Shared Decision-Making Aid for Stroke-Prevention Strategies in Patients With Atrial Fibrillation Receiving Maintenance Hemodialysis (SIMPLIFY-HD): A Mixed-Methods Study

Overview

Journal Can J Kidney Health Dis

Publisher Sage Publications

Date 2025 Feb 24

PMID 39991201

Authors

Olivier Masse

Noemie Maurice

Yu Hong

Claudia Mercurio

Catherine Tremblay

Lysane Senecal

Amelie Bernier-Jean

Nicolas Dugre

Gabriel Dallaire

Affiliations

Soon will be listed here.

Abstract

Background: Recent atrial fibrillation guidelines recommend shared decision-making between clinicians and patients when choosing stroke-prevention therapies. Although decision aids improve patients' knowledge and decisional conflicts, there is no decision aid for stroke-prevention strategies in people with atrial fibrillation receiving hemodialysis.

Objective: The objective was to develop and field test the first decision aid for Atrial Fibrillation in HemoDialysis (AFHD-DA) for stroke prevention in atrial fibrillation and hemodialysis.

Design: This is a sequential 3-phase mixed-methods study following the International Patient Decision Aid Standards and the Ottawa Decision Support Framework.

Setting: This study was conducted in 2 ambulatory hemodialysis centers in Montreal and Laval (Canada).

Participants: Adults with atrial fibrillation receiving hemodialysis and clinicians (physicians, pharmacists, or nurse practitioners) involved in their care.

Methods: In phase 1, we conducted systematic and 2 rapid reviews and formed the steering committee to pilot the first version of AFHD-DA. In phase 2, we refined the AFHD-DA through 4 rounds of focus groups and interviews, using a qualitative analysis of transcripts and a descriptive analysis of acceptability and usability scores. In phase 3, we field-tested the decision aid during 16 simulated clinical consultations. We assessed decisional conflict and patient knowledge using before-and-after paired -tests and compared the proportion of patients with high decisional conflict using McNemar's test. We used the Ottawa Hospital preparation for decision-making scale and participants' feedback to evaluate how AFHD-DA facilitated shared decision-making.

Results: We enrolled 8 patients and 10 clinicians in phase 2. The predefined usability and acceptability thresholds (68 and 66, respectively) were reached. Theme saturation was achieved in the fourth round of focus groups and interviews. Four major themes emerged: acceptability, usability, decision-making process, and scientific value of the decision aid. Sixteen patients and 10 clinicians field-tested the decision aid in phase 3. In clinical settings, AFHD-DA significantly decreased the mean decisional conflict score from 41.0 to 13.6 ( < .001) and the proportion of patients with decisional conflicts from 81.3 to 18.8% ( = .002). It improved the patients' mean knowledge score from 62.7 to 76.6 ( = .001), and 81% of patients and 90% of clinicians felt highly prepared for decision-making. Clinical consultations lasted, on average, 21 minutes (standard deviation = 8).

Limitations: The main limitations were the low quality of existing literature, the small number of participants, and the absence of a control group.

Conclusions: The decision aid facilitated time-efficient shared decision-making between clinicians and patients, improved patients' knowledge, and reduced decisional conflict around selecting a stroke-prevention strategy for patients with atrial fibrillation receiving hemodialysis.

References

Stacey D, Legare F, Boland L, Lewis K, Loiselle M, Hoefel L . 20th Anniversary Ottawa Decision Support Framework: Part 3 Overview of Systematic Reviews and Updated Framework. Med Decis Making. 2020; 40(3):379-398. DOI: 10.1177/0272989X20911870. View

Coulter A, Stilwell D, Kryworuchko J, Mullen P, Jenn Ng C, van der Weijden T . A systematic development process for patient decision aids. BMC Med Inform Decis Mak. 2014; 13 Suppl 2:S2. PMC: 4044159. DOI: 10.1186/1472-6947-13-S2-S2. View

Witteman H, Ndjaboue R, Vaisson G, Chipenda Dansokho S, Arnold B, Bridges J . Clarifying Values: An Updated and Expanded Systematic Review and Meta-Analysis. Med Decis Making. 2021; 41(7):801-820. PMC: 8482297. DOI: 10.1177/0272989X211037946. View

Trevena L, Bonner C, Okan Y, Peters E, Gaissmaier W, Han P . Current Challenges When Using Numbers in Patient Decision Aids: Advanced Concepts. Med Decis Making. 2021; 41(7):834-847. DOI: 10.1177/0272989X21996342. View

van Doorn S, Debray T, Kaasenbrood F, Hoes A, Rutten F, Moons K . Predictive performance of the CHA2DS2-VASc rule in atrial fibrillation: a systematic review and meta-analysis. J Thromb Haemost. 2017; 15(6):1065-1077. DOI: 10.1111/jth.13690. View

