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PI Name Protocol Number Protocol Title Status Approval Date
ADAMS JR, JAMES M H-10381 IMPROVING MEDICATION SAFETY BY LEARNING FROM EXPERIENCE Approved 9/24/2007

 

Funding Source

Aetna Foundation Quality Care Research Fund

Background Info

Errors resulting in adverse drug events are frequent, costly, and cause significant morbidity and mortality. As one of its five principles for the design of safety systems, the recent Institute of Medicine report on error in medicine recommended that healthcare organizations "create a learning environment" and "implement mechanisms of feedback and learning from error." This recommendation makes sense and sounds straightforward: health care organizations need to learn from their mistakes. But little is known about how health care organizations learn. We propose a study of organizational learning processes in two urban tertiary care hospitals and their pharmacies.

Purpose and Objectives

Using qualitative research methods, we will study how organizations seek to learn from safety-related medication events. The term safety-related medication events includes actual or potential adverse drug events and error, but excludes unanticipated drug interactions.

The specific aims are:

1) To describe four fundamental processes that contribute to organizational learning from safety-related medication events: event definition, data collection, analysis and interpretation, and decision making and implementation.


2) To identify the organizational factors that influence these four processes. Based on our pilot study and organizational theory, these factors may include (a) incentives, (b) communication channels, (c) attention allocation, (d) task specialization coordination, and (e) the distribution of decision-making authority.


3) To examine how the key organizational factors identified in aim 2, both individually and in combination, affect the four fundamental processes of learning described in aim 1.


4) To describe how different methods of defining events and gathering and analyzing data interact to influence how hospitals learn from their experience.


5) To develop a self- assessment tool for hospitals and their pharmacies to examine howthey learn from safety-related medication events.

Design

Questionnaire/survey/interview

Potential Risks

Because we will be discussing errors, and possibly injuries to patients, there is a risk of psychological and/or legal harm to the subjects if confidentiality of interview transcripts or field notes is breached. There is absolutely no risk of physical harm to any subjects, and extensive measures will be taken to prevent loss of confidentiality that could result in psychological harm.

Potential Benefits

Participants will receive no direct benefit from participation in this study. However, their participation may help the investigators better understand how hospitals learn from safety-related medication events. Therefore, this study may improve patient safety. Participants will not be reimbursed for participating in the study.

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