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

Not Applicable

Completed

• Conditions: Congestive Heart Failure; Acute Renal Failure; Infections; Sepsis; Stroke
• Interventions: Other: Script and CPR/Mechanical ventilation video.

• Registration Number: NCT01878968
• Lead Sponsor: Jewish Hospital, Cincinnati, Ohio

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-05-07
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-17
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-04
• Last Update Posted: 2016-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Script and Video	Script and CPR/Mechanical ventilation 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.
Script only	Script and CPR/Mechanical ventilation video.	Patients in the Script only arm will receive information on CPR and mechanical ventilation via a script only.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Hospital Mortality	Length of patient's hospital stay	Number of deaths in each group in the hospital
Number of patients undergoing intubation	Length of patient's hospital stay	Number of patients in each group who undergo intubation during their hospital stay.

Trial Locations

Locations (1)

The Jewish Hospital; 🇺🇸 Cincinnati, Ohio, United States