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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01878968
• Other study ID #: 13-06
• Status: Completed
• Phase: N/A
• First received: May 7, 2013
• Last updated: January 4, 2016
• Start date: April 2013
• Est. completion date: November 2014

Study information

• Verified date: January 2016
• Source: Jewish Hospital, Cincinnati, Ohio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Congestive Heart Failure
• Heart Failure
• Infections
• Sepsis
• Stroke

Intervention

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.

Locations

Country	Name	City	State
United States	The Jewish Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Jewish Hospital, Cincinnati, Ohio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients opting out of routine care - no intubation	Number of patients in each group who opt out of intubation 48 hours after admission.	48 hours	No
Primary	Number of patients opting out of routine care - no CPR	Number of patients in each group who opt out of CPR within 48 hours of admission.	48 hours	No
Secondary	Hospital Mortality	Number of deaths in each group in the hospital	Length of patient's hospital stay	No
Secondary	30-day mortality	Number of deaths in each group after 30 days.	30 days	No
Secondary	90 day mortality	Number of deaths in each group in 90 days.	90 days	No
Secondary	Number of patients undergoing CPR	Number of patients in each group who undergo CPR during their hospitalization.	Length of patient's hospital stay	No
Secondary	Number of patients undergoing intubation	Number of patients in each group who undergo intubation during their hospital stay.	Length of patient's hospital stay	No