up investigations. The Safety Action Feedback and Engagement (SAFE) Loop has five key attributes designed to transform hospital incident reporting systems into effective tools for improving patient safety: obtaining nurses’ input about which medication safety problems to address; focusing on selected high- priority events; prompting nurses to report high-priority events during a designated period and training them to write more informative reports; integrating information from reports, investigations, and other internal and external sources; and providing feedback to nurses on the problems identified and mitigation plans. To compare use of the SAFE Loop and an existing incident reporting system, the investigators will conduct a cluster randomized controlled trial of 20 acute care nursing units at Cedars-Sinai Medical Center in Los Angeles, where 1980 nurses provide over 294,000 patient-days of care per year. Corresponding to three study Aims, outcome measures include: (1) incident reporting practices (rates at which nurses report high- priority medication incidents and numbers of contributing factors described per report), (2) nurses’ attitudes toward incident reporting (AHRQ Hospital Survey on Patient Safety Culture™, particularly perceptions of feedback and communication about error and of the frequency with which events are reported), and (3) rates of high-priority medication events (determined via IHI Trigger Tool method of medical record review). Analyses will compare changes in outcomes between from before to after implementation in intervention and control arms. Qualitative interviews of nurses the SAFE Loop arm will provide insight into implementation. If effective, the SAFE Loop will have several benefits: increasing nurses’ engagement with reporting, producing more informative reports, enabling safety leaders to understand problems and design system-based solutions more effectively and more efficiently, and lowering rates of medication errors. In turn, receiving feedback about problems and system-based solutions will further improve nurses’ perceptions of reporting. In addition to the local benefits to hospitals that implement the SAFE Loop, these changes will create secondary benefits nationally by enhancing the functioning of AHRQ Patient Safety Organizations, which rely on incident reports as critical sources of insights into safety concerns in hospitals and potential solutions.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Research on Healthcare Costs, Quality and Outcomes	000	5	5/7/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $377,043 )
2024	2024	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Research on Healthcare Costs, Quality and Outcomes	000	5	5/31/2024	NON-COMPETING CONTINUATION	$377,043
														Subtotal = $377,043

Issue Date FY: 2023 ( Subtotal = $379,279 )
2023	2023	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Research on Healthcare Costs, Quality and Outcomes	000	4	7/5/2023	NON-COMPETING CONTINUATION	$379,279
														Subtotal = $379,279

Issue Date FY: 2022 ( Subtotal = $379,574 )
2022	2022	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	WEST HOLLYWOOD	CA	90048	LOS ANGELES	USA	Research on Healthcare Costs, Quality and Outcomes	000	3	7/22/2022	NON-COMPETING CONTINUATION	$379,574
														Subtotal = $379,574

Issue Date FY: 2021 ( Subtotal = $392,899 )
2021	2021	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Research on Healthcare Costs, Quality and Outcomes	001	2	7/9/2021	NON-COMPETING CONTINUATION	$392,899
2021	2020	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Research on Healthcare Costs, Quality and Outcomes	000	1	5/25/2021	NEW	$0
														Subtotal = $392,899

Issue Date FY: 2020 ( Subtotal = $391,919 )
2020	2020	CEDARS-SINAI MEDICAL CENTER	8700 BEVERLY BLVD	LOS ANGELES	CA	90048	LOS ANGELES	USA	Research on Healthcare Costs, Quality and Outcomes	000	1	9/25/2020	NEW	$391,919
														Subtotal = $391,919

Grand Total All Awards = $1,920,714

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A Cluster Randomized Controlled Trial Comparing the Safety Action Feedback and Engagement (SAFE) Loop with an Established Incident Reporting System

Award Number: R01HS027455

ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY

OPDIV: AHRQ

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2020

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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