SDM4Afib: SDM for Stroke Prevention in Atrial Fibrillation

• Sponsor: Mayo Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02905032
• Collaborator: Park Nicollet Clinic (Other), Hennepin County Medical Center, Minneapolis (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Enrollment: 1,186
• Locations: 5
• Arms: 2
• Actual Duration (Months): 45.8
• Patients Per Site: 237.2
• Patients Per Site Per Month: 5.2

Study Details

Study Description

Brief Summary

The objective of this project is to evaluate a treatment decision aid for patients with atrial fibrillation.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	Behavioral: Decision Aid	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1186 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Shared Decision Making for Stroke Prevention in Atrial Fibrillation (SDM4Afib): A Randomized Trial
• Actual Study Start Date: Sep 1, 2016
• Actual Primary Completion Date: Jun 27, 2019
• Actual Study Completion Date: Jun 27, 2020

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard Care Observations in clinical encounter via video, audio or observational notes.
Active Comparator: Standard Care + Decision Aid 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.; Other Names: DA

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. Number of Participants With Anticoagulant Medication Use [12 months]

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

2. 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.

3. Encounter Duration [1 month]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama	Birmingham	Alabama	United States	35294
2	Hennepin County Medical Center	Minneapolis	Minnesota	United States	55415
3	Mayo Clinic in Rochester	Rochester	Minnesota	United States	55905
4	Park Nicollet Health Partners	Saint Louis Park	Minnesota	United States	55416
5	University of Mississippi Medical Center	Jackson	Mississippi	United States	39216

Sponsors and Collaborators

• Mayo Clinic
• Park Nicollet Clinic
• Hennepin County Medical Center, Minneapolis
• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: Peter A Noseworthy, Mayo Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 12, 2021

More Information

Additional Information:

• Mayo Clinic Clinical Trials

Publications

None provided.

• Responsible Party: Peter A. Noseworthy, M.D., M.D., Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02905032
• Other Study ID Numbers: 16-005409; 1R01HL131535
• First Posted: Sep 19, 2016
• Last Update Posted: Jan 25, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Peter A. Noseworthy, M.D., M.D., Mayo Clinic: Afib; Atrial fib; Shared; Decision; Making; Aid; AF
• Additional relevant MeSH terms: Atrial Fibrillation

Study Results

Participant Flow

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

Baseline Characteristics

Arm/Group Title	Standard Care	Standard Care + Decision Aid	Clinicians	Total
Arm/Group Description	Observations were in the clinical encounter via video, audio or observational notes.	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 (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible atrial fibrillation patients at participating sites	Total of all reporting groups
Overall Participants	459	463	244	1166
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71 (10)	71 (11)	42 (12)	65 (15)
Sex: Female, Male (Count of Participants)
Female	191 41.6%	172 37.1%	112 45.9%	475 40.7%
Male	268 58.4%	291 62.9%	110 45.1%	669 57.4%
Race/Ethnicity, Customized (Count of Participants)
Not Collected	6 1.3%	3 0.6%	244 100%	253 21.7%
American Indian or Alaska Native	1 0.2%	4 0.9%	0 0%	5 0.4%
Asian	5 1.1%	5 1.1%	0 0%	10 0.9%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	54 11.8%	48 10.4%	0 0%	102 8.7%
White	380 82.8%	387 83.6%	0 0%	767 65.8%
Hispanic or Latino	3 0.7%	4 0.9%	0 0%	7 0.6%
More than one race	8 1.7%	10 2.2%	0 0%	18 1.5%
Unknown	2 0.4%	2 0.4%	0 0%	4 0.3%
Region of Enrollment (participants) [Number]
United States	459 100%	463 100%	244 100%	1166 100%

Outcome Measures

1. Primary Outcome

Title	Number of Clinician Satisfied Encounters
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Standard Care	Standard Care + Decision Aid
Arm/Group Description	Observations were in the clinical encounter via video, audio or observational notes.	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.
Measure Participants	448	453
Number [encounters]	277	400

2. Primary Outcome

Title	Number of Clinician Recommendation
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Standard Care	Standard Care + Decision Aid
Arm/Group Description	Observations were in the clinical encounter via video, audio or observational notes.	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.
Measure Participants	448	453
Number [encounters]	199	396

3. Secondary Outcome

Title	Number of Participants With Anticoagulant Medication Use
Description	The number of subjects who chose to start or continue receive an anticoagulant medication.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Care	Standard Care + Decision Aid
Arm/Group Description	Observations were in the clinical encounter via video, audio or observational notes.	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.
Measure Participants	459	463
Count of Participants [Participants]	391 85.2%	399 86.2%

4. Secondary Outcome

Title	Patient Involvement
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Standard Care	Standard Care + Decision Aid
Arm/Group Description	Observations were in the clinical encounter via video, audio or observational notes.	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.
Measure Participants	411	419
Mean (Standard Deviation) [score on a scale]	29.1 (13.1)	33.0 (10.8)

5. Secondary Outcome

Title	Encounter Duration
Description	The length of time for the subjects visit with the clinician, as measured in minutes.
Time Frame	1 month

Outcome Measure Data

Analysis Population Description

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/Group Title	Standard Care	Standard Care + Decision Aid
Arm/Group Description	Observations were in the clinical encounter via video, audio or observational notes.	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.
Measure Participants	411	419
Mean (Standard Deviation) [minutes]	31 (17)	32 (16)

Adverse Events

Time Frame	Adverse Events were collected from baseline to end of study, approximately 12 months.
Arm/Group Title	Standard Care		Standard Care + Decision Aid		Clinicians
Arm/Group Description	Observations were in the clinical encounter via video, audio or observational notes.		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 (MDs, NP/PAs, PharmDs) that are responsible for the modality of Anticoagulation in eligible atrial fibrillation patients at participating sites
All Cause Mortality
	Standard Care		Standard Care + Decision Aid		Clinicians
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	19/459 (4.1%)		15/463 (3.2%)		0/244 (0%)
Serious Adverse Events
	Standard Care		Standard Care + Decision Aid		Clinicians
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	52/459 (11.3%)		52/463 (11.2%)		0/244 (0%)
Blood and lymphatic system disorders
Major Bleeding	48/459 (10.5%)	63	47/463 (10.2%)	61	47/244 (19.3%)	61
Nervous system disorders
Stroke	6/459 (1.3%)		7/463 (1.5%)		7/244 (2.9%)
Other (Not Including Serious) Adverse Events
	Standard Care		Standard Care + Decision Aid		Clinicians
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/459 (0%)		0/463 (0%)		0/244 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.