# Handoffs and Transitions in Critical Care - Understanding Scalability

> **NIH NIH R01** · UNIVERSITY OF PENNSYLVANIA · 2021 · $144,646

## Abstract

PROJECT SUMMARY:
“Handoffs and Transitions in Critical Care – Acute care Implementation Research Ethics
(HATRICC-AIRE)”
There is an urgent need to characterize implementation strategies suitable for use in the fast-paced, high stakes
environment of critical care, a setting that is underrepresented in the implementation science literature. At the
same time, such research must be conducted in an ethical fashion, one that respects the rights of research
subjects. Investigators and research ethics boards face recurrent difficulties evaluating ethics in implementation
research, which presents issues that have not been clearly or comprehensively addressed in prominent medical
ethical guidelines. For example, it is frequently unclear whether the health professionals targeted by
implementation studies should be considered “research subjects,” whether and how they should give informed
consent, and which gatekeepers can appropriately give permission for institutions to participate in
implementation trials. Healthcare professionals are meanwhile exposed to a number of potential risks by
implementation research, including sanction for certain care practices, altered relationships with colleagues,
altered relationships with patients and families, interruptions to clinical workflow, and retaliation for deciding to
opt out of an implementation study. In this project, we use qualitative methods to unmask and explore challenges
to the ethical conduct of implementation research in acute care settings. We will elicit the perspectives of diverse
stakeholders in acute care implementation research, including clinicians and other frontline employees, clinical
and administrative leaders, and institutional review board members. We will then refine current research ethics
frameworks to more closely address the unique challenges raised by implementation research. The proximate
goal of this work is to facilitate the hybrid effectiveness-implementation study supported by the parent grant. The
longer-term goal is to guide the ethical conduct of implementation research by developing a framework that can
be employed in future studies based in acute care. The findings of this study will be disseminated in the scientific
literature to facilitate widespread use. The potential public health impact of this work is significant because the
resulting ethical framework will meaningfully augment investigators’ ability to conduct ethical, rigorous acute care
implementation research aimed at narrowing the evidence-to-practice gap. This project is specific to bioethics
research; it is relevant to the NIH’s interest in bioethical issues in research including the interface of clinical
research and clinical care in the learning health system and methods for obtaining and documenting informed
consent. It is also relevant to the NHLBI’s interest in bioethical questions related to implementation science
research.

## Key facts

- **NIH application ID:** 10364299
- **Project number:** 3R01HL153735-02S1
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** Meghan Brooks Lane-Fall
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $144,646
- **Award type:** 3
- **Project period:** 2020-09-01 → 2025-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10364299

## Citation

> US National Institutes of Health, RePORTER application 10364299, Handoffs and Transitions in Critical Care - Understanding Scalability (3R01HL153735-02S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10364299. Licensed CC0.

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