Table III.

Secondary outcomes measures and their descriptions

Secondary outcomes
Measure	Description
Decision making outcomes
Decision regret49	Measured by asking patients to reflect on the decision they made about initiating anticoagulation and/or anticoagulant choice after their encounter with their clinician. The measure consists of 5 items assessed on a 5-point Likert scale from “Strongly agree” to “Strongly disagree.” Higher scores are indicative of higher regret.
Preparation for decision making scale50	Assesses patients’ perspectives of decision aid usefulness in preparing them to communicate with their clinicians and for SDM with 10 questions measured on a 5-point Likert scale from “Not at all” to “A great deal.” Higher scores indicate feeling better prepared for decision making.
Quality of communication51	Measured using the 3-item modified version of the CAHPS Clinician and Group survey.28 Determines the extent to which communication is patient-centered, contains technical information that is easily understood, and is respectful. Each individually reported item is assessed on a 3-point scale (Yes, definitely; Yes, somewhat; and No). The higher the score, the better quality of communication.
9-Item Shared Decision-Making Questionnaire (SDMQ9)52	Assesses quality of patient involvement in the process of decision making with their clinician from the perspective of the patient. Comprised of 9 statements measured on a 6-point scale from “Completely disagree” to “Completely agree.” Higher scores are associated with a greater extent of SDM.
Control preference scale53	Assesses patients’ desire to participate in SDM with one question. Asks if the patient prefers to make the decision alone, with their clinician, or have their clinician decide using a 5-point scale. Adapted from the Degnar & Sloan’s Control Preference Scale.54
Patient satisfaction with decision aid55, 56	Consists of 3 questions that ask about patients’ likelihood to recommend the PDA (1) “Not at all” [likely] to (5) “Extremely” [likely], the amount of information in the PDA (1) “Too little” to (5) “Too much”), and if the PDA was biased toward a certain treatment outcome or medication (Warfarin, DOAC, No treatment, Balanced). Higher scores indicated a higher level of satisfaction.
Adapted illness intrusiveness ratings57, 58	Assesses the extent to which disease (AF) and treatment interfere with meaningful daily living among those affected by chronic disease using a modified version of the Illness Intrusiveness Ratings scale. It consists of 13 questions asking how much AF or stroke prevent treatments affects the patient’s life using a scale from (1) “Not very much” to (7) “Very much,” with an option for “Not applicable.” Higher scores are associated with a higher impact of AF on daily living.
Min-Max scale59	Determines if patients have medical minimizer or maximizer tendencies. Medical minimizers prefer to do as little as possible when it comes to medical treatments and their health, whereas medical maximizers prefer active and aggressive medical treatments both of which can lead to appropriate or inappropriate use of health care (ie, Minimizers avoiding low-benefit health care procedures, but also high-benefit procedures, and maximizers participating in both kinds).60 It consists of one question on a 6-point Likert scale from (1) “I strongly lean toward waiting and seeing” to (6) “I strongly lean toward taking action.”
Values trade-off scale41	Assesses patients’ perceptions of the trade-offs between increased bleeding or stroke risk by asking patients to choose between taking an anticoagulant every day, which has a risk of causing serious bleeding (Scenario A) or not taking an anticoagulant every day, even though stroke risk is higher (Scenario B). This will be assessed on a 5-point Likert scale from “Strongly prefer Scenario A” to “Strongly prefer Scenario B” measuring which scenario is preferred.
Collaborative agreement	Assesses decision concordance between the patient and the clinician. Both the patient and clinician will be asked to report about decisions made during the index encounter; take a stroke prevention medication (yes/no), and if yes, which stroke prevention medication was chosen (warfarin, DOAC, antiplatelet). Decisions will also be abstracted from electronic medical records (EMR) and through assessment of audiovisual recordings by research staff. Agreement will be calculated between all four sources and reported.
Clinician satisfaction	Assessed using: (1) a 5-point Likert scale (Very satisfied to Very unsatisfied) pertaining to clinician satisfaction with anticoagulant discussion; and (2) a question pertaining to whether clinician would recommend the approach used to other clinicians (yes/no/not sure). Higher scores are indicative of higher satisfaction,
Treatment choice	Assesses which treatment patient chose and whether their decision would be different if there were no out-of-pocket costs.
Encounter outcomes
Encounter length	Length in minutes of the discussion about anticoagulation and of the total office encounter when available.
Fidelity of PDA and EDA tools	Assessed using checklist of key elements (ie, mentioning the tool, discussion of risk). Potential contamination will be assessed by reviewing video recordings. A sum of key elements will be calculated for each recording and across study arms 1–3. For encounters where audio/video recording was declined, a study coordinator may be present taking notes with the consent of the clinician and patient.
Anticoagulation outcomes
Anticoagulation choice	Assessed by reviewing EMR, patient- and clinician-reported choice, and encounter recordings. Switches to another anticoagulant will be determined by comparing initial choice and patient self-reported medication use in the 12 months post intervention to pharmacy records. When available, documented reasons for initial choice and switching will be recorded. The individual who made the decision to switch medication will be noted when available (eg, patient, clinician)
Anticoagulation adherence61	Assessed using: (1) a 100-point visual analogue scale where participants indicate the percentage of medication taken since the prior encounter; and (2) a self-reported 7-day recall of pill-taking behavior including how many days they took it and evaluation of any potential side effects.
Anticoagulation persistence	Patients will authorize access to pharmacy dispensing records from all pharmacies used to fill prescriptions. Persistence will be assessed using the percent days covered (PDC) (total days’ supply of anticoagulant filled / total days of observation from the first prescription fill date; range 0%-100%). For patients with prior history of using anticoagulation, pharmacy refill records for the 12 months prior to enrollment will also be accessed to allow calculation of persistence before and after study participation.
Warfarin use	Assessed using secondary measures of adherence: (1) the proportion of INR tests obtained/scheduled; and (2) percentage of time in the therapeutic international normalized ratio range (typically INR 2–3) using linear interpolation.45
Health outcomes
Clinical events	Assessed using manual review of the EMR to identify clinical outcome events including death from any cause, stroke, systemic embolism, transient ischemic attack, clinically-relevant non-major bleeding,47 and major bleeding.48

Abbreviations: AF, atrial fibrillation; DOAC, direct oral anticoagulant; EDA, encounter decision aid; EMR, electronic medical record; INR, international normalized ratio; PDA, patient decision aid; SDM, shared decision making.