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Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation (RED-AF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04357288
Recruitment Status : Not yet recruiting
First Posted : April 22, 2020
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
Mayo Clinic
American Heart Association
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Elissa Ozanne, University of Utah

Brief Summary:
This study will compare the effectiveness of the use of a Patient Decision Aid (PDA) and an Encounter Decision Aid (EDA) on Shared Decision Making (SDM) and health outcomes for at-risk participants with Atrial Fibrillation (AF) at 6 study sites. We hypothesize the combination of the PDA and EDA will be more effective in promoting high-quality SDM and in adoption of and adherence to anticoagulation than either tool alone.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Other: Patient Decision Aid Other: Encounter Decision Aid Not Applicable

Detailed Description:

Background Information:

Atrial fibrillation (AF) is the most common cardiac arrhythmia worldwide, and it continues to grow in prevalence, afflicting an estimated 3 million Americans. While treatment of AF symptoms can be resource-intensive, another source of physical, social, and economic burden is thromboembolic stroke, the major cause of morbidity and mortality for both symptomatic and asymptomatic people with AF. People with AF must decide on a stroke prevention medication (typically, Warfarin or Oral Anti-Coagulants (OACs)).

Shared Decision Making (SD) is particularly useful when decisions, such as this, are value laden and complex. Models of SDM stress clear communication of the risks and benefits of all treatment options (including no treatment) to patients, who in turn need opportunities to share their treatment preferences, relevant values, and goals of care.

Decision aids are tools designed to support both people with AF and clinicians in SDM by 1) providing accurate, balanced information; 2) clarifying patients' values; and 3) improving SDM skills.

Two types of decision aids will be evaluated in the study: a patient-centered Patient Decision Aid (PDA) and an Encounter Decision Aid for collaborative use by the clinician and patient. The PDA is intended to help people with AF prepare for the medical visit with foundational understanding and questions. The EDA is intended to promote SDM between the clinician and person with AF.

Research Design & Methods:

Through a randomized controlled trial, our study will address whether the use of a PDA, and EDA, a combination of the 2, or usual care achieves the best SDM process and health outcomes. We will assess the comparative effectiveness of those 4 approaches in terms of their ability to affect the following outcomes: 1) SDM outcomes, including decisional conflict, knowledge, and quality of patient-clinician communication; and 2) health outcomes, including adoption rates of anticoagulation therapy, adherence to anticoagulation therapy regimen, bleeding, stroke/systemic embolism, and death. Data collection will include medical record review, survey completion, and video/audio recording of the clinician encounter.

Study sites:

Recruitment is planned to occur from 6 sites within the US.

Data Collection:

Self-reported outcomes from people with AF and clinicians will be collected at the end of each clinical encounter. In addition, clinicians will complete a survey that collects data on their demographics and practice characteristics.

Data from the medical record will be abstracted for all enrolled participants with AF to capture demographic, clinical, and medication prescription data.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Patient Decision Aid
Participants in this arm will use the Patient Decision Aid (PDA), an online education tool about atrial fibrillation designed for patient use, prior to the encounter with their provider.
Other: Patient Decision Aid
The Patient Decision Aid (PDA) is an interactive website designed for use by a participant without the need of their clinician present. It provides information about the atrial fibrillation diagnosis, possible treatments, the effect of this diagnosis on daily life, and how to prepare for a discussion about medications with a clinician. Participants may interact with the website by inputting their health information into the stroke risk calculator or answering questions about their values, goals, thoughts, etc. that they would like to discuss with their clinician.

Experimental: Encounter Decision Aid
Participants in this arm will use the Encounter Decision Aid (EDA), an online educational tool about atrial fibrillation designed for patient-provider use, during the encounter with their provider.
Other: Encounter Decision Aid
The Encounter Decision Aid (EDA) is an interactive website designed for use by a participant and their clinician together. Together, the clinician and participant can go through the website together and input the participant's health information into the same stroke risk calculator also in the PDA. The EDA also provides information about the diagnosis of AF, living with this diagnosis, and possible treatments, and prompts discussion of how a participant's values affects these aspects of AF.

Experimental: Patient & Encounter Decision Aids
Participants in this arm will use both the PDA & EDA as described above.
Other: Patient Decision Aid
The Patient Decision Aid (PDA) is an interactive website designed for use by a participant without the need of their clinician present. It provides information about the atrial fibrillation diagnosis, possible treatments, the effect of this diagnosis on daily life, and how to prepare for a discussion about medications with a clinician. Participants may interact with the website by inputting their health information into the stroke risk calculator or answering questions about their values, goals, thoughts, etc. that they would like to discuss with their clinician.

