Atrial FibrillationIMPACT-AFibNCT03259373
IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation
A study testing Early Patient-Level and Provider-Level Educational Intervention and Delayed Provider-Level Educational Intervention in people with Atrial Fibrillation and Stroke, run by Harvard Pilgrim Health Care at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Atrial Fibrillation, Stroke
- What is being tested?
- Early Patient-Level and Provider-Level Educational Intervention and Delayed Provider-Level Educational Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64,666 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Sep 2017to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- CHA₂DS₂-VASc score of 2 or greater
- 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
- Age 30 years or greater as of the last date in the current approved data used for cohort identification
Who cannot join
- 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)
- 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
- Pregnancy within 6 months of the last date in the current approved data used for cohort identification
- Any known history of intracranial hemorrhage prior to the last date in the current approved data used for cohort identification
- Hospitalization for bleeding within the last 6 months of the last date in the current approved data used for cohort identification
- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Aetna, Inc.
Blue Bell, Pennsylvania, 19422
Humana Healthcare Research, Inc.
Louisville, Kentucky, 40202
Harvard Pilgrim Health Care
Quincy, Massachusetts, 02169
OptumInsight, Inc
Waltham, Massachusetts, 02451
About this study
Official title: IMplementation of a Randomized Controlled Trial (RCT) 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.
Read the 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 intervention cohort and a control 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 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 control 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 control 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 control arm. Patients randomized to the control 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 control patients will be examined at the same time point as the 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, 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 control 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.
- Conditions
- Atrial Fibrillation, Stroke
- Being tested
- Early Patient-Level and Provider-Level Educational Intervention, Delayed Provider-Level Educational Intervention
- Keywords
- AF, AFib, OAC, Atrial fibrillation, Oral anticoagulant, Education
- Medical subject headings
- Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Patient-Level and Provider-Level Educational InterventionBehavioural
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.
Delayed Provider-Level Educational InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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 Receives: Behavioral: Early Patient-Level and Provider-Level Educational Intervention |
| Control | Experimental | 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. Receives: Behavioral: Delayed Provider-Level Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients With Evidence of at Least One OAC Dispensing (Prescription Fill) (Defined as One OAC Dispensing or 4 INR (International Normalized Ratio) Tests)
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.
Measured: Outcome assessed at 42 days, 90 days, 183 days, and one year of follow-up time.
Secondary outcomes (12)
Rates of Hospitalization for Ischemic or Unknown Stroke
Evaluate the impact of the patient and provider education interventions on rates of ischemic / unknown stroke hospitalization
Measured: Outcome assessed at one year of follow-up time.
Rates of Hospitalization for Hemorrhagic Stroke
Evaluate the impact of the patient and provider education interventions on rates of hospitalization for hemorrhagic stroke
Measured: Outcome assessed at one year of follow-up time.
Rates of Hospitalization for Ischemic or Hemorrhagic Stroke
Evaluate the impact of the patient and provider education interventions on rates of hospitalization for ischemic or hemorrhagic stroke
Measured: Outcome assessed at one year of follow-up time.
Rates of Hospitalization for Ischemic or Hemorrhagic Stroke or Systemic Embolism
Evaluate the impact of the patient and provider education interventions on rates of hospitalization for ischemic or hemorrhagic stroke or systemic embolism
Measured: Outcome assessed at one year of follow-up time.
Rates of Hospitalization for Ischemic or Hemorrhagic Stroke or Systemic Embolism or Bleeding
Evaluate the impact of the patient and provider education interventions on rates of hospitalization for ischemic or hemorrhagic stroke or systemic embolism or bleeding
Measured: Outcome assessed at one year of follow-up time.
Rates of Hospitalization for Bleeding
Evaluate the impact of the patient and provider education interventions on rates of hospitalization for any bleeding
Measured: Outcome assessed at one year of follow-up time.
Proportion of Patients Dispensed an OAC Within One Year
Evaluate the impact of the patient and provider education interventions on time to first OAC dispensing (prescription fill)
Measured: Outcome assessed at one year of follow-up time.
Number of Days Covered by OAC Dispensing
Evaluate the impact of the patient and provider education interventions on proportion of days covered by OAC dispensings (prescription fills)
Measured: Outcome assessed at one year of follow-up time.
Proportion of Patients on Oral Anticoagulation
Evaluate the impact of the patient and provider education interventions on proportion of patients on oral anticoagulation at 12 months of follow-up
Measured: Outcome assessed at one year of follow-up time.
All-cause In-hospital Mortality Rates
Evaluate the impact of the patient and provider education interventions on all-cause in-hospital mortality rates
Measured: Outcome assessed at one year of follow-up time.
Health Care Utilization for AF Patients
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.)
Measured: Outcome assessed at one year of follow-up time.
Health Care Utilization for AF Patients, Days
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.)
Measured: Outcome assessed at one year of follow-up time.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2017
- Study start25 Sep 2017
- Primary completion30 Sep 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64,666 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Pilgrim Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Clinical Research Institute, Clinical Trials Transformation Initiative, Humana Inc., Aetna, Inc., OptumInsight Life Sciences, Inc., Food and Drug Administration (FDA)
- Responsible party
- Principal investigator, Richard Platt, Harvard Pilgrim Health Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03259373
- Sponsor's protocol ID
- IMPACT-AFib
- Acronym
- IMPACT-AFib
- Status last verified
- Apr 2025
- First submitted
- 7 Jul 2017
- Last updated
- 9 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pokorney SD, Cocoros N, Al-Khalidi HR, Haynes K, Li S, Al-Khatib SM, Corrigan-Curay J, Driscoll MR, Garcia C, Calvert SB, Harkins T, Jin R, Knecht D, Levenson M, Lin ND, Martin D, McCall D, McMahill-Walraven C, Nair V, Parlett L, Petrone A, Temple R, Zhang R, Zhou Y, Platt R, Granger CB. Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2214321. doi: 10.1001/jamanetworkopen.2022.14321.
