Back to resultsDoes Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?
Primary Purpose
Congestive Heart Failure, Infections, Sepsis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Script and CPR/Mechanical ventilation video.
Sponsored by
About this trial
This is an interventional health services research trial for Congestive Heart Failure
Eligibility Criteria
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
Sites / Locations
- The Jewish Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Script and Video
Script only
Arm Description
Patients in the Script and CPR/Mechanical ventilation video arm will receive information on CPR and mechanical ventilation via a script and a video.
Patients in the Script only arm will receive information on CPR and mechanical ventilation via a script only.
Outcomes
Primary Outcome Measures
Number of patients opting out of routine care - no intubation
Number of patients in each group who opt out of intubation 48 hours after admission.
Number of patients opting out of routine care - no CPR
Number of patients in each group who opt out of CPR within 48 hours of admission.
Secondary Outcome Measures
Hospital Mortality
Number of deaths in each group in the hospital
30-day mortality
Number of deaths in each group after 30 days.
90 day mortality
Number of deaths in each group in 90 days.
Number of patients undergoing CPR
Number of patients in each group who undergo CPR during their hospitalization.
Number of patients undergoing intubation
Number of patients in each group who undergo intubation during their hospital stay.
Full Information
NCT ID
NCT01878968
First Posted
May 7, 2013
Last Updated
January 4, 2016
Sponsor
Jewish Hospital, Cincinnati, Ohio
1. Study Identification
Unique Protocol Identification Number
NCT01878968
Brief Title
Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?
Official Title
Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jewish Hospital, Cincinnati, Ohio
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Infections, Sepsis, Acute Renal Failure, Stroke
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Script and Video
Arm Type
Experimental
Arm Description
Patients in the Script and CPR/Mechanical ventilation video arm will receive information on CPR and mechanical ventilation via a script and a video.
Arm Title
Script only
Arm Type
Experimental
Arm Description
Patients in the Script only arm will receive information on CPR and mechanical ventilation via a script only.
Intervention Type
Other
Intervention Name(s)
Script and CPR/Mechanical ventilation video.
Intervention Description
Patients will be randomized to receive the script (see addendum) plus video. Video was produced by and is the property of the study investigators.
Primary Outcome Measure Information:
Title
Number of patients opting out of routine care - no intubation
Description
Number of patients in each group who opt out of intubation 48 hours after admission.
Time Frame
48 hours
Title
Number of patients opting out of routine care - no CPR
Description
Number of patients in each group who opt out of CPR within 48 hours of admission.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Hospital Mortality
Description
Number of deaths in each group in the hospital
Time Frame
Length of patient's hospital stay
Title
30-day mortality
Description
Number of deaths in each group after 30 days.
Time Frame
30 days
Title
90 day mortality
Description
Number of deaths in each group in 90 days.
Time Frame
90 days
Title
Number of patients undergoing CPR
Description
Number of patients in each group who undergo CPR during their hospitalization.
Time Frame
Length of patient's hospital stay
Title
Number of patients undergoing intubation
Description
Number of patients in each group who undergo intubation during their hospital stay.
Time Frame
Length of patient's hospital stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imran Naqvi, MD
Organizational Affiliation
Jewish Hospital of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Jewish Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?
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