CODE: Choice of Diction's Effect

Sponsor
Rutgers, The State University of New Jersey (Other)
Overall Status
Recruiting
CT.gov ID
NCT04896411
Collaborator
(none)
100
1
2
18
5.6

Study Details

Study Description

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)

Condition or Disease Intervention/Treatment Phase
  • Other: Alternative phrasing for no code
  • Other: Standard of care for no code
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Choice Of Diction's Effect: Effects in No Code Phrasing on Code Status Discussions
Actual Study Start Date :
Aug 9, 2021
Anticipated Primary Completion Date :
Aug 8, 2022
Anticipated Study Completion Date :
Feb 8, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Code Status Selection [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

Secondary Outcome Measures

  1. Participant Satisfaction with Decision [Immediately collected after consent and randomization into a study arm]

    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)

  2. Length of Conversation [Immediately collected after consent and randomization into a study arm]

    Determine whether there is a difference of conversation length between phrasing groups (measured in minutes)

Other Outcome Measures

  1. Durability of Code Status Decision In the Study Arms at 6 Months (Assessed by Asking Code Status Using the Intervention Phrase Again) [At approximately 6 months, patients will receive a follow-up phone call to determine this]

    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)

  2. Information That May Modify Outcomes 1-4 [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]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Robert Wood Johnson University Hospital, New Brunswick New Brunswick New Jersey United States 08901

Sponsors and Collaborators

  • Rutgers, The State University of New Jersey

Investigators

  • Principal Investigator: Karthik Kota, MD MPH, Rutgers Robert Wood Johnson Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Karthik Joshua Kota, MD MPH, Instructor, Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT04896411
Other Study ID Numbers:
  • Pro2020002188
First Posted:
May 21, 2021
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Karthik Joshua Kota, MD MPH, Instructor, Rutgers, The State University of New Jersey

Study Results

No Results Posted as of Apr 25, 2022