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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23HL151381-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| Johns Hopkins University | OTHER |
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This study will compare two strategies that target distinct determinants of blood culture overuse in an exploratory, hybrid, pilot trial in 8 PICUs. It aims to determine if there is any association between specific strategies used to reduce blood culture overuse on unit-wide blood culture rates, patient safety, and concurrently explore aspects of the implementation process (acceptability, feasibility, appropriateness).
Blood cultures are an important test to diagnose bacterial bloodstream infections, but can be ordered reflexively, excessively, and lead to downstream negative patient consequences such as unnecessary antibiotic exposure. Work to date has demonstrated safe and effective reduction in blood culture rates in the pediatric intensive care unit (PICU) setting, but optimal strategies to reduce culture use are currently unknown.
The primary study team will initially work with all enrolled sites in an identical fashion, facilitating a core series of steps for implementing a quality improvement blood culture diagnostic stewardship program which is identical to the steps used in the parent study, called BrighT STAR (Testing STewardship to reduce Antibiotic use and Resistance). In addition, the primary study team will randomize sites into two arms, in which different strategies are introduced that each target distinct determinants of blood culture overuse. The primary study team will examine the impact on blood culture rates, as well as evaluate aspects of the implementation process, in all sites pre- vs-post intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Default Bias | Experimental | This intervention consists of a checklist to guide blood culture decisions, that a clinician in a site randomized to Arm A will be asked to consult and complete prior to ordering or not ordering a blood culture; as the relevant clinical scenario occurs. |
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| Loss Aversion | Experimental | This intervention consists of targeted messaging and education that the primary study team will create and ask the Arm B sites to deliver to the PICU clinicians, which focuses on the importance of diagnostic stewardship and the current evidence for the benefit/low risk nature of the stewardship program to date. Sites in this arm will also receive a checklist to guide blood culture decisions, that clinicians at sites will be asked to consult and complete prior to ordering or not ordering a blood culture. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Checklist | Behavioral | This intervention consists of a checklist to guide blood culture decisions, that a clinician in a site randomized to Arm A will be asked to consult and complete prior to ordering or not ordering a blood culture; as the relevant clinical scenario occurs. Meaning, if a clinician in Arm A is faced with a scenario in which it is customary or usual care to consider a blood culture, the clinician will be asked to first review this checklist. The checklist is not a binding or absolute process - the clinician should use both the checklist and typical clinical judgment to decide if the blood culture test is needed or not. The checklist is based on prototypes used in the completed parent study, BrighT STAR and the earlier preliminary studies at Johns Hopkins. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Blood Culture Rates | Compare differences in clinical outcomes, via total blood culture rates, before and after intervention, as well as between intervention arms | Approximately 24 months |
| Acceptability of Intervention Measure (AIM) | Compare differences in implementation outcomes, via AIM surveys, before and after intervention, as well as between intervention arms. The AIM survey consists of a 4-item measure using a 5-point Likert scale, where 1=Completely disagree and 5=Completely agree | one year |
| Intervention Appropriateness Measure | Compare differences in implementation outcomes, via Implementation Appropriateness Measure (IAM) surveys, before and after intervention, as well as between intervention arms. The IAM survey consists of a 4-item measure using a 5-point Likert scale, where 1=Completely disagree and 5=Completely agree | one year |
| Feasibility of Intervention Measure (FIM) | Compare differences in implementation outcomes, via FIM surveys, before and after intervention, as well as between intervention arms. The FIM survey consists of a 4-item measure using a 5-point Likert scale, where 1=Completely disagree and 5=Completely agree | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcomes Post-Intervention | Monitor safety outcomes of the blood culture diagnostic stewardship program in all sites, defined as episodes of delay in diagnosis of bacteremia in enrolled sites post-implementation of the pilot study; using chart review and a standardized safety event review form that is identical to the completed parent study, BrighT STAR. | one year |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Interview Data | Analyze qualitative interview data from each sites' lead team members to better understand the implementation process for a blood culture diagnostic stewardship program. | one year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlotte Woods-Hill, MD | Children's Hospital of Philadelphia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Mattel Children's Hospital | Los Angeles | California | 90095 | United States | ||
| UCSF Benioff Children's Hospital Mission Bay |
Individual participant data will not be made available to other researchers. Summary level data will be published.
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Study sites will be randomized into two arms, in which different strategies are introduced that each target distinct determinants of blood culture overuse
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The primary study team will know which arm the participating site PICUs will be in, but the local study team and care teams will be blinded.
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| Targeted Messaging | Behavioral | This intervention consists of targeted messaging and education that the primary study team will create and ask the Arm B sites to deliver to the PICU clinicians, which focuses on the importance of diagnostic stewardship and the current evidence for the benefit/low risk nature of the stewardship program to date. |
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| San Francisco |
| California |
| 94158 |
| United States |
| Nemours / AI DuPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | United States |
| Norton Children's Hospital | Louisville | Kentucky | 40202 | United States |
| Kravis Children's Hospital | New York | New York | 10019 | United States |
| New York-Presbyterian Morgan Stanley Children's Hospital | New York | New York | 10032 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53201 | United States |
| ID | Term |
|---|---|
| D057189 | Checklist |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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