NCT03259373: IMPACT-AFib

IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation

Completed NA Results posted Last updated 9 April 2025

What this trial tests

NA trial testing Early Patient-Level and Provider-Level Educational Intervention in Atrial Fibrillation in 64,666 participants. Completed in 31 December 2021.

Timeline

25 September 2017

Primary endpoint
30 September 2020

31 December 2021

Quick facts

Lead sponsor	Harvard Pilgrim Health Care
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	64,666
Start date	25 September 2017
Primary completion	30 September 2020
Estimated completion	31 December 2021
Sites	4 locations across United States

Drugs / interventions tested

• Early Patient-Level and Provider-Level Educational Intervention
• Delayed Provider-Level Educational Intervention

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Stroke — all drugs for Stroke →

Sponsor

Harvard Pilgrim Health Care — full company profile →

Who can join

30 and older, any sex, with Atrial Fibrillation or Stroke. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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) Primary · 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.

OAC initiation at one year (primary)

Group	Value	95% CI
Intervention	2,328
Control	2,330

OAC initiation at 183 days

Group	Value	95% CI
Intervention	1403
Control	1362

OAC initiation at 90 days

Group	Value	95% CI
Intervention	769
Control	738

OAC initiation at 42 days

Group	Value	95% CI
Intervention	394
Control	361

OAC initiation at one year, female

Group	Value	95% CI
Intervention	1,146
Control	1,081

OAC initiation at one year, male

Group	Value	95% CI
Intervention	1,182
Control	1,249

OAC initiation at one year, age <65 years

Group	Value	95% CI
Intervention	141
Control	145

OAC initiation at one year, age 65-74 years

Group	Value	95% CI
Intervention	704
Control	707

Rates of Hospitalization for Ischemic or Unknown Stroke Secondary · Outcome assessed at one year of follow-up time.

Evaluate the impact of the patient and provider education interventions on rates of ischemic / unknown stroke hospitalization

Group	Value	95% CI
Intervention	341
Control	375

Rates of Hospitalization for Hemorrhagic Stroke Secondary · Outcome assessed at one year of follow-up time.

Evaluate the impact of the patient and provider education interventions on rates of hospitalization for hemorrhagic stroke

Group	Value	95% CI
Intervention	81
Control	64

Rates of Hospitalization for Ischemic or Hemorrhagic Stroke Secondary · Outcome assessed at one year of follow-up time.

Evaluate the impact of the patient and provider education interventions on rates of hospitalization for ischemic or hemorrhagic stroke

Group	Value	95% CI
Intervention	419
Control	436

Rates of Hospitalization for Ischemic or Hemorrhagic Stroke or Systemic Embolism Secondary · Outcome assessed at one year of follow-up time.

Evaluate the impact of the patient and provider education interventions on rates of hospitalization for ischemic or hemorrhagic stroke or systemic embolism

Group	Value	95% CI
Intervention	441
Control	453

Rates of Hospitalization for Ischemic or Hemorrhagic Stroke or Systemic Embolism or Bleeding Secondary · Outcome assessed at one year of follow-up time.

Evaluate the impact of the patient and provider education interventions on rates of hospitalization for ischemic or hemorrhagic stroke or systemic embolism or bleeding

Group	Value	95% CI
Intervention	733
Control	760

Rates of Hospitalization for Bleeding Secondary · Outcome assessed at one year of follow-up time.

Evaluate the impact of the patient and provider education interventions on rates of hospitalization for any bleeding

Group	Value	95% CI
Intervention	382
Control	385

Proportion of Patients Dispensed an OAC Within One Year Secondary · Outcome assessed at one year of follow-up time.

Evaluate the impact of the patient and provider education interventions on time to first OAC dispensing (prescription fill)

Group	Value	95% CI
Intervention	9.84	9.46 – 10.22
Control	9.74	9.36 – 10.12

Number of Days Covered by OAC Dispensing Secondary · Outcome assessed at one year of follow-up time.

Evaluate the impact of the patient and provider education interventions on proportion of days covered by OAC dispensings (prescription fills)

Group	Value	95% CI
Intervention	166.48	± 129.75
Control	168.15	± 130.12

Proportion of Patients on Oral Anticoagulation Secondary · Outcome assessed at one year of follow-up time.

Evaluate the impact of the patient and provider education interventions on proportion of patients on oral anticoagulation at 12 months of follow-up

Group	Value	95% CI
Intervention	1,135
Control	1,183

All-cause In-hospital Mortality Rates Secondary · Outcome assessed at one year of follow-up time.

Evaluate the impact of the patient and provider education interventions on all-cause in-hospital mortality rates

Group	Value	95% CI
Intervention	492
Control	482

Health Care Utilization for AF Patients Secondary · Outcome assessed at one year 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.)

Total number of encounters at patient level

Group	Value	95% CI
Intervention	40.40	± 39.45
Control	40.51	± 39.51

Number of outpatient/ambulatory encounters

Group	Value	95% CI
Intervention	38.17	± 36.74
Control	38.27	± 36.81

Number of emergency department (ED) encounters

Group	Value	95% CI
Intervention	0.66	± 1.50
Control	0.69	± 1.75

Number of hospital admissions

Group	Value	95% CI
Intervention	0.43	± 0.91
Control	0.44	± 0.96

Number of institutional stays

Group	Value	95% CI
Intervention	1.14	± 3.36
Control	1.10	± 3.23

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events listed as secondary outcome measures in the protocol were assessed at 12 months following baseline. Adverse events were also passively monitored using a free telephone hotline, for 31 months following baseline for each participant. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention

Serious: 737/23546 (3%)

Deaths: 493/23546

Control

Serious: 760/23787 (3%)

Deaths: 483/23787

Serious adverse events (6 terms)

Reaction	System	Intervention	Control
Hospitalization for ischemic or hemorrhagic stroke or systemic embolism or bleeding	Vascular disorders	—	—
Hospitalization for ischemic or hemorrhagic stroke or systemic embolism	Vascular disorders	—	—
Hospitalization for ischemic or hemorrhagic stroke	Vascular disorders	—	—
Hospitalization for Bleeding	Vascular disorders	—	—
Hospitalization for ischemic stroke or unknown stroke	Vascular disorders	—	—
Hospitalization for hemorrhagic stroke	Vascular disorders	—	—

Most-reported serious reactions: Hospitalization for ischemic or hemorrhagic stroke or systemic embolism or bleeding, Hospitalization for ischemic or hemorrhagic stroke or systemic embolism, Hospitalization for ischemic or hemorrhagic stroke, Hospitalization for Bleeding, Hospitalization for ischemic stroke or unknown stroke, Hospitalization for hemorrhagic stroke.

Data from ClinicalTrials.gov NCT03259373 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Think Pragmatically: Investigators' Obligations to Patient-Subjects When Research is Embedded in Care.
   Morain S, Largent E. · · 2023 · cited 21× · PMID 35435790 · DOI 10.1080/15265161.2022.2063435
2. Practical challenges in the conduct of pragmatic trials embedded in health plans: Lessons of IMPACT-AFib, an FDA-Catalyst trial.
   Garcia CJ, Haynes K, Pokorney SD, Lin ND, et al · · 2020 · cited 11× · PMID 32589056 · DOI 10.1177/1740774520928426
3. Effect of Mailing Educational Material to Patients With Atrial Fibrillation and Their Clinicians on Use of Oral Anticoagulants: A Randomized Clinical Trial.
   Pokorney SD, Cocoros N, Al-Khalidi HR, Haynes K, et al · · 2022 · cited 8× · PMID 35639381 · DOI 10.1001/jamanetworkopen.2022.14321
4. Pragmatic guidance for embedding pragmatic clinical trials in health plans: Large simple trials aren't so simple.
   Cocoros NM, Gurwitz JH, Cziraky MJ, Granger CB, et al · · 2023 · cited 6× · PMID 37322894 · DOI 10.1177/17407745231160459
5. Decentralized clinical trials: A comprehensive analysis of trends, technologies, and global challenges.
   Kijewski S, McBride C, Owens E, Bernheim E, et al · · 2026 · PMID 41544140 · DOI 10.1371/journal.pdig.0001191