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The study aims to evaluate the effectiveness and safety of a collaborative nurse-allergist approach in penicillin allergy delabeling services. It also seeks to assess the impact on patients' quality of life and compare resource utilization and cost-effectiveness between the nurse-allergist collaborative approach and the traditional allergist-led approach.
This study hypothesizes that by involving both nurses and allergists in the delabeling process and categorizing patients based on risk levels, it will achieve comparable success rates, safety, and improvements in patients' quality of life. This approach is expected to offer superior advantages in terms of time efficiency, resource utilization, and cost-effectiveness compared to traditional allergist-led services.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nurse-led group | Receive Nurse-led penicillin allergy delabelling service |
| |
| Allergist-led group | Receive Allergist-led penicillin allergy delabelling service |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-led penicillin allergy delabelling service | Diagnostic Test | Patients in this group undergo risk assessment and categorization by nurses to identify low-risk individuals for delabeling. For these patients, nurses will collaborate with allergists in the delabeling process. |
| Measure | Description | Time Frame |
|---|---|---|
| Delabelling Success Rate | Assess the proportion of low-risk patients who are no longer considered allergic to penicillin after delabeling. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Health-Related Quality of Life | Measure changes in patients' quality of life before and after delabeling using the validated Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q). The DrHy-Q is a 15-item instrument answered on a 5-point Likert scale, with scores ranging from 15 (no QoL impairment) to 225 (worst QoL impairment). | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Patients treated at a participating hospital who have a documented penicillin allergy label, are evaluated for penicillin allergy through either the nurse-allergist or allergist-led approach, and have available demographic and clinical data.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elaine Lee | Contact | 852 9440 3349 | le446@hku.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Recruiting | Hong Kong | 999077 | Hong Kong | ||
| Princess Margaret Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19252115 | Background | Schnyder B, Pichler WJ. Mechanisms of drug-induced allergy. Mayo Clin Proc. 2009 Mar;84(3):268-72. doi: 10.4065/84.3.268. | |
| 29712672 | Background | Abrams EM, Khan DA. Diagnosing and managing drug allergy. CMAJ. 2018 Apr 30;190(17):E532-E538. doi: 10.1503/cmaj.171315. No abstract available. |
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| ID | Term |
|---|---|
| D004342 | Drug Hypersensitivity |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
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| Allergist-led penicillin allergy delabelling service | Diagnostic Test | Patients assigned to this group will undergo risk assessment and delabeling led by allergists for both low-risk and high-risk cases. |
|
| Antibiotic Usage Rate | Evaluate changes in the usage rates of penicillin and alternative antibiotics after delabeling. | 6 months |
| Age Group Analysis | Compare delabeling success rates across different age groups (e.g., 18-30 years, 31-50 years, and 51 years and older). | 6 months |
| Immunocompetence Status | Analyze differences in delabeling success rates and safety between immunocompetent and immunocompromised patients. | 6 months |
| Initial vs. Recurrent Labeling | Compare delabeling success rates between patients with an initial penicillin allergy label and those with recurrent labels. | 6 months |
| Recruiting |
| Hong Kong |
| 999077 |
| Hong Kong |
| Queen Elizabeth Hospital | Recruiting | Hong Kong | 999077 | Hong Kong |
| Queen Mary Hospital | Recruiting | Hong Kong | 999077 | Hong Kong |
| 9002492 | Background | Classen DC, Pestotnik SL, Evans RS, Lloyd JF, Burke JP. Adverse drug events in hospitalized patients. Excess length of stay, extra costs, and attributable mortality. JAMA. 1997 Jan 22-29;277(4):301-6. |
| 19075990 | Background | Pourpak Z, Fazlollahi MR, Fattahi F. Understanding adverse drug reactions and drug allergies: principles, diagnosis and treatment aspects. Recent Pat Inflamm Allergy Drug Discov. 2008 Jan;2(1):24-46. doi: 10.2174/187221308783399289. |
| 29313907 | Background | Patton K, Borshoff DC. Adverse drug reactions. Anaesthesia. 2018 Jan;73 Suppl 1:76-84. doi: 10.1111/anae.14143. |