Patient HandoffHATRICCNCT02267174
Handoffs and Transitions in Critical Care
A study testing Standardized handoff in people with Patient Handoff and Healthcare Team, run by University of Pennsylvania at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Handoff, Healthcare Team, Communication
- What is being tested?
- Standardized handoff
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All clinicians caring for patients being transferred from the operating room to intensive care unit.
Who cannot join
- None.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: 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.
Read the 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.
- Being tested
- Standardized handoff
- Keywords
- Implementation, quality improvement, patient safety, handoffs, intensive care unit, postoperative care, simulation
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized handoffBehavioural
A standardized handoff will be implemented that consists of choreographed handoffs utilizing a structured handoff tool to facilitate information exchange.
| Study group | Role | What they receive |
|---|---|---|
| Standardized OR to ICU handoff | Other | A standardized handoff process for conducting OR to ICU handoffs will be implemented in two intensive care units without a standard process. Receives: Behavioral: Standardized handoff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in information omissions
The number of information omissions per handoff episodes will be determined by direct observation.
Measured: baseline to 1 month post-intervention
Secondary outcomes (2)
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.
Measured: baseline to 1 month post-intervention
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.
Measured: baseline to 1 month post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Patient HandoffStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Anesthesia Patient Safety Foundation
- Responsible party
- Sponsor
- Investigators
- Meghan B Lane-Fall, MD, MSHP, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267174
- Sponsor's protocol ID
- AWD-10044739, 819726
- Acronym
- HATRICC
- Status last verified
- Jun 2020
- First submitted
- 7 Oct 2014
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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.
PubMed 30499797Lane-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.
PubMed 25410548
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Handoffs and Transitions in Critical Care (HATRICC): Optimizing Operating Room to Intensive Care Unit Handoffs
- ClinicalTrials.gov ID
- NCT02267174
- Acronym / sponsor ID
- HATRICC / AWD-10044739, 819726
- Keywords
- Implementation, quality improvement, patient safety, handoffs, intensive care unit, postoperative care, simulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Anesthesia Patient Safety Foundation
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 17 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Standardized OR to ICU handoff | Other | Behavioral: Standardized handoffA standardized handoff process for conducting OR to ICU handoffs will be implemented in two intensive care units without a standard process. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All clinicians caring for patients being transferred from the operating room to intensive care unit.
Key exclusion criteria (1 listed)
- None.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized handoffA standardized handoff will be implemented that consists of choreographed handoffs utilizing a structured handoff tool to facilitate information exchange. | Behavioural | Standardized OR to ICU handoff |
Primary outcome
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.
2 secondary outcomes
Change in teamwork score
Time frame: baseline to 1 month post-intervention
Change in patient length of stay
Time frame: baseline to 1 month post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
- Derived from this study: PubMed 30499797Lane-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.
- Derived from this study: PubMed 25410548Lane-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.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Patient Handoff
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Continuity of Care, Patient Safety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan B Lane-Fall, MD, MSHP principal investigator
University of Pennsylvania
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized handoff in people with Patient Handoff and Healthcare Team, run by University of Pennsylvania at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in information omissions (time frame: baseline to 1 month post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02267174, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.