Changing the Paradigm of In-Hospital Cardiopulmonary Resuscitation

NCT01558817 | Completed DMC

• 1 other identifier: PilotCPR001
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 3

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.

Conditions

Oxygen Dependent COPD; Advanced Malignancy

Keywords

CPR; Palliative; Outcome

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• Depression

  Baseline (day of intervention) and 2 weeks after intervention

• Anxiety

  Baseline (day of intervention) and two weeks after intervention

• Physician Order for Life Sustaining Treatment (POLST)

  Baseline (day of intervention) and 2 weeks after intervention

• DNR status preference

  Two weeks after the intervention

• Report on acceptability of the informed assent approach

  Within couple of hours (up to 2 weeks) after intervention

Study Arms (2)

Informational brochure

ACTIVE COMPARATOR

Patients receive an informational brochure

Behavioral: Informational Brochure

Intervention

EXPERIMENTAL

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

Behavioral: Informed Assent

Interventions

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.

Intervention

Informational Brochure BEHAVIORAL

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

Informational brochure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Vermont: lead

Study Sites (3)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Vermont and Fletcher Allen Health Care

Burlington, Vermont, 05405, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associatet Professor, Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: February 21, 2012
• First Posted: March 20, 2012
• Study Start: February 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: April 1, 2014
• Last Updated: May 14, 2025

Record last verified: 2025-02

Locations

US (3)