Clinical trial NCT01558817: Changing the Paradigm of In-Hospital Cardiopulmonary Resuscitation
Official title: Changing the Paradigm of In-Hospital Cardiopulmonary Resuscitation With Informed Assent: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oxygen Dependent COPD
Advanced Malignancy
Keywords: CPR
Palliative
Outcome
Lead sponsor: University of Vermont
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Cardiopulmonary Resuscitation Preference
timeFrame: Within couple of hours before the intervention and immediately (up to 2 days) after the intervention
Secondary outcomes:
measure: Depression
timeFrame: Baseline (day of intervention) and 2 weeks after intervention
measure: Anxiety
timeFrame: Baseline (day of intervention) and two weeks after intervention
measure: Physician Order for Life Sustaining Treatment (POLST)
timeFrame: Baseline (day of intervention) and 2 weeks after intervention
measure: DNR status preference
timeFrame: Two weeks after the intervention
measure: Report on acceptability of the informed assent approach
timeFrame: Within couple of hours (up to 2 weeks) after intervention
measure: Assessment of DNR status change or intervention follow-up from primary physician
timeFrame: Three months after the intervention
measure: Resource utilization
timeFrame: Up to 6 months after intervention or until death
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Burlington
country: United States
facility: University of Vermont and Fletcher Allen Health Care
state: Vermont
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: