Formative Evaluation to Inform Implementation of Sepsis Bundles in Emergency Departments - 20/08/25
, Nima Sarani, MD b, Jacqueline F. Hayes a, Ruben G. Martinez a, Jessyca Goldstein, BA c, Laura Evans, MD, MSc d, Gary Phillips, MAS, MAT e, R. Phillip Dellinger, MD, MCCM f, David Portelli, MD, FACEP g, Christa Schorr, DNP, MSN h, Kathleen M. Terry, PhD i, Lori Harmon, MBA, CPHQ j, Sean Townsend, MD k, Mitchell M. Levy, MD, MCCM cAbstract |
Study objective |
Sepsis bundles are effective in reducing mortality for sepsis, the leading cause of admissions to intensive care units. However, little is known about factors that hinder and facilitate the delivery of sepsis bundles in emergency departments. Guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS) Framework, the objective of the present study was to characterize determinants of implementing sepsis bundles in emergency departments in the United States.
Methods |
A formative evaluation guided by the EPIS was conducted with nurses, physicians, and pharmacists using qualitative interviews (N=66 interviews) and quantitative surveys (N=86 surveys). Qualitative interviews were analyzed using a matrix-guided rapid analytic approach. Quantitative surveys were analyzed descriptively.
Results |
Scores on quantitative measures indicated that participants perceived evidence-based interventions positively and had moderately positive perceptions of implementation climate and organizational readiness for change. Qualitative results indicate barriers aligned with the EPIS constructs of outer context (eg, perceived rigidity related to Centers for Medicare & Medicaid Services bundle requirements), inner context (eg, alert fatigue), bridging factors (eg, staffing shortages), and innovation factors (eg, concerns about fluid overload). Participants reported facilitators including nurse-driven protocols (inner context) and bundles being straightforward (innovation factors).
Conclusions |
Findings highlight areas that warrant attention during sepsis bundle implementation efforts in emergency departments, including staff turnover, hesitancy in initiating bundles, competing or misaligned priorities related to bundle implementation, and developing hospital cultures that promote sepsis bundle compliance. These findings will be used to tailor implementation strategies that will support bundle compliance in a hybrid type II effectiveness-implementation trial.
Le texte complet de cet article est disponible en PDF.Keywords : Sepsis, Septic shock, Sepsis bundles, Implementation science, Formative evaluation
Plan
| Please see page 265 for the Editor’s Capsule Summary of this article. |
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| Supervising editor: Alan E. Jones, MD. Specific detailed information about possible conflict of interest for individual editors is available at editors. |
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| Author contributions: HEF is a study coinvestigator who contributed to study design and wrote the initial draft of the manuscript. JG, JFH, and RGM assisted with data collection and analysis. LE, GP, DP, NS, CS, and KT are co-investigators and/or consultants and made contributions to the study design and manuscript revisions. RPD and SRT revised the initial draft of the manuscript. LH is the study project manager and has contributed to trial planning and coordination of study activities, including management of multi-site ethics approvals. MML is the Principal Investigator; he conceived of the parent study and led the proposal development. All authors read and approved the final manuscript. HEF takes responsibility for the paper as a whole. |
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| Data sharing statement: The data set generated and analyzed during the current study is not publicly available due to the sensitive nature of interview transcript data. Publication of entire transcripts risks identifying research participants. |
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| All authors attest to meeting the four ICMJE.org authorship criteria: (1) Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND (2) Drafting the work or revising it critically for important intellectual content; AND (3) Final approval of the version to be published; AND (4) Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. |
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| Funding and support: By Annals’ policy, all authors are required to disclose any and all commercial, financial, and other relationships in any way related to the subject of this article as per ICMJE conflict of interest guidelines (see www.icmje.org/). Dr. Evans is a cochair for the Adult Surviving Sepsis Guidelines, coauthor of SSC Hour-1 Bundle, and member of the Scientific Advisory Board for Endpoint Health (USA). Dr. Dellinger held a leadership position in the Surviving Sepsis Campaign 2002-2016. Dr. Schorr has been in a leadership position for the Surviving Sepsis Campaign from 2006 to the present and is a paid consultant on the current grant (NHLBI R01 HL153268). Dr. Townsend is a measure steward for the Centers for Medicare and Medicaid Services sepsis quality measure. Dr. Levy receives funding from T32 HL134625, 1RO1HL162954-0, is coauthor of the SSC Hour-1 Bundle, and is on scientific advisory boards for Inotrem (France) and Endpoint Health (USA). All other authors declare that they have no competing interests. This study is funded by the National Heart, Lung, and Blood Institute (NHLBI: R01HL153268). The funding body did not have a role in the design of the study, collection, analysis, and interpretation of the data, or writing the manuscript. |
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| Trial registration number: Registry Name: ClinicalTrials.gov; Registration Number: NCT05491941; Registration Date: August 8, 2022 |
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| A podcast for this article is available at www.annemergmed.com. |
Vol 86 - N° 3
P. 264-274 - septembre 2025 Retour au numéro
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