Trial Outcomes & Findings for IMplementation of an RCT to imProve Treatment With Oral AntiCoagulanTs in Patients With Atrial Fibrillation (NCT NCT03259373)
NCT ID: NCT03259373
Last Updated: 2025-04-09
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
64666 participants
Primary outcome timeframe
Outcome assessed at 42 days, 90 days, 183 days, and one year of follow-up time.
Results posted on
2025-04-09
Participant Flow
Patients and their treating clinicians were identified through health insurance claims data from commercially-insured and Medicare Advantage populations.
Participant milestones
| Measure |
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
Overall Study
STARTED
|
32295
|
32371
|
|
Overall Study
COMPLETED
|
23546
|
23787
|
|
Overall Study
NOT COMPLETED
|
8749
|
8584
|
Reasons for withdrawal
| Measure |
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
Overall Study
Evidence of OAC treatment prior to start date based on more complete data
|
636
|
118
|
|
Overall Study
Disenrolled earlier than originally captured in data (due to changing in data over time)
|
320
|
344
|
|
Overall Study
Unable to be identified in dataset used for analysis
|
43
|
49
|
|
Overall Study
Censored between old dataset and the follow-up start date (due to changing in data over time)
|
3446
|
3599
|
|
Overall Study
Censored prior to old dataset, other reason (unable to specify reason from available data)
|
32
|
63
|
|
Overall Study
On OAC treatment at follow up start (due to data lags)
|
4272
|
4411
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention
n=23 Participants
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.
Early Patient-Level and Provider-Level Educational 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.
|
Control
n=23 Participants
Delayed Provider-Level Educational Intervention: The control arm patients received "usual care" for the time between randomization and a delayed educational mailing, which was sent after one year.
Delayed intervention included the following:
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 letters to patients' providers, where they may be identified, 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.
|
Total
n=47333 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77.8 years
STANDARD_DEVIATION 9.7 • n=23 Participants
|
77.9 years
STANDARD_DEVIATION 9.7 • n=23 Participants
|
77.8 years
STANDARD_DEVIATION 9.7 • n=47333 Participants
|
|
Age, Customized
Age < 55 yr
|
471 Participants
n=23 Participants
|
436 Participants
n=23 Participants
|
907 Participants
n=47333 Participants
|
|
Age, Customized
Age 55-59 yr
|
569 Participants
n=23 Participants
|
562 Participants
n=23 Participants
|
1131 Participants
n=47333 Participants
|
|
Age, Customized
Age 60-64 yr
|
934 Participants
n=23 Participants
|
979 Participants
n=23 Participants
|
1913 Participants
n=47333 Participants
|
|
Age, Customized
Age 65-69 yr
|
2,341 Participants
n=23 Participants
|
2,360 Participants
n=23 Participants
|
4701 Participants
n=47333 Participants
|
|
Age, Customized
Age 70-74 yr
|
4,642 Participants
n=23 Participants
|
4,762 Participants
n=23 Participants
|
9404 Participants
n=47333 Participants
|
|
Age, Customized
Age 75-79 yr
|
4,814 Participants
n=23 Participants
|
4,946 Participants
n=23 Participants
|
9760 Participants
n=47333 Participants
|
|
Age, Customized
Age 80-84 yr
|
4,182 Participants
n=23 Participants
|
3,966 Participants
n=23 Participants
|
8148 Participants
n=47333 Participants
|
|
Age, Customized
Age 85-89 yr
|
3,169 Participants
n=23 Participants
|
3,205 Participants
n=23 Participants
|
6374 Participants
n=47333 Participants
|
|
Age, Customized
Age 90 and older
|
2,424 Participants
n=23 Participants
