Choice of Diction's Effect (CODE)

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)

Study Overview

• Status: Recruiting
• Conditions: Communication; Cardiopulmonary Resuscitation; Decision Making; Advance Directives
• Intervention / Treatment: Other: Alternative phrasing for no code; Other: Standard of care for no code

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karthik Kota, MD MPH; Phone Number: 732-235-7122; Email: karthik.kota@rutgers.edu
• Study Contact Backup: Name: Michael Steinberg, MD MPH; Phone Number: 732-235-7122; Email: steinbmb@rwjms.rutgers.edu

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08901
      • Recruiting
      • Robert Wood Johnson University Hospital, New Brunswick
      • Contact: Karthik J Kota, MD MPH; Phone Number: 732-235-7112

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alternative Phrase; This arm will have the code status question randomized to offer CPR vs the alternative phrase	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
Active Comparator: Standard of care phrase; This arm will have the code status question randomized to offer CPR vs the standard of care phrase	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Karthik Kota, MD MPH, Rutgers Robert Wood Johnson Medical School

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2021
• Primary Completion (Anticipated): August 8, 2022
• Study Completion (Anticipated): February 8, 2023

Study Registration Dates

• First Submitted: May 11, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 21, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Older Adult; Allow a Natural Death; Do Not Resuscitate; Resuscitation Decisions
• Other Study ID Numbers: Pro2020002188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual patient data will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No