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Completed

NCT Number: NCT02905032

SDM for Stroke Prevention in Atrial Fibrillation

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

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Behavior Cardiovascular Diseases Heart Diseases Helping Behavior Pathologic Processes Pathological Conditions, Signs and Symptoms Social Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Decision aid

Behavioral

Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.

Other names: DA

Primary outcomes

  1. Number of Clinician Satisfied Encounters

    Time frame: 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

    Time frame: 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 outcomes

  1. Number of Participants With Anticoagulant Medication Use

    Time frame: 12 months

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

  2. Patient Involvement

    Time frame: 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

    Time frame: 1 month

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

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

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

Registry information

Official study title

Shared Decision Making for Stroke Prevention in Atrial Fibrillation (SDM4Afib): A Randomized Trial

Acronym: SDM4Afib

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Sep 19, 2016
Registry last updated
Jan 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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