NPSF Letter of Intent:Title: Improving the Safety and Efficacy of Pediatric Sedation Practice through the Creation of the Pediatric Sedation Research ConsortiumPrincipal Investigator: Joseph P. Cravero MD FAAP, Associate Professor of Anesthesiology and Pediatrics – Dartmouth Hitchcock Medical Center. joseph.cravero@hitchcock.orgExecutive Summary: Pediatric sedation practice varies greatly throughout the United States. There is evidence that a major gap exists between common sedation practices versus state-of-the-art care using available technology. This gap results in significant patient harm in the form of: procedural pain, anxiety, psychological trauma, suboptimal and/or failed procedures, sedation related airway obstruction, respiratory depression, and even death. We propose the creation of a multidisciplinary consortium of institutions and individuals that will allow us to use epidemiological methods to characterize (in detail) the nature of pediatric sedation as it is currently practiced within the United States. Specifically, we will use a common data collection tool to capture patient demographics, procedural factors, provider factors, pharmacologic and non-pharmacologic techniques, and environmental factors used to provide sedation care. Outcomes in terms of the procedure, the sedation, events, and satisfaction will also be captured in common. This consortium will collect data from over 50,000 procedures performed per year in aggregate. This empiric data will allow us to understand how pediatric procedural sedation is currently practiced and the events that represent threats to patient safety. In addition, the consortium will be organized in such a way as to identify “best practices” through the evaluation of prospectively collected data on sedation from member institutions. Finally, the consortium will allow innovative strategies for improving the safety and efficacy of pediatric procedural sedation (e.g., simulator based training) to be evaluated in outcome studies using a cohort of institutions. Background: Each day thousands of children enter hospitals across the United States requiring sedation for diagnostic and therapeutic procedures. The approach taken to achieve the goals of sedation for a particular procedure varies widely from one institution to another. In addition, the number of requests for sedation often outstrips the availability of sedation experts. The resources allocated to accommodate these requests also vary across the country and even within a given hospital or organization. Some services employ direct physician involvement while others rely on trained nursing personnel. Still others have developed the concept of a “sedation room” or a “sedation team.” (1, 2) The major goals of pediatric procedural sedation are to provide anxiety relief, pain control, and (usually) a still child. The rate of failure to achieve these goals has been reported by various investigators to be as low as 2-3% (3, 4, 5) and by others to be 10-20%. (6-10) The safety of pediatric procedural sedation is also problematic. In 2000 Coté and coworkers published a review of a series of sedation “critical incidents”. (11) Their analysis reveals that the overwhelming majority of these critical events were preventable and due to avoidable errors, thus representing a safety problem.

Expert consensus that respiratory depression caused by sedative drugs should not lead to morbidity or mortality catalyzed the American Academy of Pediatrics (AAP), the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), the American Society of Anesthesiology, the American Academy of Pediatric Dentistry, and the American Dental Society

Joseph P. Cravero, M.D. NPSF Letter of Intent 1 of 3

of Anesthesiologists to issue practice guidelines for sedation.(12-15) Unfortunately, even clinicians adhering to current practice guidelines for pediatric procedural sedation appear to be at risk of causing iatrogenic injuries. (16) It remains impossible to quantify the magnitude of this problem since all published reports (to date) simply lack the statistical power to yield a reasonable estimate of sedation critical incident occurrence because of low event rates (1 in 1,000s) and small study groups (10s to100s). (1-10, 17, 18) Previous Research: Detailed “micro-world” view of pediatric procedural sedation: Using support from the National Patient Safety Foundation under Primary Investigator George Blike MD, we have previously undertaken a study of the process of pediatric sedation at the Children’s Hospital at Dartmouth (CHaD) using a human factors approach. Observational video data confirmed that errors (under-use, over-use and misuse of sedative medications) are commonplace in the practice of procedural sedation. In subsequent NIH funded work, a human patient simulator is being used to probe sedation care systems for “failure to rescue” errors. This work has allowed for a procedural sedation care to be modeled in terms state feed back control (19). Ultimately, this research aims to use detailed video observational data to identify threats to patient safety and to design innovative countermeasures to mitigate risk and thus enhance patient safety.

