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

NCT07108374 | Enrolling By Invitation

• 2 other identifiers: 70193HS029298-03
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Red Blood Cell Transfusions

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  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).

  18 months

Secondary Outcomes (2)

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

  18 months

• Reach of computerized clinical decision support (CCDS) tools

  18 months

Other Outcomes (17)

• Unintended consequences of CCDS tools - Surveys - 6 months

  Provider surveys at 6 months post-CCDS implementation

• Unintended consequences of CCDS tools - Surveys - 12 months

  Provider surveys at 12 months post-CCDS implementation

• Unintended consequences of CCDS tools - Interviews 6 months

  Provider surveys and interviews at 6 months post-CCDS implementation

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• Lucile Packard Children's Hospital: collaborator
• Children's Hospital of Philadelphia: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (2)

Lucile Packard Children's Hospital, Stanford University

Palo Alto, California, 94304, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, School of Medicine, Department of Pediatrics, Division of Pediatric Critical Care Medicine

Model Details: 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.

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: August 7, 2025
• Study Start: November 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 7, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)