Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03770481 |
Other study ID # |
1 F31 NR018584-01 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
October 1, 2020 |
Est. completion date |
February 28, 2021 |
Study information
Verified date |
April 2021 |
Source |
State University of New York at Buffalo |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Communication is one of the greatest health needs for high quality end-of-life (EOL) care in
the intensive care unit (ICU), especially when patients are too ill to speak for themselves
and rely on surrogates to make EOL decisions. Yet, there is no effective nursing intervention
designed to improve communication between surrogates and clinicians. In order to enhance
understanding of the surrogates' needs in the transition to EOL, this study will propose a
new theory-grounded communication intervention, Nurse-Led Communication Strategy (NLCS) and
will evaluate its feasibility, acceptability, and preliminary effects.
Description:
Background: In 2014, 14.7% of Americans died using intensive care unit (ICU) services. It is
a clinical imperative to provide high quality EOL care. Strong communication with surrogates
is vital for high quality EOL care due to the fact that seriously ill patients often cannot
talk, and they rely on surrogates (often family members) to make EOL decisions. There have
been many studies conducted in the past, trying to improve EOL communication. Yet, evidence
shows that communication remains poor in the ICU. To date, there is lack of evidence for a
particular nursing strategy that effectively improves communication and the quality of EOL
care in the ICU. The goal of this proposed study is to develop a new nurse-led communication
strategy (NLCS). Specific Aim: To assess the NLCS's feasibility, acceptability, and
preliminary effects among surrogates of patients who are unable to communicate in the ICU.
Theory: NLCS is grounded in the state-of-the art framework "COMFORT" which has guided a
validated and effective communication training for nurses in the care of patients with
life-threatening illness and their families. NLCS applies 'COMFORT' into a usable nursing
communication strategy that research nurses use the framework to engage one communication
session per day with surrogates during the ICU stay. Methods: A single-center pilot
two-groups comparison study. The study design involves the recruitment of surrogates in the
ICU to evaluate the feasibility, acceptability, and preliminary effects of the NLCS.
Analysis: To assess feasibility, we will use descriptive statistics and a COSORT
(Consolidated Standards of Reporting Trials) flow diagram to determine recruitment and
attrition. For acceptability, we will use an unpaired (independent) t test to compare the
scores of the Client Satisfaction Questionnaire (CSQ-8)and between intervention and control
groups. To evaluate preliminary effects of the intervention, we will compare the pre- and
post-test scores of the Quality of Communication (QOC) questionnaire, Hospital Anxiety and
Depression Scale (HADS), and Decisional Conflict Scale (DCS) between intervention and control
groups. It determines whether the NLCS is perceived as appropriate, acceptable, and
potentially effective. The by-product analysis uses a linear regression to determine which
factors are associated with the scores of the . This proposal provides an opportunity for the
first time to develop a theory-grounded nursing communication strategy that is feasible,
acceptable, and poses low cognitive load for surrogates in the ICU, and it enhances the
understanding of surrogates' needs in the transition to EOL and thereby potentially improves
the quality of EOL care. This research training will take place at the University at Buffalo
School of Nursing, an exceptional research-intensive university, under the mentorship of Dr.
Chang and Dr. Lorenz (methodology), Dr. Sullivan (EOL studies), and Dr. Wittenberg
(communication theory). The training plan will provide the investigator with research skills
and the preliminary data.