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

Study Overview
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Brief Summary
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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
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Oxygen Dependent COPD, Advanced Malignancy

Intervention / Treatment
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* Behavioral: Informed Assent
* Behavioral: Informational Brochure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Informational brochure<br>Patients receive an informational brochure | Behavioral: Informational Brochure<br>* An informational brochure about CPR will be given without a discussion with a physician.<br>|
| Experimental: Intervention<br>Patients receive physician-directed informed assent intervention regarding CPR and informational brochure. | Behavioral: Informed Assent<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative, Outcome, CPR