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Clinical Trials/NCT01558817
NCT01558817
Completed
Not Applicable

Changing the Paradigm of In-Hospital Cardiopulmonary Resuscitation With Informed Assent: A Pilot Study

University of Vermont3 sites in 1 country29 target enrollmentFebruary 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Oxygen Dependent COPD
Sponsor
University of Vermont
Enrollment
29
Locations
3
Primary Endpoint
Cardiopulmonary Resuscitation Preference
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

Outcomes after in-hospital cardiopulmonary resuscitation (CPR) are very poor, particularly in patients with oxygen dependent chronic obstructive pulmonary disease (COPD) or metastatic cancer. Recent work found that in-hospital CPR is being performed more often before death with unchanging survival and that fewer CPR survivors are being discharged home, thus suggesting that CPR is increasingly performed without benefit and that the burden of this ineffective treatment is increasing. Unlike other medical procedures, CPR has become the default provided to all patients even those with tremendously poor outcomes. It is time to change the paradigm of CPR. Through comparing an innovative "informed assent" approach toward in-hospital CPR (informing patients that their underlying chronic illness makes outcomes of CPR so poor that CPR is not performed while allowing them to disagree) versus usual care in a group of chronically ill patients with reduced life expectancy, the investigators aspire to demonstrate that CPR delivery can be reduced. And in addition that DNR status increases, while preserving patient quality of life and decreasing the burden of this ineffective treatment to both patients and families. If effective, this informed assent intervention has the potential to revolutionize how the investigators discuss CPR with the investigators chronically ill patients.

Registry
clinicaltrials.gov
Start Date
February 2012
End Date
April 2014
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Renee Stapleton

Associatet Professor, Pulmonary and Critical Care Medicine

University of Vermont

Eligibility Criteria

Inclusion Criteria

  • 18 years or older
  • Oxygen dependent COPD or Advanced Malignancy
  • Life expectancy of less than two years

Exclusion Criteria

  • Subjects who have already firmly decided to undergo CPR
  • Subjects enrolled in a hospice program
  • Subjects unable to speak English
  • Subjects incapable of making their own decisions at the time of enrollment
  • Subjects cared for by the study investigator

Outcomes

Primary Outcomes

Cardiopulmonary Resuscitation Preference

Time Frame: Within couple of hours before the intervention and immediately (up to 2 days) after the intervention

The primary outcome will be the difference in the proportion of patients in the informed assent intervention and informational brochure groups reporting preferences to be DNR (do not rescusitate).

Secondary Outcomes

  • Depression(Baseline (day of intervention) and 2 weeks after intervention)
  • Anxiety(Baseline (day of intervention) and two weeks after intervention)
  • Report on acceptability of the informed assent approach(Within couple of hours (up to 2 weeks) after intervention)
  • Resource utilization(Up to 6 months after intervention or until death)
  • DNR status preference(Two weeks after the intervention)
  • Physician Order for Life Sustaining Treatment (POLST)(Baseline (day of intervention) and 2 weeks after intervention)
  • Assessment of DNR status change or intervention follow-up from primary physician(Three months after the intervention)

Study Sites (3)

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