Choice of Diction's Effect

NCT04896411 | Unknown

• 1 other identifier: Pro2020002188
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

Communication; Advance Directives; Decision Making; Cardiopulmonary Resuscitation

Keywords

Older Adult; Allow a Natural Death; Do Not Resuscitate; Resuscitation Decisions

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Participant Satisfaction with Decision

  Immediately collected after consent and randomization into a study arm

• Length of Conversation

  Immediately collected after consent and randomization into a study arm

Other Outcomes (2)

• 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

• 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

Study Arms (2)

Alternative Phrase

EXPERIMENTAL

This arm will have the code status question randomized to offer CPR vs the alternative phrase

Other: Alternative phrasing for no code

Standard of care phrase

ACTIVE COMPARATOR

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

Interventions

Alternative phrasing for no code OTHER

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

Alternative Phrase

Standard of care for no code OTHER

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

Standard of care phrase

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (1)

Robert Wood Johnson University Hospital, New Brunswick

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Communication

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Karthik Kota, MD MPH

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karthik Kota, MD MPH

CONTACT

732-235-7122; karthik.kota@rutgers.edu

Michael Steinberg, MD MPH

CONTACT

732-235-7122; steinbmb@rwjms.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 21, 2021
• Study Start: August 9, 2021
• Primary Completion: August 8, 2022
• Study Completion: February 8, 2023
• Last Updated: April 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)