Other: Encounter Decision Aid
The Encounter Decision Aid (EDA) is an interactive website designed for use by a participant and their clinician together. Together, the clinician and participant can go through the website together and input the participant's health information into the same stroke risk calculator also in the PDA. The EDA also provides information about the diagnosis of AF, living with this diagnosis, and possible treatments, and prompts discussion of how a participant's values affects these aspects of AF.

No Intervention: Standard Care
Participants in this arm will receive standard care, that is they will not use either the PDA or EDA.



Primary Outcome Measures :
  1. Decisional Conflict Scale [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit ]
    Validated scale of 16 questions that evaluates 1) uncertainty in making a healthcare decision, 2) factors contributing to the uncertainty, and 3) the participant's perceived effective decision making. Answers range in a 5 point Likert scale from 0=strongly agree to 4=strongly disagree. Clarity and understanding are indicated if the participant "strongly agrees" to the statements, so smaller scores are better.

  2. Patient Knowledge [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit ]
    An 8-question survey assesses a participant's knowledge about atrial fibrillation and anticoagulation use after the intervention. Participants not in the intervention arm will also take this survey for comparison. Each question uses a response format of "true / false / do not know". All questions are answered with full access to the decision aid(s) (if not in standard care arm) since they are not meant to test recall. "Better" scores will be measured by how many questions that a participant answers correctly.

  3. Shared Decision Making [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit ]
    The extent of shared decision making between the participant and provider that took place during the encounter will be assessed by study team members using the Observing Patient Involvement scale (OPTION12). The scale consists of 12 items scored from 0, "the behavior is not observed," to 4, "the behavior is observed and executed to a high standard." The more shared decision making behaviors observed the better, so a higher score is "better" for this scale.


Secondary Outcome Measures :
  1. Decision Regret [ Time Frame: Survey will be given at 6 months after enrollment and again at 12 months after enrollment ]
    Decision Regret will be assessed by asking participants to reflect on the decision they made about taking a blood thinner and/or which blood thinner to take 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".

  2. Preparation for Decision Making [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit ]
    Preparation for Decision Making Scale is a validated scale which will assess participants' perspectives of the tools' usefulness in preparing them to communicate with their clinicians and for Shared Decision Making. These questions are answered on a Likert scale ranging from 1=not at all to 5=a great deal. A higher score indicates that they are better prepared and, thus, a better outcome.

  3. Quality of Communication [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit ]
    The Quality of Communication survey is a 3-item modified version of the CAHPS Clinician and Group survey to determine the extent to which communication is patient-centered, contains technical information that is easily understood, and is respectful. Each item is assessed on a 3-point scale that will be individually reported: 1=Yes, definitely; 2=Yes, somewhat; and 3=No. The more 1's that are chosen indicates the higher quality of communication and, thus, a better outcome.

  4. 9-item Shared Decision Making Questionnaire (SDMQ9) [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit ]
    The SDMQ9 assesses the quality of participant involvement in the process of decision-making with their clinician from the perspective of the participant. Each item is assessed on a 6-point Likert scale from "completely disagree" to "completely agree". Clarity and knowledge would be indicated by "completely agree", so a higher score is "better".

  5. Control Preference Scale [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit ]
    This scale assesses participants' desire to participate in Shared Decision Making. This scale is an adaptation of the Degner & Sloan's Control Preference Scale. It is a one item question that asks people if they want to make the decision alone, with their clinician, or have their clinician make it. There is no right or wrong answer; it is up to patient preference, so no answer indicates a "better" than another.

  6. Patient Satisfaction with the Decision Aid [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months ]
    This will be assessed with 5 questions. Participants will be asked questions about if they used the PDA before their appointment, used the PDA during their appointment, their likelihood to recommend the PDA, the amount of information presented, and if the PDA seemed biased. There is no "better" or more correct answer; it is up to the patient's opinion.

  7. Anti-Clot Treatment Scale [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months ]
    The validated Anti-Clot Treatment Scale assesses participants' satisfaction with their anticoagulation treatment with 15 questions on a 5-point Likert Scale. Questions address both the burdens and benefits of the anticoagulant the participant experienced. Answers range from 1=not at all to 5=extremely. The questions are asking how bothered by their treatment they are, so the lower scores are "better".

  8. Collaborative Agreement [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit ]
    Collaborative agreement will assess decision concordance between the participant and the clinician. Both the participant and clinician will be asked to report about what decision (anticoagulation no/yes-which one) was made during the index visit. Decisions will also be abstracted from Electronic Health Records and through assessment of audiovisual recordings by research staff. Agreement will be calculated between all four sources and reported. There is no "better" score besides how many answers line up between the clinician and the patient; we are measuring understanding between them.