|
2,571 Participants
n=23 Participants
|
4995 Participants
n=47333 Participants
|
|
Sex: Female, Male
Female
|
11,262 Participants
n=23 Participants
|
11,162 Participants
n=23 Participants
|
22424 Participants
n=47333 Participants
|
|
Sex: Female, Male
Male
|
12,284 Participants
n=23 Participants
|
12,625 Participants
n=23 Participants
|
24909 Participants
n=47333 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States · New England
|
645 Participants
n=23 Participants
|
731 Participants
n=23 Participants
|
1376 Participants
n=47333 Participants
|
|
Region of Enrollment
United States · Mid-Atlantic
|
1,162 Participants
n=23 Participants
|
1,298 Participants
n=23 Participants
|
2460 Participants
n=47333 Participants
|
|
Region of Enrollment
United States · South-Atlantic
|
14,340 Participants
n=23 Participants
|
14,286 Participants
n=23 Participants
|
28626 Participants
n=47333 Participants
|
|
Region of Enrollment
United States · Midwest
|
4,723 Participants
n=23 Participants
|
4,885 Participants
n=23 Participants
|
9608 Participants
n=47333 Participants
|
|
Region of Enrollment
United States · Mountain
|
1,484 Participants
n=23 Participants
|
1,470 Participants
n=23 Participants
|
2954 Participants
n=47333 Participants
|
|
Region of Enrollment
United States · Pacific
|
906 Participants
n=23 Participants
|
859 Participants
n=23 Participants
|
1765 Participants
n=47333 Participants
|
|
Region of Enrollment
United States · Unknown/missing
|
286 Participants
n=23 Participants
|
258 Participants
n=23 Participants
|
544 Participants
n=47333 Participants
|
|
History of hypertension
|
22,338 Participants
n=23 Participants
|
22,583 Participants
n=23 Participants
|
44921 Participants
n=47333 Participants
|
|
History of diabetes
|
9,671 Participants
n=23 Participants
|
9,625 Participants
n=23 Participants
|
19296 Participants
n=47333 Participants
|
|
History of peripheral vascular disease
|
6,001 Participants
n=23 Participants
|
5,981 Participants
n=23 Participants
|
11982 Participants
n=47333 Participants
|
|
History of prior cerebrovascular disease
|
4,944 Participants
n=23 Participants
|
4,863 Participants
n=23 Participants
|
9807 Participants
n=47333 Participants
|
|
History of heart failure
|
9,451 Participants
n=23 Participants
|
9,452 Participants
n=23 Participants
|
18903 Participants
n=47333 Participants
|
|
History of MI
|
2,827 Participants
n=23 Participants
|
2,744 Participants
n=23 Participants
|
5571 Participants
n=47333 Participants
|
|
History of CABG
|
3,409 Participants
n=23 Participants
|
3,500 Participants
n=23 Participants
|
6909 Participants
n=47333 Participants
|
|
History of coronary stent
|
1,205 Participants
n=23 Participants
|
1,188 Participants
n=23 Participants
|
2393 Participants
n=47333 Participants
|
|
Dialysis
|
664 Participants
n=23 Participants
|
616 Participants
n=23 Participants
|
1280 Participants
n=47333 Participants
|
|
CHA2DS2-VASc score, mean
|
4.53 units on a scale
STANDARD_DEVIATION 1.7 • n=23 Participants
|
4.50 units on a scale
STANDARD_DEVIATION 1.7 • n=23 Participants
|
4.51 units on a scale
STANDARD_DEVIATION 1.7 • n=47333 Participants
|
|
ATRIA Score ≥ 5
|
11,165 Participants
n=23 Participants
|
11,239 Participants
n=23 Participants
|
22404 Participants
n=47333 Participants
|
|
History of hospitalization for bleeding
|
4,409 Participants
n=23 Participants
|
4,481 Participants
n=23 Participants
|
8890 Participants
n=47333 Participants
|
PRIMARY outcome
Timeframe: Outcome assessed at 42 days, 90 days, 183 days, and one year of follow-up time.Population: Overall number of participants, as well as prespecified sex, age, and CHA2DS2-VASC score subgroups.
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.
