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植入式心脏复律除颤器更换的决策支持:一项初步可行性随机对照试验

Decision Support for Implantable Cardioverter-Defibrillator Replacement: A Pilot Feasibility Randomized Controlled Trial.

作者信息

Lewis Krystina B, Birnie David, Carroll Sandra L, Brousseau-Whaley Carolynne, Clark Lorraine, Green Martin, Nair Girish M, Nery Pablo B, Redpath Calum, Stacey Dawn

出版信息

J Cardiovasc Nurs. 2021;36(2):143-150. doi: 10.1097/JCN.0000000000000694.

DOI:10.1097/JCN.0000000000000694
PMID:32453274
Abstract

BACKGROUND

Decision support can help patients facing implantable cardioverter-defibrillator (ICD) replacement understand their options and reach an informed decision reflective of their preferences.

OBJECTIVE

The aim of this study was to evaluate the feasibility of a decision support intervention for patients faced with the decision to replace their ICD.

METHODS

A pilot feasibility randomized trial was conducted. Patients approaching ICD battery depletion were randomized to decision support intervention or usual care. Feasibility outcomes included recruitment rates, intervention use, and completeness of data; secondary outcomes were knowledge, values-choice concordance, decisional conflict, involvement in decision making, and choice.

RESULTS

A total of 30 patients were randomized to intervention (n = 15) or usual care (n = 15). The intervention was used as intended, with 2% missing data. Patients in the intervention arm had better knowledge (77.4% vs 51.1%; P = .002). By 12 months, 8 of 13 (61.5%) in the intervention arm and 10 of 14 (71.4%) in the usual care arm accepted ICD replacement; 1 per arm declined (7.7% vs 7.1%, respectively).

CONCLUSION

It was feasible to deliver the intervention, collect data, despite slow recruitment. The decision support intervention has the potential to improve ICD replacement decision quality.

摘要

背景

决策支持可帮助面临植入式心脏复律除颤器(ICD)更换的患者了解其选择,并做出反映其偏好的明智决策。

目的

本研究的目的是评估针对面临ICD更换决策的患者进行决策支持干预的可行性。

方法

进行了一项初步可行性随机试验。接近ICD电池耗尽的患者被随机分配到决策支持干预组或常规治疗组。可行性结果包括招募率、干预措施的使用情况和数据完整性;次要结果包括知识水平、价值观与选择的一致性、决策冲突、参与决策程度和选择情况。

结果

共有30名患者被随机分配到干预组(n = 15)或常规治疗组(n = 15)。干预措施按预期使用,数据缺失率为2%。干预组患者的知识水平更高(77.4%对51.1%;P = .002)。到12个月时,干预组13名患者中有8名(61.5%)接受了ICD更换,常规治疗组14名患者中有10名(71.4%)接受了ICD更换;每组各有1名患者拒绝(分别为7.7%和7.1%)。

结论

尽管招募速度较慢,但实施干预措施并收集数据是可行的。决策支持干预有可能提高ICD更换决策的质量。

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Decision Support for Implantable Cardioverter-Defibrillator Replacement: A Pilot Feasibility Randomized Controlled Trial.植入式心脏复律除颤器更换的决策支持:一项初步可行性随机对照试验
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