Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— RED-AF  

Official title:

Randomized Evaluation of Decision Support Interventions for Atrial Fibrillation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04357288
• Other study ID #: IRB_00124127
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 16, 2020
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1200
• Est. completion date: July 2024
• Est. primary completion date: July 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Northwestern University	Chicago	Illinois
United States	Vanderbilt University	Nashville	Tennessee
United States	The Mayo Clinic	Rochester	Minnesota
United States	University of Utah Health	Salt Lake City	Utah

Sponsors (8)

Lead Sponsor	Collaborator
University of Utah	American Heart Association, Mayo Clinic, Northwestern University, Patient-Centered Outcomes Research Institute, University of Alabama at Birmingham, University of Michigan, Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (66)

Agency for Healthcare Research and Quality. CAHPS Clinician & Group Survey. 2018.

Benjamin EJ, Wolf PA, D'Agostino RB, Silbershatz H, Kannel WB, Levy D. Impact of atrial fibrillation on the risk of death: the Framingham Heart Study. Circulation. 1998 Sep 8;98(10):946-52. doi: 10.1161/01.cir.98.10.946. — View Citation

Bennett C, Graham ID, Kristjansson E, Kearing SA, Clay KF, O'Connor AM. Validation of a preparation for decision making scale. Patient Educ Couns. 2010 Jan;78(1):130-3. doi: 10.1016/j.pec.2009.05.012. Epub 2009 Jun 26. — View Citation

Boehringer-Ingelheim. Dabigatran prescribing information. http://docs.boehringer-ingelheim.com/Prescribing Information/PIs/Pradaxa/Pradaxa.pdf. Published 2017. Accessed January 8, 2018.

Brehaut JC, O'Connor AM, Wood TJ, Hack TF, Siminoff L, Gordon E, Feldman-Stewart D. Validation of a decision regret scale. Med Decis Making. 2003 Jul-Aug;23(4):281-92. doi: 10.1177/0272989X03256005. — View Citation

Bristol-Myers Squibb Company. Apixaban prescribing information. https://packageinserts.bms.com/pi/pi_eliquis.pdf. Published 2016. Accessed January 8, 2017.

Budnitz DS, Lovegrove MC, Shehab N, Richards CL. Emergency hospitalizations for adverse drug events in older Americans. N Engl J Med. 2011 Nov 24;365(21):2002-12. doi: 10.1056/NEJMsa1103053. — View Citation

Byrne PJ, Murphy A. Informed consent and hypoplastic left heart syndrome. Acta Paediatr. 2005 Sep;94(9):1171-5. doi: 10.1111/j.1651-2227.2005.tb02069.x. — View Citation

Camm AJ, Lip GY, De Caterina R, Savelieva I, Atar D, Hohnloser SH, Hindricks G, Kirchhof P; ESC Committee for Practice Guidelines (CPG). 2012 focused update of the ESC Guidelines for the management of atrial fibrillation: an update of the 2010 ESC Guidelines for the management of atrial fibrillation. Developed with the special contribution of the European Heart Rhythm Association. Eur Heart J. 2012 Nov;33(21):2719-47. doi: 10.1093/eurheartj/ehs253. Epub 2012 Aug 24. No abstract available. Erratum In: Eur Heart J. 2013 Mar;34(10):790. Eur Heart J. 2013 Sep;34(36):2850-1. — View Citation

Conen D, Chae CU, Glynn RJ, Tedrow UB, Everett BM, Buring JE, Albert CM. Risk of death and cardiovascular events in initially healthy women with new-onset atrial fibrillation. JAMA. 2011 May 25;305(20):2080-7. doi: 10.1001/jama.2011.659. — View Citation

Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361(12):1139-51. doi: 10.1056/NEJMoa0905561. Epub 2009 Aug 30. Erratum In: N Engl J Med. 2010 Nov 4;363(19):1877. — View Citation

Daichii Sankyo Inc. Edoxaban prescribing information. http://dsi.com/prescribing-information-portlet/getPIContent?productName=Savaysa&inline=true. Published 2017. Accessed January 8, 2018.

Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43. — View Citation

Degner LF, Sloan JA. Decision making during serious illness: what role do patients really want to play? J Clin Epidemiol. 1992 Sep;45(9):941-50. doi: 10.1016/0895-4356(92)90110-9. — View Citation

Dorian P, Kongnakorn T, Phatak H, Rublee DA, Kuznik A, Lanitis T, Liu LZ, Iloeje U, Hernandez L, Lip GY. Cost-effectiveness of apixaban vs. current standard of care for stroke prevention in patients with atrial fibrillation. Eur Heart J. 2014 Jul 21;35(28):1897-906. doi: 10.1093/eurheartj/ehu006. Epub 2014 Feb 9. — View Citation

Elwyn G, Hutchings H, Edwards A, Rapport F, Wensing M, Cheung WY, Grol R. The OPTION scale: measuring the extent that clinicians involve patients in decision-making tasks. Health Expect. 2005 Mar;8(1):34-42. doi: 10.1111/j.1369-7625.2004.00311.x. — View Citation

Feigin VL, Forouzanfar MH, Krishnamurthi R, Mensah GA, Connor M, Bennett DA, Moran AE, Sacco RL, Anderson L, Truelsen T, O'Donnell M, Venketasubramanian N, Barker-Collo S, Lawes CM, Wang W, Shinohara Y, Witt E, Ezzati M, Naghavi M, Murray C; Global Burden of Diseases, Injuries, and Risk Factors Study 2010 (GBD 2010) and the GBD Stroke Experts Group. Global and regional burden of stroke during 1990-2010: findings from the Global Burden of Disease Study 2010. Lancet. 2014 Jan 18;383(9913):245-54. doi: 10.1016/s0140-6736(13)61953-4. Erratum In: Lancet. 2014 Jan 18;383(9913):218. — View Citation

Freeman JV, Zhu RP, Owens DK, Garber AM, Hutton DW, Go AS, Wang PJ, Turakhia MP. Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in atrial fibrillation. Ann Intern Med. 2011 Jan 4;154(1):1-11. doi: 10.7326/0003-4819-154-1-201101040-00289. Epub 2010 Nov 1. — View Citation

Gallagher AM, Rietbrock S, Plumb J, van Staa TP. Initiation and persistence of warfarin or aspirin in patients with chronic atrial fibrillation in general practice: do the appropriate patients receive stroke prophylaxis? J Thromb Haemost. 2008 Sep;6(9):1500-6. doi: 10.1111/j.1538-7836.2008.03059.x. Epub 2008 Jun 28. — View Citation

Giugliano RP, Ruff CT, Braunwald E, Murphy SA, Wiviott SD, Halperin JL, Waldo AL, Ezekowitz MD, Weitz JI, Spinar J, Ruzyllo W, Ruda M, Koretsune Y, Betcher J, Shi M, Grip LT, Patel SP, Patel I, Hanyok JJ, Mercuri M, Antman EM; ENGAGE AF-TIMI 48 Investigators. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2013 Nov 28;369(22):2093-104. doi: 10.1056/NEJMoa1310907. Epub 2013 Nov 19. — View Citation

Go AS, Hylek EM, Chang Y, Phillips KA, Henault LE, Capra AM, Jensvold NG, Selby JV, Singer DE. Anticoagulation therapy for stroke prevention in atrial fibrillation: how well do randomized trials translate into clinical practice? JAMA. 2003 Nov 26;290(20):2685-92. doi: 10.1001/jama.290.20.2685. — View Citation

Go AS, Hylek EM, Phillips KA, Chang Y, Henault LE, Selby JV, Singer DE. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors in Atrial Fibrillation (ATRIA) Study. JAMA. 2001 May 9;285(18):2370-5. doi: 10.1001/jama.285.18.2370. — View Citation

Graham DJ, Reichman ME, Wernecke M, Zhang R, Southworth MR, Levenson M, Sheu TC, Mott K, Goulding MR, Houstoun M, MaCurdy TE, Worrall C, Kelman JA. Cardiovascular, bleeding, and mortality risks in elderly Medicare patients treated with dabigatran or warfarin for nonvalvular atrial fibrillation. Circulation. 2015 Jan 13;131(2):157-64. doi: 10.1161/CIRCULATIONAHA.114.012061. Epub 2014 Oct 30. — View Citation

Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 Sep 15;365(11):981-92. doi: 10.1056/NEJMoa1107039. Epub 2011 Aug 27. — View Citation

Harrington AR, Armstrong EP, Nolan PE Jr, Malone DC. Cost-effectiveness of apixaban, dabigatran, rivaroxaban, and warfarin for stroke prevention in atrial fibrillation. Stroke. 2013 Jun;44(6):1676-81. doi: 10.1161/STROKEAHA.111.000402. Epub 2013 Apr 2. — View Citation

Hart RG, Benavente O, McBride R, Pearce LA. Antithrombotic therapy to prevent stroke in patients with atrial fibrillation: a meta-analysis. Ann Intern Med. 1999 Oct 5;131(7):492-501. doi: 10.7326/0003-4819-131-7-199910050-00003. — View Citation

Hart RG, Pearce LA, Aguilar MI. Meta-analysis: antithrombotic therapy to prevent stroke in patients who have nonvalvular atrial fibrillation. Ann Intern Med. 2007 Jun 19;146(12):857-67. doi: 10.7326/0003-4819-146-12-200706190-00007. — View Citation

Haynes RB, McKibbon KA, Kanani R. Systematic review of randomised trials of interventions to assist patients to follow prescriptions for medications. Lancet. 1996 Aug 10;348(9024):383-6. doi: 10.1016/s0140-6736(96)01073-2. Erratum In: Lancet 1997 Apr 19;349(9059):1180. — View Citation

Haynes RB, Taylor DW, Sackett DL, Gibson ES, Bernholz CD, Mukherjee J. Can simple clinical measurements detect patient noncompliance? Hypertension. 1980 Nov-Dec;2(6):757-64. doi: 10.1161/01.hyp.2.6.757. — View Citation

Hylek EM, Evans-Molina C, Shea C, Henault LE, Regan S. Major hemorrhage and tolerability of warfarin in the first year of therapy among elderly patients with atrial fibrillation. Circulation. 2007 May 29;115(21):2689-96. doi: 10.1161/CIRCULATIONAHA.106.653048. Epub 2007 May 21. — View Citation

Janssen Pharmaceuticals Inc. Rivaroxaban prescribing information. https://www.xareltohcp.com/shared/product/xarelto/prescribing-information.pdf. Published 2011. Accessed January 8, 2018.

January CT, Wann LS, Alpert JS, Calkins H, Cigarroa JE, Cleveland JC Jr, Conti JB, Ellinor PT, Ezekowitz MD, Field ME, Murray KT, Sacco RL, Stevenson WG, Tchou PJ, Tracy CM, Yancy CW; ACC/AHA Task Force Members. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. 2014 Dec 2;130(23):e199-267. doi: 10.1161/CIR.0000000000000041. Epub 2014 Mar 28. No abstract available. Erratum In: Circulation. 2014 Dec 2;130(23):e272-4. — View Citation

Jowett S, Bryan S, Mant J, Fletcher K, Roalfe A, Fitzmaurice D, Lip GY, Hobbs FD. Cost effectiveness of warfarin versus aspirin in patients older than 75 years with atrial fibrillation. Stroke. 2011 Jun;42(6):1717-21. doi: 10.1161/STROKEAHA.110.600767. Epub 2011 Apr 21. — View Citation

Kaatz S, Ahmad D, Spyropoulos AC, Schulman S; Subcommittee on Control of Anticoagulation. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost. 2015 Nov;13(11):2119-26. doi: 10.1111/jth.13140. No abstract available. — View Citation

Kamel H, Johnston SC, Easton JD, Kim AS. Cost-effectiveness of dabigatran compared with warfarin for stroke prevention in patients with atrial fibrillation and prior stroke or transient ischemic attack. Stroke. 2012 Mar;43(3):881-3. doi: 10.1161/STROKEAHA.111.641027. Epub 2012 Feb 3. — View Citation

Kim MH, Johnston SS, Chu BC, Dalal MR, Schulman KL. Estimation of total incremental health care costs in patients with atrial fibrillation in the United States. Circ Cardiovasc Qual Outcomes. 2011 May;4(3):313-20. doi: 10.1161/CIRCOUTCOMES.110.958165. Epub 2011 May 3. — View Citation

