Handoffs and Transitions in Critical Care - Understanding Scalability

NCT ID: NCT04571749

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

4000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-11

Study Completion Date

2026-07-31

Brief Summary

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The investigators will leverage implementation science and engineering to adapt, implement, and rigorously evaluate tailored postoperative handoff protocols and implementation strategies. In doing so, the investigators will develop a vital understanding of the factors needed for successful and sustained use of evidence-based interventions in acute care. This knowledge will inform approaches to bridge the evidence-to-practice gap that prevents effective interventions from realizing the promise of improved patient outcomes in acute care settings.

Detailed Description

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Surgical patients who require post-surgical critical care are usually transferred from the operating room (OR) to the intensive care unit (ICU) for ongoing care. The process of transferring the patient from the OR to the ICU is called a "handoff." Handoffs involve the transfer of patient information and transfer of patient care responsibilities from the OR team to the ICU team. Multiple studies suggest that these handoffs can expose patients to preventable harm, which can be avoided with standardization of the handoff. The Handoffs and Transitions in Critical Care (HATRICC; IRB #819726) study, started in 2014, developed and implemented a standardized OR to ICU handoff process in two Penn surgical ICUs (SICUs) that did not have a standardized handoff process.

Four clinicians (surgeon, anesthetist, ICU provider, and ICU nurse) from two teams (surgical and intensive care) usually take part in handoff communication. During the HATRICC study, the investigators evaluated handoff communication between the OR and ICU teams before and after implementation of the new standardized handoff process (the "HATRICC process") in multiple ways, using observations, interviews, focus groups, and surveys. The investigators demonstrated a 20% improvement in information exchange after implementation of the HATRICC standardized handoff process, a process tailored to meet the needs of the different clinicians participating in OR to ICU handoffs.

Prior studies have indicated short-term success in standardizing OR to ICU handoffs, but sustainability of these improvement interventions has been less well studied. Two studies have demonstrated sustained or improved information exchange following the institution of structured OR to ICU handoff processes, but the factors influencing sustainability remain to be elucidated.

The aims of this study are to:

1. Ascertain determinants of OR-to-ICU handoff protocol adoption and use in 12 adult and pediatric ICUs in five health systems.
2. Adapt handoff protocols using engineering approaches and select tailored implementation strategies with implementation mapping.
3. Test the effectiveness of tailored, multifaceted, multilevel implementation strategies.
4. Design and create a digital toolkit for other ICUs to identify implementation determinants, customize OR-to-ICU handoff protocol, and select appropriate implementation strategies.

Conditions

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Patient Handoff Healthcare Team Communication Patient Safety Intensive Care Units

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Customized Or to ICU handoff protocol

Tailored implementation strategies will be used in 12 ICUs to facilitate the uptake and sustained use of a customized handoff protocol to be used by clinicians at the time of patient care transition from the operating room to the intensive care unit.

Group Type EXPERIMENTAL

Customized handoff

Intervention Type BEHAVIORAL

A customized handoff will be implemented that consists of choreographed handoffs utilizing a structured handoff tool to facilitate information exchange.

Interventions

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Customized handoff

A customized handoff will be implemented that consists of choreographed handoffs utilizing a structured handoff tool to facilitate information exchange.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Cares for patients at any point in the surgical continuum of care, including pre-operative, intra-operative, or post-operative care, OR has administrative responsibilities relevant to patient care at the study hospitals
* Fluency in English


• Patient admitted for inpatient care at the study hospitals and experiences a post-operative handoff from the operating room to the intensive care unit.

Exclusion Criteria

• Being a member of research staff


• (none)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Meghan B Lane-Fall, MD, MSHP

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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Johns Hopkins

Baltimore, Maryland, United States

Site Status

Cooper Health

Camden, New Jersey, United States

Site Status

Temple Health

Philadelphia, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

References

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Lane-Fall MB, Christakos A, Russell GC, Hose BZ, Dauer ED, Greilich PE, Hong Mershon B, Potestio CP, Pukenas EW, Kimberly JR, Stephens-Shields AJ, Trotta RL, Beidas RS, Bass EJ. Handoffs and transitions in critical care-understanding scalability: study protocol for a multicenter stepped wedge type 2 hybrid effectiveness-implementation trial. Implement Sci. 2021 Jun 15;16(1):63. doi: 10.1186/s13012-021-01131-1.

Reference Type DERIVED
PMID: 34130725 (View on PubMed)

Related Links

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http://www.hatricc.us/

HATRICC Website

Other Identifiers

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R01HL153735

Identifier Type: NIH

Identifier Source: secondary_id

View Link

843670

Identifier Type: -

Identifier Source: org_study_id

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