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

NCT01878968 | Completed

• 1 other identifier: 13-06
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (5)

• Hospital Mortality

  Length of patient's hospital stay

• 30-day mortality

  30 days

• 90 day mortality

  90 days

• Number of patients undergoing CPR

  Length of patient's hospital stay

• Number of patients undergoing intubation

  Length of patient's hospital stay

Study Arms (2)

Script and Video

EXPERIMENTAL

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.

Script only

EXPERIMENTAL

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.

Interventions

Script and CPR/Mechanical ventilation video. 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 and Video; Script only

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• All patients
• ≥65 yrs
• Admitted to the hospitalist Medicine Service

You may not qualify if:

• 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

Sponsors & Collaborators

• Jewish Hospital, Cincinnati, Ohio: lead

Study Sites (1)

The Jewish Hospital

Cincinnati, Ohio, 45236, United States

Location

MeSH Terms

Conditions

Heart Failure; Infections; Sepsis; Acute Kidney Injury; Stroke

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Study Officials

• Imran Naqvi, MD

  Jewish Hospital of Cincinnati

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Hospitalist, Associate Program Director Internal Medicine Residency

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: June 17, 2013
• Study Start: April 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: January 6, 2016

Record last verified: 2016-01

Locations

US (1)