Choice of Diction's Effect

Communication Clinical Trial

— CODE  

Official title:

Choice Of Diction's Effect: Effects in No Code Phrasing on Code Status Discussions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04896411
• Other study ID #: Pro2020002188
• Status: Recruiting
• Phase: N/A
• Start date: August 9, 2021
• Est. completion date: February 8, 2023

Study information

• Verified date: April 2022
• Source: Rutgers, The State University of New Jersey
• Contact: Karthik Kota, MD MPH
• Phone: 732-235-7122
• Email: karthik.kota[@]rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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)

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 8, 2023
• Est. primary completion date: August 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 65 or older
• English-fluency in reading and speaking
• Capacity to consent

Exclusion Criteria:

• Unstable psychiatric illness
• Unstable/critically ill patients requiring ICU-level care
• Active substance abuse

Related Conditions & MeSH terms

• Advance Directives
• Cardiopulmonary Resuscitation
• Communication
• Decision Making

Intervention

Other:
• Alternative phrasing for no code
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 code
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

Locations

Country	Name	City	State
United States	Robert Wood Johnson University Hospital, New Brunswick	New Brunswick	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Durability of Code Status Decision In the Study Arms at 6 Months (Assessed by Asking Code Status Using the Intervention Phrase Again)	Determine whether the decision made for code status is durable between the two groups. Patients will again be asked their code status as in outcome 1 during a follow-up phone call (after information about new medical experiences/diagnoses and other code status discussions in the last six months is collected)	At approximately 6 months, patients will receive a follow-up phone call to determine this
Other	Information That May Modify Outcomes 1-4	To assess the possibility of other factors modifying the above outcomes, this study will collect additional information. Initially, we will ask about history of prior code status discussion; general demographic information (e.g., income, religion, etc); medical history (including diagnoses, medications, and substance use). At follow-up, we will ask about recent hospitalizations, new medical problems/medications, life stressors (using the Holmes-Rahe Index), and further discussions about code status	Additional information collected "initially" will be at time of consent/randomization into the study arm; additional information collected at "follow-up" will be at approximately six months
Primary	Code Status Selection	Selection of "code" versus "no code" decision depending on phrasing used, stratified by GO-FAR calculation	Immediately collected after consent and randomization into a study arm
Secondary	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)	Immediately collected after consent and randomization into a study arm
Secondary	Length of Conversation	Determine whether there is a difference of conversation length between phrasing groups (measured in minutes)	Immediately collected after consent and randomization into a study arm