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| ID | Type | Description | Link |
|---|---|---|---|
| HS029298-03 | Other Grant/Funding Number | AHRQ |
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| Name | Class |
|---|---|
| Lucile Packard Children's Hospital | OTHER |
| Children's Hospital of Philadelphia | OTHER |
| Agency for Healthcare Research and Quality (AHRQ) | FED |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in transfusion recommendation adherence at 18 months (transfusions that require clinical judgement) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Unintended consequences of CCDS tools - Surveys - 6 months | Provider survey questions will explore any unintended consequences of the CCDS tools. There is no published specific tool or scale that will be used. | Provider surveys at 6 months post-CCDS implementation |
| Unintended consequences of CCDS tools - Surveys - 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucile Packard Children's Hospital, Stanford University | Palo Alto | California | 94304 | United States | ||
Because PEDSnet is not a public data repository, individual-level datasets are not typically released publicly outside of the network. Due to the complexity and privacy concerns associated with electronic health record data, certified PEDSnet data scientists lead the execution of all data analyses. While the data generated for this study cannot be shared publicly, our study team will make every effort to assist interested investigators and teams in leveraging the PEDSnet network to collaborate to obtain the entire dataset from this study or subset of data necessary for conducting secondary analyses or in answering a new, intended study question. Our study team will provide a final report(s) on our research findings and the investigators will relate that data can be made available for subsequent analyses through PEDSnet and provide necessary contact information to submit a Collaboration Request through PEDSnet or Dr. Steffen.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form: Informed consent form: post implementation survey | May 30, 2024 | Jul 22, 2025 | ICF_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form: post implementation interview | May 30, 2024 | Jul 22, 2025 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Pre-Implementation Survey | Nov 26, 2024 | Jul 22, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed Consent Form: Practice Impact Survey | Nov 26, 2024 | Jul 22, 2025 | ICF_003.pdf |
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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.
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| 18 months |
| Reach of computerized clinical decision support (CCDS) tools | 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). | 18 months |
Provider survey questions will explore any unintended consequences of the CCDS tools. There is no published specific tool or scale that will be used. |
| Provider surveys at 12 months post-CCDS implementation |
| Unintended consequences of CCDS tools - Interviews 6 months | Provider interview questions will explore any unintended consequences of the CCDS tools. There is no specific tool or scale that will be used. | Provider surveys and interviews at 6 months post-CCDS implementation |
| Unintended consequences of CCDS tools - Interviews 12 months | Provider interview questions will explore any unintended consequences of the CCDS tools. There is no specific tool or scale that will be used. | Provider surveys and interviews at 12months post-CCDS implementation |
| Impact of CCDS tools on quality of care - Surveys - 6 months | 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. | Provider surveys at 6 months post-CCDS implementation |
| Impact of CCDS tools on quality of care - Surveys - 12 months | 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. | Provider surveys at 12 months post-CCDS implementation |
| Impact of CCDS tools on quality of care - Interviews - 6 months | 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. | Provider interviews at 6 months post-CCDS implementation |
| Impact of CCDS tools on quality of care - Interviews - 12 months | 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. | Provider interviews at 12 months post-CCDS implementation |
| Adoption of CCDS tools | 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. | Provider surveys post-CCDS implementation |
| Barriers to CCDS implementation - Surveys - 6 months | Surveys will explore barriers to CCDS implementation at the individual, unit, and hospital levels. | Provider surveys and interviews at 6 months post-CCDS implementation |
| Barriers to CCDS implementation - Surveys - 12 months | Surveys will explore barriers to CCDS implementation at the individual, unit, and hospital levels. | Provider surveys and interviews at 12 months post-CCDS implementation |
| Barriers to CCDS implementation - Interviews - 6 months | 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. | Provider interviews at 6 months post-CCDS implementation |
| Barriers to CCDS implementation - Interviews - 12 months | 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. | Provider interviews at 12 months post-CCDS implementation |
| Enabling factors to CCDS implementation - Surveys - 6 months | Surveys will explore enabling factors to CCDS implementation at the individual, unit, and hospital levels. | Provider surveys at 6 months post-CCDS implementation |
| Enabling factors to CCDS implementation - Surveys - 12 months | Surveys will explore enabling factors to CCDS implementation at the individual, unit, and hospital levels. | Provider surveys at 12 months post-CCDS implementation |
| Enabling factors to CCDS implementation - Interviews - 6 months | 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. | Provider interviews at 6 months post-CCDS implementation |
| Enabling factors to CCDS implementation - Interviews - 12 months | 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. | Provider interviews at 12 months post-CCDS implementation |
| The Children's Hospital of Philadelphia |
| Philadelphia |
| Pennsylvania |
| 19104 |
| United States |