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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 goal of this RENEW-EVAL project is to understand the potential barriers to implementation of the RENEW intervention into the routine clinical care of patients with a hematological malignancy.
The RENEW clinical intervention is designed to evaluate the impact of a comprehensive beta lactam (BL) 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. The RENEW intervention will test the impact of a pharmacist-led BL allergy delabeling intervention on clinical outcomes and antibiotic use in hospitalized patients with HM.
The implementation of clinical interventions are often affected by non-clinical factors including workflow challenges and the beliefs of patients, their families, and clinical staff.
The RENEW-EVAL study is a concurrent mixed methods process evaluation of the RENEW intervention that aims to identify the social and behavioral factors that shape implementation of the intervention and to measure implementation outcomes including feasibility, acceptability, and fidelity.
Three types of data will be gathered by the research team as part of the RENEW-EVAL project: 1) semistructured interviews with patients and clinicians, (2) ethnographic observations of the delivery of the RENEW intervention, and 3) surveys assessing patient and clinician attitudes towards BL allergy delabeling, and implementation outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients who enroll in the RENEW intervention | 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 who decline enrollment in the RENEW intervention | Patients who were approached for enrollment in the RENEW intervention but declined consent. |
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| Clinicians | Clinicians who provide clinical care to patients enrolled in the intervention. |
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| RENEW Clinical Pharmacist | The RENEW Clinical Pharmacist will screen, recruit, and consent potential participants and perform the RENEW intervention. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semi-structured interview | Behavioral | Interviews designed to obtain information about patient reasons for enrolling or declining participation in the RENEW Intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Implementation | Feasibility of implementation among clinicians and patients measured by questionnaire. Items are adapted from the validated Feasibility of Implementation Measure (FIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better feasibility. The items are analyzed individually and not summed to a total score. | From baseline Month 1 to Month 36 |
| Acceptability of Implementation | Acceptability of implementation among clinicians and patients measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better acceptability. The items are analyzed individually and not summed to a total score. | From baseline Month 1 to Month 36 |
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Inclusion Criteria:
Patient participants:
Clinician participants:
Exclusion Criteria:
Patient participants:
Clinician participants:
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The study population includes patient participants who are admitted to an inpatient oncology service at the Hospital of the University of Pennsylvania, and clinician participants who provide clinical care during the admission. By definition, the Clinical Pharmacist who enrolls patient participants will also be part of the study population.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of the University of Pennsylvania | 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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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| Survey | Behavioral | Survey which will incorporate a series of closed-ended questions eliciting attitudes about the feasibility and acceptability of the intervention, allergy delabeling and future BL antibiotic use |
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| Ethnographic observation | Behavioral | Observations designed to identify communication and contextual barriers to the implementation of RENEW |
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| Survey | Behavioral | Survey instruments will measure knowledge,attitudes, and practices surrounding allergy delabeling and antibiotic stewardship in patients with HM and perceptions of the feasibility and acceptability of the RENEW intervention |
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| Semi-structured interview | Behavioral | Interviews designed to obtain information from clinicians about their perception of the implementation of the RENEW intervention |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |