Patient and Intimate Partner Intervention to Improve Health Outcomes After an ICD

描述（由申请人提供）：这是1 R01 HL086580-02“患者和亲密伴侣干预以改善ICD后健康结果”的第三次也是最后一次重新提交。在我们之前的工作“心脏骤停后的护理干预”[NINR， R01 NRO 4766]中，我们证明了首次接受植入式心律转复除颤器（ICD）的心脏骤停（SCA）幸存者在症状、焦虑、知识和自我效能方面的改善，同时减少了与ICD相关的门诊就诊次数。此外，我们发现亲密伴侣在ICD后SCA幸存者的整体调整中的关键重要性。在之前的研究中，我们没有资金来干预亲密伴侣。因此，本随机试验的目的是测试患者+伴侣干预（SI-NTS- ptg）与患者单独干预（SI-NTS）对ICD植入后患者和伴侣恢复结果的影响。通过对ICD患者及其伴侣进行干预，我们希望进一步改善患者的预后，并帮助伴侣康复。在美国，SCA每年夺去大约40万人的生命，占心血管疾病死亡总人数的65%。在过去几年中，ICD的适应症已经扩大，每年大约有10万例新的ICD植入物用于SCA的一级和二级预防。有了一种有效的替代方案来中止心源性猝死，就有必要解决患者及其家属如何适应这项技术。在5年的时间里，我们将使用2组（N=150/组）随机临床试验设计，测试ICD植入后第一年12周患者+伴侣（SI-NTS- ptg）干预与患者单独干预（SI-NTS）的效果。收集ICD患者及其亲密伴侣在ICD植入后出院、1、3、6、12个月的相关数据。四个主要结果是：身体功能、心理调整、医疗保健利用和关系影响。治疗效果的主要分析是患者和伴侣从基线到3个月结局变量的变化。其次，探索干预的长期效果，确定ICD植入原因的理论要素和干预效果。所有干预措施都旨在通过电话或通过美国邮件提供，以便接触到无法开车和居住在农村地区的ICD患者和合作伙伴。本研究通过促进心理和行为干预来改善心脏骤停后的结果，推进了NHLBI的科学议程。

DESCRIPTION (provided by applicant): This is the third and final re-submission of 1 R01 HL086580-02 "Patient and Intimate Partner Intervention to Improve Health Outcomes after an ICD". In our previous work, "Nursing Interventions Following Sudden Cardiac Arrest" [NINR, R01 NRO 4766], we demonstrated improvements in symptoms, anxiety, knowledge, and self-efficacy while reducing the number of ICD related outpatient visits in sudden cardiac arrest (SCA) survivors who received an implantable cardioverter defibrillator (ICD) for the first time. In addition, we discovered the pivotal importance of the intimate partner in the overall adjustment of the SCA survivor after an ICD. We were not funded in our previous study to intervene with intimate partners. Therefore, the goal of this randomized trial is to test a patient+partner intervention (SI-NTS-PTG) against the patient only intervention (SI- NTS) on recovery outcomes of patients and partners after ICD implantation. By intervening with both ICD patients and their partners, we expect to further improve outcomes of patients and aid in recovery of partners. SCA claims approximately 400,000 lives in the US per year, representing 65% of the total deaths resulting from cardiovascular disease. The indications for an ICD have expanded in the last few years, resulting in approximately 100,000 new ICD implants for both primary and secondary prevention of SCA/year. With an effective alternative in place to abort sudden cardiac death, it is necessary to address how patients and their families adapt to the technology. Over a five year period we will test the effects of a 12 week patient+partner (SI-NTS-PTG) intervention against a patient only intervention (SI-NTS) in the first year subsequent to ICD implantation, using a 2 group (N=150/group) randomized clinical trial design. Relevant data will be collected on ICD patients and intimate partners at hospital discharge, 1, 3, 6, 12 months post-ICD implantation. The four major outcomes are: physical functioning, psychological adjustment, health care utilization, and relationship impact. The primary analysis of treatment effect is the change in outcome variables from baseline to 3 months for the patient and partner. Secondarily, exploring long term effects of the intervention, theoretical elements, and the intervention effects by ICD implant reason will be determined. All interventions are designed to be delivered over the telephone or through U.S. mail in order to reach ICD patients and partners who are not able to drive and live in rural areas. This study advances the scientific agenda of the NHLBI by contributing to the knowledge of psychological and behavioral interventions to improve outcomes after sudden cardiac arrest. PUBLIC HEALTH RELEVANCE: The goal of this randomized trial is to test a patient and partner intervention against the patient only intervention on recovery outcomes of patients and partners after ICD implantation. By intervening with both ICD patients and their partners, we expect to further improve outcomes of patients and aid in recovery of partners. SCA claims approximately 400,000 lives in the US per year, representing 65% of the total deaths resulting from cardiovascular disease. The indications for an ICD have expanded in the last few years, resulting in approximately 35,000 new ICD implants for both primary and secondary prevention of SCA/year. With an effective alternative in place to abort sudden cardiac death, it is necessary to address how patients and their families adapt to the technology.