PubMed 35639381Garcia CJ, Haynes K, Pokorney SD, Lin ND, McMahill-Walraven C, Nair V, Parlett L, Martin D, Al-Khalidi HR, McCall D, Granger CB, Platt R, Cocoros NM. Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial. Clin Trials. 2020 Aug;17(4):360-367. doi: 10.1177/1740774520928426. Epub 2020 Jun 26.
PubMed 32589056
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMplementation of a Randomized Controlled Trial (RCT) to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT03259373
- Acronym / sponsor ID
- IMPACT-AFib / IMPACT-AFib
- Conditions
- Atrial Fibrillation, Stroke
- Keywords
- AF, AFib, OAC, Atrial fibrillation, Oral anticoagulant, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64,666 participants (actual)
- Lead sponsor
- Harvard Pilgrim Health CareUniversity, hospital or other
- Collaborators
- Duke Clinical Research Institute, Clinical Trials Transformation Initiative, Humana Inc., Aetna, Inc., OptumInsight Life Sciences, Inc., Food and Drug Administration (FDA)
- Study start
- 25 Sep 2017 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Aug 2017 (actual)
- Results
- Posted 9 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 intervention cohort and a control 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 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 control 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 control 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 control arm. Patients randomized to the control 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 control patients will be examined at the same time point as the 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, 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 control 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Early Patient-Level and Provider-Level Educational InterventionEducational 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 |
| Control | Experimental | Behavioral: Delayed Provider-Level Educational InterventionEducational 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- CHA₂DS₂-VASc score of 2 or greater
- 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
- Age 30 years or greater as of the last date in the current approved data used for cohort identification
Key exclusion criteria (6 listed)
- 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)
- 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
- Pregnancy within 6 months of the last date in the current approved data used for cohort identification
- Any known history of intracranial hemorrhage prior to the last date in the current approved data used for cohort identification
- Hospitalization for bleeding within the last 6 months of the last date in the current approved data used for cohort identification
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early Patient-Level and Provider-Level Educational InterventionLetters 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. | Behavioural | Intervention |
| Delayed Provider-Level Educational InterventionDelayed 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. | Behavioural | Control |
Primary outcome
Proportion of Patients With Evidence of at Least One OAC Dispensing (Prescription Fill) (Defined as One OAC Dispensing or 4 INR (International Normalized Ratio) Tests)
Time frame: Outcome assessed at 42 days, 90 days, 183 days, and one year 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.
12 secondary outcomes
Rates of Hospitalization for Ischemic or Unknown Stroke
Time frame: Outcome assessed at one year of follow-up time.
Rates of Hospitalization for Hemorrhagic Stroke
Time frame: Outcome assessed at one year of follow-up time.
Rates of Hospitalization for Ischemic or Hemorrhagic Stroke
Time frame: Outcome assessed at one year of follow-up time.
Rates of Hospitalization for Ischemic or Hemorrhagic Stroke or Systemic Embolism
Time frame: Outcome assessed at one year of follow-up time.
Rates of Hospitalization for Ischemic or Hemorrhagic Stroke or Systemic Embolism or Bleeding
Time frame: Outcome assessed at one year of follow-up time.
Rates of Hospitalization for Bleeding
Time frame: Outcome assessed at one year of follow-up time.
Proportion of Patients Dispensed an OAC Within One Year
Time frame: Outcome assessed at one year of follow-up time.
Number of Days Covered by OAC Dispensing
Time frame: Outcome assessed at one year of follow-up time.
Proportion of Patients on Oral Anticoagulation
Time frame: Outcome assessed at one year of follow-up time.
All-cause In-hospital Mortality Rates
Time frame: Outcome assessed at one year of follow-up time.
Health Care Utilization for AF Patients
Time frame: Outcome assessed at one year of follow-up time.
Health Care Utilization for AF Patients, Days
Time frame: Outcome assessed at one year of follow-up time.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35639381Pokorney SD, Cocoros N, Al-Khalidi HR, Haynes K, Li S, Al-Khatib SM, Corrigan-Curay J, Driscoll MR, Garcia C, Calvert SB, Harkins T, Jin R, Knecht D, Levenson M, Lin ND, Martin D, McCall D, McMahill-Walraven C, Nair V, Parlett L, Petrone A, Temple R, Zhang R, Zhou Y, Platt R, Granger CB. Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2214321. doi: 10.1001/jamanetworkopen.2022.14321.
- Derived from this study: PubMed 32589056Garcia CJ, Haynes K, Pokorney SD, Lin ND, McMahill-Walraven C, Nair V, Parlett L, Martin D, Al-Khalidi HR, McCall D, Granger CB, Platt R, Cocoros NM. Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial. Clin Trials. 2020 Aug;17(4):360-367. doi: 10.1177/1740774520928426. Epub 2020 Jun 26.
- White Paper: Developing Approaches to Conducting Randomized Trials Using the Mini-Sentinel Distributed DatabaseLink provided by the sponsor.
- Sentinel Initiative IMPACT-AFib Project PageLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Patient-Level and Provider-Level Educational Intervention and Delayed Provider-Level Educational Intervention in people with Atrial Fibrillation and Stroke, run by Harvard Pilgrim Health Care at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients With Evidence of at Least One OAC Dispensing (Prescription Fill) (Defined as One OAC Dispensing or 4 INR (International Normalized Ratio) Tests) (time frame: Outcome assessed at 42 days, 90 days, 183 days, and one year of follow-up time.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03259373, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.