Dataset Information

Randomized evaluation of decision support interventions for atrial fibrillation: Rationale and design of the RED-AF study.

ABSTRACT:

Background

Shared decision making (SDM) improves the likelihood that patients will receive care in a manner consistent with their priorities. To facilitate SDM, decision aids (DA) are commonly used, both to prepare a patient before their clinician visit, as well as to facilitate discussion during the visit. However, the relative efficacy of patient-focused or encounter-based DAs on SDM and patient outcomes remains largely unknown. We aim to directly estimate the comparative effectiveness of two DA's on SDM observed in encounters to discuss stroke prevention strategies in patients with atrial fibrillation (AF).

Methods

The study aims to recruit 1200 adult patients with non-valvular AF who qualify for anticoagulation therapy, and their clinicians who manage stroke prevention strategies, in a 2x2 cluster randomized multi-center trial at six sites. Two DA's were developed as interactive, online, non-linear tools: a patient decision aid (PDA) to be used by patients before the encounter, and an encounter decision aid (EDA) to be used by clinicians with their patients during the encounter. Patients will be randomized to PDA or usual care; clinicians will be randomized to EDA or usual care.

Results

Primary outcomes are quality of SDM, patient decision making, and patient knowledge. Secondary outcomes include anticoagulation choice, adherence, and clinical events.

Conclusion

This trial is the first randomized, head-to-head comparison of the effects of an EDA versus a PDA on SDM. Our results will help to inform future SDM interventions to improve patients' AF outcomes and experiences with stroke prevention strategies.

SUBMITTER: Jones AE

PROVIDER: S-EPMC11348720 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

Randomized evaluation of decision support interventions for atrial fibrillation: Rationale and design of the RED-AF study.

Jones Aubrey E AE McCarty Madeleine M MM Brito Juan P JP Noseworthy Peter A PA Cavanaugh Kerri L KL Cameron Kenzie A KA Barnes Geoffrey D GD Steinberg Benjamin A BA Witt Daniel M DM Crossley George H GH Passman Rod R Kansal Preeti P Hargraves Ian I Schmidt Monika M Jackson Elizabeth E Guzman Adriana A Ariotti Anthony A Pershing Mandy L ML Herrick Jennifer J Montori Victor M VM Fagerlin Angela A Ozanne Elissa M EM

American heart journal 20220224

<h4>Background</h4>Shared decision making (SDM) improves the likelihood that patients will receive care in a manner consistent with their priorities. To facilitate SDM, decision aids (DA) are commonly used, both to prepare a patient before their clinician visit, as well as to facilitate discussion during the visit. However, the relative efficacy of patient-focused or encounter-based DAs on SDM and patient outcomes remains largely unknown. We aim to directly estimate the comparative effectiveness ...[more]

PMID: 35218727

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Project description:Study objectiveIn the United States, nearly 70% of emergency department (ED) visits for atrial fibrillation result in hospitalization. The incidence of serious 30-day adverse events after an ED evaluation for atrial fibrillation remains low. This study's goal was to prospectively validate our previously reported Risk Estimator Decision Aid for Atrial Fibrillation (RED-AF) model for estimating a patient's risk of experiencing a 30-day adverse event.MethodsThis was a prospective cohort study, which enrolled a convenience sample of ED patients presenting with atrial fibrillation. RED-AF, previously derived from a retrospective cohort of 832 patients, assigns points according to age, sex, coexisting disease (eg, heart failure, hypertension, chronic obstructive pulmonary disease), smoking, home medications (eg, β-blocker, diuretic), physical examination findings (eg, dyspnea, palpitations, peripheral edema), and adequacy of ED ventricular rate control. Primary outcome was occurrence of greater than or equal to 1 atrial fibrillation-related adverse outcome (ED visits, rehospitalization, cardiovascular complications, death) within 30 days. We identified a clinically relevant threshold and measured RED-AF's performance in this prospective cohort, assessing its calibration, discrimination, and diagnostic accuracy.ResultsThe study enrolled 497 patients between June 2010 and February 2013. Of these, 120 (24%) had greater than or equal to 1 adverse event within 30 days. A RED-AF score of 87 was identified as an optimal threshold, resulting in sensitivity and specificity of 96% (95% confidence interval [CI] 91% to 98%) and 19% (95% CI 15% to 23%), respectively. Positive and negative predictive values were 27% (95% CI 23% to 32%) and 93% (95% CI 85% to 97%), respectively. The c statistic for RED-AF was 0.65 (95% CI 0.59 to 0.71).ConclusionIn this separate validation cohort, RED-AF performed moderately well and similar to the original derivation cohort for identifying the risk of short-term atrial fibrillation-related adverse events in ED patients receiving a diagnosis of atrial fibrillation.

