
Beyond the Protocol: Integrating Trauma-Informed Principles in Clinical Research with Intensive Care Unit Survivors
Overview
Trauma-informed care (TIC) is an important and influential construct being increasingly used in clinical contexts. The principles of TIC shape the way physicians, nurses, social workers, and other healthcare providers interact with patients, leading to better outcomes, yet TIC constructs are rarely used to shape and influence the conduct of clinical research—whether in medicine generally or, more specially, with intensive care unit (ICU) patients and survivors, an often heavily traumatized group who are the focus of this review. Relying on case studies and relevant patient vignettes, this paper argues for the broad implementation of TIC principles in ICU outcomes research to uphold principles such as beneficence, to minimize potential trauma, and to better honor the unique challenges of a large, growing, and often vulnerable population. ICU experiences often involve fear, terror, loss of control, and vulnerability, which can lead to lasting psychological impacts. For ICU survivors, the process of participating in research may inadvertently re-traumatize them through various pathways, including the informed consent process, potentially distressing questions, and the environment in which patients are seen, to name a few. This paper emphasizes critical factors such as safety, trust, and privacy in shaping patients’ research participation, while outlining six key TIC principles: safety, trustworthiness and transparency, peer support, collaboration and mutuality, cultural considerations, and empowerment. By integrating these principles into clinical research practices, investigators can enhance participant welfare, reduce attrition, and improve data quality leading to better and more accurate outcomes and, most importantly, honor the humanity of participants.
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Target Audience
Pulmonologists, critical care specialists, translational researchers, and clinicians
Learning Objectives
At the conclusion of this activity, learners should be able to:
- Analyze the six core principles of trauma-informed care (TIC) and their specific applications in clinical research with intensive care unit (ICU) survivors.
- Evaluate strategies for minimizing re-traumatization risks during research participation for critically ill patients.
- Demonstrate how to implement trauma-informed principles across different states of clinical research, from recruitment to follow up.
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Accreditation Statement
The American Thoracic Society is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.
Disclosure Declaration
Article Authorship Disclosures (as submitted to the ATS prior to article publication date)
Jennifer MacDonald, LMSW (Vanderbilt University Medical Center, Nashville, TN) reported no relevant financial relationships with ineligible companies.
Amanda Heller, BSW (Vanderbilt University Medical Center, Nashville, TN) reported no relevant financial relationships with ineligible companies.
Rachel Kramer, BSN, RN (Vanderbilt University Medical Center, Nashville, TN) reported no relevant financial relationships with ineligible companies.
Olivia Vyge, MS (Vanderbilt University Medical Center, Nashville, TN) reported no relevant financial relationships with ineligible companies.
James C. Jackson, PsyD (Vanderbilt University Medical Center, Nashville, TN) reported no relevant financial relationships with ineligible companies.
Leanne M. Boehm, PhD, RN, ACNS-BC (Vanderbilt University Medical Center, Nashville, TN) reported a grant from the NIH/NIA and a leadership role in the Board of Directors at the American Delirium Society.
AnnalsATS CME Planners
Margaret M. Hayes, M.D.
Harvard Medical School, Boston, MA, USA
Dr. Hayes reported receiving payments as an author for a chapter on heliox for UpToDate
Caroline Okorie, M.D., M.P.H.
Stanford University School of Medicine, Stanford CA, USA
Dr. Okorie reported no financial relationships with ineligible companies,
Off-Label Usage Disclosure
None
All relevant financial relationships have been reviewed and mitigated.
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Available Credit
- 1.00 AMA PRA Category 1 Credit(s)™The American Thoracic Society designates this for a maximum of 1.00 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
- 1.00 Participation

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