Atrial Fibrillation
Conditions
Keywords
Afib, Atrial fib, Shared, Decision, Making, Aid, AF
Brief summary
The objective of this project is to evaluate a treatment decision aid for patients with atrial fibrillation.
Detailed description
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.
Interventions
BEHAVIORALDecision Aid
Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.
Sponsors
Park Nicollet Clinic
Hennepin County Medical Center, Minneapolis
National Heart, Lung, and Blood Institute (NHLBI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clinician Inclusion Criteria: • All clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible AF patients at participating sites, without exclusion Patient Inclusion Criteria: * ≥ 18 years of age * Chronic nonvalvular atrial fibrillation deemed at high risk of thromboembolic strokes (CHA2D2-VASc Score ≥ 1, or 2 in women) * Able to read and understand (despite cognitive, sensorial, hearing or language challenges) the informed consent document as determined by the study coordinator during consent Patient
Exclusion criteria
• Clinician indicates that patient is not a candidate for a discussion about anticoagulation medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Clinician Satisfied Encounters | 1 month | 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. |
| Number of Clinician Recommendation | 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anticoagulant Medication Use | 12 months | The number of subjects who chose to start or continue receive an anticoagulant medication. |
| Patient Involvement | 1 month | 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. |
| Encounter Duration | 1 month | The length of time for the subjects visit with the clinician, as measured in minutes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Care Observations were in the clinical encounter via video, audio or observational notes. | 459 |
| Standard Care + Decision Aid Observation were in the clinical encounter using the decision aid via video, audio, or observational notes.
Decision Aid: Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient. | 463 |
| Clinicians Clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible atrial fibrillation patients at participating sites | 244 |
| Total | 1,166 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Protocol Violation | 6 | 12 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Standard Care | Standard Care + Decision Aid | Clinicians |
|---|---|---|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 15 | 71 years STANDARD_DEVIATION 10 | 71 years STANDARD_DEVIATION 11 | 42 years STANDARD_DEVIATION 12 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 5 Participants | 1 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 10 Participants | 5 Participants | 5 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 102 Participants | 54 Participants | 48 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 7 Participants | 3 Participants | 4 Participants | 0 Participants |
| Race/Ethnicity, Customized More than one race | 18 Participants | 8 Participants | 10 Participants | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Collected | 253 Participants | 6 Participants | 3 Participants | 244 Participants |
| Race/Ethnicity, Customized Unknown | 4 Participants | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 767 Participants | 380 Participants | 387 Participants | 0 Participants |
| Region of Enrollment United States | 1166 participants | 459 participants | 463 participants | 244 participants |
| Sex: Female, Male Female | 475 Participants | 191 Participants | 172 Participants | 112 Participants |
| Sex: Female, Male Male | 669 Participants | 268 Participants | 291 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 19 / 459 | 15 / 463 | 0 / 244 |
| other Total, other adverse events | 0 / 459 | 0 / 463 | 0 / 244 |
| serious Total, serious adverse events | 52 / 459 | 52 / 463 | 0 / 244 |
Outcome results
Primary
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
Population: Data was not analyzed nor collected for 11 subjects in Standard Care arm. Data was not analyzed nor collected for 10 subjects in Standard Care + Decision Aid arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | Number of Clinician Recommendation | 199 encounters |
| Standard Care + Decision Aid | Number of Clinician Recommendation | 396 encounters |
Primary
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
Population: Data was not analyzed nor collected for 11 subjects in Standard Care arm. Data was not analyzed nor collected for 10 subjects in Standard Care + Decision Aid arm
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Care | Number of Clinician Satisfied Encounters | 277 encounters |
| Standard Care + Decision Aid | Number of Clinician Satisfied Encounters | 400 encounters |
Secondary
Encounter Duration
The length of time for the subjects visit with the clinician, as measured in minutes.
Time frame: 1 month
Population: Data was not analyzed nor collected for 48 subjects in Standard Care arm. Data was not analyzed nor collected for 44 subjects in Standard Care + Decision Aid arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Encounter Duration | 31 minutes | Standard Deviation 17 |
| Standard Care + Decision Aid | Encounter Duration | 32 minutes | Standard Deviation 16 |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care | Number of Participants With Anticoagulant Medication Use | 391 Participants |
| Standard Care + Decision Aid | Number of Participants With Anticoagulant Medication Use | 399 Participants |
Secondary
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
Population: Data was not analyzed nor collected for 48 subjects in Standard Care arm. Data was not analyzed nor collected for 44 subjects in Standard Care + Decision Aid arm
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care | Patient Involvement | 29.1 score on a scale | Standard Deviation 13.1 |
| Standard Care + Decision Aid | Patient Involvement | 33.0 score on a scale | Standard Deviation 10.8 |