Project description:BackgroundAppropriate thromboprophylaxis for patients with atrial fibrillation or atrial flutter (AF) remains a national challenge. The recent availability of direct oral anticoagulants (DOACs) with comparable efficacy and improved safety compared with warfarin alters the balance between risk factors for stroke and benefit of anticoagulation. Our objective was to examine the impact of DOACs as an alternative to warfarin on the net benefit of oral anticoagulant therapy (OAT) in a real-world population of AF patients.MethodsThis is a retrospective cohort study of patients with paroxysmal or persistent nonvalvular AF. We updated an Atrial Fibrillation Decision Support Tool (AFDST) to include DOACs as treatment options. The tool generates patient-specific recommendations based upon individual patient risk factor profiles for stroke and major bleeding using quality-adjusted life-years (QALYs) calculated for each treatment strategy by a decision analytic model. The setting included inpatient and ambulatory sites in an academic health center in the midwestern United States. The study involved 5,121 adults with nonvalvular AF seen for any ambulatory visit or inpatient hospitalization over the 1-year period (January through December 2016). Outcome measure was net clinical benefit in QALYs.ResultsWhen DOACs are a therapeutic option, the AFDST recommends OAT for 4,134 (81%) patients and no antithrombotic therapy or aspirin for 489 (9%). A strong recommendation for OAT could not be made in 498 (10%) patients. When warfarin is the only option, OAT is recommended for 3,228 (63%) patients and no antithrombotic therapy or aspirin for 973 (19%). A strong recommendation for OAT could not be made in 920 (18%) patients. In total, 1,508 QALYs could be gained if treatment were changed to that recommended by the AFDST.ConclusionsAvailability of DOACs increases the proportion of patients for whom oral anticoagulation therapy is recommended in a real-world cohort of AF patients and increased projected QALYs by more than 1,500 when all patients are receiving thromboprophylaxis as recommended by the AFDST compared with current treatment.

Project description:IntroductionA multidisciplinary approach is needed for the management of atrial fibrillation (AF) in which the patient has a central role. Smart devices create opportunities to improve AF management. This paper aimed to evaluate the in-house developed AF-EduApp application on its usability, satisfaction, and communication effectiveness with the care team.MethodsDuring a multicenter, prospective randomized controlled trial, 153 AF patients were included in the AF-EduApp study, with a minimum follow-up of 12 months and a maximum follow-up of 15 months if taking oral anticoagulation (OAC). The AF-EduApp contains six main modules: Questionnaires, Education, Measurement data entry, Medication overview with reminders, Appointments, and Communication with the care team. The App focuses on four main goals: (1) to improve AF knowledge, (2) to increase self-care capabilities, (3) electronic monitoring to improve therapy adherence to OAC, and (4) communication with the care team. Patients unable to use the AF-EduApp were assigned to a no-App control group (n = 41) without intervention comparable to the standard care group (SC, n = 346) of the AF-EduCare study.ResultsA total of 152 patients effectively used the App during a mean follow-up of 386.8 ± 108. 1 days (one included patient could not install the application due to an iPhone from the United States). They opened the application on average on 130.1 ± 144.7 days. Of the 109 patients still in follow-up after 12 months (i.e. patients who did not withdraw and on OAC), 90 patients (82.6%) actively used the application at least one day in the next 41 days. The Measurement module was the most used, with a median of used days over the total available days of 6.4%. A total of 75 App patients (49.3%) asked questions, mostly clinical-related questions (e.g. medication use, or actionability on clinical entered parameters). A mean score of 8.1 ± 1.7 about the "perceived quality of follow-up in the past year" was given by the App ITT patients, compared to a score of 7.7 ± 2.0 by the SC group (P = .072). Patients who used the App were more attracted to future follow-up with an application compared to patients who would be capable of using the application of the SC group (31.6% vs. 12.5%; P < .001).ConclusionThis study showed a positive attitude towards using a mobile application, with AF patients using the application one-third of the available days. Patients used the App most for entering measured parameters, and to contact the care team.

Dataset Information

Randomized evaluation of decision support interventions for atrial fibrillation: Rationale and design of the RED-AF study.

Background

Methods

Results

Conclusion

Publications

Randomized evaluation of decision support interventions for atrial fibrillation: Rationale and design of the RED-AF study.

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