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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Imran Naqvi, Jewish Hospital, Cincinnati, Ohio
ClinicalTrials.gov Identifier:
NCT01878968
First received: May 7, 2013
Last updated: October 29, 2013
Last verified: June 2013
  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:
  • Hospital length of stay [ Time Frame: Participants will be followed for the duration of the study, an average time period of 8 weeks. ] [ Designated as safety issue: No ]
  • ICU Days [ Time Frame: Assessed from first day of ICU transfer - participants will be followed until discharge or death, an expected average of 8 weeks. ] [ Designated as safety issue: No ]
  • Days on mechanical ventilation [ Time Frame: Day 1 of mechanical ventilation until day of extubation, an expected average of 8 weeks. ] [ Designated as safety issue: No ]
  • Hospital Mortality [ Time Frame: Number of deaths in each group. ] [ Designated as safety issue: No ]
  • Number of patients opting out of routine care - no CPR. [ Time Frame: Number assessed on day of admission (hospital day 1). ] [ Designated as safety issue: No ]
  • Number of patients opting out of routine care - no mechanical ventilation [ Time Frame: Number assessed on day of admission (hospital day 1). ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control Group
Patients remain full code, or 'routine care'.
Experimental: Intervention - changed code status
Patients who watch CPR mechanical ventilation video and hear script that changed their code status.
Other: Script and CPR/Mechanical ventilation video.
Patients will be randomized to receive the intervention or routine care. The intervention is a scripted discussion (see addendum) AND a 3 minute video produced at Harvard for similar studies that depicts CPR and mechanical ventilation that will be delivered by study staff in the first 24 hours of admission. The video showing CPR and MV is open to the public and has been used in several similar published informed consent studies: http://www.acpdecisions.org/videos/generic-cpr/
Experimental: Intervention - remained full code
Patients who watched video and heard script that wish to remain full code.
Other: Script and CPR/Mechanical ventilation video.
Patients will be randomized to receive the intervention or routine care. The intervention is a scripted discussion (see addendum) AND a 3 minute video produced at Harvard for similar studies that depicts CPR and mechanical ventilation that will be delivered by study staff in the first 24 hours of admission. The video showing CPR and MV is open to the public and has been used in several similar published informed consent studies: http://www.acpdecisions.org/videos/generic-cpr/

  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
  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: October 29, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Heart Failure
Acute Kidney Injury
Renal Insufficiency
Sepsis
Stroke
Heart Diseases
Cardiovascular Diseases
Kidney Diseases
Urologic Diseases
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 20, 2014