Table 1.
Completed Decision Aid for Identifying and Selecting a Laboratory Medicine Quality Gap for Potential Intervention: High-Risk Medication Monitoringa
| Consideration | Completed Assessment (in Brief) for High-Risk Medication Monitoring Potential Gap |
|---|---|
| Quality gap is preventable or has potential targets for improvement (list specifics | Yes. Laboratory monitoring (CBC, ALT, AST, SCr) is recommended for many of these agents for safety and/or appropriate dosage |
| Strategies/interventions could be used to reduce the gap (list) | Practice level intervention using EHR or laboratory decision support reminder to order recommended laboratory monitoring; patient IVR laboratory test reminder intervention |
| Potential harms that might be associated with the interventions (list) | Unintended consequences that change existing workflow |
| Intermediate surrogate outcomes that could be measured (list) | Yes. Compliance with guidelines/labeling recommendations: No. (%) with laboratory test(s) completed System: Time to dosage or medication change after laboratory test result available |
| Clinical: (1) No. (%) with elevated ALT/AST, (2) No. (%) with neutropenia, (3) No. (%) with elevated SCr | |
| Long-term outcomes that could directly affect patients or the health care system (list) | Early detection of developing adverse events |
| Timely laboratory results enhance ability to titrate dosage to better manage condition | |
| Decreased provider burden associated with laboratory outreach | |
| Enhanced guideline concordance | |
| Local importance (low/medium/high; potential effect size at least moderate) | Medium |
| National importance (low/medium/high; include references) | Medium. Impacts moderate No. of patients |
| Drug toxicity contributes to patient morbidity and mortality | |
| HEDIS criteria include DMARD use | |
| American College of Rheumatology recommends optimal follow-up intervals for complete blood count, liver transaminase levels, and creatinine for patients with rheumatoid arthritis receiving DMARDs | |
| Product labeling from FDA recommends laboratory monitoring for safe DMARD use | |
| Local health care system conducive to the intervention (yes/no; explain) | Yes. Rheumatoid arthritis registry in development that includes patient-specific laboratory monitoring status. EHR Smart Set reminds providers to order laboratory tests for rheumatoid arthritis patients |
| Registries planned for gastrointestinal and dermatology patients receiving these agents | |
| Clinical pharmacy specialist resources in rheumatology, gastroenterology, and dermatology are enthusiastic about opportunity to support appropriate laboratory monitoring of these high-risk drugs | |
| Feasibility of establishing baseline status (low/medium/high; explain) | High. Required data already in VDW |
| Baseline data indicate a gap in performance (yes/no; provide summary) | Yes |
| Availability of published standards/criteria to enable evaluation (provide references) | Singh et al32 |
| Feasibility of assessing outcomes using MDW (low/medium/high; explain) | High. Data in VDW |
| Experience using these laboratory and drug data | |
| Relevant data in MDW (list data needed) | Laboratory results (CBC, ALT/AST, SCr) |
| Drug dispensing and infusion data | |
| Data needed from outside MDW (yes/no; if yes, list) | No |
| Potential challenges (list) | Interventions to reduce quality gap likely will require electronic patient outreach and/or EHR alerts or messages. These intervention types require development assistance and approvals from departments not on the study. Such activities have been collaboratively accomplished in other projects; time frame to develop must be coordinated with these other departments |
| Guidelines for monitoring are changing over time | |
| Differences in laboratory monitoring frequencies exist between patients newly started on DMARD and patients being chronically maintained on DMARD. Different programming and evaluation needed for different patient groups | |
| Differences in recommended laboratory monitoring by individual agents increases complexity | |
| Not a high-intensity intervention |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; CBC, complete blood count; DMARD, disease-modifying antirheumatic drug; EHR, electronic health record; FDA, US Food and Drug Administration; HEDIS, Healthcare Effectiveness Data and Information Set; IVR, interactive voice response; MDW, medical data warehouse; SCr, serum creatinine; VDW, virtual data warehouse.
a
Completed decision aids for the laboratory medicine quality gaps test ordering and diagnosis, detection, and documentation are available in Supplemental Tables 1 and 2.