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| ID | Type | Description | Link |
|---|---|---|---|
| R01HS029879 | U.S. AHRQ Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Utah | OTHER |
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The overall goal of the RENEW-IN intervention is to assess the impact of a BL allergy delabeling intervention on antibiotic use and clinical outcomes in patients with a hematologic malignancy.
The RENEW clinical intervention is designed to evaluate the impact of a comprehensive beta lactam allergy delabeling intervention on clinical outcomes among patients hospitalized with a hematologic malignancy (HM).
HM patients are at a high risk of infection-related complications but are limited to antibiotic therapy based on self-reported allergies.
Beta-lactam (BL) antibiotics are a preferred treatment option for many bacterial infections, however, these antibiotics remain inaccessible as a treatment option for patients with a self-reported BL allergy. In the hospital setting, BL allergies are documented in the electronic medical record in up to 20% of hospitalized patients. Prior studies have shown that 90% of the patients for whom these allergies are reported are able to tolerate penicillin (PCN) or other BLs. Delabeling strategies to correctly identify true BL allergies in the general hospital population have proven successful. However, these studies have not been conducted among patients diagnosed with a hematological malignancy. The investigators propose to test the impact of a pharmacist-led BL allergy delabeling intervention on clinical outcomes and antibiotic use in hospitalized patients with HM.
The intervention is a multi-step PCN delabeling strategy that includes 1) an assessment of the participant's BL allergy by a clinical pharmacist based on a detailed medical history; 2) assignment of additional allergy testing based on the RENEW-IN algorithm; and 3) delabeling of the allergy within the participants electronic medical record if appropriate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who enroll in the RENEW intervention | Other | Patients who agree to actively participate in the RENEW intervention designed to identify opportunities to have the beta lactam allergy label removed from their electronic medical record. |
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| Patients hospitalized with a hematologic malignancy in the time period prior to the intervention | Other | Patients who are hospitalized with a hematologic malignancy who would meet the inclusion criteria for the intervention but who were not approached since they were hospitalized in the time period prior to introduction of the intervention. These patients will be used as a control group. Charts for these patients will be retrospectively reviewed and data will be extracted for analysis of the primary and secondary outcomes. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RENEW-IN Algorithm for assessment of a beta-lactam intervention | Diagnostic Test | The RENEW-IN intervention includes a detailed assessment of the participant's beta-lactam allergy history and determination of a risk-level for allergy-delabeling. |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic Days of therapy | Proportion of participants prescribed an antibiotic during index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first | From baseline enrollment to end of index hospitalization or death, up to 36 months |
| Hospital length of stay | Number of days participants are admitted to the hospital during the index visit, from enrollment in the study to hospital discharge or death, whichever occurs first | From baseline enrollment to end of index index hospitalization or death, up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Cultures positive for multi-drug resistant organisms | Proportion of participants diagnosed with multi-drug resistant organism during index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first | From baseline enrollment to end of index index hospitalization or death, up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ebbing Lautenbach, MD,MPH,MSCE | Contact | 215-898-6977 | ebbing@pennmedicine.upenn.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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Interrupted Time Series Analysis
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| EMR Review | Other | Electronic medical record review for comparative analysis |
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| Clinical Cultures positive for Clostridioides difficile infection |
Proportion of participants diagnosed with Clostridioides difficile infection during index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first |
| From baseline enrollment to end of index index hospitalization or death, up to 36 months |
| Clinical Cultures positive for Health-care Associated Infections (HAIs) | Proportion of participants diagnosed during index visit with an infection identified as related to their hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first | From baseline enrollment to end of index index hospitalization or death, up to 36 months |
| Need for ICU transfer | Proportion of participants admitted to the ICU during their index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first | From baseline enrollment to end of index index hospitalization or death, up to 36 months |
| ICU length of stay | Number of days participants are admitted to the ICU during their index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first | From baseline enrollment to end of index index hospitalization or death, up to 36 months |
| Patient Disposition | Proportion of participants who are discharged from the hospital at the end of their index visit compared to the number of participants who expire during their index visit | From baseline enrollment to end of index index hospitalization or death, up to 36 months |