Patient HandoffHATRICC-USNCT04571749
Handoffs and Transitions in Critical Care - Understanding Scalability
A study testing Customized handoff in people with Patient Handoff and Healthcare Team, run by University of Pennsylvania at 5 sites in United States.
Trial summary
The investigators will leverage implementation science and engineering to adapt, implement, and rigorously evaluate tailored postoperative handoff protocols and implementation strategies. 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?
- Customized handoff
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,000 participants
- Where
- 5 sitesUnited States
- Study dates
- 11 Apr 2021to 31 Jul 2026
- 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
- 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.
Who cannot join
- Being a member of research staff
- (none)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Johns Hopkins
Baltimore, Maryland, 21218
Cooper Health
Camden, New Jersey, 08103
UT Southwestern Medical Center
Dallas, Texas, 75390
Temple Health
Philadelphia, Pennsylvania, 19103
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the detailed description
Surgical patients who require post-surgical critical care are usually transferred from the operating room (OR) to the intensive care unit (ICU) for ongoing care. The process of transferring the patient from the OR to the ICU is called a "handoff." Handoffs involve the transfer of patient information and transfer of patient care responsibilities from the OR team to the ICU team. Multiple studies suggest that these handoffs can expose patients to preventable harm, which can be avoided with standardization of the handoff. The Handoffs and Transitions in Critical Care (HATRICC; IRB #819726) study, started in 2014, developed and implemented a standardized OR to ICU handoff process in two Penn surgical ICUs (SICUs) that did not have a standardized handoff process.
Four clinicians (surgeon, anesthetist, ICU provider, and ICU nurse) from two teams (surgical and intensive care) usually take part in handoff communication. During the HATRICC study, the investigators evaluated handoff communication between the OR and ICU teams before and after implementation of the new standardized handoff process (the "HATRICC process") in multiple ways, using observations, interviews, focus groups, and surveys. The investigators demonstrated a 20% improvement in information exchange after implementation of the HATRICC standardized handoff process, a process tailored to meet the needs of the different clinicians participating in OR to ICU handoffs.
Prior studies have indicated short-term success in standardizing OR to ICU handoffs, but sustainability of these improvement interventions has been less well studied. Two studies have demonstrated sustained or improved information exchange following the institution of structured OR to ICU handoff processes, but the factors influencing sustainability remain to be elucidated.
The aims of this study are to:
- Ascertain determinants of OR-to-ICU handoff protocol adoption and use in 12 adult and pediatric ICUs in five health systems.
- Adapt handoff protocols using engineering approaches and select tailored implementation strategies with implementation mapping.
- Test the effectiveness of tailored, multifaceted, multilevel implementation strategies.
- Design and create a digital toolkit for other ICUs to identify implementation determinants, customize OR-to-ICU handoff protocol, and select appropriate implementation strategies.
- Being tested
- Customized handoff
- Keywords
- Implementation, Quality Improvement, Patient Safety, Handoffs, Intensive Care Unit, Postoperative Care
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Customized handoffBehavioural
A customized handoff will be implemented that consists of choreographed handoffs utilizing a structured handoff tool to facilitate information exchange.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Customized handoff |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Acceptability is defined as "the perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory." (Proctor et al, Adm Policy Ment Health (2011) 38:65-76). Acceptability will be measured using the Acceptability of Intervention Measure (AIM) developed by Weiner et al (Implement Sci. 2017;12(1):108; see Appendix). Interview and focus group transcripts and field notes will be analyzed to develop a more nuanced understanding of acceptability. Unit of analysis: individual (employed staff)
Measured: 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
Appropriateness is defined as "the perceived fit, relevance, or compatibility of the innovation or evidence based practice for a given practice setting, provider, or consumer; and/or perceived fit of the innovation to address a particular issue or problem." (Proctor et al, Adm Policy Ment Health (2011) 38:65-76). Appropriateness will be measured using the Intervention Appropriateness Measure (IAM) developed by Weiner et al (Implement Sci. 2017;12(1):108; see Appendix). Interview and focus group transcripts and field notes will be analyzed to develop a more nuanced understanding of appropriateness. Unit of analysis: individual (employed staff)
Measured: 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.
