NCT02905032

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,186

participants targeted

Target at P75+ for not_applicable atrial-fibrillation

Timeline
Completed

Started Sep 2016

Typical duration for not_applicable atrial-fibrillation

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 9, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 27, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 27, 2020

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 25, 2022

Completed
Last Updated

January 25, 2022

Status Verified

December 1, 2021

Enrollment Period

2.8 years

First QC Date

September 9, 2016

Results QC Date

November 11, 2021

Last Update Submit

December 29, 2021

Conditions

Atrial Fibrillation

Keywords

AfibAtrial fibSharedDecisionMakingAidAF

Outcome Measures

Primary Outcomes (2)

  • Number of Clinician Satisfied Encounters

    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.

    1 month

  • Number of Clinician Recommendation

    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.

    1 month

Secondary Outcomes (3)

  • Number of Participants With Anticoagulant Medication Use

    12 months

  • Patient Involvement

    1 month

  • Encounter Duration

    1 month

Study Arms (2)

Standard Care

NO INTERVENTION

Observations in clinical encounter via video, audio or observational notes.

Standard Care + Decision Aid

ACTIVE COMPARATOR

Observation of clinical encounter using the decision aid via video, audio, or observational notes.

Behavioral: Decision Aid

Interventions

Decision AidBEHAVIORAL

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

Also known as: DA
Standard Care + Decision Aid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 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

You may not qualify if:

  • Clinician indicates that patient is not a candidate for a discussion about anticoagulation medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of Alabama

Birmingham, Alabama, 35294, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Park Nicollet Health Partners

Saint Louis Park, Minnesota, 55416, United States

Location

University of Mississippi Medical Center

Jackson, Mississippi, 39216, United States

Location

Related Publications (6)

  • Sivly A, Gorr HS, Gravholt D, Branda ME, Linzer M, Noseworthy P, Hargraves I, Kunneman M, Doubeni CA, Suzuki T, Brito JP, Jackson EA, Burnett B, Wambua M, Montori VM; Shared Decision-Making for Atrial Fibrillation (SDM4AFib) Trial Investigators. Enrolling people of color to evaluate a practice intervention: lessons from the shared decision-making for atrial fibrillation (SDM4AFib) trial. BMC Health Serv Res. 2022 Aug 12;22(1):1032. doi: 10.1186/s12913-022-08399-z.

    PMID: 35962351DERIVED

  • Noseworthy PA, Branda ME, Kunneman M, Hargraves IG, Sivly AL, Brito JP, Burnett B, Zeballos-Palacios C, Linzer M, Suzuki T, Lee AT, Gorr H, Jackson EA, Hess E, Brand-McCarthy SR, Shah ND, Montori VM; SDM4AFib (Shared Decision-Making for Atrial Fibrillation) Trial Investigators *. Effect of Shared Decision-Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial. J Am Heart Assoc. 2022 Jan 18;11(2):e023048. doi: 10.1161/JAHA.121.023048. Epub 2022 Jan 13.

    PMID: 35023356DERIVED

  • Kamath CC, Giblon R, Kunneman M, Lee AI, Branda ME, Hargraves IG, Sivly AL, Bellolio F, Jackson EA, Burnett B, Gorr H, Torres Roldan VD, Spencer-Bonilla G, Shah ND, Noseworthy PA, Montori VM, Brito JP; Shared Decision Making for Atrial Fibrillation (SDM4AFib) Trial Investigators. Cost Conversations About Anticoagulation Between Patients With Atrial Fibrillation and Their Clinicians: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2021 Jul 1;4(7):e2116009. doi: 10.1001/jamanetworkopen.2021.16009.

    PMID: 34255051DERIVED

  • Kunneman M, Branda ME, Hargraves IG, Sivly AL, Lee AT, Gorr H, Burnett B, Suzuki T, Jackson EA, Hess E, Linzer M, Brand-McCarthy SR, Brito JP, Noseworthy PA, Montori VM; Shared Decision Making for Atrial Fibrillation (SDM4AFib) Trial Investigators. Assessment of Shared Decision-making for Stroke Prevention in Patients With Atrial Fibrillation: A Randomized Clinical Trial. JAMA Intern Med. 2020 Sep 1;180(9):1215-1224. doi: 10.1001/jamainternmed.2020.2908.

    PMID: 32897386DERIVED

  • Spencer-Bonilla G, Thota A, Organick P, Ponce OJ, Kunneman M, Giblon R, Branda ME, Sivly AL, Behnken E, May CR, Montori VM; Shared Decision Making for Atrial Fibrillation (SDM4AFib) Trial Investigators. Normalization of a conversation tool to promote shared decision making about anticoagulation in patients with atrial fibrillation within a practical randomized trial of its effectiveness: a cross-sectional study. Trials. 2020 May 12;21(1):395. doi: 10.1186/s13063-020-04305-2.

    PMID: 32398149DERIVED

  • Kunneman M, Branda ME, Noseworthy PA, Linzer M, Burnett B, Dick S, Spencer-Bonilla G, Fernandez CA, Gorr H, Wambua M, Keune S, Zeballos-Palacios C, Hargraves I, Shah ND, Montori VM. Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial. Trials. 2017 Sep 29;18(1):443. doi: 10.1186/s13063-017-2178-y.

    PMID: 28962662DERIVED

Related Links

MeSH Terms

Conditions

Atrial FibrillationHelping Behavior

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Peter A. Noseworthy, M.D.
Organization
Mayo Clinci
Noseworthy.Peter@mayo.edu
507-255-2446

Study Officials

  • Peter A Noseworthy

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

September 9, 2016

First Posted

September 19, 2016

Study Start

September 1, 2016

Primary Completion

June 27, 2019

Study Completion

June 27, 2020

Last Updated

January 25, 2022

Results First Posted

January 25, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(5)