Lip G, Nieuwlaat R, Pisters R, Lane D, Crijns H . Refining clinical risk stratification for predicting stroke and thromboembolism in atrial fibrillation using a novel risk factor-based approach: the euro heart survey on atrial fibrillation. Chest. 2009; 137(2):263-72. DOI: 10.1378/chest.09-1584. View

Raj R, Thiruvengadam S, Ahuja K, Frandsen M, Jose M . Discussions during shared decision-making in older adults with advanced renal disease: a scoping review. BMJ Open. 2019; 9(11):e031427. PMC: 6887047. DOI: 10.1136/bmjopen-2019-031427. View

Andrade J, Aguilar M, Atzema C, Bell A, Cairns J, Cheung C . The 2020 Canadian Cardiovascular Society/Canadian Heart Rhythm Society Comprehensive Guidelines for the Management of Atrial Fibrillation. Can J Cardiol. 2020; 36(12):1847-1948. DOI: 10.1016/j.cjca.2020.09.001. View

Sepucha K, Abhyankar P, Hoffman A, Bekker H, Leblanc A, Levin C . Standards for UNiversal reporting of patient Decision Aid Evaluation studies: the development of SUNDAE Checklist. BMJ Qual Saf. 2017; 27(5):380-388. PMC: 5965362. DOI: 10.1136/bmjqs-2017-006986. View

10.

de Jong Y, Ramspek C, Van der Endt V, Rookmaaker M, Blankestijn P, Vernooij R . A systematic review and external validation of stroke prediction models demonstrates poor performance in dialysis patients. J Clin Epidemiol. 2020; 123:69-79. DOI: 10.1016/j.jclinepi.2020.03.015. View

11.

Lip G, Banerjee A, Boriani G, Chiang C, Fargo R, Freedman B . Antithrombotic Therapy for Atrial Fibrillation: CHEST Guideline and Expert Panel Report. Chest. 2018; 154(5):1121-1201. DOI: 10.1016/j.chest.2018.07.040. View

12.

Friberg L, Rosenqvist M, Lip G . Evaluation of risk stratification schemes for ischaemic stroke and bleeding in 182 678 patients with atrial fibrillation: the Swedish Atrial Fibrillation cohort study. Eur Heart J. 2012; 33(12):1500-10. DOI: 10.1093/eurheartj/ehr488. View

13.

Martin R, Brogard Andersen S, OBrien M, Bravo P, Hoffmann T, Olling K . Providing Balanced Information about Options in Patient Decision Aids: An Update from the International Patient Decision Aid Standards. Med Decis Making. 2021; 41(7):780-800. DOI: 10.1177/0272989X211021397. View

14.

Meulenkamp B, Brillinger J, Fergusson D, Stacey D, Graham I . Development and field testing of a patient decision aid for management of acute Achilles tendon rupture: a study protocol. BMC Med Inform Decis Mak. 2021; 21(1):225. PMC: 8310595. DOI: 10.1186/s12911-021-01589-5. View

15.

Hendriks J, Crijns H, Tieleman R, Vrijhoef H . The atrial fibrillation knowledge scale: development, validation and results. Int J Cardiol. 2013; 168(2):1422-8. DOI: 10.1016/j.ijcard.2012.12.047. View

16.

Kunneman M, Branda M, Hargraves I, Sivly A, Lee A, Gorr H . Assessment of Shared Decision-making for Stroke Prevention in Patients With Atrial Fibrillation: A Randomized Clinical Trial. JAMA Intern Med. 2020; 180(9):1215-1224. PMC: 7372497. DOI: 10.1001/jamainternmed.2020.2908. View

17.

Roldan V, Brand-McCarthy S, Ponce O, Belluzzo T, Urtecho M, Espinoza Suarez N . Shared Decision Making Tools for People Facing Stroke Prevention Strategies in Atrial Fibrillation: A Systematic Review and Environmental Scan. Med Decis Making. 2021; 41(5):540-549. PMC: 8191170. DOI: 10.1177/0272989X211005655. View

18.

Taylor D, Fraser S, Bradley J, Bradley C, Draper H, Metcalfe W . A Systematic Review of the Prevalence and Associations of Limited Health Literacy in CKD. Clin J Am Soc Nephrol. 2017; 12(7):1070-1084. PMC: 5498363. DOI: 10.2215/CJN.12921216. View

19.

Muscat D, Smith J, Mac O, Cadet T, Giguere A, Housten A . Addressing Health Literacy in Patient Decision Aids: An Update from the International Patient Decision Aid Standards. Med Decis Making. 2021; 41(7):848-869. PMC: 8815094. DOI: 10.1177/0272989X211011101. View

20.

LaHaye S, Regpala S, Lacombe S, Sharma M, Gibbens S, Ball D . Evaluation of patients' attitudes towards stroke prevention and bleeding risk in atrial fibrillation. Thromb Haemost. 2013; 111(3):465-73. DOI: 10.1160/TH13-05-0424. View