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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Imran Naqvi, Jewish Hospital, Cincinnati, Ohio
ClinicalTrials.gov Identifier:
NCT01878968
First received: May 7, 2013
Last updated: October 29, 2013
Last verified: June 2013

May 7, 2013
October 29, 2013
April 2013
October 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
  • 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 ]
Same as current
Complete list of historical versions of study NCT01878968 on ClinicalTrials.gov Archive Site
Not Provided
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 intervention or routine care. The intervention is a scripted discussion (see addendum) AND a 3 minute video produced at Harvard for similar studies that depicts CPR and mechanical ventilation that will be delivered by study staff in the first 24 hours of admission. The video showing CPR and MV is open to the public and has been used in several similar published informed consent studies: http://www.acpdecisions.org/videos/generic-cpr/
  • No Intervention: Control Group
    Patients remain full code, or 'routine care'.
  • Experimental: Intervention - changed code status
    Patients who watch CPR mechanical ventilation video and hear script that changed their code status.
    Intervention: Other: Script and CPR/Mechanical ventilation video.
  • Experimental: Intervention - remained full code
    Patients who watched video and heard script that wish to remain full code.
    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.
 
Active, not recruiting
100
Not Provided
October 2013   (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 information is only displayed when the study is recruiting subjects
United States
 
NCT01878968
13-06
No
Imran Naqvi, Jewish Hospital, Cincinnati, Ohio
Jewish Hospital, Cincinnati, Ohio
Not Provided
Not Provided
Jewish Hospital, Cincinnati, Ohio
June 2013

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