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Enrolling by invitation NCT04571749

Handoffs and Transitions in Critical Care - Understanding Scalability

No phase Interventional Patient Handoff Healthcare Team Communication Patient Safety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Customized handoff.
Who it may be relevant to
Registry conditions: Patient Handoff, Healthcare Team, Communication, Patient Safety. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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.

Interventions

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

Primary outcome measures

  • Adherence to standardized handoff intervention (Fidelity) measured by number of handoff steps followed. [Time frame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.]
  • New-onset organ failure [Time frame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year5]
Secondary outcome measures (12)
  • Perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory (Acceptability) [Time frame: Baseline (Year 1); within 2months of implementation; within 2 months of beginning sustainment]
  • Perceived fit, relevance, or compatibility of the innovation in a practice setting or to address a particular issue (Appropriateness), measured by the Intervention Appropriateness Measure [Time frame: Baseline (Year 1); within 2months of implementation; within 2 months of beginning sustainment]
  • Feasibility of treatment or innovation to be carried out in a practice setting, measured using the Feasibility of Intervention Measure. [Time frame: Baseline (Year 1); within 2months of implementation; within 2 months of beginning sustainment]
  • Fidelity over time (Sustainment) [Time frame: This outcome will be measured at monthly intervals starting 2 years after implementation, up to 5 years.]
  • Monetary and non-monetary costs measured using the line item classification system [Time frame: This outcome will be measured within 2 months of implementation; within2 months of beginning sustainment]
  • Teamwork (effectiveness) measured using the Team Emergency Assessment Measure. [Time frame: This outcome will be measured at quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5]
  • Clinician satisfaction measured at the individual level. [Time frame: This outcome will be measured annually from Years 1 to 5.]
  • Workload measured using the NASA Task Load Index. [Time frame: This outcome will be measured at quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.]
  • Completeness of information exchange (Information Omissions) measured using a structured observation form. [Time frame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year5]
  • Weighted average of the reliability-adjusted observed-to-expected ratios for component indicators of adverse events [Time frame: This outcome will be measured at quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.]
  • AHRQ PSI 9: Perioperative hemorrhage or hematoma rate(effectiveness) [Time frame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5]
  • AHRQ PSI 10: Postoperative physiologic or metabolic derangement rate (effectiveness) [Time frame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.]

Eligibility criteria

Inclusion Criteria for Clinicians:

  • 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

Inclusion Criteria for Patients:

  • 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 for Clinicians:

  • Being a member of research staff

Exclusion Criteria for Patients:

  • (none)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 5 centers
  • Johns Hopkins — Baltimore
  • Cooper Health — Camden
  • Temple Health — Philadelphia
  • University of Pennsylvania — Philadelphia
  • UT Southwestern Medical Center — Dallas

Publications

  • Ashcraft LE, Watson MA, Vaughan C, Lee S, Yang S, Lane-Fall MB. Rapid and pragmatic implementation mapping for pre-implementation contextual analysis in multisite implementation trials. Front Health Serv. 2026 Jul 3;6:1782980. doi: 10.3389/frhs.2026.1782980. eCollection 2026. PMID 42490896
  • 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 PMID 34130725

Identifiers

NCT: NCT04571749 · 843670 · R01HL153735

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