A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data

Wallace, Bryan C; Allen, Larry A.; Knoepke, Christopher E.; Glasgow, Russell E.; Lewis, Carmen L.; Fairclough, Diane L.; Helmkamp, Laura; Fitzgerald, Monica D.; Tzou, Wendy S.; Kramer, Daniel B.; Varosy, Paul D.; Gupta, Sanjaya; Mandrola, John; Brancato, Scott; Peterson, Pamela N.; Matlock, Daniel D.

doi:10.1016/j.ahj.2020.04.010

Cited by 9 publications

(3 citation statements)

References 41 publications

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“…The outcomes evaluations are guided by the RE-AIM framework (the precursor to PRISM), 19,20 which assesses an intervention’s potential for dissemination and population impact using the following 5 criteria: reach, effectiveness, adoption, implementation, and maintenance (of which we included all but adoption—the number of centers agreeing to participate over the number approached—which has been previously described. 13…”

Section: Methodsmentioning

confidence: 99%

“…The DECIDE-ICD Trial (Decision Support Intervention for Patients offered implantable Cardioverter-Defibrillators) was a pragmatic, type 2 implementation-effectiveness hybrid, stepped-wedge randomized controlled trial, conducted at 7 sites across the United States, the design of which has been reported elsewhere. 13 Briefly, the primary goal of DECIDE-ICD was to simultaneously assess effectiveness and implementation of a suite of DAs meant for patients considering primary prevention ICD placement. Effectiveness outcomes were related to patient-centric decisions.…”

Section: Setting and Overviewmentioning

confidence: 99%

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Experiences Implementing a Suite of Decision Aids for Implantable Cardioverter Defibrillators: Qualitative Insights From the DECIDE-ICD Trial

Knoepke

Wallace²,

Allen

et al. 2022

Circ: Cardiovascular Quality and Outcomes

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Background: Shared decision making (SDM) is gaining importance in cardiology, including Centers for Medicare & Medicaid Services (CMS) reimbursement policies requiring documented SDM for patients considering primary prevention implantable cardioverter defibrillators. The DECIDE-ICD Trial (Decision Support Intervention for Patients offered implantable Cardioverter-Defibrillators) assessed the implementation and effectiveness of patient decision aids (DAs) using a stepped-wedge design at 7 sites. The purpose of this subanalysis was to qualitatively describe electrophysiology clinicians’ experience implementing and using the DAs. Methods: This included semi-structured individual interviews with electrophysiology clinicians at participating sites across the US, at least 6 months following conversion into the implementation phase of the trial (from June 2020 through February 2022). The interview guide was structured according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance [implementation evaluation model]) framework, assessing clinician experiences, which can impact implementation domains, and was qualitatively assessed using a mixed inductive/deductive method. Results: We completed 22 interviews post-implementation across all 7 sites. Participants included both physicians (n=16) and other clinicians who counsel patients regarding treatment options (n=6). While perception of SDM and the DA were positive, participants highlighted reasons for uneven delivery of DAs to appropriate patients. The CMS mandate for SDM was not universally viewed as associating with patients receiving DA’s, but rather (1) logistics of DA delivery, (2) perceived effectiveness in improving patient decision-making, and (3) match of DA content to current patient populations. Remaining tensions include the specific trial data used in DAs and reconciling timing of delivery with when patients are actively making decisions. Conclusions: Clinicians charged with delivering DAs to patients considering primary prevention implantable cardioverter defibrillators were generally supportive of the tenets of SDM, and of the DA tools themselves, but noted several opportunities to improve the reach and continued use of them in routine care. Registration: URL: https://www.clinicaltrials.gov ; Unique Identifier: NCT03374891.

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Section: Methodsmentioning

confidence: 99%

Section: Setting and Overviewmentioning

confidence: 99%

Experiences Implementing a Suite of Decision Aids for Implantable Cardioverter Defibrillators: Qualitative Insights From the DECIDE-ICD Trial

Knoepke

Wallace²,

Allen

et al. 2022

Circ: Cardiovascular Quality and Outcomes

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“…One of the main cultural barriers affecting device selection in cardiology is the belief system of healthcare professionals and patients [ 2 ]. Different cultures have different beliefs about health and illness, which can influence their choice of medical treatments and devices.…”

Section: Introductionmentioning

confidence: 99%

Navigating Cultural Diversity in the Selection of Cardiovascular Device Treatments: A Comprehensive Review

Hasan,

Tabassum,

Tabassum

et al. 2023

Cureus

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In cardiology, patients' cultural beliefs, linguistic differences, lack of knowledge, and socioeconomic status can create barriers to choosing device treatment. To address this issue, we conducted a thorough literature review using online databases such as PubMed, Google Scholar, and Texas Tech University Health Sciences Center's research portal. Our review found that cultural, religious, and linguistic barriers can contribute to patients' apprehension and reservations about device placement. These barriers can also impact patients' adherence to treatment and clinical outcomes. Patients from lower socioeconomic backgrounds may have difficulty accessing and affording device-based treatments. Additionally, fear and inadequate understanding of surgical procedures can deter patients from accepting device treatment in cardiology. To overcome these cultural barriers, healthcare providers must raise awareness about the benefits of device treatment and provide better training to overcome these challenges. It is crucial to address the unique needs of patients from different cultural backgrounds and socioeconomic statuses to ensure they receive the care they need.

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Understanding Patient Perspectives Toward Shared Decision-Making in Patients With Pulmonary Hypertension

Tobita,

Sakamoto,

Inami

et al. 2024

The American Journal of Cardiology

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A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data

Cited by 9 publications

References 41 publications

Experiences Implementing a Suite of Decision Aids for Implantable Cardioverter Defibrillators: Qualitative Insights From the DECIDE-ICD Trial

Experiences Implementing a Suite of Decision Aids for Implantable Cardioverter Defibrillators: Qualitative Insights From the DECIDE-ICD Trial

Navigating Cultural Diversity in the Selection of Cardiovascular Device Treatments: A Comprehensive Review

Understanding Patient Perspectives Toward Shared Decision-Making in Patients With Pulmonary Hypertension

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