Outcome measures
| Measure |
Intervention
n=23 Participants
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
n=23 Participants
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
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)
OAC initiation at 183 days
|
1403 Participants
|
1362 Participants
|
|
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)
OAC initiation at 90 days
|
769 Participants
|
738 Participants
|
|
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)
OAC initiation at 42 days
|
394 Participants
|
361 Participants
|
|
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)
OAC initiation at one year, female
|
1,146 Participants
|
1,081 Participants
|
|
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)
OAC initiation at one year, age <65 years
|
141 Participants
|
145 Participants
|
|
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)
OAC initiation at one year, age 65-74 years
|
704 Participants
|
707 Participants
|
|
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)
OAC initiation at one year, age 75-84 years
|
987 Participants
|
954 Participants
|
|
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)
OAC initiation at one year (primary)
|
2,328 Participants
|
2,330 Participants
|
|
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)
OAC initiation at one year, male
|
1,182 Participants
|
1,249 Participants
|
|
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)
OAC initiation at one year, age >=85
|
424 Participants
|
440 Participants
|
|
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)
OAC initiation at one year, CHA2DS2-VASC score of 2-3
|
657 Participants
|
683 Participants
|
|
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)
OAC initiation at one year, CHA2DS2-VASC score of 4-5
|
1,041 Participants
|
992 Participants
|
|
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)
OAC initiation at one year, CHA2DS2-VASC score >=6
|
629 Participants
|
654 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Intervention
n=23 Participants
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
n=23 Participants
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
Rates of Hospitalization for Ischemic or Unknown Stroke
|
341 Participants
|
375 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Intervention
n=22 Participants
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
n=22 Participants
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
Rates of Hospitalization for Hemorrhagic Stroke
|
81 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Intervention
n=23 Participants
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
n=23 Participants
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
Rates of Hospitalization for Ischemic or Hemorrhagic Stroke
|
419 Participants
|
436 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Intervention
n=23 Participants
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
n=23 Participants
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
Rates of Hospitalization for Ischemic or Hemorrhagic Stroke or Systemic Embolism
|
441 Participants
|
453 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Intervention
n=23 Participants
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
n=23 Participants
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
Rates of Hospitalization for Ischemic or Hemorrhagic Stroke or Systemic Embolism or Bleeding
|
733 Participants
|
760 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Intervention
n=22 Participants
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
n=22 Participants
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
Rates of Hospitalization for Bleeding
|
382 Participants
|
385 Participants
|
SECONDARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Intervention
n=23 Participants
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
n=23 Participants
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
Proportion of Patients Dispensed an OAC Within One Year
|
9.84 Percent of participants
Interval 9.46 to 10.22
|
9.74 Percent of participants
Interval 9.36 to 10.12
|
SECONDARY outcome
Timeframe: Outcome assessed at one year of follow-up time.Population: Number of days on an OAC during all follow-up time among those initiated on OAC
Evaluate the impact of the patient and provider education interventions on proportion of days covered by OAC dispensings (prescription fills)
Outcome measures
| Measure |
Intervention
n=2 Participants
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
n=2 Participants
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
Number of Days Covered by OAC Dispensing
|
166.48 days
Standard Deviation 129.75
|
168.15 days
Standard Deviation 130.12
|
SECONDARY outcome
Timeframe: Outcome assessed at one year of follow-up time.Population: Patients actively on an oral anticoagulant (OAC) at the end of follow-up among those treated for at least 1 day.
Evaluate the impact of the patient and provider education interventions on proportion of patients on oral anticoagulation at 12 months of follow-up
Outcome measures
| Measure |
Intervention
n=2 Participants
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
n=2 Participants
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
Proportion of Patients on Oral Anticoagulation
|
1,135 Participants
|
1,183 Participants
|
SECONDARY outcome
Timeframe: 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
Outcome measures
| Measure |
Intervention
n=22 Participants
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
n=23 Participants
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
All-cause In-hospital Mortality Rates
|
492 Participants
|
482 Participants
|
SECONDARY outcome
Timeframe: 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.)