Kon AA, Ackerson L, Lo B. How pediatricians counsel parents when no "best-choice" management exists: lessons to be learned from hypoplastic left heart syndrome. Arch Pediatr Adolesc Med. 2004 May;158(5):436-41. doi: 10.1001/archpedi.158.5.436. — View Citation

Kriston L, Scholl I, Holzel L, Simon D, Loh A, Harter M. The 9-item Shared Decision Making Questionnaire (SDM-Q-9). Development and psychometric properties in a primary care sample. Patient Educ Couns. 2010 Jul;80(1):94-9. doi: 10.1016/j.pec.2009.09.034. Epub 2009 Oct 30. — View Citation

Krug S. Rocket Surgery Made Easy: The Do-It Yourself Guide to Finding and Fixing Usability Problems. Berkley, CA: New Riders; 2010.

Lee S, Anglade MW, Pham D, Pisacane R, Kluger J, Coleman CI. Cost-effectiveness of rivaroxaban compared to warfarin for stroke prevention in atrial fibrillation. Am J Cardiol. 2012 Sep 15;110(6):845-51. doi: 10.1016/j.amjcard.2012.05.011. Epub 2012 May 30. — View Citation

Limone BL, Baker WL, Kluger J, Coleman CI. Novel anticoagulants for stroke prevention in atrial fibrillation: a systematic review of cost-effectiveness models. PLoS One. 2013 Apr 23;8(4):e62183. doi: 10.1371/journal.pone.0062183. Print 2013. — View Citation

Lin HJ, Wolf PA, Kelly-Hayes M, Beiser AS, Kase CS, Benjamin EJ, D'Agostino RB. Stroke severity in atrial fibrillation. The Framingham Study. Stroke. 1996 Oct;27(10):1760-4. doi: 10.1161/01.str.27.10.1760. — View Citation

Lloyd-Jones DM, Wang TJ, Leip EP, Larson MG, Levy D, Vasan RS, D'Agostino RB, Massaro JM, Beiser A, Wolf PA, Benjamin EJ. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study. Circulation. 2004 Aug 31;110(9):1042-6. doi: 10.1161/01.CIR.0000140263.20897.42. Epub 2004 Aug 16. — View Citation

Mann DM, Ponieman D, Montori VM, Arciniega J, McGinn T. The Statin Choice decision aid in primary care: a randomized trial. Patient Educ Couns. 2010 Jul;80(1):138-40. doi: 10.1016/j.pec.2009.10.008. Epub 2009 Dec 2. — View Citation

McGrath ER, Kapral MK, Fang J, Eikelboom JW, Conghaile Ao, Canavan M, O'Donnell MJ; Investigators of the Ontario Stroke Registry. Association of atrial fibrillation with mortality and disability after ischemic stroke. Neurology. 2013 Aug 27;81(9):825-32. doi: 10.1212/WNL.0b013e3182a2cc15. Epub 2013 Jul 31. Erratum In: Neurology. 2016 Feb 2;86(5):492. O'Conghaile, Aengus [Corrected to Conghaile, Aengus o]. — View Citation

Montori VM, Shah ND, Pencille LJ, Branda ME, Van Houten HK, Swiglo BA, Kesman RL, Tulledge-Scheitel SM, Jaeger TM, Johnson RE, Bartel GA, Melton LJ 3rd, Wermers RA. Use of a decision aid to improve treatment decisions in osteoporosis: the osteoporosis choice randomized trial. Am J Med. 2011 Jun;124(6):549-56. doi: 10.1016/j.amjmed.2011.01.013. — View Citation

Moyer A, Salovey P. Patient participation in treatment decision making and the psychological consequences of breast cancer surgery. Womens Health. 1998 Summer;4(2):103-16. — View Citation

Mullan RJ, Montori VM, Shah ND, Christianson TJ, Bryant SC, Guyatt GH, Perestelo-Perez LI, Stroebel RJ, Yawn BP, Yapuncich V, Breslin MA, Pencille L, Smith SA. The diabetes mellitus medication choice decision aid: a randomized trial. Arch Intern Med. 2009 Sep 28;169(17):1560-8. doi: 10.1001/archinternmed.2009.293. — View Citation

Naccarelli GV, Varker H, Lin J, Schulman KL. Increasing prevalence of atrial fibrillation and flutter in the United States. Am J Cardiol. 2009 Dec 1;104(11):1534-9. doi: 10.1016/j.amjcard.2009.07.022. — View Citation

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.

