Clinical trial NCT04896411: Choice of Diction's Effect
Official title: Choice Of Diction's Effect: Effects in No Code Phrasing on Code Status Discussions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Communication
Advance Directives
Decision Making
Cardiopulmonary Resuscitation
Keywords: Older Adult
Allow a Natural Death
Do Not Resuscitate
Resuscitation Decisions
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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)

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

Eligibility criteria: 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

Primary outcomes:
measure: Code Status Selection
timeFrame: Immediately collected after consent and randomization into a study arm
Secondary outcomes:
measure: Participant Satisfaction with Decision
timeFrame: Immediately collected after consent and randomization into a study arm
measure: Length of Conversation
timeFrame: Immediately collected after consent and randomization into a study arm
Other outcomes:
measure: Durability of Code Status Decision In the Study Arms at 6 Months (Assessed by Asking Code Status Using the Intervention Phrase Again)
timeFrame: At approximately 6 months, patients will receive a follow-up phone call to determine this
measure: Information That May Modify Outcomes 1-4
timeFrame: 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
Locations:
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital, New Brunswick
state: New Jersey
Study officials:
affiliation: Rutgers Robert Wood Johnson Medical School
name: Karthik Kota, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: