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.|
|ClinicalTrials.gov Identifier: NCT01558817|
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : July 25, 2014
|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|
|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|
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.
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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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?
- 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.
- 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.
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 ClinicalTrials.gov 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|