Qualitative “macro-world” view of pediatric procedural sedation: To help determine whether our findings (based on a solitary hospital) could be generalized, we convened an AHRQ- supported expert conference on pediatric sedation in September 1999. This multi-specialty evaluation of pediatric sedation provided subjective evidence that the model proposed would not be limited to the patient population at CHaD. A common research agenda was produced by the panel of 20 experts that called for improved communication between specialties and the need for epidemiologic data on safety and efficacy of pediatric sedation practice.

Pre-work: Establishing a consortium dedicating to improving pediatric sedation careIn answer to this call, Cravero and Blike began publishing the Pediatric Sedation Newsletter (all literature available at http://www.hitchcock.org/dept/painfree). This forum has facilitated cross- disciplinary collaboration and the conception of the Pediatric Sedation Research Consortium (funding for which we are seeking through this grant request). Specific Aims: The goals of this project will be to: 1) organize a representative sample of institutions that provide pediatric procedural sedation for a complete spectrum of procedures in a range of geographic and sociologic care settings into a consortium; 2) develop a common data collection tool that defines the procedural demands, sedation care resources and patient outcomes for each sedation case in consortium hospitals; 3) demonstrate the capacity to use collaborative methods to identify “best practices” and disseminate safety interventions. Further data collection will determine if changes in practice result in improved pediatric sedation outcomes in relation to the larger consortium group.Methods: Twenty eight participating centers of various sized organizational structures have committed to this project (Pediatric Sedation Research Consortium – PSRC). The consortium has been put together with representatives from all specialties that deliver pediatric sedation – including pediatrics, critical care, emergency medicine, anesthesiology, pediatric oncology, dentistry, and oral surgery. The PSRC will also have representatives from physician, physician assistant, advanced practice nursing, and registered nursing personnel. Centers involved serve various populations including, both urban and rural, and will include all ethnic groups.

Joseph P. Cravero, M.D. NPSF Letter of Intent 2 of 3

The proposed two year project will include two phases:1. Data Collection (Finding the “n”). This phase of the study will begin with the development of a web-based data collection tool. This tool will be paired with a data management system with capability of storing massive amounts of sedation-related data on a server located at Dartmouth Medical School. Data from sedation services delivered by all types of providers under widely varying conditions will be collected during the first year of the project. It is conservatively expected that this group could collect 50 thousand patient encounters in a year. The Bioinformatics Group at Dartmouth College has experience in creating this type of database and is poised to start work on this project.2. Data analysis will begin in the second year even as data continues to be collected. Project data generated in Phase One will be used to determine which Centers have extraordinarily high rates of success with sedation for various specific procedures. In addition Centers with high rates of critical incidents or nearly critical incidents will be identified. System elements that characterize these centers will be sought. Hypothesis testing will be done once associations are identified. Cohort studies to establish new knowledge will be feasible, but are beyond the scope of this proposal. However, best practices (such as simulator-based training, adaptive learning models, etc.) if they have an existing evidence-base, will be disseminated throughout the consortium using collaborative methodologies.Impact: Organizing twenty-eight organizations and rigorously developing a data collection tool will yield representative information based on >50,000 encounters per year. Accurate information from such a large group with the common purpose to protect children from sedation related harm will have tremendous leverage. Previous work funded by the NPSF and NIH, editing the Pediatric Sedation Newsletter with a circulation of over 3,000 clinicians, and the proposed funding will position Joe Cravero and George Blike to lead this effort. Patient Safety, in general, will be advanced as we demonstrate how threat identification and countermeasure design work (using human factors methods) needs to be integrated with the proposed outcomes evidence-based research (using epidemiological methods).

Budget: Total Direct Costs for Entire Proposed Period of Support: $100,000

Year One Year TwoPersonnel Joseph P. Cravero, MD, Principal Investigator

(10% effort)*George Blike, MD, Human Factors Consultant

$23,000

$5,000

$23,000

$5,000Consulting Database design, collection, and analysis $20,000 $20,000Other Consortium meeting organization $2,000 $2,000

Additional support: consortium members will contribute to cost of meetings and site visits; DHMC Department of Anesthesiology will fund indirect costs associated with this project, and use of the Human Patient Simulator.

*Based on 2003 NIH salary cap and fringe of 35%

Joseph P. Cravero, M.D. NPSF Letter of Intent 3 of 3