Feasibility is defined as "the extent to which a new treatment, or an innovation, can be successfully used or carried out within a given agency or setting." (Proctor et al, Adm Policy Ment Health (2011) 38:65-76). Feasibility will be measured using the Feasibility of Intervention Measure (FIM) developed by Weiner et al (Implement Sci. 2017;12(1):108; see Appendix). Interview and focus group transcripts and field notes will be analyzed to develop a more nuanced understanding of feasibility. Unit of analysis: individual (employed staff)
Measured: Baseline (Year 1); within 2months of implementation; within 2 months of beginning sustainment
Fidelity over time (Sustainment)
Sustainment is defined as fidelity over time. We define the sustainment phase as starting two years after implementation. Units of analysis: patient level (handoff level), ICU level.
Measured: 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
We will conduct a retrospective cost analysis as described by Hoeft et al (Implementation Science 2019;14(1):37). We will use the line item classification system, in which accounting principles are used to calculate costs, and will attempt to include both monetary costs and non-monetary costs (e.g., opportunity costs). Activities undertaken only for research (e.g., interviews and focus groups) will not be included in this analysis. Field notes will be the primary data source for this outcome. Unit of analysis: ICU level.
Measured: This outcome will be measured within 2 months of implementation; within2 months of beginning sustainment
Teamwork (effectiveness) measured using the Team Emergency Assessment Measure.
Teamwork will be measured using a validated instrument, the Team Emergency Assessment Measure (TEAM) (Cooper et al, Resuscitation 2010;81(4):446-452). Unit of analysis: handoff team.
Measured: This outcome will be measured at quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5
Clinician satisfaction measured at the individual level.
Clinician satisfaction will be measured using a non-validated instrument adapted from the parent HATRICC study (see Appendix). Unit of analysis: individual.
Measured: This outcome will be measured annually from Years 1 to 5.
Workload measured using the NASA Task Load Index.
Workload is a measure of effectiveness and will be measured using the validated NASA Task Load Index.
Measured: This outcome will be measured at quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
Completeness of information exchange (Information Omissions) measured using a structured observation form.
Information omissions is a measure of the completeness of information exchange. It will be measured at the same time as fidelity using a structured observation form (see Appendix). Unit of analysis: patient level (handoff level).
Measured: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year5
Weighted average of the reliability-adjusted observed-to-expected ratios for component indicators of adverse events
This is a composite measure defined by AHRQ as "the weighted average of the reliability-adjusted observed-to-expected ratios (indirect standardization of the smoothed rates) for the following component indicators: PSI 03 Pressure Ulcer Rate; PSI 06 Iatrogenic Pneumothorax Rate; PSI 07 Central Venous Catheter-Related Blood Stream Infection Rate; PSI 08 Postoperative Hip Fracture Rate; PSI 09 Perioperative Hemorrhage or Hematoma Rate; PSI 10 Postoperative Physiologic and Metabolic Derangement Rate; PSI 11 Postoperative Respiratory Failure Rate; PSI 12 Perioperative Pulmonary Embolism or Deep Vein Thrombosis Rate; PSI 13 Postoperative Sepsis Rate; PSI 14 Postoperative Wound Dehiscence Rate; PSI 15 Accidental Puncture or Laceration Rate." We note that some of the components of this measure overlap with our primary effectiveness outcome. Unit of analysis: ICU-level.
Measured: This outcome will be measured at quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
AHRQ PSI 9: Perioperative hemorrhage or hematoma rate(effectiveness)
This measure is one of the five components of the co-primary outcome of new-onset organ failure. It is defined by AHRQ as "perioperative hemorrhage or hematoma cases with control of perioperative hemorrhage, drainage of hematoma, or a miscellaneous hemorrhage- or hematoma-related procedure following surgery per 1,000 surgical discharges." AHRQ collects this information for patients aged 18 and older, but we will collect this outcome for pediatric patients in the two pediatric ICUs. Unit of analysis: ICU-level.
Measured: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5
AHRQ PSI 10: Postoperative physiologic or metabolic derangement rate (effectiveness)
This measure is one of the five components of the co-primary outcome of new-onset organ failure. It is defined by AHRQ as "postoperative acute renal failure (secondary diagnosis) with dialysis per 1,000 elective surgical discharges." AHRQ collects this information for patients aged 18 and older, but we will collect this outcome for pediatric patients in the two pediatric ICUs. Unit of analysis: ICU-level.
