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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?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01878968
Enrollment
200
Registered
2013-06-17
Start date
2013-04-30
Completion date
2014-11-30
Last updated
2016-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure, Congestive Heart Failure, Infections, Sepsis, Stroke

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.

Interventions

OTHERScript 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.

Sponsors

Jewish Hospital, Cincinnati, Ohio
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of patients opting out of routine care - no intubation48 hoursNumber of patients in each group who opt out of intubation 48 hours after admission.
Number of patients opting out of routine care - no CPR48 hoursNumber of patients in each group who opt out of CPR within 48 hours of admission.

Secondary

MeasureTime frameDescription
90 day mortality90 daysNumber of deaths in each group in 90 days.
Hospital MortalityLength of patient's hospital stayNumber of deaths in each group in the hospital
Number of patients undergoing intubationLength of patient's hospital stayNumber of patients in each group who undergo intubation during their hospital stay.
Number of patients undergoing CPRLength of patient's hospital stayNumber of patients in each group who undergo CPR during their hospitalization.
30-day mortality30 daysNumber of deaths in each group after 30 days.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026