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Implementation of Red Blood Cell Transfusion Recommendations in the Pediatric Intensive Care Unit

Transfusion Recommendations Implemented in the PICU (TRIP)

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07108374
Acronym
TRIP
Enrollment
200
Registered
2025-08-07
Start date
2024-11-30
Completion date
2027-02-01
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Red Blood Cell Transfusions

Keywords

Red blood cell transfusions, Pediatric critical care medicine, Implementation Science, Clinical Recommendations

Brief summary

Evidence demonstrates that the risks of red blood cell transfusions outweigh benefits in many patients who are hospitalized in the pediatric intensive care unit with increased risk of organ dysfunction, infection, delirium, and death. Recommendations have been developed to restrict transfusion in patients who are unlikely to benefit; however, these recommendations have not been consistently adopted into clinical practice. This study examines use of targeted efforts (implementation strategies) to improve implementation of the recommendations, with a goal of reducing unnecessary transfusions and improving patient outcomes in critically ill children.

Interventions

OTHERImplementation strategies to increase use of transfusion recommendations

Five implementation strategies will be employed in this study to enhance use of the blood transfusion recommendations. These include 1) building consensus, 2) provider education, 3) identifying and empowering champions ,4) use of computerized clinical decision support tools, and 5) provide quantitative metric-based feedback. Strategies 1-3 will occur prior to initiation of CCDS tools. All patients admitted to the PICU following the date of CCDS tool initiation will be considered to be part of the post-implementation phase. The investigators will collect data from the EHR on CCDS use and conduct provider surveys and interviews following CCDS tool initiation. Surveys and interviews will be both be conducted at 6 and 12 months post-CCDS tool initiation. Process and outcomes measures will be assessed before an after use of the implementation strategies.

Sponsors

Lucile Packard Children's Hospital
CollaboratorOTHER
Children's Hospital of Philadelphia
CollaboratorOTHER
Agency for Healthcare Research and Quality (AHRQ)
CollaboratorFED
Stanford University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

This study is best characterized as an interventional prospective cohort study. The investigators will deploy 5 implementation strategies intended to increase use of the red blood cell transfusion recommendations in two pediatric intensive care units. While all strategies will all be used, the investigators anticipate that implementation of the Computerized Clinical Decision Support (CCDS) tools will pose the greatest operational challenges in future studies and thus the focus of this study is on the implementation evaluation of these CCDS tools using an implementation framework (RE-AIM) customized for clinical informatics interventions. The investigators will prospectively evaluate the CCDS tools using the RE-AIM framework using a mixed methods approach that includes data collection from the Electronic Health Record (EHR) based on CCDS use, provider surveys, and data from brief, focused provider interviews.

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Employed at Lucile Packard Children's Hospital at Stanford University or the Children's Hospital of Philadelphia AND * Employed in one of the following roles: * PICU nurse * PICU attending * PICU fellow * PICU resident * PICU advanced practice provider * Other physician or surgeon in subspecialties whose patients regularly receive transfusions in the PICU * PICU TRIP implementation team member * PICU nursing leader * PICU physician leader * Bood bank leader.

Exclusion criteria

* Unwilling to participate * Directly report to the primary investigator.

Design outcomes

Primary

MeasureTime frameDescription
Mean change from baseline in transfusion recommendation adherence at 18 months (evidence-based threshold alert)18 monthsThe investigators will assess the mean rate of nonadherent transfusions at monthly intervals in the pre- (12 months prior to CCDS tool initiation) and post-implementation period (18 months following CCDS tool initiation).

Secondary

MeasureTime frameDescription
Mean change from baseline in transfusion recommendation adherence at 18 months (transfusions that require clinical judgement)18 monthsThe investigators will assess the mean rate of nonadherent transfusions at monthly intervals in the pre- (12 months prior to CCDS tool initiation) and post-implementation period (18 months following CCDS tool initiation) for transfusions that require provider clinical judgement. Data analysis will be exploratory.
Reach of computerized clinical decision support (CCDS) tools18 monthsWe will assess Reach of the CCDS tools by assessing the number of triggered CCDS alerts as compared with the total number of patients at risk for unnecessary transfusion (as determined through the PEDSnet database under IRB 16-012878, PEDSnet Master Secondary Use Protocol, under amendment 96, Appendix 28).

