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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02267174
Other study ID # AWD-10044739, 819726
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 2014
Est. completion date July 2016

Study information

Verified date June 2020
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- None.

Study Design


Intervention

Behavioral:
Standardized handoff
A standardized handoff will be implemented that consists of choreographed handoffs utilizing a structured handoff tool to facilitate information exchange.

Locations

Country Name City State
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Penn Presbyterian Medical Center Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania Anesthesia Patient Safety Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in qualitative implementation outcomes Acceptability, appropriateness and fidelity will be assessed qualitatively baseline to 1 month post-intervention
Primary Change in information omissions The number of information omissions per handoff episodes will be determined by direct observation. baseline to 1 month post-intervention
Secondary Change in teamwork score 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
Secondary Change in patient length of stay 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
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