The purpose of this study is to use a decentralized claims database to determine whether education on stroke prevention in atrial fibrillation (AF) among AF patients and their providers can result in increased use of oral anticoagulants (OAC) for stroke prevention among those AF patients with guideline-based indications for oral anticoagulation (CHA₂DS₂-VASc score of 2 or greater). Specifically, the investigators will conduct a prospective, randomized, open-label education intervention trial to evaluate the effect of the early patient and provider education interventions on the proportion of patients with evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4 international normalized ratio (INR) tests) over the course of the 12-months of follow-up. A total of approximately 80,000 patients will be enrolled within multiple major health plans across the United States. The randomization will be performed by the central coordinating center, and the health plans will mail the educational intervention materials to their members and providers.
The study is a prospective, randomized, and open-label education intervention trial. Patients with AF and a CHA₂DS₂-VASc score of 2 or greater will be randomized in a 1:1 ratio to an early intervention cohort and a delayed intervention cohort within each participating health plan. The definition for OAC medication fill will be an OAC medication dispensing or at least 4 INR tests in the claims data. The claims records of the patients randomized to the early intervention cohort will then be linked to "fresh" (i.e. about 1 month old) pharmacy claims data at the time of randomization. Patients without evidence of an OAC medication fill during the 12 months prior to randomization will be included in the patient-level and provider-level early educational intervention. In addition to usual care, these patients and their providers, where an individual provider may be identified, will receive a one-time mailing at trial start. Patients randomized to this early intervention with evidence of an OAC medication fill during the 12 months prior to randomization will be excluded from the trial.
The delayed intervention cohort will receive usual care over the initial 12-month study period. After the first 12 months of the study, "fresh" pharmacy claims data for the delayed intervention cohort that was generated and locked at the time of randomization will be used to assess trial eligibility, and those patients without evidence of an OAC medication fill during the 12 months prior to randomization will be included in the primary and secondary analyses as the delayed intervention arm. Patients randomized to the delayed intervention arm with evidence of an OAC medication fill during the 12 months prior to randomization will be excluded from the trial and will not be included in analyses. The baseline characteristics of the delayed intervention patients will be examined at the same time point as the early intervention patients, meaning at the time of randomization (not at the time of patient eligibility assessment 12 months after enrollment). The primary outcome is a comparison of the proportion of patients not on OAC during the 12 months prior to randomization, who were started on OAC over the course of a 12-month study period in the early versus the delayed intervention arm. A total of approximately 80,000 patients (randomized 1:1) across all participating data partners (Aetna, Harvard Pilgrim, Anthem [of which HealthCore is a subsidiary], Humana, and Optum) will be enrolled from participating data partners across the United States. The follow-up time for the primary outcome will be 12 months from enrollment (date on which early intervention materials are mailed).
The providers of patients in the delayed cohort who did not receive OAC medication during the course of the 12-month study period and meet the inclusion criteria will receive the delayed intervention: the provider-only education intervention, a one-time mailing administered 12 months after enrollment (patients will not receive any educational materials). The investigators intend to assess the primary and secondary endpoints again at 24 months after enrollment to assess the durability and longer-term outcomes of the effect of the patient- and provider-level education intervention, as well as the use of OAC following the delayed provider-level education intervention. However, as this second assessment is exploratory, investigators may not conduct these analyses if the results at the 12-month time point are consistently null.
- Early Intervention Behavioral
Intervention Desc: Letters to patients that (1) explain to the patient that he or she appears to have AF, characterize the risk of stroke, and emphasize that although there may be a medical reason, the patient does not seem to be on an anticoagulant and (2) encourage the patient to discuss this with his or her provider to ask if he or she might benefit from OAC therapy to prevent stroke. Early intervention letters to providers explain this project, the nature of the problem, and identify a list of the provider's patients who have been contacted, as the provider and patient letters will be sent at approximately the same time; describe evidence and guidelines regarding oral anticoagulation. ARM 1: Kind: Experimental Label: Early Intervention Description: Educational mailing to (1) AF patients with guideline-based indications for oral anticoagulation (CHA₂DS₂-VASc score of 2 or greater) who appear to not have received OAC treatment at time of randomization and (2) their providers
- Delayed Intervention Behavioral
Intervention Desc: Delayed intervention letters to patients' providers, where they may be identified, that explain this project, the nature of the problem, and identify a list of their patients who are flagged as at risk for stroke and have not been treated with an oral anticoagulant; describe evidence and guidelines regarding oral anticoagulation. ARM 1: Kind: Experimental Label: Delayed Intervention Description: Educational mailing to AF patients with guideline-based indications for oral anticoagulation (CHA₂DS₂-VASc score of 2 or greater) who appear to not have received OAC treatment in the year following randomization. These patients will have received 'usual care' for the year between randomization and delayed educational mailing.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Proportion of patients with evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4 INR tests)||12 months of follow-up|
|Secondary||Rates of stroke/transient ischemic attack (TIA) hospitalization||At 12 months|
|Secondary||Rates of hospitalization for stroke||At 12 months|
|Secondary||Time to first OAC prescription fill||Within 12 months|
|Secondary||Proportion of days covered by OAC prescription fills||During 12 months|
|Secondary||Proportion of patients on oral anticoagulation||At 12 months|
|Secondary||Rates of hospitalization for bleeding||At 12 months|
|Secondary||All-cause in-hospital mortality rates||At 12 months|
|Secondary||All-cause mortality rates among patients with accurate out-of-hospital mortality data||At 12 months|
|Secondary||Health care utilization for AF patients, which would be reported as counts of number of health care utilization events||At 12 months|