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Completed

NCT Number: NCT01558817

Changing the Paradigm of In-Hospital Cardiopulmonary Resuscitation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina, Charleston, South Carolina, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Informed Assent

Behavioral

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

Behavioral

An informational brochure about CPR will be given without a discussion with a physician.

Primary outcomes

  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 outcomes

  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:

    • 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?
  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.

Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Mar 20, 2012
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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