  9. Anticoagulation Adherence 1 - Visual Analogue Scale [ Time Frame: Survey will be given at 6 months after enrollment and again at 12 months after enrollment ]
    Anticoagulation Adherence 1 will be assessed by a 100-point visual analogue scale (VAS) where participants indicate the percentage of medication taken since prior visit. This ranges from 0% (did not take any of their medication as prescribed) to 100% (took all of their medication as prescribed). A "better" score would be indicated on how close to 100%, as the patient should be taking the medication as prescribed by their clinician.

  10. Anticoagulation Adherence 2 - Self-Report [ Time Frame: Survey will be given at 6 months after enrollment and again at 12 months after enrollment ]
    A self-reported 7-day recall of pill-taking behavior. This asks participants whether they forgot to take any of their doses of medication (as prescribed). If they answer yes, they indicate the number of tablets missed per day, per week, and/or per month. Then they are asked how many pills they skipped in the past 7 days. They are asked how many days in the past week that they took more than the prescribed dosage of drug. The are asked if they had any side effects from their drugs, and if yes, what those side effects were. They are asked if they missed any doses due to the side effects. They are asked if the cost of their medication affected taking it. Finally, they are asked how taking their medication has changed their life.

  11. Anticoagulation Adherence 3 - Warfarin Use [ Time Frame: We gather this information throughout the length of the participant's enrollment (approximately 12 months) ]
    For participants who choose to stay on Warfarin, we will also use as a measure of adherence: the proportion of international normalized ration (INR) tests obtained/scheduled. This includes 2 questions: was the patient on Warfarin prior to enrollment, and were INR measures taken after enrollment.

  12. Anticoagulation Adherence 4 - Time in Therapeutic Range [ Time Frame: We gather this information throughout the length of the participant's enrollment (approximately 12 months) ]
    For participants who choose to stay on Warfarin, we will also use as a measure of adherence Time in Therapeutic Range. This is the duration of time in which the patients International Normalized Ratio (INR) is in the target range, typically values between 2 - 3. (INR is a blood test administered by the clinician to determine the patient's anticoagulation control.)

  13. Treatment Choice [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months ]
    Treatment Choice will be assessed by asking participants to identify which treatment (drug) they chose and if their decisions would be different if there were no out-of-pocket costs.

  14. Fidelity of Decision Aids [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit ]
    Fidelity of SDM Tool by the clinician will be assessed by a review of the recording looking for key items to be addressed. A checklist of key elements will be assessed in all four arms to assess not only the fidelity but potential contamination. A sum of the components in the checklist will be calculated for each recording and compared across arms. There is no "better" score; we are measuring how they use the Decision Aid.

  15. Clinical Events [ Time Frame: Survey will be given and data will be collected at 12 months after enrollment ]
    Strokes and bleeds requiring medical assistance will be monitored. Because very few of these are expected, we will rely on participant/clinician self-report and medical record review 12 months post enrollment for each participant. Chart review will include identification of clinical event outcomes: death, stroke, systemic embolism, transient ischemic attack clinically-relevant non-major bleeding, and major bleeding.

  16. Encounter Length [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit ]
    Encounter Length will be assessed by comparing the length in minutes of the discussion about anticoagulation and of the office visit between the different arms, when available. Study notes and video/audio records will be used to assess encounter length.

  17. Min/Max Scale [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit ]
    1-item instrument that determines if patients have minimizer or maximizer tendencies. Medical minimizers are individuals who prefer to do as little as possible when it comes to medicine and their health, whereas medical maximizers prefer active and aggressive medical treatments and being proactive about their health. There is no "better" score; it is up to patient opinion.

  18. Anticoagulation Persistence [ Time Frame: Approximately 12 months after enrollment ]
    Anticoagulation persistence: Using data from pharmacy refills, we will calculate anticoagulation persistence throughout enrollment using the percent days covered (PDC) based on prescription refill behaviors (total days supply of anticoagulant filled / total days of observation from the first prescription fill date; range 0-100%). We will also pull all pharmacy refills for the 12 months prior to enrollment. This will allow us to calculate persistence for prior use of anticoagulants for the review cohort to compare to persistence post encounter and see if there is an impact.

  19. Medical History [ Time Frame: We gather medical information at the time of enrollment, again at 6 months after enrollment, and again at 12 months after enrollment. ]
    Medical history relevant to study aims will be collected will be physiological parameters: such as hypertension, congestive heart failure, rheumatic heart disease, prior heart valve replacement, implantable cardiac device, deep vein thrombosis/pulmonary embolism, prior cerebrovascular events, diabetes mellitus, chronic renal disease, liver disease, coronary artery disease, peripheral arterial disease, prior major bleeding or predisposition to bleeding, medication usage predisposing to bleeding, alcohol use, medication prescribed during enrollment visit, concomitant medications, prior use of systematic anticoagulation for any reason, and INR measures (if the patient was on Warfarin previously, if INR measures were taken after enrollment).

