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SDM for Stroke Prevention in Atrial Fibrillation (SDM4Afib)

Primary Purpose

Atrial Fibrillation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Atrial Fibrillation focused on measuring Afib, Atrial fib, Shared, Decision, Making, Aid, AF

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • Hennepin County Medical Center
  • Mayo Clinic in Rochester
  • Park Nicollet Health Partners
  • University of Mississippi Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Standard Care

Standard Care + Decision Aid

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Number of Participants With Anticoagulant Medication Use
The number of subjects who chose to start or continue receive an anticoagulant medication.
Patient Involvement
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.
Encounter Duration
The length of time for the subjects visit with the clinician, as measured in minutes.

Full Information

First Posted
September 9, 2016
Last Updated
December 29, 2021
Sponsor
Mayo Clinic
Collaborators
Park Nicollet Clinic, Hennepin County Medical Center, Minneapolis, National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT02905032
Brief Title
SDM for Stroke Prevention in Atrial Fibrillation
Acronym
SDM4Afib
Official Title
Shared Decision Making for Stroke Prevention in Atrial Fibrillation (SDM4Afib): A Randomized Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2016 (Actual)
Primary Completion Date
June 27, 2019 (Actual)
Study Completion Date
June 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Park Nicollet Clinic, Hennepin County Medical Center, Minneapolis, National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
Keywords
Afib, Atrial fib, Shared, Decision, Making, Aid, AF

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Observations in clinical encounter via video, audio or observational notes.
Arm Title
Standard Care + Decision Aid
Arm Type
Active Comparator
Arm Description
Observation of clinical encounter using the decision aid via video, audio, or observational notes.
Intervention Type
Behavioral
Intervention Name(s)
Decision Aid
Other Intervention Name(s)
DA
Intervention Description
Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.
Primary Outcome Measure Information:
Title
Number of Clinician Satisfied Encounters
Description
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.
Time Frame
1 month
Title
Number of Clinician Recommendation
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Number of Participants With Anticoagulant Medication Use
Description
The number of subjects who chose to start or continue receive an anticoagulant medication.
Time Frame
12 months
Title
Patient Involvement
Description
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.
Time Frame
1 month
Title
Encounter Duration
Description
The length of time for the subjects visit with the clinician, as measured in minutes.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Noseworthy
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Park Nicollet Health Partners
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35962351
Citation
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.
Results Reference
derived
PubMed Identifier
35023356
Citation
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.
Results Reference
derived
PubMed Identifier
34255051
Citation
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.
Results Reference
derived
PubMed Identifier
32897386
Citation
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.
Results Reference
derived
PubMed Identifier
32398149
Citation
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.
Results Reference
derived
PubMed Identifier
28962662
Citation
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.
Results Reference
derived
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

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SDM for Stroke Prevention in Atrial Fibrillation

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