- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02267174
Handoffs and Transitions in Critical Care (HATRICC)
June 25, 2020 updated by: University of Pennsylvania
Handoffs and Transitions in Critical Care (HATRICC): Optimizing Operating Room to Intensive Care Unit Handoffs
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.
Study Overview
Status
Completed
Intervention / Treatment
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
Enrollment (Actual)
1000
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Hospital of the University of Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Penn Presbyterian Medical Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- All clinicians caring for patients being transferred from the operating room to intensive care unit.
Exclusion Criteria:
- None.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
A standardized handoff will be implemented that consists of choreographed handoffs utilizing a structured handoff tool to facilitate information exchange.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline to 1 month post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline to 1 month post-intervention
|
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.
|
baseline to 1 month post-intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in qualitative implementation outcomes
Time Frame: baseline to 1 month post-intervention
|
Acceptability, appropriateness and fidelity will be assessed qualitatively
|
baseline to 1 month post-intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Meghan B Lane-Fall, MD, MSHP, University of Pennsylvania
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lane-Fall MB, Pascual JL, Peifer HG, Di Taranti LJ, Collard ML, Jablonski J, Gutsche JT, Halpern SD, Barg FK, Fleisher LA; HATRICC study team (Kimberly Allen, BSN, RN; Mark Barry, MD; Sruthi Buddai, BA; Tyler Chavez, BA; Mahrukh Choudhary, BA; Della George; Megan Linehan, DO; Enrique Torres Hernandez; Jerome Watts, BA. A Partially Structured Postoperative Handoff Protocol Improves Communication in 2 Mixed Surgical Intensive Care Units: Findings From the Handoffs and Transitions in Critical Care (HATRICC) Prospective Cohort Study. Ann Surg. 2020 Mar;271(3):484-493. doi: 10.1097/SLA.0000000000003137.
- Lane-Fall MB, Beidas RS, Pascual JL, Collard ML, Peifer HG, Chavez TJ, Barry ME, Gutsche JT, Halpern SD, Fleisher LA, Barg FK. Handoffs and transitions in critical care (HATRICC): protocol for a mixed methods study of operating room to intensive care unit handoffs. BMC Surg. 2014 Nov 19;14:96. doi: 10.1186/1471-2482-14-96.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
October 7, 2014
First Submitted That Met QC Criteria
October 14, 2014
First Posted (Estimate)
October 17, 2014
Study Record Updates
Last Update Posted (Actual)
June 26, 2020
Last Update Submitted That Met QC Criteria
June 25, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AWD-10044739, 819726
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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