Measured: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
AHRQ PSI 11: Postoperative respiratory failure rate (effectiveness)
This measure is one of the five components of the co-primary outcome of new-onset organ failure. It is defined by AHRQ as "postoperative respiratory failure (secondary diagnosis), prolonged mechanical ventilation, or reintubation cases per 1,000 elective surgical discharges." AHRQ collects this information for patients aged 18 and older, but we will collect this outcome for pediatric patients in the two pediatric ICUs. Unit of analysis: ICU-level.
Measured: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5
AHRQ PSI 12: Perioperative pulmonary embolism or DVT rate (effectiveness)
This measure is one of the five components of the co-primary outcome of new-onset organ failure. It is defined by AHRQ as "perioperative pulmonary embolism or deep vein thrombosis (secondary diagnosis) per 1,000 surgical discharges." AHRQ collects this information for patients aged 18 and older, but we will collect this outcome for pediatric patients in the two pediatric ICUs. Unit of analysis: ICU-level.
Measured: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5
AHRQ PSI 13: Post operative sepsis rate (effectiveness)
This measure is one of the five components of the co-primary outcome of new-onset organ failure. It is defined by AHRQ as "postoperative sepsis cases (secondary diagnosis) per 1,000 elective surgical discharges." AHRQ collects this information for patients aged 18 and older, but we will collect this outcome for pediatric patients in the two pediatric ICUs. Unit of analysis: ICU-level.
Measured: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5
Professionalism of handoff team during handoff.
Professionalism will be characterized qualitatively using field notes from trained observers. Unit of analysis: handoff team.
Measured: At quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start11 Apr 2021
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Why it stopped: PI Lane-Fall moved to a new institution. The original funding period ended and the grant was closed by the original institution before it was moved. We are working on reestablishing the IRB at the new institution to finish analysis procedures.
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
- 4,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Meghan B Lane-Fall, MD, MSHP, Principal investigator, Columbia University Vagelos College of Physicians and Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571749
- Sponsor's protocol ID
- 843670
- Other IDs
- R01HL153735
- Acronym
- HATRICC-US
- Status last verified
- Oct 2026
- First submitted
- 30 Jul 2020
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ashcraft LE, Watson MA, Vaughan C, Lee S, Yang S, Lane-Fall MB. Rapid and pragmatic implementation mapping for pre-implementation contextual analysis in multisite implementation trials. Front Health Serv. 2026 Jul 3;6:1782980. doi: 10.3389/frhs.2026.1782980. eCollection 2026.
PubMed 42490896Lane-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.
PubMed 34130725
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Handoffs and Transitions in Critical Care - Understanding Scalability
- ClinicalTrials.gov ID
- NCT04571749
- Acronym / sponsor ID
- HATRICC-US / 843670
- Keywords
- Implementation, Quality Improvement, Patient Safety, Handoffs, Intensive Care Unit, Postoperative Care
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI Lane-Fall moved to a new institution. The original funding period ended and the grant was closed by the original institution before it was moved. We are working on reestablishing the IRB at the new institution to finish analysis procedures.
- Enrolment
- 4,000 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 11 Apr 2021 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 1 Oct 2020 (actual)
- 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 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.
Detailed description
Surgical patients who require post-surgical critical care are usually transferred from the operating room (OR) to the intensive care unit (ICU) for ongoing care. The process of transferring the patient from the OR to the ICU is called a "handoff." Handoffs involve the transfer of patient information and transfer of patient care responsibilities from the OR team to the ICU team. Multiple studies suggest that these handoffs can expose patients to preventable harm, which can be avoided with standardization of the handoff. The Handoffs and Transitions in Critical Care (HATRICC; IRB #819726) study, started in 2014, developed and implemented a standardized OR to ICU handoff process in two Penn surgical ICUs (SICUs) that did not have a standardized handoff process.
Four clinicians (surgeon, anesthetist, ICU provider, and ICU nurse) from two teams (surgical and intensive care) usually take part in handoff communication. During the HATRICC study, the investigators evaluated handoff communication between the OR and ICU teams before and after implementation of the new standardized handoff process (the "HATRICC process") in multiple ways, using observations, interviews, focus groups, and surveys. The investigators demonstrated a 20% improvement in information exchange after implementation of the HATRICC standardized handoff process, a process tailored to meet the needs of the different clinicians participating in OR to ICU handoffs.
