Handoffs and Transitions in Critical Care - Understanding Scalability

NCT04571749 | Enrolling By Invitation

• 2 other identifiers: 843670R01HL153735
• Study Type: interventional
• Target: 4,000
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Patient Handoff; Healthcare Team; Communication; Patient Safety; Intensive Care Units

Keywords

Implementation; Quality Improvement; Patient Safety; Handoffs; Intensive Care Unit; Postoperative Care

Outcome Measures

Primary Outcomes (2)

• Adherence to standardized handoff intervention (Fidelity) measured by number of handoff steps followed.

  Fidelity is defined as adherence to the standardized handoff intervention. Fidelity is a count of handoff steps followed, with scores ranging from 0 to 10. Fidelity will be measured by trained site-based observers. Field notes by trained observers will inform the interpretation of fidelity. Units of analysis: patient level (handoff level), ICU level.

  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

  Per-protocol handoffs enable clinicians to follow expected care practices and to anticipate and avoid postoperative deterioration.

  This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year5

Secondary Outcomes (16)

• Perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory (Acceptability)

  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

  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.

  Baseline (Year 1); within 2months of implementation; within 2 months of beginning sustainment

• Fidelity over time (Sustainment)

  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

  This outcome will be measured within 2 months of implementation; within2 months of beginning sustainment

Study Arms (1)

Customized Or to ICU handoff protocol

EXPERIMENTAL

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.

Behavioral: Customized handoff

Interventions

Customized handoff BEHAVIORAL

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

Customized Or to ICU handoff protocol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Being a member of research staff
• (none)

Sponsors & Collaborators

• University of Pennsylvania: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (5)

Johns Hopkins

Baltimore, Maryland, 21218, United States

Location

Cooper Health

Camden, New Jersey, 08103, United States

Location

Temple Health

Philadelphia, Pennsylvania, 19103, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (1)

• 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.

  PMID: 34130725 DERIVED

Related Links

• HATRICC Website

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Meghan B Lane-Fall, MD, MSHP

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: October 1, 2020
• Study Start: April 11, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)