Trial Outcomes & Findings for SDM for Stroke Prevention in Atrial Fibrillation (NCT NCT02905032)

Last Updated: 2022-01-25

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

1186 participants

Primary outcome timeframe

1 month

Results posted on

2022-01-25

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Care Observations were in the clinical encounter via video, audio or observational notes.	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.	Clinicians Clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible atrial fibrillation patients at participating sites
Overall Study STARTED	467	475	244
Overall Study COMPLETED	459	463	244
Overall Study NOT COMPLETED	8	12	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Standard Care Observations were in the clinical encounter via video, audio or observational notes.	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.	Clinicians Clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible atrial fibrillation patients at participating sites
Overall Study Withdrawal by Subject	2	0	0
Overall Study Protocol Violation	6	12	0

Baseline Characteristics

Did not collect the age for 22 Clinicians

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Care n=459 Participants Observations were in the clinical encounter via video, audio or observational notes.	Standard Care + Decision Aid n=463 Participants 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.	Clinicians n=244 Participants Clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible atrial fibrillation patients at participating sites	Total n=1166 Participants Total of all reporting groups
Age, Continuous	71 years STANDARD_DEVIATION 10 • n=459 Participants • Did not collect the age for 22 Clinicians	71 years STANDARD_DEVIATION 11 • n=463 Participants • Did not collect the age for 22 Clinicians	42 years STANDARD_DEVIATION 12 • n=222 Participants • Did not collect the age for 22 Clinicians	65 years STANDARD_DEVIATION 15 • n=1144 Participants • Did not collect the age for 22 Clinicians
Sex: Female, Male Female	191 Participants n=459 Participants • Did not collect the gender for 22 Clinicians	172 Participants n=463 Participants • Did not collect the gender for 22 Clinicians	112 Participants n=222 Participants • Did not collect the gender for 22 Clinicians	475 Participants n=1144 Participants • Did not collect the gender for 22 Clinicians
Sex: Female, Male Male	268 Participants n=459 Participants • Did not collect the gender for 22 Clinicians	291 Participants n=463 Participants • Did not collect the gender for 22 Clinicians	110 Participants n=222 Participants • Did not collect the gender for 22 Clinicians	669 Participants n=1144 Participants • Did not collect the gender for 22 Clinicians
Race/Ethnicity, Customized Not Collected	6 Participants n=459 Participants	3 Participants n=463 Participants	244 Participants n=244 Participants	253 Participants n=1166 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=459 Participants	4 Participants n=463 Participants	0 Participants n=244 Participants	5 Participants n=1166 Participants
Race/Ethnicity, Customized Asian	5 Participants n=459 Participants	5 Participants n=463 Participants	0 Participants n=244 Participants	10 Participants n=1166 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=459 Participants	0 Participants n=463 Participants	0 Participants n=244 Participants	0 Participants n=1166 Participants
Race/Ethnicity, Customized Black or African American	54 Participants n=459 Participants	48 Participants n=463 Participants	0 Participants n=244 Participants	102 Participants n=1166 Participants
Race/Ethnicity, Customized White	380 Participants n=459 Participants	387 Participants n=463 Participants	0 Participants n=244 Participants	767 Participants n=1166 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 Participants n=459 Participants	4 Participants n=463 Participants	0 Participants n=244 Participants	7 Participants n=1166 Participants
Race/Ethnicity, Customized More than one race	8 Participants n=459 Participants	10 Participants n=463 Participants	0 Participants n=244 Participants	18 Participants n=1166 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=459 Participants	2 Participants n=463 Participants	0 Participants n=244 Participants	4 Participants n=1166 Participants
Region of Enrollment United States	459 participants n=459 Participants	463 participants n=463 Participants	244 participants n=244 Participants	1166 participants n=1166 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Standard Care n=448 Participants Observations were in the clinical encounter via video, audio or observational notes.	Standard Care + Decision Aid n=453 Participants 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.
Number of Clinician Satisfied Encounters	277 encounters	400 encounters

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Standard Care n=448 Participants Observations were in the clinical encounter via video, audio or observational notes.	Standard Care + Decision Aid n=453 Participants 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.
Number of Clinician Recommendation	199 encounters	396 encounters

SECONDARY outcome

Timeframe: 12 months

The number of subjects who chose to start or continue receive an anticoagulant medication.

Outcome measures

Outcome measures
Measure	Standard Care n=459 Participants Observations were in the clinical encounter via video, audio or observational notes.	Standard Care + Decision Aid n=463 Participants 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.
Number of Participants With Anticoagulant Medication Use	391 Participants	399 Participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Standard Care n=411 Participants Observations were in the clinical encounter via video, audio or observational notes.	Standard Care + Decision Aid n=419 Participants 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.
Patient Involvement	29.1 score on a scale Standard Deviation 13.1	33.0 score on a scale Standard Deviation 10.8

SECONDARY outcome

Timeframe: 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

The length of time for the subjects visit with the clinician, as measured in minutes.

Outcome measures

Outcome measures
Measure	Standard Care n=411 Participants Observations were in the clinical encounter via video, audio or observational notes.	Standard Care + Decision Aid n=419 Participants 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.
Encounter Duration	31 minutes Standard Deviation 17	32 minutes Standard Deviation 16

Adverse Events

Standard Care

Serious events: 52 serious events

Other events: 0 other events

Deaths: 19 deaths

Standard Care + Decision Aid

Serious events: 52 serious events

Other events: 0 other events

Deaths: 15 deaths

Clinicians

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard Care n=459 participants at risk Observations were in the clinical encounter via video, audio or observational notes.	Standard Care + Decision Aid n=463 participants at risk 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.	Clinicians n=244 participants at risk Clinicians (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible atrial fibrillation patients at participating sites
Nervous system disorders Stroke	1.3% 6/459 • Adverse Events were collected from baseline to end of study, approximately 12 months.	1.5% 7/463 • Adverse Events were collected from baseline to end of study, approximately 12 months.	0.00% 0/244 • Adverse Events were collected from baseline to end of study, approximately 12 months.
Blood and lymphatic system disorders Major Bleeding	10.5% 48/459 • Number of events 63 • Adverse Events were collected from baseline to end of study, approximately 12 months.	10.2% 47/463 • Number of events 61 • Adverse Events were collected from baseline to end of study, approximately 12 months.	0.00% 0/244 • Adverse Events were collected from baseline to end of study, approximately 12 months.

Other adverse events

Adverse event data not reported

Additional Information

Peter A. Noseworthy, M.D.

Mayo Clinci

Phone: 507-255-2446

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place