<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03770481</url>
  </required_header>
  <id_info>
    <org_study_id>1 F31 NR018584-01</org_study_id>
    <nct_id>NCT03770481</nct_id>
  </id_info>
  <brief_title>Using a Nurse-Led Communication Strategy for Surrogates in the Intensive Care Unit</brief_title>
  <official_title>Using a Nurse-Led Communication Strategy to Improve Surrogates' Perception of Communication in the Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>State University of New York at Buffalo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>State University of New York at Buffalo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Communication is one of the greatest health needs for high quality end-of-life (EOL) care in&#xD;
      the intensive care unit (ICU), especially when patients are too ill to speak for themselves&#xD;
      and rely on surrogates to make EOL decisions. Yet, there is no effective nursing intervention&#xD;
      designed to improve communication between surrogates and clinicians. In order to enhance&#xD;
      understanding of the surrogates' needs in the transition to EOL, this study will propose a&#xD;
      new theory-grounded communication intervention, Nurse-Led Communication Strategy (NLCS) and&#xD;
      will evaluate its feasibility, acceptability, and preliminary effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: In 2014, 14.7% of Americans died using intensive care unit (ICU) services. It is&#xD;
      a clinical imperative to provide high quality EOL care. Strong communication with surrogates&#xD;
      is vital for high quality EOL care due to the fact that seriously ill patients often cannot&#xD;
      talk, and they rely on surrogates (often family members) to make EOL decisions. There have&#xD;
      been many studies conducted in the past, trying to improve EOL communication. Yet, evidence&#xD;
      shows that communication remains poor in the ICU. To date, there is lack of evidence for a&#xD;
      particular nursing strategy that effectively improves communication and the quality of EOL&#xD;
      care in the ICU. The goal of this proposed study is to develop a new nurse-led communication&#xD;
      strategy (NLCS). Specific Aim: To assess the NLCS's feasibility, acceptability, and&#xD;
      preliminary effects among surrogates of patients who are unable to communicate in the ICU.&#xD;
      Theory: NLCS is grounded in the state-of-the art framework &quot;COMFORT&quot; which has guided a&#xD;
      validated and effective communication training for nurses in the care of patients with&#xD;
      life-threatening illness and their families. NLCS applies 'COMFORT' into a usable nursing&#xD;
      communication strategy that research nurses use the framework to engage one communication&#xD;
      session per day with surrogates during the ICU stay. Methods: A single-center pilot&#xD;
      two-groups comparison study. The study design involves the recruitment of surrogates in the&#xD;
      ICU to evaluate the feasibility, acceptability, and preliminary effects of the NLCS.&#xD;
      Analysis: To assess feasibility, we will use descriptive statistics and a COSORT&#xD;
      (Consolidated Standards of Reporting Trials) flow diagram to determine recruitment and&#xD;
      attrition. For acceptability, we will use an unpaired (independent) t test to compare the&#xD;
      scores of the Client Satisfaction Questionnaire (CSQ-8)and between intervention and control&#xD;
      groups. To evaluate preliminary effects of the intervention, we will compare the pre- and&#xD;
      post-test scores of the Quality of Communication (QOC) questionnaire, Hospital Anxiety and&#xD;
      Depression Scale (HADS), and Decisional Conflict Scale (DCS) between intervention and control&#xD;
      groups. It determines whether the NLCS is perceived as appropriate, acceptable, and&#xD;
      potentially effective. The by-product analysis uses a linear regression to determine which&#xD;
      factors are associated with the scores of the . This proposal provides an opportunity for the&#xD;
      first time to develop a theory-grounded nursing communication strategy that is feasible,&#xD;
      acceptable, and poses low cognitive load for surrogates in the ICU, and it enhances the&#xD;
      understanding of surrogates' needs in the transition to EOL and thereby potentially improves&#xD;
      the quality of EOL care. This research training will take place at the University at Buffalo&#xD;
      School of Nursing, an exceptional research-intensive university, under the mentorship of Dr.&#xD;
      Chang and Dr. Lorenz (methodology), Dr. Sullivan (EOL studies), and Dr. Wittenberg&#xD;
      (communication theory). The training plan will provide the investigator with research skills&#xD;
      and the preliminary data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">February 28, 2021</completion_date>
  <primary_completion_date type="Actual">February 28, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Two-groups comparison study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rates of enrollment and drop-outs between intervention group (surrogates receive nurse-led communication strategy) and control group (surrogates receive treatment as usual communication)</measure>
    <time_frame>During ICU stay, approximately 5 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>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)</measure>
    <time_frame>During ICU stay, approximately 5 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pre- and post-intervention scores of the Quality of Communication (QOC) questionnaire between intervention group and control group.</measure>
