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

Not Applicable

Completed

• Conditions: Oxygen Dependent COPD; Advanced Malignancy
• Interventions: Behavioral: Informational Brochure; Behavioral: Informed Assent

• Registration Number: NCT01558817
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-03-19
• Study First Posted: 2012-03-20
• Primary Completion: 2013-10
• Study Completion: 2014-04
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-23
• Last Update Posted: 2014-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Informational brochure	Informational Brochure	Patients receive an informational brochure
Intervention	Informed Assent	Patients receive physician-directed informed assent intervention regarding CPR and informational brochure.

Primary Outcome Measures

Name	Time	Method
Cardiopulmonary Resuscitation Preference	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

Name	Time	Method
Depression	Baseline (day of intervention) and 2 weeks after intervention	Patients' and family members' symptomes of depression will be measured by the PHQ-8 questionnaire.
Anxiety	Baseline (day of intervention) and two weeks after intervention	Patients and families will complete the GAD-7 questionnaire, a measure of generalized anxiety disorder.
Report on acceptability of the informed assent approach	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?
Resource utilization	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.
DNR status preference	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.
Physician Order for Life Sustaining Treatment (POLST)	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.
Assessment of DNR status change or intervention follow-up from primary physician	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.

Trial Locations

Locations (3)

University of Washington; 🇺🇸 Seattle, Washington, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

University of Vermont and Fletcher Allen Health Care; 🇺🇸 Burlington, Vermont, United States