- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03770481
Using a Nurse-Led Communication Strategy for Surrogates in the Intensive Care Unit
Using a Nurse-Led Communication Strategy to Improve Surrogates' Perception of Communication in the Intensive Care Unit
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14203
- Buffalo General Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Assess the NLCS' feasibility
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. |
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.
|
Experimental: Assess the NLCS' acceptability
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). |
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.
|
Experimental: Assess the NLCS' preliminary effects
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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)
Time Frame: During ICU stay, approximately 5 days
|
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.
Time Frame: During ICU stay, approximately 5 days
|
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.
Time Frame: During ICU stay, approximately 5 days
|
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.
Time Frame: During ICU stay, approximately 5 days
|
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
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1 F31 NR018584-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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