Communication ResearchNCT03770481
Using a Nurse-Led Communication Strategy for Surrogates in the Intensive Care Unit
A study testing nurse-led communication strategy in people with Communication Research, run by State University of New York at Buffalo at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication Research
- What is being tested?
- nurse-led communication strategy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2020to 28 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Buffalo General Medical Center
Buffalo, New York, 14203
About this study
Official title: Using a Nurse-Led Communication Strategy to Improve Surrogates' Perception of Communication in the Intensive Care Unit
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.
Read the detailed 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.
- Conditions
- Communication Research
- Being tested
- nurse-led communication strategy
- Keywords
- communication, end-of-life, intensive care unit
- Medical subject headings
- Communication, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse-led communication strategyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: 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. Receives: Behavioral: nurse-led communication strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: During ICU stay, approximately 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2018
- Study start1 Oct 2020
- Primary completion28 Feb 2021
- Study completion28 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Communication ResearchStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two-groups comparison study
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiahui Chen, State University of New York at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03770481
- Sponsor's protocol ID
- 00008241
- Status last verified
- Aug 2024
- First submitted
- 5 Dec 2018
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35802350
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using a Nurse-Led Communication Strategy to Improve Surrogates' Perception of Communication in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03770481
- Acronym / sponsor ID
- 00008241
- Conditions
- Communication Research
- Keywords
- communication, end-of-life, intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 28 Feb 2021 (actual)
- First posted
- 10 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Two-groups comparison study
| Arm | Type | Receives |
|---|---|---|
| Assess the NLCS' feasibility | Experimental | Behavioral: nurse-led communication strategyHypothesis: 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. |
| Assess the NLCS' acceptability | Experimental | Behavioral: nurse-led communication strategyHypothesis: 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). |
| Assess the NLCS' preliminary effects | Experimental | Behavioral: nurse-led communication strategyHypothesis: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients
- Surrogates
Key exclusion criteria (8 listed)
- Patients
- Surrogates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nurse-led communication strategyNurse-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. | Behavioural | Assess the NLCS' acceptability, Assess the NLCS' feasibility, Assess the NLCS' preliminary effects |
Primary outcome
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.
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.
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.
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.
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Derived from this study: PubMed 35802350Ryan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurse-led communication strategy in people with Communication Research, run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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) (time frame: During ICU stay, approximately 5 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03770481, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.