CommunicationCODENCT04896411
Choice of Diction's Effect
A study testing Alternative phrasing for no code in people with Communication and Advance Directives, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The purpose of the research is to determine how the language used when discussing preferences about cardiopulmonary resuscitation (CPR) affects decisions regarding this (code status) Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication, Advance Directives, Decision Making
- What is being tested?
- Alternative phrasing for no code
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2021to 8 Feb 2023
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 65 or older
- English-fluency in reading and speaking
- Capacity to consent
Who cannot join
- Unstable psychiatric illness
- Unstable/critically ill patients requiring ICU-level care
- Active substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Robert Wood Johnson University Hospital, New Brunswick
New Brunswick, New Jersey, 08901
Karthik J Kota, MD MPH, 732-235-7112
About this study
Official title: Choice Of Diction's Effect: Effects in No Code Phrasing on Code Status Discussions
The purpose of the research is to determine how the language used when discussing preferences about cardiopulmonary resuscitation (CPR) affects decisions regarding this (code status)
Read the detailed description
Most Americans express a preference for dying at home naturally and surrounded by loved ones. However, many also believe that cardiopulmonary resuscitation (CPR) is more effective than it is, and want to have CPR even when the chances for a good outcome is poor. Among other reasons, the alternative term (Do Not Resuscitate, or DNR) has been shown in the literature to be associated by patients with passive, sub-optimal, and low quality care.
This study will attempt to determine patient preference for the "no CPR" term on patients admitted to the hospital using alternate phrasing. During admission to the Medical Teaching Service, patients over the age of 65 who are able to consent and who are not critically ill/unstable will be approached. After checking brief background questions (such as if they ever had discussions like these before), they will be randomized into two groups and asked code status using one of the two phrases. This question will determine the patient's "code status;" asking for this is a routine part of hospitalized care that is required by law (the exact terminology is left to the care team). After determining the patient's code status, they will be asked how satisfied they were with the decision; the investigator will be asked if they agree with the decision separately. Demographic and clinical information will be collected. Six months later, the patient will be contacted again; at this time, they will be asked about recent life and health changes. Finally, they will be asked their code status one more time. This will conclude the participant's involvement in the study
- Being tested
- Alternative phrasing for no code, Standard of care for no code
- Keywords
- Older Adult, Allow a Natural Death, Do Not Resuscitate, Resuscitation Decisions
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternative phrasing for no codeOther
This intervention will use the alternative phrase noted in the literature when discussing code status. This will be the only intervention, and all other aspects of trial participation will be collection of data
Standard of care for no codeOther
This intervention will use the standard of care phrase noted in the literature when discussing code status. This will be the only intervention, and all other aspects of trial participation will be collection of data
| Study group | Role | What they receive |
|---|---|---|
| Alternative Phrase | Experimental | This arm will have the code status question randomized to offer CPR vs the alternative phrase Receives: Other: Alternative phrasing for no code |
| Standard of care phrase | Active comparator | This arm will have the code status question randomized to offer CPR vs the standard of care phrase Receives: Other: Standard of care for no code |
What is being measured
The primary outcome is the main question the study is designed to answer.
