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

描述(由申请人提供)：这是R01 HL086580-02“ICD后患者和亲密伴侣干预改善健康结局”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，我们展示了症状、焦虑、知识和自我效能的改善，同时减少了首次接受植入式心脏复律除颤器(ICD)的心脏骤停(SCA)幸存者与ICD相关的门诊就诊次数。此外，我们还发现亲密伴侣在ICD后SCA存活者整体适应中的关键作用。在我们之前的研究中，我们没有得到对亲密伴侣进行干预的资金。因此，这项随机试验的目的是测试患者+伴侣干预(SI-NTS-PTG)和仅患者干预(SI-NTS)对ICD植入后患者和伴侣康复结果的影响。通过对ICD患者和他们的伴侣进行干预，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每年夺走大约40万人的生命，占心血管疾病死亡总数的65%。在过去的几年里，ICD的适应症已经扩大，每年大约有100,000个新的ICD植入物用于SCA的一级和二级预防。有了有效的替代方案来终止心源性猝死，有必要解决患者及其家人如何适应这项技术的问题。在为期五年的时间里，我们将采用2组(N=150/组)随机临床试验设计，在ICD植入后的第一年，测试12周患者+伴侣(SI-NTS-PTG)干预与仅患者干预(SI-NTS)的效果。将收集ICD患者和亲密伴侣在ICD植入后1、3、6、12个月出院时的相关数据。四个主要结果是：身体功能、心理调整、卫生保健利用和关系影响。治疗效果的主要分析是患者和伴侣的结果变量从基线到3个月的变化。其次，探讨干预的长期效果、理论要素，以及ICD植入原因对干预效果的影响。所有干预措施都旨在通过电话或美国邮件提供，以便接触到无法在农村地区开车和生活的ICD患者和伴侣。这项研究推进了NHLBI的科学议程，通过促进心理和行为干预的知识来改善心脏骤停后的预后。 公共卫生相关性：这项随机试验的目标是测试患者和伴侣干预对ICD植入后患者和伴侣康复结局的影响。通过对ICD患者和他们的伴侣进行干预，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每年夺走大约40万人的生命，占心血管疾病死亡总数的65%。在过去的几年里，ICD的适应症已经扩大，每年大约有35,000个新的ICD植入物用于SCA的一级和二级预防。有了有效的替代方案来终止心源性猝死，有必要解决患者及其家人如何适应这项技术的问题。

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.