ASSESSING THE FEASIBILITY OF DELIVERING A PRE-IMPLANTATION NURSE-LED EDUCATIONAL INTERVENTION TO PRIMARY PREVENTION IMPLANTABLE CARDIOVERTER DEFIBRILLATOR CANDIDATES: A RANDOMIZED FEASIBILITY TRIAL

Abstract

Implantable cardioverter defibrillators (ICDs) deliver therapy in the form of an internal shock should a life-threatening arrhythmia occur. Current literature suggests ICD patients often have unmet information needs. This study assessed the feasibility of delivering a pre-implantation nurse-led educational intervention (EI) to ICD candidates within an outpatient clinic. Consented participants were randomized to standard care (SC) or SC plus EI. An evidence-based EI was delivered during the pre-operative visit addressing information gaps identified in the ICD literature. Feasibility outcomes were: recruitment rate, consent rate, randomization, completion rate, EI delivery time, and content delivery. Baseline data and Patient-Reported Outcomes Measurement Information System (PROMIS) anxiety scores were collected. Four weeks post-ICD implantation, participants completed the PROMIS, Florida Patient Acceptance Survey (FPAS) and Florida Shock Anxiety Scale (FSAS). Twenty patients consented (10 per group). Feasibility outcomes were (1) recruitment rate 80%, (2) consent rate 87%, (3) randomization rate 100% (4) completion of questionnaires 80%, (5) EI sessions were completed in < 45 minutes 100% and (6) EI content completion 100%. 4-week mean (SD) FPAS scores were 80.0 (13.4) in EI group compared to SC 77.0 (16.5) indicating greater device acceptance scores in EI. Mean (SE) four-week PROMIS scores were 45.4 (6.4) in EI and 43.7 (8.6) in SC. Mean FSAS scores were 14.7 (4.6) in EI and 13.3 (3.9) in SC. Implications. The results highlight the potential for successful delivery of a nurse-led educational intervention within a clinic setting. The study found delivery of an educational intervention in a clinic setting to be feasible.