Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation

NCT04357288 | Completed

• 1 other identifier: IRB_00124127
• Study Type: interventional
• Target: 1,117
• Locations: 1 country
• Sites: 6

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.

Conditions

Atrial Fibrillation

Keywords

Shared Decision Making

Outcome Measures

Primary Outcomes (3)

• Decisional Conflict Scale

  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.

  Post encounter surveys will be given or sent within 1 week after the visit

• Patient Knowledge

  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.

  Post encounter surveys will be given or sent within 1 week after the visit

• Shared Decision Making

  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.

  Post encounter surveys will be given or sent within 1 week after the visit

Secondary Outcomes (23)

• Decision Regret

  Survey will be given at 6 months after enrollment and again at 12 months after enrollment

• Preparation for Decision Making

  Post encounter surveys will be given or sent within 1 week after the visit

• Quality of Communication

  Post encounter surveys will be given or sent within 1 week after the visit

• 9-item Shared Decision Making Questionnaire (SDMQ9)

  Post encounter surveys will be given or sent within 1 week after the visit

• Control Preference Scale

  Post encounter surveys will be given or sent within 1 week after the visit

Study Arms (4)

Patient Decision Aid

EXPERIMENTAL

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

Encounter Decision Aid

EXPERIMENTAL

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

Patient & Encounter Decision Aids

EXPERIMENTAL

Participants in this arm will use both the PDA \& EDA as described above.

Other: Patient Decision Aid; Other: Encounter Decision Aid

Standard Care

NO INTERVENTION

Participants in this arm will receive standard care, that is they will not use either the PDA or EDA.

Interventions

Patient Decision Aid OTHER

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.

Patient & Encounter Decision Aids; Patient Decision Aid

Encounter Decision Aid OTHER

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.

Encounter Decision Aid; Patient & Encounter Decision Aids

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead
• American Heart Association: collaborator
• Patient-Centered Outcomes Research Institute: collaborator
• Mayo Clinic: collaborator
• Northwestern University: collaborator
• Vanderbilt University: collaborator
• University of Michigan: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (6)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

The Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

University of Utah Health

Salt Lake City, Utah, 84108, United States

Location

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• Ozanne EM, Barnes GD, Brito JP, Cameron KA, Cavanaugh KL, Greene T, Jackson EA, Montori VM, Steinberg BA, Witt DM, Noseworthy P, Passman RS, Kansal P, Crossley G, Roden DM, Christensen JT, Ariotti A, Jones AE, Bardsley T, Wu C, Fagerlin A; STEP-UP Writing Group. Effectiveness of shared decision making strategies for stroke prevention among patients with atrial fibrillation: cluster randomized controlled trial. BMJ. 2025 Jan 9;388:e079976. doi: 10.1136/bmj-2024-079976.

  PMID: 39788611 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Elissa Ozanne, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

• Angela Fagerlin, PhD

  University of Utah

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 22, 2020
• Study Start: December 16, 2020
• Primary Completion: September 20, 2024
• Study Completion: September 20, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: We will follow the funders' open-data policies.
• Access Criteria: We will follow the funders' open-data policies.

Locations

US (6)