Underuse of oral anticoagulants in privately insured patients with atrial fibrillation: A population being targeted by the IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib)

Al‐Khatib, Sana M.; Pokorney, Sean D.; Al‐Khalidi, Hussein R.; Haynes, Kevin; Garcia, Crystal; Martín, David; Goldsack, Jennifer C.; Harkins, Thomas; Cocoros, Noelle M; Lin, Nancy D.; Lipowicz, Hana; McCall, Debbe; Nair, Vinit; Parlett, Lauren E.; McMahill‐Walraven, Cheryl N.; Platt, Richard; Granger, Christopher B.

doi:10.1016/j.ahj.2020.07.012

Cited by 15 publications

(15 citation statements)

References 24 publications

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“…Two similarly designed randomized clinical trials, one in hypertension and one in heart failure, using coded and text data in outpatient electronic health records, found that outpatient pharmacist intervention led to a 34% reduction in any adverse drug events and medication errors 63,64 . Another clinical trial, IMPACT‐AFib, was conducted in 5 health plans to assess the impact of mailing information about the use of anticoagulants to 80,000 patients with atrial fibrillation who met clinical guidelines for anticoagulant treatment for stroke prevention and were not on therapy and to their providers 65,66 . The trial compared early vs. delayed (12 months later) communication.…”

Section: Specific Issues With the Use Of Real‐world Data To Assess The Impact Of Regulatory Actionsmentioning

confidence: 99%

The Use of Real‐World Data to Assess the Impact of Safety‐Related Regulatory Interventions

Pan

2021

Clin Pharma and Therapeutics

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The regulation of medicines seeks to ensure the efficacy, safety, and quality of prescription and non‐prescription medicines. Given that the conditions under which a medicine’s benefits outweigh its risks are complex, it is essential that communications about the safe and effective use of medicines be clear and actionable. Assessing the impact of interventions to improve the safe and effective use of medicines is a developing area, and one in which real‐world data are playing an increasingly important role. Although real‐world data are commonly used to assess the impact of regulatory interventions, there are several areas where their use could be improved. Specific areas for improvement include assessing regulatory interventions across a wider range of medicines, rather than concentrating on a relatively few therapeutic areas; assessing more clinically relevant outcomes rather than relying on measures such as changes in the number of prescriptions, which may not always correlate with the desired impact; assessing the potential unintended or negative consequences of regulatory interventions; applying methods to address potential confounders; assessing long‐term, rather than just short‐term, impacts of an intervention; increasing the use of comparator groups, when feasible; and evaluating the impact of regulatory interventions from multiple dimensions, rather than from a single dimension. Expanded use of real‐world data could inform some of these efforts, although data sources beyond administrative claims data will likely be necessary to achieve all these goals.

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Section: Specific Issues With the Use Of Real‐world Data To Assess The Impact Of Regulatory Actionsmentioning

confidence: 99%

The Use of Real‐World Data to Assess the Impact of Safety‐Related Regulatory Interventions

Pan

2021

Clin Pharma and Therapeutics

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“…Earlier studies have shown significant underutilization of oral anti-coagulants (OACs) in AF patients at high risk of stroke [ 6 – 9 ]. This low utilization has persisted even after the introduction of direct acting oral anti-coagulants (DOACs) despite their ease of use by the patients.…”

Section: Introductionmentioning

confidence: 99%

Contemporary clinical and economic outcomes among oral anticoagulant treated and untreated elderly patients with atrial fibrillation: Insights from the United States Medicare database

et al. 2022

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Background Oral anticoagulants (OACs) mitigate the risk of stroke in atrial fibrillation (AF) patients. Objective Elderly AF patients who were treated with OACs (apixaban, dabigatran, edoxaban, rivaroxaban, or warfarin) were compared against AF patients who were not treated with OACs with respect to their clinical and economic outcomes. Methods Newly diagnosed AF patients were identified between January 2013 and December 2017 in the Medicare database. Evidence of an OAC treatment claim on or after the first AF diagnosis was used to classify patients into treatment-defined cohorts, and these cohorts were further stratified based on the initial OAC prescribed. The risks of stroke/systemic embolism (SE), major bleeding (MB), and death were analyzed using inverse probability treatment weighted time-dependent Cox regression models, and costs were compared with marginal structural models. Results The two treatment groups were composed of 1,421,187 AF patients: OAC treated (N = 583,350, 41.0% [36.4% apixaban, 4.9% dabigatran, 0.1% edoxaban, 26.7% rivaroxaban, and 31.9% warfarin patients]) and untreated (N = 837,837, 59.0%). OAC-treated patients had a lower adjusted risk of stroke/SE compared to untreated patients (hazard ratio [HR]: 0.70; 95% confidence interval [CI]: 0.68–0.72). Additionally patients receiving OACs had a lower adjusted risk of death (HR: 0.56; 95% CI: 0.55–0.56) and a higher risk of MB (HR: 1.57; 95% CI: 1.54–1.59) and this trend was consistent across each OAC sub-group. The OAC-treated cohort had lower adjusted total healthcare costs per patient per month ($4,381 vs $7,172; p < .0001). Conclusion For the OAC-treated cohort in this elderly US population, stroke/SE and all-cause death were lower, while risk of MB was higher. Among OAC treated patients, total healthcare costs were lower than those of the untreated cohort.

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“…IMPACT-AFib (ClinicalTrials.gov identifier: NCT03259373 ) was a prospective, multicenter, open-label, educational intervention randomized clinical trial conducted from September 25, 2017, to May 1, 2019 (trial protocol and statistical analysis plan in Supplement 1 ). 22 Patients were randomized to receive an intervention of patient and clinician education (eFigure 1 and eFigure 2 in Supplement 2 ) either at the inception of the study (intervention) or after 1 year (the usual-care control). Patients and their treating clinicians were identified through health insurance claims data from commercially insured and Medicare Advantage populations.…”

Section: Methodsmentioning

confidence: 99%

“…Among more than 17 million members enrolled in the 5 health plans, 241 044 were randomized after meeting all inclusion and exclusion criteria, including patients treated and not treated with OACs, from whom we identified the primary analysis subset of those not receiving OACs (determined at baseline for the intervention cohort and determined [retrospectively to match the baseline status] after 12 months in the control group). 22 Missing baseline data necessary to contact patients or clinicians at 1 data partner resulted in imbalances between the intervention and control patients from that data partner; all patients from that data partner were excluded from the primary analysis. The primary analysis included 4 data partners (47 333 patients); the fifth data partner (12 772 patients) was included in a sensitivity analysis (eTable 1 and eFigures 3-5 in Supplement 2 ).…”

Section: Methodsmentioning

confidence: 99%

Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants

et al. 2022

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Key Points Question Does a single educational mailing to a patient with atrial fibrillation and their clinician increase the use of oral anticoagulants for stroke prevention? Findings This randomized clinical trial found no statistically significant increase in initiation of oral anticoagulants among patients with atrial fibrillation after a single educational mailing to patients and their clinicians. Meaning More-intensive interventions are needed to address the public health issue of underuse of anticoagulation for stroke prevention among patients with atrial fibrillation.

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Underuse of oral anticoagulants in privately insured patients with atrial fibrillation: A population being targeted by the IMplementation of a randomized controlled trial to imProve treatment with oral AntiCoagulanTs in patients with Atrial Fibrillation (IMPACT-AFib)

Cited by 15 publications

References 24 publications

The Use of Real‐World Data to Assess the Impact of Safety‐Related Regulatory Interventions

The Use of Real‐World Data to Assess the Impact of Safety‐Related Regulatory Interventions

Contemporary clinical and economic outcomes among oral anticoagulant treated and untreated elderly patients with atrial fibrillation: Insights from the United States Medicare database

Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants

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