Code Status Selection
Selection of "code" versus "no code" decision depending on phrasing used, stratified by GO-FAR calculation
Measured: Immediately collected after consent and randomization into a study arm
Secondary outcomes (2)
Participant Satisfaction with Decision
Determine patient satisfaction of, and provider agreement with, code discussion. The former will be measured using a modified Satisfaction with Decision Scale, a six-item Likert scale indicating agreement or not with the statements provided. The latter will be determined by asking the physician if they agree (yes/no/unsure)
Measured: Immediately collected after consent and randomization into a study arm
Length of Conversation
Determine whether there is a difference of conversation length between phrasing groups (measured in minutes)
Measured: Immediately collected after consent and randomization into a study arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2021
- Study start9 Aug 2021
- Primary completion8 Aug 2022 (estimated)
- Study completion8 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CommunicationStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karthik Joshua Kota, MD MPH, Rutgers, The State University of New Jersey
- Investigators
- Karthik Kota, MD MPH, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04896411
- Sponsor's protocol ID
- Pro2020002188
- Acronym
- CODE
- Status last verified
- Apr 2022
- First submitted
- 11 May 2021
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual patient data will be shared
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Choice Of Diction's Effect: Effects in No Code Phrasing on Code Status Discussions
- ClinicalTrials.gov ID
- NCT04896411
- Acronym / sponsor ID
- CODE / Pro2020002188
- Keywords
- Older Adult, Allow a Natural Death, Do Not Resuscitate, Resuscitation Decisions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 8 Aug 2022 (estimated)
- Study completion
- 8 Feb 2023 (estimated)
- First posted
- 21 May 2021 (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.
The purpose of the research is to determine how the language used when discussing preferences about cardiopulmonary resuscitation (CPR) affects decisions regarding this (code status)
Detailed description
Most Americans express a preference for dying at home naturally and surrounded by loved ones. However, many also believe that cardiopulmonary resuscitation (CPR) is more effective than it is, and want to have CPR even when the chances for a good outcome is poor. Among other reasons, the alternative term (Do Not Resuscitate, or DNR) has been shown in the literature to be associated by patients with passive, sub-optimal, and low quality care.
This study will attempt to determine patient preference for the "no CPR" term on patients admitted to the hospital using alternate phrasing. During admission to the Medical Teaching Service, patients over the age of 65 who are able to consent and who are not critically ill/unstable will be approached. After checking brief background questions (such as if they ever had discussions like these before), they will be randomized into two groups and asked code status using one of the two phrases. This question will determine the patient's "code status;" asking for this is a routine part of hospitalized care that is required by law (the exact terminology is left to the care team). After determining the patient's code status, they will be asked how satisfied they were with the decision; the investigator will be asked if they agree with the decision separately. Demographic and clinical information will be collected. Six months later, the patient will be contacted again; at this time, they will be asked about recent life and health changes. Finally, they will be asked their code status one more time. This will conclude the participant's involvement in the study
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternative Phrase | Experimental | Other: Alternative phrasing for no codeThis arm will have the code status question randomized to offer CPR vs the alternative phrase |
| Standard of care phrase | Active comparator | Other: Standard of care for no codeThis arm will have the code status question randomized to offer CPR vs the standard of care phrase |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 or older
- English-fluency in reading and speaking
- Capacity to consent
Key exclusion criteria (3 listed)
- Unstable psychiatric illness
- Unstable/critically ill patients requiring ICU-level care
- Active substance abuse
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 |
|---|---|---|
| Alternative phrasing for no codeThis intervention will use the alternative phrase noted in the literature when discussing code status. This will be the only intervention, and all other aspects of trial participation will be collection of data | Other | Alternative Phrase |
| Standard of care for no codeThis intervention will use the standard of care phrase noted in the literature when discussing code status. This will be the only intervention, and all other aspects of trial participation will be collection of data | Other | Standard of care phrase |
Primary outcome
Code Status Selection
Time frame: Immediately collected after consent and randomization into a study arm
Selection of "code" versus "no code" decision depending on phrasing used, stratified by GO-FAR calculation
2 secondary outcomes
Participant Satisfaction with Decision
Time frame: Immediately collected after consent and randomization into a study arm
Length of Conversation
Time frame: Immediately collected after consent and randomization into a study arm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: No. No individual patient data will be shared
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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.
Karthik Kota, MD MPH principal investigator
Rutgers Robert Wood Johnson Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternative phrasing for no code in people with Communication and Advance Directives, run by Rutgers, The State University of New Jersey 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 25 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karthik Kota, MD MPH (732-235-7122, karthik.kota@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Code Status Selection (time frame: Immediately collected after consent and randomization into a study arm). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2022.