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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04896411
Other study ID # Pro2020002188
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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