Clinical trial NCT04571749: Handoffs and Transitions in Critical Care - Understanding Scalability
Official title: Handoffs and Transitions in Critical Care - Understanding Scalability
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Patient Handoff
Healthcare Team
Communication
Patient Safety
Intensive Care Units
Keywords: Implementation
Quality Improvement
Patient Safety
Handoffs
Intensive Care Unit
Postoperative Care
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-10-01
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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:

1. Ascertain determinants of OR-to-ICU handoff protocol adoption and use in 12 adult and pediatric ICUs in five health systems.
2. Adapt handoff protocols using engineering approaches and select tailored implementation strategies with implementation mapping.
3. Test the effectiveness of tailored, multifaceted, multilevel implementation strategies.
4. Design and create a digital toolkit for other ICUs to identify implementation determinants, customize OR-to-ICU handoff protocol, and select appropriate implementation strategies.

Eligibility criteria: Inclusion Criteria for Clinicians:

* 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

Inclusion Criteria for Patients:

• Patient admitted for inpatient care at the study hospitals and experiences a post-operative handoff from the operating room to the intensive care unit.

Exclusion Criteria for Clinicians:

• Being a member of research staff

Exclusion Criteria for Patients:

• (none)

Primary outcomes:
measure: Adherence to standardized handoff intervention (Fidelity) measured by number of handoff steps followed.
timeFrame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
measure: New-onset organ failure
timeFrame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year5
Secondary outcomes:
measure: Perception among implementation stakeholders that a given treatment, service, practice, or innovation is agreeable, palatable, or satisfactory (Acceptability)
timeFrame: Baseline (Year 1); within 2months of implementation; within 2 months of beginning sustainment
measure: 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
timeFrame: Baseline (Year 1); within 2months of implementation; within 2 months of beginning sustainment
measure: Feasibility of treatment or innovation to be carried out in a practice setting, measured using the Feasibility of Intervention Measure.
timeFrame: Baseline (Year 1); within 2months of implementation; within 2 months of beginning sustainment
measure: Fidelity over time (Sustainment)
timeFrame: This outcome will be measured at monthly intervals starting 2 years after implementation, up to 5 years.
measure: Monetary and non-monetary costs measured using the line item classification system
timeFrame: This outcome will be measured within 2 months of implementation; within2 months of beginning sustainment
measure: Teamwork (effectiveness) measured using the Team Emergency Assessment Measure.
timeFrame: This outcome will be measured at quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5
measure: Clinician satisfaction measured at the individual level.
timeFrame: This outcome will be measured annually from Years 1 to 5.
measure: Workload measured using the NASA Task Load Index.
timeFrame: This outcome will be measured at quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
measure: Completeness of information exchange (Information Omissions) measured using a structured observation form.
timeFrame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year5
measure: Weighted average of the reliability-adjusted observed-to-expected ratios for component indicators of adverse events
timeFrame: This outcome will be measured at quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
measure: AHRQ PSI 9: Perioperative hemorrhage or hematoma rate(effectiveness)
timeFrame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5
measure: AHRQ PSI 10: Postoperative physiologic or metabolic derangement rate (effectiveness)
timeFrame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
measure: AHRQ PSI 11: Postoperative respiratory failure rate (effectiveness)
timeFrame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5
measure: AHRQ PSI 12: Perioperative pulmonary embolism or DVT rate (effectiveness)
timeFrame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5
measure: AHRQ PSI 13: Post operative sepsis rate (effectiveness)
timeFrame: This outcome will be measured at monthly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5
measure: Professionalism of handoff team during handoff.
timeFrame: At quarterly intervals starting Year 1, Quarter 2 and continuing until the end of Year 5.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Camden
country: United States
facility: Cooper Health
state: New Jersey
city: Philadelphia
country: United States
facility: Temple Health
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: University of Pennsylvania
name: Meghan B Lane-Fall, MD, MSHP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lane-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.