Prior studies have indicated short-term success in standardizing OR to ICU handoffs, but sustainability of these improvement interventions has been less well studied. Two studies have demonstrated sustained or improved information exchange following the institution of structured OR to ICU handoff processes, but the factors influencing sustainability remain to be elucidated.
The aims of this study are to:
- Ascertain determinants of OR-to-ICU handoff protocol adoption and use in 12 adult and pediatric ICUs in five health systems.
- Adapt handoff protocols using engineering approaches and select tailored implementation strategies with implementation mapping.
- Test the effectiveness of tailored, multifaceted, multilevel implementation strategies.
- Design and create a digital toolkit for other ICUs to identify implementation determinants, customize OR-to-ICU handoff protocol, and select appropriate implementation strategies.
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 |
|---|---|---|
| Customized Or to ICU handoff protocol | Experimental | Behavioral: Customized handoffTailored 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Being a member of research staff
- (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 |
|---|---|---|
| Customized handoffA customized handoff will be implemented that consists of choreographed handoffs utilizing a structured handoff tool to facilitate information exchange. | Behavioural | Customized Or to ICU handoff protocol |
Primary outcome
Adherence to standardized handoff intervention (Fidelity) measured by number of handoff steps followed.
Time frame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
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.
New-onset organ failure
Time frame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year5
Per-protocol handoffs enable clinicians to follow expected care practices and to anticipate and avoid postoperative deterioration.
16 secondary outcomes
Perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory (Acceptability)
Time frame: 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
Time frame: 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.
Time frame: Baseline (Year 1); within 2months of implementation; within 2 months of beginning sustainment
Fidelity over time (Sustainment)
Time frame: 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
Time frame: This outcome will be measured within 2 months of implementation; within2 months of beginning sustainment
Teamwork (effectiveness) measured using the Team Emergency Assessment Measure.
Time frame: This outcome will be measured at quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5
Clinician satisfaction measured at the individual level.
Time frame: This outcome will be measured annually from Years 1 to 5.
Workload measured using the NASA Task Load Index.
Time frame: This outcome will be measured at quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
Completeness of information exchange (Information Omissions) measured using a structured observation form.
Time frame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year5
Weighted average of the reliability-adjusted observed-to-expected ratios for component indicators of adverse events
Time frame: This outcome will be measured at quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
AHRQ PSI 9: Perioperative hemorrhage or hematoma rate(effectiveness)
Time frame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5
AHRQ PSI 10: Postoperative physiologic or metabolic derangement rate (effectiveness)
Time frame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
AHRQ PSI 11: Postoperative respiratory failure rate (effectiveness)
Time frame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5
AHRQ PSI 12: Perioperative pulmonary embolism or DVT rate (effectiveness)
Time frame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5
AHRQ PSI 13: Post operative sepsis rate (effectiveness)
Time frame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5
Professionalism of handoff team during handoff.
Time frame: At quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
Results and safety
The study was stopped early (reason given: PI Lane-Fall moved to a new institution. The original funding period ended and the grant was closed by the original institution before it was moved. We are working on reestablishing the IRB at the new institution to finish analysis procedures.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Derived from this study: PubMed 42490896Ashcraft LE, Watson MA, Vaughan C, Lee S, Yang S, Lane-Fall MB. Rapid and pragmatic implementation mapping for pre-implementation contextual analysis in multisite implementation trials. Front Health Serv. 2026 Jul 3;6:1782980. doi: 10.3389/frhs.2026.1782980. eCollection 2026.
- Derived from this study: PubMed 34130725Lane-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.
- HATRICC WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Patient Handoff
Not yet recruiting
Automatic Feedback Indicator to Enhance the Hospital Discharge Communication Between Acute Care and Primary Care.
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
Columbia University Vagelos College of Physicians and Surgeons
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Customized handoff in people with Patient Handoff and Healthcare Team, run by University of Pennsylvania at 5 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 was stopped early (reason given: PI Lane-Fall moved to a new institution. The original funding period ended and the grant was closed by the original institution before it was moved. We are working on reestablishing the IRB at the new institution to finish analysis procedures.). Results are not available in the source record.
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?
Adherence to standardized handoff intervention (Fidelity) measured by number of handoff steps followed. (time frame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.). The study lists 2 primary outcomes in all. 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 NCT04571749, 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 13 Oct 2026.