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Handoffs and Transitions in Critical Care (HATRICC)

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ClinicalTrials.gov Identifier: NCT02267174
Recruitment Status : Completed
First Posted : October 17, 2014
Last Update Posted : July 31, 2017
Sponsor:
Collaborator:
Anesthesia Patient Safety Foundation
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The HATRICC study will use mixed methods to implement a standardized process for operating room to intensive care unit handoffs that is accepted and sustainably used by perioperative clinicians.

Condition or disease Intervention/treatment Phase
Patient Handoff Healthcare Team Communication Patient Safety Intensive Care Units Behavioral: Standardized handoff Not Applicable

Detailed Description:
BACKGROUND: Operating room to intensive care unit handoffs are high-risk events for critically ill patients. Studies in selected patient populations show that standardizing operating room to intensive care unit handoffs improves information exchange and decreases errors. To adapt these findings to mixed surgical populations, the investigators propose to study the implementation of a standardized operating room to intensive care unit handoff process in two intensive care units currently without an existing standard process. METHODS/DESIGN: The Handoffs and Transitions in Critical Care (HATRICC) study is a hybrid effectiveness-implementation trial of operating room to intensive care unit handoffs. The investigators will use mixed methods to conduct a needs assessment of the current handoff process, adapt published handoff processes, and implement a new standardized handoff process in two academic intensive care units. Needs assessment - The investigators will use nonparticipant observation to observe the current handoff process. Focus groups, interviews, and surveys of clinicians will elicit participants' impressions about the current process. Adaptation and implementation - The investigators will adapt published standardized handoff processes using the needs assessment findings. The investigators will use small group simulation to test the new process' feasibility. After simulation, the investigators will incorporate the new handoff process into the clinical work of all providers in the study units. Evaluation - Using the same methods employed in the needs assessment phase, the investigators will evaluate use of the new handoff process. Data analysis - The primary effectiveness outcome is the number of information omissions per handoff episode as compared to the pre-intervention period. Additional intervention outcomes include patient intensive care unit length of stay and intensive care unit mortality. The primary implementation outcome is acceptability of the new process. Additional implementation outcomes include feasibility, fidelity and sustainability. DISCUSSION: The HATRICC study will examine the effectiveness and implementation of a standardized operating room to intensive care unit handoff process. Findings from this study have the potential to improve healthcare communication and outcomes for critically ill patients.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Handoffs and Transitions in Critical Care (HATRICC): Optimizing Operating Room to Intensive Care Unit Handoffs
Study Start Date : July 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Critical Care
U.S. FDA Resources

Arm Intervention/treatment
Standardized OR to ICU handoff
A standardized handoff process for conducting OR to ICU handoffs will be implemented in two intensive care units without a standard process.
Behavioral: Standardized handoff
A standardized handoff will be implemented that consists of choreographed handoffs utilizing a structured handoff tool to facilitate information exchange.



Primary Outcome Measures :
  1. Change in information omissions [ Time Frame: baseline to 1 month post-intervention ]
    The number of information omissions per handoff episodes will be determined by direct observation.


Secondary Outcome Measures :
  1. Change in teamwork score [ Time Frame: baseline to 1 month post-intervention ]
    Quantitative teamwork score will be determined for each episode of operating room to intensive care unit handoff after the intervention is implemented.

  2. Change in patient length of stay [ Time Frame: baseline to 1 month post-intervention ]
    Patient length of stay in the intensive care unit and in the hospital will be assessed in the post-intervention period.


Other Outcome Measures:
  1. Change in qualitative implementation outcomes [ Time Frame: baseline to 1 month post-intervention ]
    Acceptability, appropriateness and fidelity will be assessed qualitatively



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All clinicians caring for patients being transferred from the operating room to intensive care unit.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267174


Locations
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Anesthesia Patient Safety Foundation
Investigators
Principal Investigator: Meghan B Lane-Fall, MD, MSHP University of Pennsylvania Perelman School of Medicine

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02267174     History of Changes
Other Study ID Numbers: AWD-10044739, 819726
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: July 31, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Pennsylvania:
Implementation
quality improvement
patient safety
handoffs
intensive care unit
postoperative care
simulation