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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2014 by Jewish Hospital, Cincinnati, Ohio
Sponsor:
Information provided by (Responsible Party):
Imran Naqvi, Jewish Hospital, Cincinnati, Ohio
ClinicalTrials.gov Identifier:
NCT01878968
First received: May 7, 2013
Last updated: August 22, 2014
Last verified: August 2014

May 7, 2013
August 22, 2014
April 2013
November 2014   (final data collection date for primary outcome measure)
  • Number of patients opting out of routine care - no intubation [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Number of patients in each group who opt out of CPR within 48 hours of admission.
  • Number of patients opting out of routine care - no mechanical ventilation [ Time Frame: Number assessed on day of admission (hospital day 1). ] [ Designated as safety issue: No ]
  • Number of patients opting out of routine care - no CPR. [ Time Frame: Number assessed on day of admission (hospital day 1). ] [ Designated as safety issue: No ]
  • Hospital length of stay [ Time Frame: Participants will be followed for the duration of the study, an average time period of 8 weeks. ] [ Designated as safety issue: No ]
  • ICU Days [ Time Frame: Assessed from first day of ICU transfer - participants will be followed until discharge or death, an expected average of 8 weeks. ] [ Designated as safety issue: No ]
  • Days on mechanical ventilation [ Time Frame: Day 1 of mechanical ventilation until day of extubation, an expected average of 8 weeks. ] [ Designated as safety issue: No ]
  • Hospital Mortality [ Time Frame: Number of deaths in each group. ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01878968 on ClinicalTrials.gov Archive Site
  • Hospital Mortality [ Time Frame: Length of patient's hospital stay ] [ Designated as safety issue: No ]
    Number of deaths in each group in the hospital
  • 30-day mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Number of deaths in each group after 30 days.
  • 90 day mortality [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Number of deaths in each group in 90 days.
  • Number of patients undergoing CPR [ Time Frame: Length of patient's hospital stay ] [ Designated as safety issue: No ]
    Number of patients in each group who undergo CPR during their hospitalization.
  • Number of patients undergoing intubation [ Time Frame: Length of patient's hospital stay ] [ Designated as safety issue: No ]
    Number of patients in each group who undergo intubation during their hospital stay.
Not Provided
Not Provided
Not Provided
 
Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?
Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
  • Congestive Heart Failure
  • Infections
  • Sepsis
  • Acute Renal Failure
  • Stroke
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 and CPR/Mechanical ventilation video.
Patients in the intervention arm will receive information on CPR and mechanical ventilation via a script and a video.
Intervention: Other: Script and CPR/Mechanical ventilation video.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
200
Not Provided
November 2014   (final data collection date for primary outcome measure)

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
Both
65 Years and older
No
Contact: Imran R Naqvi, MD 5136865446 NaqviMD@gmail.com
Contact: Caitlyn Richardson-Royer, MD 5135354997 c.richardson.royer@gmail.com
United States
 
NCT01878968
13-06
No
Imran Naqvi, Jewish Hospital, Cincinnati, Ohio
Jewish Hospital, Cincinnati, Ohio
Not Provided
Principal Investigator: Imran Naqvi, MD Jewish Hospital of Cincinnati
Jewish Hospital, Cincinnati, Ohio
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP