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Enrolling by Invitation

NCT Number: NCT07108374

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

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.

Enrolling by Invitation

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Key information

Conditions

Red Blood Cell Transfusions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital, Stanford University, Palo Alto, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Implementation strategies to increase use of transfusion recommendations

Other

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.

Primary outcomes

  1. Mean change from baseline in transfusion recommendation adherence at 18 months (evidence-based threshold alert)

    Time frame: 18 months

    The 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 outcomes

  1. Mean change from baseline in transfusion recommendation adherence at 18 months (transfusions that require clinical judgement)

    Time frame: 18 months

    The 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.

  2. Reach of computerized clinical decision support (CCDS) tools

    Time frame: 18 months

    We 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 outcomes

  1. Unintended consequences of CCDS tools - Surveys - 6 months

    Time frame: Provider surveys at 6 months post-CCDS implementation

    Provider survey questions will explore any unintended consequences of the CCDS tools. There is no published specific tool or scale that will be used.

  2. Unintended consequences of CCDS tools - Surveys - 12 months

    Time frame: Provider surveys at 12 months post-CCDS implementation

    Provider survey questions will explore any unintended consequences of the CCDS tools. There is no published specific tool or scale that will be used.

  3. Unintended consequences of CCDS tools - Interviews 6 months

    Time frame: Provider surveys and interviews at 6 months post-CCDS implementation

    Provider interview questions will explore any unintended consequences of the CCDS tools. There is no specific tool or scale that will be used.

  4. Unintended consequences of CCDS tools - Interviews 12 months

    Time frame: Provider surveys and interviews at 12months post-CCDS implementation

    Provider interview questions will explore any unintended consequences of the CCDS tools. There is no specific tool or scale that will be used.

  5. Impact of CCDS tools on quality of care - Surveys - 6 months

    Time frame: Provider surveys at 6 months post-CCDS implementation

    Provider 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.

  6. Impact of CCDS tools on quality of care - Surveys - 12 months

    Time frame: Provider surveys at 12 months post-CCDS implementation

    Provider 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.

  7. Impact of CCDS tools on quality of care - Interviews - 6 months

    Time frame: Provider interviews at 6 months post-CCDS implementation

    Provider 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.

  8. Impact of CCDS tools on quality of care - Interviews - 12 months

    Time frame: Provider interviews at 12 months post-CCDS implementation

    Provider 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.

  9. Adoption of CCDS tools

    Time frame: Provider surveys post-CCDS implementation

    Provider 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.

  10. Barriers to CCDS implementation - Surveys - 6 months

    Time frame: Provider surveys and interviews at 6 months post-CCDS implementation

    Surveys will explore barriers to CCDS implementation at the individual, unit, and hospital levels.

  11. Barriers to CCDS implementation - Surveys - 12 months

    Time frame: Provider surveys and interviews at 12 months post-CCDS implementation

    Surveys will explore barriers to CCDS implementation at the individual, unit, and hospital levels.

  12. Barriers to CCDS implementation - Interviews - 6 months

    Time frame: Provider interviews at 6 months post-CCDS implementation

    Interviews 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.

  13. Barriers to CCDS implementation - Interviews - 12 months

    Time frame: Provider interviews at 12 months post-CCDS implementation

    Interviews 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.

  14. Enabling factors to CCDS implementation - Surveys - 6 months

    Time frame: Provider surveys at 6 months post-CCDS implementation

    Surveys will explore enabling factors to CCDS implementation at the individual, unit, and hospital levels.

  15. Enabling factors to CCDS implementation - Surveys - 12 months

    Time frame: Provider surveys at 12 months post-CCDS implementation

    Surveys will explore enabling factors to CCDS implementation at the individual, unit, and hospital levels.

  16. Enabling factors to CCDS implementation - Interviews - 6 months

    Time frame: Provider interviews at 6 months post-CCDS implementation

    Interviews 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.

  17. Enabling factors to CCDS implementation - Interviews - 12 months

    Time frame: Provider interviews at 12 months post-CCDS implementation

    Interviews 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • Children's Hospital of Philadelphia
  • Lucile Packard Children's Hospital

Registry information

Official study title

Transfusion Recommendations Implemented in the PICU (TRIP)

Acronym: TRIP

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 7, 2025
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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