Other

MeasureTime frameDescription
Unintended consequences of CCDS tools - Interviews 12 monthsProvider surveys and interviews at 12months post-CCDS implementationProvider interview questions will explore any unintended consequences of the CCDS tools. There is no specific tool or scale that will be used.
Impact of CCDS tools on quality of care - Surveys - 6 monthsProvider surveys at 6 months post-CCDS implementationProvider survey questions will explore provider's subjective assessment of impact of the CCDS tools on the quality of care. There is no specific tool or scale that will be used.
Impact of CCDS tools on quality of care - Surveys - 12 monthsProvider surveys at 12 months post-CCDS implementationProvider survey questions will explore provider's subjective assessment of impact of the CCDS tools on the quality of care. There is no specific tool or scale that will be used.
Impact of CCDS tools on quality of care - Interviews - 6 monthsProvider interviews at 6 months post-CCDS implementationProvider interview questions will explore provider's subjective assessment of impact of the CCDS tools on the quality of care. There is no specific tool or scale that will be used.
Impact of CCDS tools on quality of care - Interviews - 12 monthsProvider interviews at 12 months post-CCDS implementationProvider interview questions will explore provider's subjective assessment of impact of the CCDS tools on the quality of care. There is no specific tool or scale that will be used.
Adoption of CCDS toolsProvider surveys post-CCDS implementationProvider survey questions will address if providers reference the guidelines, if providers have encountered the CCDS alerts, the frequency with which they encounter the CCDS alerts, resources used to learn about the guidelines, and willingness and comfort using the CCDS alert recommendations. There is no specific score or scale being used for this outcome.
Barriers to CCDS implementation - Surveys - 6 monthsProvider surveys and interviews at 6 months post-CCDS implementationSurveys will explore barriers to CCDS implementation at the individual, unit, and hospital levels.
Unintended consequences of CCDS tools - Surveys - 6 monthsProvider surveys at 6 months post-CCDS implementationProvider survey questions will explore any unintended consequences of the CCDS tools. There is no published specific tool or scale that will be used.
Barriers to CCDS implementation - Interviews - 6 monthsProvider interviews at 6 months post-CCDS implementationInterviews will explore barriers to CCDS implementation at the individual, unit, and hospital levels. Provider interviews will also inquire about enabling factors in the following areas: CCDS tool delivery and intended use, time and resources needed to integrate the CCDS tools.
Barriers to CCDS implementation - Interviews - 12 monthsProvider interviews at 12 months post-CCDS implementationInterviews will explore barriers to CCDS implementation at the individual, unit, and hospital levels. Provider interviews will also inquire about enabling factors in the following areas: CCDS tool delivery and intended use, time and resources needed to integrate the CCDS tools.
Enabling factors to CCDS implementation - Surveys - 6 monthsProvider surveys at 6 months post-CCDS implementationSurveys will explore enabling factors to CCDS implementation at the individual, unit, and hospital levels.
Enabling factors to CCDS implementation - Surveys - 12 monthsProvider surveys at 12 months post-CCDS implementationSurveys will explore enabling factors to CCDS implementation at the individual, unit, and hospital levels.
Enabling factors to CCDS implementation - Interviews - 6 monthsProvider interviews at 6 months post-CCDS implementationInterviews will explore enabling factors to CCDS implementation at the individual, unit, and hospital levels. Provider interviews will inquire about enabling factors in the following areas: CCDS tool delivery and intended use, time and resources needed to integrate the CCDS tools.
Enabling factors to CCDS implementation - Interviews - 12 monthsProvider interviews at 12 months post-CCDS implementationInterviews will explore enabling factors to CCDS implementation at the individual, unit, and hospital levels. Provider interviews will inquire about enabling factors in the following areas: CCDS tool delivery and intended use, time and resources needed to integrate the CCDS tools.
Barriers to CCDS implementation - Surveys - 12 monthsProvider surveys and interviews at 12 months post-CCDS implementationSurveys will explore barriers to CCDS implementation at the individual, unit, and hospital levels.
Unintended consequences of CCDS tools - Surveys - 12 monthsProvider surveys at 12 months post-CCDS implementationProvider survey questions will explore any unintended consequences of the CCDS tools. There is no published specific tool or scale that will be used.
Unintended consequences of CCDS tools - Interviews 6 monthsProvider surveys and interviews at 6 months post-CCDS implementationProvider interview questions will explore any unintended consequences of the CCDS tools. There is no specific tool or scale that will be used.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026