Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?

January 4, 2016 updated by: Imran Naqvi, Jewish Hospital, Cincinnati, Ohio
There is evidence to suggest that patients make different end-of-life decisions if they understand the risks, benefits and alternatives of CPR and mechanical ventilation. This study will examine whether evidence-based informed consent impacts patients choices and healthcare outcomes compared to routine care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • The Jewish Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All patients
  • ≥65 yrs
  • Admitted to the hospitalist Medicine Service

Exclusion Criteria:

  • Patients who have pre-existing, pan-institutional (e.g. to be applied at nursing homes and hospitals) orders of no CPR and/or no mechanical ventilation will be screened (demographic and outcomes data collected) but NOT randomized.
  • Patients already receiving critical care on admission will also be excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Script and Video
Patients in the Script and CPR/Mechanical ventilation video arm will receive information on CPR and mechanical ventilation via a script and a video.
Other: Script and CPR/Mechanical ventilation video.
Patients will be randomized to receive the script (see addendum) plus video. Video was produced by and is the property of the study investigators.
Experimental: Script only
Patients in the Script only arm will receive information on CPR and mechanical ventilation via a script only.
Other: Script and CPR/Mechanical ventilation video.
Patients will be randomized to receive the script (see addendum) plus video. Video was produced by and is the property of the study investigators.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients opting out of routine care - no intubation
Time Frame: 48 hours
Number of patients in each group who opt out of intubation 48 hours after admission.
48 hours
Number of patients opting out of routine care - no CPR
Time Frame: 48 hours
Number of patients in each group who opt out of CPR within 48 hours of admission.
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Mortality
Time Frame: Length of patient's hospital stay
Number of deaths in each group in the hospital
Length of patient's hospital stay
30-day mortality
Time Frame: 30 days
Number of deaths in each group after 30 days.
30 days
90 day mortality
Time Frame: 90 days
Number of deaths in each group in 90 days.
90 days
Number of patients undergoing CPR
Time Frame: Length of patient's hospital stay
Number of patients in each group who undergo CPR during their hospitalization.
Length of patient's hospital stay
Number of patients undergoing intubation
Time Frame: Length of patient's hospital stay
Number of patients in each group who undergo intubation during their hospital stay.
Length of patient's hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jewish Hospital, Cincinnati, Ohio

Investigators

  • Principal Investigator: Imran Naqvi, MD, Jewish Hospital of Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

November 1, 2014

Study Registration Dates

First Submitted

May 7, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 17, 2013

Study Record Updates

Last Update Posted (Estimate)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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