Changing the Paradigm of In-Hospital Cardiopulmonary Resuscitation With Informed Assent

Advanced Malignancy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558817
• Other study ID #: PilotCPR001
• Status: Completed
• Phase: N/A
• First received: February 21, 2012
• Last updated: July 23, 2014
• Start date: February 2012
• Est. completion date: April 2014

Study information

• Verified date: July 2014
• Source: University of Vermont
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Advanced Malignancy
• Oxygen Dependent COPD

Intervention

Behavioral:
• Informed Assent
Patients receive informed assent approach toward in-hospital CPR outcomes. Patients are informed that their underlying chronic illness makes outcomes after CPR so poor that CPR is not performed while allowing them to disagree.
• Informational Brochure
An informational brochure about CPR will be given without a discussion with a physician.

Locations

Country	Name	City	State
United States	University of Vermont and Fletcher Allen Health Care	Burlington	Vermont
United States	Medical University of South Carolina	Charleston	South Carolina
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiopulmonary Resuscitation Preference	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).	Within couple of hours before the intervention and immediately (up to 2 days) after the intervention	No
Secondary	Depression	Patients' and family members' symptomes of depression will be measured by the PHQ-8 questionnaire.	Baseline (day of intervention) and 2 weeks after intervention	No
Secondary	Anxiety	Patients and families will complete the GAD-7 questionnaire, a measure of generalized anxiety disorder.	Baseline (day of intervention) and two weeks after intervention	No
Secondary	Physician Order for Life Sustaining Treatment (POLST)	Participants who expressed a preference to be DNR will be asked to complete a POLST form by their physician. It will also be explained that this can be changed any time the status changes.	Baseline (day of intervention) and 2 weeks after intervention	No
Secondary	DNR status preference	The difference in DNR status preference between patients in the control and invervention group at two weeks after the intervention.	Two weeks after the intervention	No
Secondary	Report on acceptability of the informed assent approach	The following questions will be asked: How helpful was this approach to discussing CPR with respect to CPR decisions?; Would you recommend this approach to discussing CPR for other patients who have serious illnesses?	Within couple of hours (up to 2 weeks) after intervention	No
Secondary	Assessment of DNR status change or intervention follow-up from primary physician	Contact the physician for each patient at 3 months after the study visit to determine whether there are changes in the DNR status or if the physician has talked with the patients about the status since the study visit.	Three months after the intervention	No
Secondary	Resource utilization	Record resource utilization for participants that includes hospitalizations, ICU care, use of hospice etc by medical record review.	Up to 6 months after intervention or until death	No