Stroke Clinical Trial
Official title:
IMplementation of a Randomized Controlled Trial to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation
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 follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time). 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 study period. After
the date on which at least 80% of eligible study participants have at least 12 months of
follow-up time, "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. 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 the follow-up through the date on which at least 80% of
eligible study participants have at least 12 months of follow-up time 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 the date at
which at least 80% of eligible study participates are enrolled (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 at least 80% of early intervention mailings have occurred (patients will not
receive any educational materials). The investigators intend to assess the primary and
secondary endpoints again 24 months after at least 80% of early intervention mailings have
occurred 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 of the primary outcome are
consistently null.
Because the Sentinel Distributed Database will be used for follow-up information, and this
information is refreshed approximately quarterly and this is done on separate timetables for
the different health plans, it is likely that when at least the required follow-up time is
available for at least 80% of people, there will be more than 12 or 24 months of followup for
over 80% of people. All participants' outcomes will be assessed using all possible
person-time; patients will have different duration of follow-up.
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