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IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation (IMPACT-AFib)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03259373
Recruitment Status : Active, not recruiting
First Posted : August 23, 2017
Last Update Posted : April 29, 2020
Sponsor:
Collaborators:
Duke Clinical Research Institute
HealthCore, Inc.
Clinical Trials Transformation Initiative
Humana, Inc
Aetna, Inc.
OptumInsight Life Sciences, Inc.
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Richard Platt, Harvard Pilgrim Health Care

Tracking Information
First Submitted Date  ICMJE July 7, 2017
First Posted Date  ICMJE August 23, 2017
Last Update Posted Date April 29, 2020
Actual Study Start Date  ICMJE September 25, 2017
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2020)
Proportion of patients with evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4 INR (International Normalized Ratio) tests) [ Time Frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time ]
Evaluate the effect of the patient and provider education interventions (versus usual care with delayed provider education intervention) on the proportion of patients with evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4 INR tests) over the course of the 12 months of follow-up.
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
Proportion of patients with evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4 INR tests) [ Time Frame: 12 months of follow-up ]
Evaluate the effect of the patient and provider education interventions (versus usual care with delayed provider education intervention) on the proportion of patients with evidence of at least one OAC prescription fill (defined as one OAC dispensing or 4 INR tests) over the course of the 12 months of follow-up.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2018)
  • Rates of stroke/transient ischemic attack (TIA) hospitalization [ Time Frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time ]
    Evaluate the impact of the patient and provider education interventions on rates of stroke/transient ischemic attack (TIA) hospitalization
  • Rates of hospitalization for stroke [ Time Frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time ]
    Evaluate the impact of the patient and provider education interventions on rates of hospitalization for stroke
  • Time to first OAC prescription fill [ Time Frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time ]
    Evaluate the impact of the patient and provider education interventions on time to first OAC prescription fill
  • Proportion of days covered by OAC prescription fills [ Time Frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time ]
    Evaluate the impact of the patient and provider education interventions on proportion of days covered by OAC prescription fills
  • Proportion of patients on oral anticoagulation [ Time Frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time ]
    Evaluate the impact of the patient and provider education interventions on proportion of patients on oral anticoagulation
  • Rates of hospitalization for bleeding [ Time Frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time ]
    Evaluate the impact of the patient and provider education interventions on rates of hospitalization for bleeding
  • All-cause in-hospital mortality rates [ Time Frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time ]
    Evaluate the impact of the patient and provider education interventions on all-cause in-hospital mortality rates
  • All-cause mortality rates among patients with accurate out-of-hospital mortality data [ Time Frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time ]
    Evaluate the impact of the patient and provider education interventions on all-cause mortality rates among patients with accurate out- of-hospital mortality data (such as Medicare Advantage patients)
  • Health care utilization for AF patients, which would be reported as counts of number of health care utilization events [ Time Frame: Follow-up through the date on which at least 80% of eligible study participants have at least 12 months of follow-up time ]
    Evaluate the impact of the patient and provider education interventions on health care utilization for AF patients, which would be reported as counts of number of health care utilization events (outpatient visits, days hospitalized, number of emergency department visits, etc.)
Original Secondary Outcome Measures  ICMJE
 (submitted: August 22, 2017)
  • Rates of stroke/transient ischemic attack (TIA) hospitalization [ Time Frame: At 12 months ]
    Evaluate the impact of the patient and provider education interventions on rates of stroke/transient ischemic attack (TIA) hospitalization
  • Rates of hospitalization for stroke [ Time Frame: At 12 months ]
    Evaluate the impact of the patient and provider education interventions on rates of hospitalization for stroke
  • Time to first OAC prescription fill [ Time Frame: Within 12 months ]
    Evaluate the impact of the patient and provider education interventions on time to first OAC prescription fill
  • Proportion of days covered by OAC prescription fills [ Time Frame: During 12 months ]
    Evaluate the impact of the patient and provider education interventions on proportion of days covered by OAC prescription fills
  • Proportion of patients on oral anticoagulation [ Time Frame: At 12 months ]
    Evaluate the impact of the patient and provider education interventions on proportion of patients on oral anticoagulation
  • Rates of hospitalization for bleeding [ Time Frame: At 12 months ]
    Evaluate the impact of the patient and provider education interventions on rates of hospitalization for bleeding
  • All-cause in-hospital mortality rates [ Time Frame: At 12 months ]
    Evaluate the impact of the patient and provider education interventions on all-cause in-hospital mortality rates
  • All-cause mortality rates among patients with accurate out-of-hospital mortality data [ Time Frame: At 12 months ]
    Evaluate the impact of the patient and provider education interventions on all-cause mortality rates among patients with accurate out- of-hospital mortality data (such as Medicare Advantage patients)
  • Health care utilization for AF patients, which would be reported as counts of number of health care utilization events [ Time Frame: At 12 months ]
    Evaluate the impact of the patient and provider education interventions on health care utilization for AF patients, which would be reported as counts of number of health care utilization events (outpatient visits, days hospitalized, number of emergency department visits, etc.)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation
Official Title  ICMJE IMplementation of a Randomized Controlled Trial (RCT) to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation
Brief Summary 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.
Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Atrial Fibrillation
  • Stroke
Intervention  ICMJE
  • Behavioral: Early Intervention

    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.

  • Behavioral: Delayed Intervention
    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.
Study Arms  ICMJE
  • Experimental: Early Intervention
    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, where an individual provider may be identified
    Intervention: Behavioral: Early Intervention
  • Experimental: Delayed Intervention
    Educational mailing to providers of 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 time following randomization. These patients will have received 'usual care' for the time between randomization and delayed educational mailing.
    Intervention: Behavioral: Delayed Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2017)
80000
Original Estimated Enrollment  ICMJE
 (submitted: August 22, 2017)
40000
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Two or more diagnoses of AF (ICD-9 and/or 10 codes) at least one day apart and with at least one diagnosis within the last 12 months prior to the last date in the current approved data used for cohort identification
  2. CHA₂DS₂-VASc score of 2 or greater
  3. Medical and pharmacy insurance coverage of at least the prior year as identified via administrative claims databases of one of the participating data partners as of the date of randomization
  4. Age 30 years or greater as of the last date in the current approved data used for cohort identification

Exclusion Criteria:

  1. Evidence of OAC medication fill during the 12 months prior to randomization (determined at randomization for the early intervention cohort and 12 months post-randomization for the delayed intervention cohort)
  2. Conditions other than AF that require anticoagulation, including treatment of deep venous thrombosis, pulmonary embolism, or ever having had a mechanical prosthetic heart valve prior to the last date in the current approved data used for cohort identification
  3. Pregnancy within 6 months of the last date in the current approved data used for cohort identification
  4. Any known history of intracranial hemorrhage prior to the last date in the current approved data used for cohort identification
  5. Hospitalization for bleeding within the last 6 months of the last date in the current approved data used for cohort identification
  6. Patients with recent P2Y12 antagonist use (i.e. clopidogrel, prasugrel, ticlopidine, or ticagrelor within 90 days of the last date in the current approved data used for cohort identification
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03259373
Other Study ID Numbers  ICMJE IMPACT-AFib
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Richard Platt, Harvard Pilgrim Health Care
Study Sponsor  ICMJE Harvard Pilgrim Health Care
Collaborators  ICMJE
  • Duke Clinical Research Institute
  • HealthCore, Inc.
  • Clinical Trials Transformation Initiative
  • Humana, Inc
  • Aetna, Inc.
  • OptumInsight Life Sciences, Inc.
  • Food and Drug Administration (FDA)
Investigators  ICMJE Not Provided
PRS Account Harvard Pilgrim Health Care
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP