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Using a Nurse-Led Communication Strategy for Surrogates in the Intensive Care Unit

University at Buffalo (UB) logo

University at Buffalo (UB)

Status

Completed

Conditions

Communication Research

Treatments

Behavioral: nurse-led communication strategy

Study type

Interventional

Funder types

Other

Identifiers

NCT03770481
00008241

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients

    1. Age ≥ 18 years
    2. in the ICU for > 24 hours
    3. Mechanically ventilated within 24 hours of ICU admission
    4. Having an Acute Physiology and Chronic Health Evaluation (APACHE) IV ICU mortality prediction ≥ 20%
  • Surrogates

    1. Age ≥ 18 years
    2. A legal New York State healthcare proxy documentation or A Family Health Care Decision Act (FHCDA) consent

Exclusion criteria

  • Patients

    1. Decease or discharge from ICU within 24 hours
    2. Mechanically ventilated after 24 hours of ICU stay
    3. Able to communicate and make own decision
    4. Lack of a legal surrogate/proxy decision-maker to consent for patient participation
  • Surrogates

    1. Lack of legal surrogate documentation
    2. Not able to complete consent process and questionnaires in English

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

41 participants in 3 patient groups

Assess the NLCS' feasibility
Experimental group
Description:
Hypothesis: No significant differences will be observed in recruitment and attrition between NLCS intervention and control groups. Approach: Determine rates of enrollment and drop-outs between groups.
Treatment:
Behavioral: nurse-led communication strategy
Assess the NLCS' acceptability
Experimental group
Description:
Hypothesis: More surrogates agree that the NLCS is suitable, appropriate, effective and willing to adhere versus treatment as usual (TAU) communication. Approach: Assess outcome using the validated instrument, Client Satisfaction Questionnaire (CSQ-8).
Treatment:
Behavioral: nurse-led communication strategy
Assess the NLCS' preliminary effects
Experimental group
Description:
Hypothesis: NLCS improves communication and decreases surrogates' psychological distress (e.g., anxiety and depression) Approach: Compare pre- and post-intervention scores of the Quality of Communication (QOC) questionnaire, Hospital Anxiety and Depression Scale (HADS), and Decisional Conflict Scale (DCS) between intervention and control groups.
Treatment:
Behavioral: nurse-led communication strategy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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