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Randomized Controlled Trial
. 2021 Nov;44(11):1842-1852.
doi: 10.1111/pace.14365. Epub 2021 Oct 9.

Development and piloting of four decision aids for implantable cardioverter-defibrillators in different media formats

Bryan C Wallace  1 , Jacqueline Jones  2 , Frederick A Masoudi  3   4 , Carolyn T Nowels  5 , Paul Varosy  4   6   7 , Richard Thomson  8 , Glyn Elwyn  9 , Angela G Brega  10 , Travis Vermilye  11 , Christopher E Knoepke  1   4 , Amneet Sandhu  12 , Larry A Allen  1   4   6   13 , Daniel D Matlock  1   12   14
Affiliations
Randomized Controlled Trial

Development and piloting of four decision aids for implantable cardioverter-defibrillators in different media formats

Bryan C Wallace et al. Pacing Clin Electrophysiol. 2021 Nov.

Abstract

Background: Using DAs for preference-sensitive decisions is an evidence-based way to improve patient-centered decisions. Reimbursement mandates have increased the need for DAs in ICD care, although none have been formally evaluated. The objectives were to develop and pilot implantable cardioverter-defibrillator (ICD) decision aids (DAs) for patients considering primary prevention ICDs.

Methods: Development Phase: An expert panel, including patients and physicians, iteratively developed four DAs: a one-page Option GridTM conversation aid, a four-page in-depth paper tool, a 17-minute video, and an interactive website. Trial Phase: At three sites, patients with heart failure who were eligible for primary prevention ICDs were randomly assigned 2:1 to intervention (received DAs) or control (usual care). We conducted a mixed-methods evaluation exploring acceptability and feasibility.

Results: Twenty-one eligible patients enrolled (15 intervention). Most intervention participants found the DAs to be unbiased (67%), helpful (89%), and would recommend them to others (100%). The pilot was feasible at all sites; however, using clinic staff to identify eligible patients was more efficient than chart review. Although the main goals were to measure acceptability and feasibility, intervention participants trended towards increased concordance between longevity values and ICD decisions (71% concordant vs. 29%, p = .06). Participants preferred the in-depth paper tool and video DAs. Access to a nurse during the decision-making window encouraged questions and improved participant-perceived confidence.

Conclusions: Participants felt the DAs provided helpful, balanced information that they would recommend to other patients. Further exploration of this larger context of DA use and strategies to promote independent use related to electrophysiology (EP) visits are needed.

Keywords: defibrillation-implantable cardioverter-defibrillator; heart failure; patient decision aid; qualitative; shared decision making.

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Figures

FIGURE 1
FIGURE 1
Development process for toolkit of four decision aids
FIGURE 2
FIGURE 2
Consort diagram of participants through pilot trial [Color figure can be viewed at wileyonlinelibrary.com]
See this image and copyright information in PMC

References

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