Nursing Interventions Following Sudden Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
Determine the benefits of implantable cardioverter defibrillator (ICD) patients participating in a structured, 8-week educational telephone intervention delivered by expert cardiovascular nurses post-ICD. To determine if individuals participating in a post-hospital telephone nursing intervention would demonstrate (1) increased physical functioning, (2) increased psychological adjustment, (3) improved self-efficacy in managing the challenges of ICD recovery, and (4) lower levels of health care utilization over usual care at 1, 3, 6 and 12 months post-ICD implantation.

Detailed Description
-----------------
The goal of the study was to determine if a short-term social cognitive theory intervention would improve physical functioning and enhance psychological adjustment after receiving a first time ICD. The central aim of this study was to determine if individuals participating in a telephone nursing intervention compared to usual care demonstrated (1) improved physical functioning, (2) improved psychological adjustment, 3) improved knowledge related to sudden cardiac arrest (SCA) and the ICD, and (4) lower levels of health care use over a 3-month period post-ICD.

Official Title
-----------------
Developing Nursing Interventions to Enhance Recovery Following Sudden Cardiac Arrest

Conditions
-----------------
ICD

Intervention / Treatment
-----------------
* Behavioral: Nursing intervention program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: the ability to read, speak, and write English, having telephone access, willingness to be followed for 1 year. Exclusion Criteria: significant clinical comorbidities that prevented their return home after hospitalization, younger than 21 years of age, Short BLESSED cognitive screening tool scores ≥10.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nursing intervention program<br>The nursing intervention program consisting of 3 parts: (1) Structural Informational (SI) booklet, (2) Nursing Telephone Support (NTS) protocol, and (3) Nurse Pager 24/7. | Behavioral: Nursing intervention program<br>* The intervention consisted of structured information (SI) provided in a booklet, nursing telephone support (NTS) and access to a nurse pager 24h/day. The SI booklet, Sudden Cardiac Arrest: A Survivor's Experience, contains 2 components: a descriptive component including individual verbatim statements about experiences of others during the first year of recovery and a management component outlining successful strategies used by others in dealing with issues in recovery. The NTS telephone calls included: check-in about current concerns, assessment of the topic for the week, review of common recovery experiences, discussion of behavioral strategies for dealing with the topic for the week, provision of positive feedback for strategies already working well, anxiety reduction statements, practice of new behaviors using role-playing and problem solving techniques, summarization, setting specific goals for the upcoming week, and collaborating on a learning assignment for the subsequent week.<br>|
| No Intervention: Usual Care Group<br>Usual care participants received treatment as usual from their health care providers. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Concerns Assessment (PCA) | scores from 0 to 58 in which lower scores reflect fewer symptoms | Change in patient concerns from baseline to 12 months | 
| SF-12 Short Form Health Survey (SF-12) | scores from 0 to 100 with higher scores representing better self-reported health | change in general health (SF-12) score from baseline to 12 months | 
| State-Trait Anxiety Inventory (STAI) | Scores range from 20 to 80. Higher scores indicating greater anxiety. | change in anxiety (STAI) score from baseline to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ICD shocks | The number of ICD shocks (if any) that the patient received from the ICD | change in number of ICD shocks from baseline to 12 months | 
| Center for Epidemiologic Studies Depression Scale (CES-D) | Scores range from 0 to 60, with high scores indicating greater depressive symptoms. | change in depression (CES-D) score from baseline to 12 months | 
| Efficacy expectations: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale) | SCA-SE scale has 2 sub-scales self-efficacy and self-management behavior. The first 8 items measure self-efficacy. Score for this sub-scale ranges from 0 to 8. higher the score greater is the self-efficacy. | change in efficacy expectations from baseline to 12 months | 
| Number of emergency room (ER) visits for ICD firings or cardiac arrhythmias | The number of times a person went to the ER for evaluation over 12 months | change in number of ER visits from baseline to 12 months | 
| Number of clinic visits related to the ICD | The number of times a person had an outpatient clinic visit for the ICD | change in number of clinic visits from baseline to 12 months | 
| Number of hospital admissions for ICD or cardiac related | The number of times a person stayed overnight, at least 24 hours, in the hospital. | change in number of hospital admission from baseline to 12 months | 
| Sudden Cardiac Arrest (SCA) Knowledge | Score ranges from 0 to 25. Higher the score greater is the ICD knowledge. | change in SCA knowledge from baseline to 12 months | 
| Heart rhythm stability | self-reported number of cardiac arrhythmias and assessed using interrogation reports from ICD devices during routine follow-up visits | change in heart rhythm stability from baseline to 12 months | 
| Self-management behavior: Sudden Cardiac Arrest Self Efficacy (SCA-SE scale) | SCA-SE scale has 2 sub-scales self-efficacy and self-management behavior. The items - to 16 measure self-management behavior. Score range from 0 to 8 for self-management behavior skills. Higher the score greater is the self-management behavior skills. | change in self-management behavior from baseline to 12 months |