Nursing Interventions Following Sudden Cardiac Arrest

Developing Nursing Interventions to Enhance Recovery Following Sudden Cardiac Arrest

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.

Study Overview

• Status: Completed
• Conditions: ICD
• Intervention / Treatment: Behavioral: Nursing intervention program

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.

• Study Type: Interventional
• Enrollment (Actual): 168
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nursing intervention program; 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; 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.
No Intervention: Usual Care Group; 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

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute of Nursing Research (NINR)
• Investigators: Principal Investigator: Cynthia M. Dougherty, PhD, ARNP, University of Washington

Publications and helpful links

General Publications

• Dougherty CM, Johnson-Crowley NR, Lewis FM, Thompson EA. Theoretical development of nursing interventions for sudden cardiac arrest survivors using social cognitive theory. ANS Adv Nurs Sci. 2001 Sep;24(1):78-86. doi: 10.1097/00012272-200109000-00009.
• Dougherty CM, Thompson EA, Lewis FM. Long-term outcomes of a telephone intervention after an ICD. Pacing Clin Electrophysiol. 2005 Nov;28(11):1157-67. doi: 10.1111/j.1540-8159.2005.09500.x.
• Dougherty CM, Lewis FM, Thompson EA, Baer JD, Kim W. Short-term efficacy of a telephone intervention by expert nurses after an implantable cardioverter defibrillator. Pacing Clin Electrophysiol. 2004 Dec;27(12):1594-602. doi: 10.1111/j.1540-8159.2004.00691.x.
• Dougherty CM, Liberato ACS, Streur MM, Burr RL, Kwan KY, Zheng T, Auld JP, Thompson EA. Physical function, psychological adjustment, and self-efficacy following sudden cardiac arrest and an initial implantable cardioverter defibrillator (ICD) in a social cognitive theory intervention: secondary analysis of a randomized control trial. BMC Cardiovasc Disord. 2022 Aug 10;22(1):369. doi: 10.1186/s12872-022-02782-8.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 1998
• Primary Completion (Actual): December 31, 2003
• Study Completion (Actual): December 31, 2003

Study Registration Dates

• First Submitted: June 16, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): July 8, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Heart Arrest; Death, Sudden, Cardiac
• Other Study ID Numbers: 13730; R01NR004766 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No