  20. Adapted Illness Intrusiveness Ratings [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months ]
    This will be collected using a modified version of the Illness Intrusiveness Ratings Scale, a 13-item self-report instrument. The AIIR assesses the extent to which disease and treatment interfere with meaningful daily living among people affected by chronic disease. Answers range from 1=Not very much to 7=very much. A lower score is "better" because it would indicate that their daily life is not bothered very much by their choice of treatment.

  21. Values Trade-off [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit ]
    1-item instrument that assesses patient preference of either taking a stroke prevention drug every day, which has a risk of causing serious bleeding, or not taking a stroke prevention drug every day, even though stroke risk is higher. There is no "better" answer; it is up to patient opinion.

  22. Clinician Satisfaction [ Time Frame: Post encounter surveys will be given or sent within 1 week after each visit ]
    This will be assessed with 6 questions answered by a 5-point Likert scale questioning satisfaction with discussion about anticoagulation medication choice. Answers range from 1=not at all satisfied to 5=completely satisfied. The clinician will also be asked whether they would recommend the approach used to other clinicians for other discussions on with a "yes/no/not sure" answer format. A lower score would indicate higher satisfaction, so lower is "better".

  23. Choice of Anticoagulant [ Time Frame: Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months ]
    We will review the electronic medical record (EMR), patient- and clinician-reported choice, and recordings of the visit to determine the prescribed anticoagulant and whether and when switches to another agent or to no anticoagulant took place. Together, they should capture choice and switches even when these occur as a result of changes in clinician (e.g., from cardiology to primary care). When available, we will note the documented reasons from clinical notes for choosing and switching as well as with which clinician the change was made (e.g primary, cardiology, etc.).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Patient Participants -

Inclusion Criteria:

  1. Adults (18 and older)
  2. Are diagnosed with Atrial Fibrillation
  3. Are aware they have been diagnosed with Atrial Fibrillation
  4. Participants with additional risk of thromboembolic events (CHA2DS2-VASc scores ≥ 1 in men and ≥ 2 in women)

Exclusion Criteria:

  1. Participants deemed by their clinician or research personnel to be ineligible for consideration of taking or of foregoing anticoagulation
  2. Have deficits in cognitive abilities or sensory input
  3. Have a language barrier significant enough to impede shared decision making and/or the provision of written informed consent.

Clinician Participants -

Inclusion Criteria:

1. All clinicians (MDs, NP/PAs, PharmDs, APPs, etc.) that are responsible for the modality of Anticoagulation in eligible AF patients at participating sites, without exclusion.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04357288


Contacts
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Contact: Maddie McCarty, BS 801-213-0935 maddie.mccarty@hsc.utah.edu
Contact: Elissa Ozanne, PhD 801-213-4130 elissa.ozanne@hsc.utah.edu

Sponsors and Collaborators
University of Utah
Mayo Clinic
American Heart Association
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: Elissa Ozanne, PhD University of Utah
Publications:
Agency for Healthcare Research and Quality. CAHPS Clinician & Group Survey. 2018.
O'Connor A, Cranney A. User Manual - Acceptability [document on internet]. 1996.
O'Connor AM, Cranney A. Sample Tool : Acceptability ( Osteoporosis Therapy ). https://decisionaid.ohri.ca/docs/develop/Tools/Acceptability_osteoporosis.pdf. Published 1996.
Boehringer-Ingelheim. Dabigatran prescribing information. http://docs.boehringer-ingelheim.com/Prescribing Information/PIs/Pradaxa/Pradaxa.pdf. Published 2017. Accessed January 8, 2018.
Daichii Sankyo Inc. Edoxaban prescribing information. http://dsi.com/prescribing-information-portlet/getPIContent?productName=Savaysa&inline=true. Published 2017. Accessed January 8, 2018.
Janssen Pharmaceuticals Inc. Rivaroxaban prescribing information. https://www.xareltohcp.com/shared/product/xarelto/prescribing-information.pdf. Published 2011. Accessed January 8, 2018.
Bristol-Myers Squibb Company. Apixaban prescribing information. https://packageinserts.bms.com/pi/pi_eliquis.pdf. Published 2016. Accessed January 8, 2017.
Krug S. Rocket Surgery Made Easy: The Do-It Yourself Guide to Finding and Fixing Usability Problems. Berkley, CA: New Riders; 2010.

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Responsible Party: Elissa Ozanne, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT04357288    
Other Study ID Numbers: IRB_00124127
First Posted: April 22, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will follow the funders' open-data policies.
Time Frame: We will follow the funders' open-data policies.
Access Criteria: We will follow the funders' open-data policies.
URL: https://professional.heart.org/professional/ResearchPrograms/AwardsPolicies/UCM_461225_Open-Science-Policy-Statements-for-AHA-Funded-Research.jsp

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elissa Ozanne, University of Utah:
Shared Decision Making
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes