Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Number of patients opting out of routine care - no intubation [48 hours]
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 [48 hours]
Number of patients in each group who opt out of CPR within 48 hours of admission.
Secondary Outcome Measures
- Hospital Mortality [Length of patient's hospital stay]
Number of deaths in each group in the hospital
- 30-day mortality [30 days]
Number of deaths in each group after 30 days.
- 90 day mortality [90 days]
Number of deaths in each group in 90 days.
- Number of patients undergoing CPR [Length of patient's hospital stay]
Number of patients in each group who undergo CPR during their hospitalization.
- Number of patients undergoing intubation [Length of patient's hospital stay]
Number of patients in each group who undergo intubation during their hospital stay.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Jewish Hospital | Cincinnati | Ohio | United States | 45236 |
Sponsors and Collaborators
- Jewish Hospital, Cincinnati, Ohio
Investigators
- Principal Investigator: Imran Naqvi, MD, Jewish Hospital of Cincinnati
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 13-06