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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-30

Study Completion Date

2027-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Transfusion-related Acute Lung Injury: a Prospective Cohort Study in Critically Ill Children

NCT02613377

Acute Lung Injury

COMPLETED

Age of Blood in Children in Pediatric Intensive Care Units

NCT01977547

Anemia

COMPLETED PHASE3

Fibrinogen Early In Severe Trauma studY Junior

NCT03508141

Trauma Hemorrhage Coagulopathy +1 more

UNKNOWN PHASE2

Pilot Optimizing Transfusion Thresholds in Critically-ill Children With Anaemia

NCT03871244

Anemia

UNKNOWN PHASE3

Tranexamic Acid Per Inhalation for Treatment of Pulmonary Hemorrhage in Pediatric Patients

NCT03676023

Pulmonary Hemorrhage MAPCA - Major Aortopulmonary Collateral Artery

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Red Blood Cell Transfusions

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Implementation 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.