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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Imran Naqvi, Jewish Hospital, Cincinnati, Ohio
ClinicalTrials.gov Identifier:
NCT01878968
First received: May 7, 2013
Last updated: April 7, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention
Congestive Heart Failure
Infections
Sepsis
Acute Renal Failure
Stroke
Other: Script and CPR/Mechanical ventilation video.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Does Detailed Informed Consent for Cardiopulmonary Resuscitation and Mechanical Ventilation Impact Patients' Decisions and Outcomes?

Resource links provided by NLM:


Further study details as provided by Jewish Hospital, Cincinnati, Ohio:

Primary Outcome Measures:
  • Number of patients opting out of routine care - no intubation [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
    Number of patients in each group who opt out of CPR within 48 hours of admission.


Secondary Outcome Measures:
  • Hospital Mortality [ Time Frame: Length of patient's hospital stay ] [ Designated as safety issue: No ]
    Number of deaths in each group in the hospital

  • 30-day mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Number of deaths in each group after 30 days.

  • 90 day mortality [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    Number of deaths in each group in 90 days.

  • Number of patients undergoing CPR [ Time Frame: Length of patient's hospital stay ] [ Designated as safety issue: No ]
    Number of patients in each group who undergo CPR during their hospitalization.

  • Number of patients undergoing intubation [ Time Frame: Length of patient's hospital stay ] [ Designated as safety issue: No ]
    Number of patients in each group who undergo intubation during their hospital stay.


Enrollment: 200
Study Start Date: April 2013
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Experimental: Script only
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.
Patients will be randomized to receive the script (see addendum) plus video. Video was produced by and is the property of the study investigators.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01878968

Locations
United States, Ohio
The Jewish Hospital
Cincinnati, Ohio, United States, 45236
Sponsors and Collaborators
Jewish Hospital, Cincinnati, Ohio
Investigators
Principal Investigator: Imran Naqvi, MD Jewish Hospital of Cincinnati
  More Information

No publications provided

Responsible Party: Imran Naqvi, Chief Hospitalist, Associate Program Director Internal Medicine Residency, Jewish Hospital, Cincinnati, Ohio
ClinicalTrials.gov Identifier: NCT01878968     History of Changes
Other Study ID Numbers: 13-06
Study First Received: May 7, 2013
Last Updated: April 7, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Acute Kidney Injury
Heart Failure
Cardiovascular Diseases
Heart Diseases
Kidney Diseases
Renal Insufficiency
Urologic Diseases

ClinicalTrials.gov processed this record on August 30, 2015