An interventional study of Decision Aid in Atrial Fibrillation, sponsored by Mayo Clinic. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-25.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Other
The objective of this project is to evaluate a treatment decision aid for patients with atrial fibrillation.
The goal of this study is to determine the extent to which the Anticoagulation Choice tool promotes shared decision making and its impact on anticoagulation use and adherence versus standard care in patients with nonvalvular atrial fibrillation.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 1,186 is above the median of 144 across 2,380 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Clinician Inclusion Criteria:
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Observations in clinical encounter via video, audio or observational notes.
Observation of clinical encounter using the decision aid via video, audio, or observational notes.
Behavioral: Decision Aid
Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.
Also known as: DA
Number of Clinician Satisfied Encounters
The number of encounters that the clinicians were satisfied with the decision-making process. The results reported for this Outcome Measure reflect the response of the clinician for each patient. A 5 point likert scale questioning satisfaction with discussion about anticoagulation medication choice. The 5 point likert scale ranges from 1-5, with 1 being not at all satisfied and 5 being completely satisfied. Any values of 4 or 5 were considered to be satisfied.
Time frame: 1 month
Number of Clinician Recommendation
The number of encounters were the clinician would recommend the decision making process approach. The results reported for this Outcome Measure reflect the response of the clinician for each patient. Clinician was asked whether they would recommend the approached used to other clinician for other discussions on a 7 point Likert scale. The 7 point likert scale ranges from 1-7, with 1 being no I would strongly recommend against it and 7 being yes I would strongly recommend it. Any values of 6 or 7 were considered to be clinician would recommend.
Time frame: 1 month
Number of Participants With Anticoagulant Medication Use
The number of subjects who chose to start or continue receive an anticoagulant medication.
Time frame: 12 months
Patient Involvement
Patient involvement in decision-making as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale. The 12 items measure observed patient involvement. Each of the 12 items have possible scores that range from 0 (the behavior is not observed) to 4 (the behavior is exhibited to a very high standard). To calculate the total score for each patient, the 12 items are summed, divided by 48 (the maximum possible score), and multiplied by 100. Total score minimum is 0, maximum is 100. The higher the total score the higher the patient involvement.
Time frame: 1 month
Encounter Duration
The length of time for the subjects visit with the clinician, as measured in minutes.
Time frame: 1 month
| Milestone | Standard Care | Standard Care + Decision Aid | Clinicians |
|---|---|---|---|
| Started | 467 | 475 | 244 |
| Completed | 459 | 463 | 244 |
| Not completed | 8 | 12 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 0 |
| Withdrew: Protocol violation | 6 | 12 | 0 |
The number of encounters that the clinicians were satisfied with the decision-making process. The results reported for this Outcome Measure reflect the response of the clinician for each patient. A 5 point likert scale questioning satisfaction with discussion about anticoagulation medication choice. The 5 point likert scale ranges from 1-5, with 1 being not at all satisfied and 5 being completely satisfied. Any values of 4 or 5 were considered to be satisfied.
| encounters | Standard Care | Standard Care + Decision Aid |
|---|---|---|
| Number of Clinician Satisfied Encounters | 277 | 400 |
The number of encounters were the clinician would recommend the decision making process approach. The results reported for this Outcome Measure reflect the response of the clinician for each patient. Clinician was asked whether they would recommend the approached used to other clinician for other discussions on a 7 point Likert scale. The 7 point likert scale ranges from 1-7, with 1 being no I would strongly recommend against it and 7 being yes I would strongly recommend it. Any values of 6 or 7 were considered to be clinician would recommend.
| encounters | Standard Care | Standard Care + Decision Aid |
|---|---|---|
| Number of Clinician Recommendation | 199 | 396 |
The number of subjects who chose to start or continue receive an anticoagulant medication.
| Participants | Standard Care | Standard Care + Decision Aid |
|---|---|---|
| Number of Participants With Anticoagulant Medication Use | 391 | 399 |
Patient involvement in decision-making as assessed through video recordings of the encounters using the Observing Patient Involvement in Decision Making 12-item scale. The 12 items measure observed patient involvement. Each of the 12 items have possible scores that range from 0 (the behavior is not observed) to 4 (the behavior is exhibited to a very high standard). To calculate the total score for each patient, the 12 items are summed, divided by 48 (the maximum possible score), and multiplied by 100. Total score minimum is 0, maximum is 100. The higher the total score the higher the patient involvement.
| score on a scale | Standard Care | Standard Care + Decision Aid |
|---|---|---|
| Patient Involvement | 29.1 ± 13.1 | 33.0 ± 10.8 |
The length of time for the subjects visit with the clinician, as measured in minutes.
| minutes | Standard Care | Standard Care + Decision Aid |
|---|---|---|
| Encounter Duration | 31 ± 17 | 32 ± 16 |
Collected over Adverse Events were collected from baseline to end of study, approximately 12 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Care | 19/459 (4.1%) | 52/459 (11.3%) | 0/459 (0%) |
| Standard Care + Decision Aid | 15/463 (3.2%) | 52/463 (11.2%) | 0/463 (0%) |
| Clinicians | 0/244 (0%) | 0/244 (0%) | 0/244 (0%) |
| Event | Standard Care | Standard Care + Decision Aid | Clinicians |
|---|---|---|---|
| Major BleedingBlood and lymphatic system disorders | 48/459 | 47/463 | — |
| StrokeNervous system disorders | 6/459 | 7/463 | — |
| Age, Continuous(years) | Standard Care | Standard Care + Decision Aid | Clinicians | Total |
|---|---|---|---|---|
| Mean | 71 ± 10 | 71 ± 11 | 42 ± 12 | 65 ± 15 |
| Sex: Female, Male(Participants) | Standard Care | Standard Care + Decision Aid | Clinicians | Total |
|---|---|---|---|---|
| Female | 191 | 172 | 112 | 475 |
| Male | 268 | 291 | 110 | 669 |
| Race/Ethnicity, Customized(Participants) | Standard Care | Standard Care + Decision Aid | Clinicians | Total |
|---|---|---|---|---|
| Not Collected | 6 | 3 | 244 | 253 |
| American Indian or Alaska Native | 1 | 4 | 0 | 5 |
| Asian | 5 | 5 | 0 | 10 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 54 | 48 | 0 | 102 |
| White | 380 | 387 | 0 | 767 |
| Hispanic or Latino | 3 | 4 | 0 | 7 |
| More than one race | 8 | 10 | 0 | 18 |
| Unknown | 2 | 2 | 0 | 4 |
| Region of Enrollment(participants) | Standard Care | Standard Care + Decision Aid | Clinicians | Total |
|---|---|---|---|---|
| United States | 459 | 463 | 244 | 1166 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
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