A patient decision aid to support shared decision-making on anti-thrombotic treatment of patients with atrial fibrillation: randomised controlled trial

Abstract

Objective: To determine the efficacy of a computerised decision aid in patients with atrial fibrillation making decisions on whether to take warfarin or aspirin therapy. Design: Two-armed open exploratory randomised controlled trial. Setting: Two research clinics deriving participants from general practices in Northeast England. Participants: 109 patients with atrial fibrillation aged over 60. Interventions: Computerised decision aid applied in shared decision-making clinic compared to evidencebased paper guidelines applied as direct advice. Main outcome measures: Primary outcome measure was the decision conflict scale. Secondary outcome measures included anxiety, knowledge, decision-making preference, treatment decision, use of primary and secondary care services and health outcomes. Results: Decision conflict was lower in the computerised decision aid group immediately after the clinic; mean difference 20.18 (95% CI 20.34 to 20.01). Participants in this group not already on warfarin were much less likely to start warfarin than those in the guidelines arm (4/16, 25% compared to the guidelines group 15/16, 93.8%, RR 0.27, 95% CI 0.11 to 0.63). Conclusions: Decision conflict was lower immediately following the use of a computerised decision aid in a shared decision-making consultation than immediately following direct doctor-led advice based on paper guidelines. Furthermore, participants in the computerised decision aid group were significantly much less likely to start warfarin than those in the guidelines arm. The results show that such an approach has a positive impact on decision conflict comparable to other studies of decision aids, but also reduces the uptake of a clinically effective treatment that may have important implications for health outcomes.

Screening strategies for atrial fibrillation: a systematic review and cost-effectiveness analysis

“…45 Warfarin needs to be dose adjusted with regular monitoring to ensure that the patient stays within the recommended therapeutic international normalised ratio (INR) range, making warfarin unacceptable to some patients. 46,47 Warfarin also has interactions with other medications including over-the-counter preparations, foods high in vitamin K and alcohol, which can impact on quality of life, meaning that some patients are reluctant to take warfarin. Recent NICE guidance DG14 48 has recommended coagulometers, devices that allow patients to self-monitor the INR, which is an alternative to regular INR monitoring, although some patients have experienced difficulties gaining access and support for these devices [Diane Eaton, AntiCoagulation Europe (ACE), 2016, personal communication].…”

Older Patients’ Involvement in Shared Decision-Making—A Systematic Review

“…However, users of the information leaflet were more accustomed to preparing themselves for the consultation than non-users [35]. A significant drop in anxiety immediately after the consultation was revealed, but there is no evidence that this reduction varied between the two groups [36].…”

“…One study failed to mention the response rate [34]. Four studies provided no description of the validity and reliability of the measurements used [33] [34]- [36]. Three studies presented the validity and reliability of some of the measurements used [37]- [39].…”

“…One study mainly comprised male participants [40]. Six studies were approved by an institution, hospital and/or university review board [34] [35] [37] [39]- [41], while two contained no information about ethical approval [33] [36]. All the included studies contained some demographic data ( Table 2).…”

A qualitative study of decision-making about the implantation of cardioverter defibrillators and deactivation during end-of-life care

“…41,42 To date, much of the existing (mostly North American) evidence is concerned with what happens in specialist centres, with little consideration of earlier stages of decision-making, particularly in secondary care for initial referral decisions. Equally, there is little available evidence about how decisions on deactivation are made, but a strong suggestion that these are generally made late, and close to death, without planning in advance.…”