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

NCT03770481 | Completed

• 1 other identifier: 00008241
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Communication Research

Keywords

communication; end-of-life; intensive care unit

Outcome Measures

Primary Outcomes (5)

• Rates of enrollment and drop-outs between intervention group (surrogates receive nurse-led communication strategy) and control group (surrogates receive treatment as usual communication)

  Feasibility is measured by the number and timing of actual versus planned recruitment. Checklist is used to calculate the weekly recruitment rate which is the ratio of the enrollment out of the total number screened. The dropout rate is used to examine attrition of the intervention.

  During ICU stay, approximately 5 days

• Scores of the Client Satisfaction Questionnaire (CSQ-8) between intervention group (surrogates receive nurse-led communication strategy) and control group (surrogates receive treatment as usual communication)

  All participants will complete the Client Satisfaction Questionnaire (CSQ-8) at the time of ICU discharge to assess the acceptability of Nurse-Led Communication Strategy (NLCS) and Treatment as Usual (TAU) communication. The CSQ-8 include eight items assessing whether the intervention is perceived as appropriate, acceptable, and effective in improving communication in the ICU and whether participants are willing to participate if a similar study is offered. Their responses are scored from 1 to 4, and thus the possible total scores range from 8 to 32. Higher scores indicate greater satisfaction.

  During ICU stay, approximately 5 days

• Pre- and post-intervention scores of the Quality of Communication (QOC) questionnaire between intervention group and control group.

  The QOC has 13 items with two subscales (general communication skill and end-of-life scales). Each item score ranged from 0 to 10. Higher score of QOC indicated a more favorable perception of physician-family communication.

  During ICU stay, approximately 5 days

• Pre- and post-intervention scores of the Hospital Anxiety and Depression Scale (HADS) between intervention group and control group.

  The HADS is a 14-item/4-point Likert self-administered scale and consists of two subscales (depression and anxiety). The subscale total scores range from 0 (no distress) to 21 (severe distress), and a score above 11 indicates clinically significant symptoms of anxiety or depression.

  During ICU stay, approximately 5 days

• Pre- and post-intervention scores of the Decisional Conflict Scale (DCS) between intervention group and control group.

  The Decisional Conflict Scale has 10 items with three subscales: (a) uncertainty in choosing options, (b) factors influencing uncertainty in decision making, and (c) effective decision making. The Decisional Conflict Scale been frequently used among surrogate decision makers to evaluated decisional conflict or uncertainty. The score ranges from 0 (no decisional conflict) to 100 (extremely high decisional conflict).

  During ICU stay, approximately 5 days

Study Arms (3)

Assess the NLCS' feasibility

EXPERIMENTAL

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.

Behavioral: nurse-led communication strategy

Assess the NLCS' acceptability

EXPERIMENTAL

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).

Behavioral: nurse-led communication strategy

Assess the NLCS' preliminary effects

EXPERIMENTAL

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.

Behavioral: nurse-led communication strategy

Interventions

nurse-led communication strategy BEHAVIORAL

Nurse-led communication strategy (NLCS) applies 'COMFORT' framework that research nurses use the framework to engage one communication session per day with surrogates and two discussions with bedside nurses or attending physician during the ICU stay.

Assess the NLCS' acceptability; Assess the NLCS' feasibility; Assess the NLCS' preliminary effects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients
• Age ≥ 18 years
• in the ICU for \> 24 hours
• Mechanically ventilated within 24 hours of ICU admission
• Having an Acute Physiology and Chronic Health Evaluation (APACHE) IV ICU mortality prediction ≥ 20%
• Surrogates
• Age ≥ 18 years
• A legal New York State healthcare proxy documentation or A Family Health Care Decision Act (FHCDA) consent

You may not qualify if:

• Patients
• Decease or discharge from ICU within 24 hours
• Mechanically ventilated after 24 hours of ICU stay
• Able to communicate and make own decision
• Lack of a legal surrogate/proxy decision-maker to consent for patient participation
• Surrogates
• Lack of legal surrogate documentation
• Not able to complete consent process and questionnaires in English

Sponsors & Collaborators

• State University of New York at Buffalo: lead

Study Sites (1)

Buffalo General Medical Center

Buffalo, New York, 14203, United States

Location

Related Publications (1)

• Ryan RE, Connolly M, Bradford NK, Henderson S, Herbert A, Schonfeld L, Young J, Bothroyd JI, Henderson A. Interventions for interpersonal communication about end of life care between health practitioners and affected people. Cochrane Database Syst Rev. 2022 Jul 8;7(7):CD013116. doi: 10.1002/14651858.CD013116.pub2.

  PMID: 35802350 DERIVED

MeSH Terms

Conditions

Communication; Death

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Two-groups comparison study

Study Record Dates

• First Submitted: December 5, 2018
• First Posted: December 10, 2018
• Study Start: October 1, 2020
• Primary Completion: February 28, 2021
• Study Completion: February 28, 2021
• Last Updated: August 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)