Outcome measures
| Measure |
Intervention
n=23 Participants
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
n=23 Participants
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
Health Care Utilization for AF Patients
Number of hospital admissions
|
0.43 Health care utilization events
Standard Deviation 0.91
|
0.44 Health care utilization events
Standard Deviation 0.96
|
|
Health Care Utilization for AF Patients
Number of institutional stays
|
1.14 Health care utilization events
Standard Deviation 3.36
|
1.10 Health care utilization events
Standard Deviation 3.23
|
|
Health Care Utilization for AF Patients
Total number of encounters at patient level
|
40.40 Health care utilization events
Standard Deviation 39.45
|
40.51 Health care utilization events
Standard Deviation 39.51
|
|
Health Care Utilization for AF Patients
Number of outpatient/ambulatory encounters
|
38.17 Health care utilization events
Standard Deviation 36.74
|
38.27 Health care utilization events
Standard Deviation 36.81
|
|
Health Care Utilization for AF Patients
Number of emergency department (ED) encounters
|
0.66 Health care utilization events
Standard Deviation 1.50
|
0.69 Health care utilization events
Standard Deviation 1.75
|
SECONDARY outcome
Timeframe: 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.)
Outcome measures
| Measure |
Intervention
n=23 Participants
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
n=23 Participants
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
Health Care Utilization for AF Patients, Days
Days from modified intention-to-treat (mITT) start date to first outpatient/ambulatory encounter
|
32.36 days
Standard Deviation 47.99
|
32.76 days
Standard Deviation 49.42
|
|
Health Care Utilization for AF Patients, Days
Number of days hospitalized
|
3.01 days
Standard Deviation 9.74
|
3.10 days
Standard Deviation 9.27
|
Adverse Events
Intervention
Serious events: 737 serious events
Other events: 0 other events
Deaths: 493 deaths
Control
Serious events: 760 serious events
Other events: 0 other events
Deaths: 483 deaths
Serious adverse events
| Measure |
Intervention
n=23546 participants at risk
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
Early Patient-Level and Provider-Level Educational 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.
|
Control
n=23787 participants at risk
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.
Delayed Provider-Level Educational 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.
|
|---|---|---|
|
Vascular disorders
Hospitalization for ischemic stroke or unknown stroke
|
1.5%
343/23546 • 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
We did not actively collect information about adverse events other than those listed as secondary outcome measures in the protocol. There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include.
|
1.6%
375/23787 • 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
We did not actively collect information about adverse events other than those listed as secondary outcome measures in the protocol. There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include.
|
|
Vascular disorders
Hospitalization for hemorrhagic stroke
|
0.35%
82/23546 • 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
We did not actively collect information about adverse events other than those listed as secondary outcome measures in the protocol. There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include.
|
0.27%
65/23787 • 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
We did not actively collect information about adverse events other than those listed as secondary outcome measures in the protocol. There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include.
|
|
Vascular disorders
Hospitalization for ischemic or hemorrhagic stroke
|
1.8%
422/23546 • 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
We did not actively collect information about adverse events other than those listed as secondary outcome measures in the protocol. There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include.
|
1.8%
436/23787 • 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
We did not actively collect information about adverse events other than those listed as secondary outcome measures in the protocol. There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include.
|
|
Vascular disorders
Hospitalization for ischemic or hemorrhagic stroke or systemic embolism
|
1.9%
444/23546 • 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
We did not actively collect information about adverse events other than those listed as secondary outcome measures in the protocol. There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include.
|
1.9%
453/23787 • 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
We did not actively collect information about adverse events other than those listed as secondary outcome measures in the protocol. There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include.
|
|
Vascular disorders
Hospitalization for ischemic or hemorrhagic stroke or systemic embolism or bleeding
|
3.1%
737/23546 • 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
We did not actively collect information about adverse events other than those listed as secondary outcome measures in the protocol. There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include.
|
3.2%
760/23787 • 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
We did not actively collect information about adverse events other than those listed as secondary outcome measures in the protocol. There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include.
|
|
Vascular disorders
Hospitalization for Bleeding
|
1.6%
384/23546 • 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
We did not actively collect information about adverse events other than those listed as secondary outcome measures in the protocol. There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include.
|
1.6%
386/23787 • 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
We did not actively collect information about adverse events other than those listed as secondary outcome measures in the protocol. There were one or two sites that had no adverse events or just one event in either or both arms, so there was no estimated effect size/variance from the multivariable models at the site level. Depending on the specific outcome, either one or two sites did not contribute to the fixed-effect meta-analysis as there was no estimated effect size or variance to include.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place