O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105. — View Citation

Ogilvie IM, Newton N, Welner SA, Cowell W, Lip GY. Underuse of oral anticoagulants in atrial fibrillation: a systematic review. Am J Med. 2010 Jul;123(7):638-645.e4. doi: 10.1016/j.amjmed.2009.11.025. — View Citation

Patel MR, Mahaffey KW, Garg J, Pan G, Singer DE, Hacke W, Breithardt G, Halperin JL, Hankey GJ, Piccini JP, Becker RC, Nessel CC, Paolini JF, Berkowitz SD, Fox KA, Califf RM; ROCKET AF Investigators. Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011 Sep 8;365(10):883-91. doi: 10.1056/NEJMoa1009638. Epub 2011 Aug 10. — View Citation

Ruff CT, Giugliano RP, Braunwald E, Hoffman EB, Deenadayalu N, Ezekowitz MD, Camm AJ, Weitz JI, Lewis BS, Parkhomenko A, Yamashita T, Antman EM. Comparison of the efficacy and safety of new oral anticoagulants with warfarin in patients with atrial fibrillation: a meta-analysis of randomised trials. Lancet. 2014 Mar 15;383(9921):955-62. doi: 10.1016/S0140-6736(13)62343-0. Epub 2013 Dec 4. — View Citation

Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x. — View Citation

Sevilla-Cazes J, Finkleman BS, Chen J, Brensinger CM, Epstein AE, Streiff MB, Kimmel SE. Association Between Patient-Reported Medication Adherence and Anticoagulation Control. Am J Med. 2017 Sep;130(9):1092-1098.e2. doi: 10.1016/j.amjmed.2017.03.038. Epub 2017 Apr 26. — View Citation

Shah SV, Gage BF. Cost-effectiveness of dabigatran for stroke prophylaxis in atrial fibrillation. Circulation. 2011 Jun 7;123(22):2562-70. doi: 10.1161/CIRCULATIONAHA.110.985655. Epub 2011 May 23. — View Citation

Siouta E, Hellstrom Muhli U, Hedberg B, Brostrom A, Fossum B, Karlgren K. Patients' experiences of communication and involvement in decision-making about atrial fibrillation treatment in consultations with nurses and physicians. Scand J Caring Sci. 2016 Sep;30(3):535-46. doi: 10.1111/scs.12276. Epub 2015 Dec 28. — View Citation

Stacey D, Legare F, Col NF, Bennett CL, Barry MJ, Eden KB, Holmes-Rovner M, Llewellyn-Thomas H, Lyddiatt A, Thomson R, Trevena L, Wu JH. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev. 2014 Jan 28;(1):CD001431. doi: 10.1002/14651858.CD001431.pub4. — View Citation

Steinberg BA, Gao H, Shrader P, Pieper K, Thomas L, Camm AJ, Ezekowitz MD, Fonarow GC, Gersh BJ, Goldhaber S, Haas S, Hacke W, Kowey PR, Ansell J, Mahaffey KW, Naccarelli G, Reiffel JA, Turpie A, Verheugt F, Piccini JP, Kakkar A, Peterson ED, Fox KAA; GARFIELD-AF; ORBIT-AF Investigators. International trends in clinical characteristics and oral anticoagulation treatment for patients with atrial fibrillation: Results from the GARFIELD-AF, ORBIT-AF I, and ORBIT-AF II registries. Am Heart J. 2017 Dec;194:132-140. doi: 10.1016/j.ahj.2017.08.011. Epub 2017 Aug 24. — View Citation

Street RL Jr, Voigt B. Patient participation in deciding breast cancer treatment and subsequent quality of life. Med Decis Making. 1997 Jul-Sep;17(3):298-306. doi: 10.1177/0272989X9701700306. — View Citation

