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

NCT ID: NCT01878968

Last Updated: 2016-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-11-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Script and CPR/Mechanical ventilation video.

Intervention Type: OTHER

Patients will be randomized to receive the script (see addendum) plus video. Video was produced by and is the property of the study investigators.

Script only

Patients in the Script only arm will receive information on CPR and mechanical ventilation via a script only.

Group Type: EXPERIMENTAL

Script and CPR/Mechanical ventilation video.

Intervention Type: OTHER

Patients will be randomized to receive the script (see addendum) plus video. Video was produced by and is the property of the study investigators.

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jewish Hospital, Cincinnati, Ohio

OTHER

Sponsor Role: lead

Responsible Party

Imran Naqvi

Chief Hospitalist, Associate Program Director Internal Medicine Residency

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Imran Naqvi, MD

Role: PRINCIPAL_INVESTIGATOR

Jewish Hospital of Cincinnati

Locations

The Jewish Hospital

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

13-06

Identifier Type: -

Identifier Source: org_study_id