    <time_frame>During ICU stay, approximately 5 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pre- and post-intervention scores of the Hospital Anxiety and Depression Scale (HADS) between intervention group and control group.</measure>
    <time_frame>During ICU stay, approximately 5 days</time_frame>
    <description>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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pre- and post-intervention scores of the Decisional Conflict Scale (DCS) between intervention group and control group.</measure>
    <time_frame>During ICU stay, approximately 5 days</time_frame>
    <description>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).</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Communication Research</condition>
  <arm_group>
    <arm_group_label>Assess the NLCS' feasibility</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hypothesis: No significant differences will be observed in recruitment and attrition between NLCS intervention and control groups.&#xD;
Approach: Determine rates of enrollment and drop-outs between groups.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Assess the NLCS' acceptability</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Hypothesis: More surrogates agree that the NLCS is suitable, appropriate, effective and willing to adhere versus treatment as usual (TAU) communication.&#xD;
Approach: Assess outcome using the validated instrument, Client Satisfaction Questionnaire (CSQ-8).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Assess the NLCS' preliminary effects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>nurse-led communication strategy</intervention_name>
    <description>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.</description>
    <arm_group_label>Assess the NLCS' acceptability</arm_group_label>
    <arm_group_label>Assess the NLCS' feasibility</arm_group_label>
    <arm_group_label>Assess the NLCS' preliminary effects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients&#xD;
&#xD;
               1. Age ≥ 18 years&#xD;
&#xD;
               2. in the ICU for &gt; 24 hours&#xD;
&#xD;
               3. Mechanically ventilated within 24 hours of ICU admission&#xD;
&#xD;
               4. Having an Acute Physiology and Chronic Health Evaluation (APACHE) IV ICU&#xD;
                  mortality prediction ≥ 20%&#xD;
&#xD;
          -  Surrogates&#xD;
&#xD;
               1. Age ≥ 18 years&#xD;
&#xD;
               2. A legal New York State healthcare proxy documentation or A Family Health Care&#xD;
                  Decision Act (FHCDA) consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients&#xD;
&#xD;
               1. Decease or discharge from ICU within 24 hours&#xD;
&#xD;
               2. Mechanically ventilated after 24 hours of ICU stay&#xD;
&#xD;
               3. Able to communicate and make own decision&#xD;
&#xD;
               4. Lack of a legal surrogate/proxy decision-maker to consent for patient&#xD;
                  participation&#xD;
&#xD;
          -  Surrogates&#xD;
&#xD;
               1. Lack of legal surrogate documentation&#xD;
&#xD;
               2. Not able to complete consent process and questionnaires in English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Buffalo General Medical Center</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>August 14, 2023</last_update_submitted>
  <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>communication</keyword>
  <keyword>end-of-life</keyword>
  <keyword>intensive care unit</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03770481
org study id: 1 F31 NR018584-01
nct id: NCT03770481
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Two-groups comparison study
primary purpose: Supportive Care
masking: Double (Participant, Care Provider)
measure: Rates of enrollment and drop-outs between intervention group (surrogates receive nurse-led communication strategy) and control group (surrogates receive treatment as usual communication)
time frame: During ICU stay, approximately 5 days
description: 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.
measure: 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)
time frame: During ICU stay, approximately 5 days
description: 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.
measure: Pre- and post-intervention scores of the Quality of Communication (QOC) questionnaire between intervention group and control group.
time frame: During ICU stay, approximately 5 days
description: 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.
measure: Pre- and post-intervention scores of the Hospital Anxiety and Depression Scale (HADS) between intervention group and control group.
time frame: During ICU stay, approximately 5 days
description: 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.
measure: Pre- and post-intervention scores of the Decisional Conflict Scale (DCS) between intervention group and control group.
time frame: During ICU stay, approximately 5 days
description: 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).
arm group label: Assess the NLCS' feasibility
arm group type: Experimental
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.
arm group label: Assess the NLCS' acceptability
arm group type: Experimental
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).
arm group label: Assess the NLCS' preliminary effects
arm group type: Experimental
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.
intervention type: Behavioral
intervention name: nurse-led communication strategy
description: 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.
arm group label: Assess the NLCS' acceptability
arm group label: Assess the NLCS' feasibility
arm group label: Assess the NLCS' preliminary effects
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No