Tu HT, Campbell BC, Christensen S, Collins M, De Silva DA, Butcher KS, Parsons MW, Desmond PM, Barber PA, Levi CR, Bladin CF, Donnan GA, Davis SM; Echoplanar Imaging Thrombolytic Evaluation Trial (EPITHET) Investigators. Pathophysiological determinants of worse stroke outcome in atrial fibrillation. Cerebrovasc Dis. 2010;30(4):389-95. doi: 10.1159/000316886. Epub 2010 Aug 5. — View Citation

Weymiller AJ, Montori VM, Jones LA, Gafni A, Guyatt GH, Bryant SC, Christianson TJ, Mullan RJ, Smith SA. Helping patients with type 2 diabetes mellitus make treatment decisions: statin choice randomized trial. Arch Intern Med. 2007 May 28;167(10):1076-82. doi: 10.1001/archinte.167.10.1076. — View Citation

Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation: a major contributor to stroke in the elderly. The Framingham Study. Arch Intern Med. 1987 Sep;147(9):1561-4. — View Citation

Wolf PA, Dawber TR, Thomas HE Jr, Kannel WB. Epidemiologic assessment of chronic atrial fibrillation and risk of stroke: the Framingham study. Neurology. 1978 Oct;28(10):973-7. doi: 10.1212/wnl.28.10.973. — View Citation

* Note: There are 66 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Decision Regret	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".	Survey will be given at 6 months after enrollment and again at 12 months after enrollment
Secondary	Preparation for Decision Making	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.	Post encounter surveys will be given or sent within 1 week after the visit
Secondary	Quality of Communication	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.	Post encounter surveys will be given or sent within 1 week after the visit
Secondary	9-item Shared Decision Making Questionnaire (SDMQ9)	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".	Post encounter surveys will be given or sent within 1 week after the visit
Secondary	Control Preference Scale	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.	Post encounter surveys will be given or sent within 1 week after the visit
Secondary	Patient Satisfaction with the Decision Aid	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.	Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months
Secondary	Collaborative Agreement	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.	Post encounter surveys will be given or sent within 1 week after the visit
Secondary	Anticoagulation Adherence 1 - Visual Analogue Scale	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.	Survey will be given at 6 months after enrollment and again at 12 months after enrollment
Secondary	Anticoagulation Adherence 2 - Self-Report	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.	Survey will be given at 6 months after enrollment and again at 12 months after enrollment
Secondary	Anticoagulation Adherence 3 - Warfarin Use	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.	We gather this information throughout the length of the participant's enrollment (approximately 12 months)
Secondary	Anticoagulation Adherence 4 - Time in Therapeutic Range	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.)	We gather this information throughout the length of the participant's enrollment (approximately 12 months)
Secondary	Treatment Choice	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.	Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months
Secondary	Fidelity of Decision Aids	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.	Post encounter surveys will be given or sent within 1 week after the visit
Secondary	Clinical Events	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.	Survey will be given and data will be collected at 12 months after enrollment
Secondary	Encounter Length	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.	Post encounter surveys will be given or sent within 1 week after the visit
Secondary	Min/Max Scale	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.	Post encounter surveys will be given or sent within 1 week after the visit
Secondary	Anticoagulation Persistence	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.	Approximately 12 months after enrollment
Secondary	Medical History	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).	We gather medical information at the time of enrollment; again at 6 months; and again at 12 months after enrollment.
Secondary	Adapted Illness Intrusiveness Ratings	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.	Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months
Secondary	Values Trade-off	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.	Post encounter surveys will be given or sent within 1 week after the visit
Secondary	Clinician Satisfaction	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".	Post encounter surveys will be given or sent within 1 week after each visit
Secondary	Choice of Anticoagulant	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.).	Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months
Secondary	Predicting Mortality and Healthcare Utilization (Quality of Life)	1-item instrument that assesses patient self-reported health on a scale from 1 = "poor" to 5 = "excellent", which predicts mortality, hospitalization, and high outpatient use.	Post encounter surveys will be given or sent within 1 week after the visit; again at 6 months; and again at 12 months