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

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Script and CPR/Mechanical ventilation video. Other
    Intervention Desc: Patients will be randomized to receive the script (see addendum) plus video. Video was produced by and is the property of the study investigators.
    ARM 1: Kind: Experimental
    Label: Intervention - changed code status
    Description: Patients who watch CPR mechanical ventilation video and hear script that changed their code status.
    ARM 2: Kind: Experimental
    Label: Intervention - remained full code
    Description: Patients who watched video and heard script that wish to remain full code.
    ARM 3: Kind: Experimental
    Label: Script and CPR/Mechanical ventilation video.
    Description: Patients in the intervention arm will receive information on CPR and mechanical ventilation via a script and a video.
    ARM 4: Kind: Experimental
    Label: Script and Video
    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 5: Kind: Experimental
    Label: Script only
    Description: Patients in the Script only arm will receive information on CPR and mechanical ventilation via a script only.

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Health Services Research
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Hospital length of stay Participants will be followed for the duration of the study, an average time period of 8 weeks. No
Primary ICU Days Assessed from first day of ICU transfer - participants will be followed until discharge or death, an expected average of 8 weeks. No
Primary Days on mechanical ventilation Day 1 of mechanical ventilation until day of extubation, an expected average of 8 weeks. No
Primary Hospital Mortality Number of deaths in each group. No
Primary Number of patients opting out of routine care - no CPR. Number assessed on day of admission (hospital day 1). No
Primary Number of patients opting out of routine care - no mechanical ventilation Number assessed on day of admission (hospital day 1). No
Primary Number of patients opting out of routine care - no intubation 48 hours No
Primary Number of patients opting out of routine care - no CPR 48 hours No
Secondary 30-day mortality 30 days No
Secondary 90 day mortality 90 days No
Secondary Number of patients undergoing CPR Length of patient's hospital stay No
Secondary Number of patients undergoing intubation Length of patient's hospital stay No

Sponsors