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Pharmacist-led, checklist intervention did not improve adherence in ambulatory patients starting/resuming DOACs
Insights
A clinical pharmacist's checklist-driven care did not improve adherence to direct-acting oral anticoagulants (DOACs) in ambulatory patients. High adherence was observed in both intervention and control groups, suggesting the need to reassess the DOAC checklist.
Area of Science:
- Pharmacology
- Clinical Pharmacy
- Thromboembolic Disease Management
Background:
- High adherence to direct-acting oral anticoagulants (DOACs) is crucial for preventing and treating thromboembolic disease.
- The Anticoagulation Forum developed a DOAC checklist to guide care processes aimed at improving patient adherence.
Purpose of the Study:
- To evaluate if a clinical pharmacist-led, checklist-driven care approach enhances adherence in ambulatory patients initiating or resuming DOAC therapy.
- To compare adherence rates between patients receiving checklist-driven care and those receiving usual care.
Main Methods:
- Ambulatory patients starting or resuming DOACs were randomized into intervention (checklist-driven care) and control groups.
- The intervention included pharmacist verification of DOAC appropriateness, dose adjustments, tele-visits, and hotline support.
- Adherence was measured by medication possession ratio (MPR) and proportion of days covered (PDC) at 90, 180, and 365 days.
Main Results:
- Of 561 randomized patients, 427 were analyzed; overall adherence was high, with only 9.6% having MPR below 80% at 90 days.
- No statistically significant difference in adherence (MPR or PDC) was found between the intervention and control groups at any time point.
- The odds ratio for adherence between groups was 0.94 (95% CI 0.60-1.49).
Conclusions:
- The checklist-driven intervention by clinical pharmacists did not significantly improve DOAC adherence in ambulatory patients compared to usual care.
- High adherence rates were observed in both groups, indicating the effectiveness of standard care and support mechanisms.
- Re-evaluation of the DOAC checklist's utility outside a traditional trial setting may be warranted.
Background:
High adherence to direct-acting oral anticoagulant (DOAC) is critical to treat and prevent thromboembolic disease. The Anticoagulation Forum recently endorsed a checklist (DOAC checklist) that recommends care processes that may improve adherence.
Objectives:
This study aimed to determine whether checklist-driven care from a clinical pharmacist improves adherence in ambulatory patients starting a DOAC or resuming it after a setback.
Methods:
This study included ambulatory patients starting a DOAC or resuming it after setback (thromboembolic event or bleeding) in an ambulatory setting. Settings included office, emergency department, and short-stay hospital visit. Following the DOAC checklist, a clinical pharmacist verified DOAC appropriateness, instructed dose de-escalation, educated through 3 tele-visits, fielded hotline calls, and handed off to a continuity provider after 3 months. Intervention and control patients received coupons and help with completing manufacturer-based medication assistance applications. Using pharmacy dispense records, our group measured medication possession ratio (MPR) at 90 days (primary outcome) and proportion of days covered (PDC) at 90 days and MPR and PDC at 180 and 365 days (secondary outcomes). Given skewing, our team analyzed adherence as < 80%, 80%-89%, and 90% or more and conducted ordered logistic regression.
Results:
Of 561 patients randomized, 427 had sufficient records to analyze. Adherence was high with only 41 patients (9.6%) having MPR less than 80% at 90 days. There was no difference in adherence between intervention and control patients for primary outcome (odds ratio 0.94 [95% CI 0.60-1.49]) or secondary outcomes.
Conclusion:
Our checklist-driven intervention did not appreciably improve adherence beyond that seen in control patients treated with usual care (plus coupons and medication assistance we provided to all patients) in ambulatory patients starting or resuming DOACs, although it should be noted that high levels of adherence in both study groups were noted. Given high adherence, reassessing the DOAC checklist outside of a traditional trial may be more fruitful.
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