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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01558817
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : July 25, 2014
Information provided by (Responsible Party):
Renee Stapleton, University of Vermont

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.

Condition or disease Intervention/treatment Phase
Oxygen Dependent COPD Advanced Malignancy Behavioral: Informed Assent Behavioral: Informational Brochure Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Study Start Date : February 2012
Actual Primary Completion Date : October 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Informational brochure
Patients receive an informational brochure
Behavioral: Informational Brochure
An informational brochure about CPR will be given without a discussion with a physician.

Experimental: Intervention
Patients receive physician-directed informed assent intervention regarding CPR and informational brochure.
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.

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Depression [ Time Frame: Baseline (day of intervention) and 2 weeks after intervention ]
    Patients' and family members' symptomes of depression will be measured by the PHQ-8 questionnaire.

  2. Anxiety [ Time Frame: Baseline (day of intervention) and two weeks after intervention ]
    Patients and families will complete the GAD-7 questionnaire, a measure of generalized anxiety disorder.

  3. Physician Order for Life Sustaining Treatment (POLST) [ Time Frame: Baseline (day of intervention) and 2 weeks after intervention ]
    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.

  4. DNR status preference [ Time Frame: Two weeks after the intervention ]
    The difference in DNR status preference between patients in the control and invervention group at two weeks after the intervention.

  5. Report on acceptability of the informed assent approach [ Time Frame: Within couple of hours (up to 2 weeks) after intervention ]

    The following questions will be asked:

    1. How helpful was this approach to discussing CPR with respect to CPR decisions?
    2. Would you recommend this approach to discussing CPR for other patients who have serious illnesses?

  6. Assessment of DNR status change or intervention follow-up from primary physician [ Time Frame: Three months after the intervention ]
    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.

  7. Resource utilization [ Time Frame: Up to 6 months after intervention or until death ]
    Record resource utilization for participants that includes hospitalizations, ICU care, use of hospice etc by medical record review.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01558817

United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Vermont
University of Vermont and Fletcher Allen Health Care
Burlington, Vermont, United States, 05405
United States, Washington
University of Washington
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Vermont

Responsible Party: Renee Stapleton, Associatet Professor, Pulmonary and Critical Care Medicine, University of Vermont Identifier: NCT01558817     History of Changes
Other Study ID Numbers: PilotCPR001
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: July 25, 2014
Last Verified: July 2014

Keywords provided by Renee Stapleton, University of Vermont: