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.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL086580-04
Application #
8294644
Study Section
Behavioral Medicine, Interventions and Outcomes Study Section (BMIO)
Program Officer
Czajkowski, Susan
Project Start
2009-07-15
Project End
2014-06-30
Budget Start
2012-07-01
Budget End
2013-06-30
Support Year
4
Fiscal Year
2012
Total Cost
$751,312
Indirect Cost
$269,702
Name
University of Washington
Department
None
Type
Schools of Nursing
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195