Oxygen Dependent COPDNCT01558817
Changing the Paradigm of In-Hospital Cardiopulmonary Resuscitation
A study testing Informed Assent and Informational Brochure in people with Oxygen Dependent COPD and Advanced Malignancy, run by University of Vermont at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxygen Dependent COPD, Advanced Malignancy
- What is being tested?
- Informed Assent and Informational Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2012to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Oxygen dependent COPD or Advanced Malignancy
- Life expectancy of less than two years
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Vermont and Fletcher Allen Health Care
Burlington, Vermont, 05405
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Washington
Seattle, Washington, 98195
About this study
Official title: Changing the Paradigm of In-Hospital Cardiopulmonary Resuscitation With Informed Assent: A Pilot Study
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
- Being tested
- Informed Assent, Informational Brochure
- Keywords
- CPR, Palliative, Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informed AssentBehavioural
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 BrochureBehavioural
An informational brochure about CPR will be given without a discussion with a physician.
| Study group | Role | What they receive |
|---|---|---|
| Informational brochure | Active comparator | Patients receive an informational brochure Receives: Behavioral: Informational Brochure |
| Intervention | Experimental | Patients receive physician-directed informed assent intervention regarding CPR and informational brochure. Receives: Behavioral: Informed Assent |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Within couple of hours before the intervention and immediately (up to 2 days) after the intervention
Secondary outcomes (7)
Depression
Patients' and family members' symptomes of depression will be measured by the PHQ-8 questionnaire.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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?
Measured: 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.
Measured: 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.
Measured: Up to 6 months after intervention or until death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionOct 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxygen Dependent COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renee Stapleton, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01558817
- Sponsor's protocol ID
- PilotCPR001
- Status last verified
- Feb 2025
- First submitted
- 21 Feb 2012
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing the Paradigm of In-Hospital Cardiopulmonary Resuscitation With Informed Assent: A Pilot Study
- ClinicalTrials.gov ID
- NCT01558817
- Acronym / sponsor ID
- PilotCPR001
- Conditions
- Oxygen Dependent COPD, Advanced Malignancy
- Keywords
- CPR, Palliative, Outcome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Informational brochure | Active comparator | Behavioral: Informational BrochurePatients receive an informational brochure |
| Intervention | Experimental | Behavioral: Informed AssentPatients receive physician-directed informed assent intervention regarding CPR and informational brochure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Oxygen dependent COPD or Advanced Malignancy
- Life expectancy of less than two years
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Informed AssentPatients 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. | Behavioural | Intervention |
| Informational BrochureAn informational brochure about CPR will be given without a discussion with a physician. | Behavioural | Informational brochure |
Primary outcome
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).
7 secondary outcomes
Depression
Time frame: Baseline (day of intervention) and 2 weeks after intervention
Anxiety
Time frame: Baseline (day of intervention) and two weeks after intervention
Physician Order for Life Sustaining Treatment (POLST)
Time frame: Baseline (day of intervention) and 2 weeks after intervention
DNR status preference
Time frame: 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
Assessment of DNR status change or intervention follow-up from primary physician
Time frame: Three months after the intervention
Resource utilization
Time frame: Up to 6 months after intervention or until death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Informed Assent and Informational Brochure in people with Oxygen Dependent COPD and Advanced Malignancy, run by University of Vermont at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiopulmonary Resuscitation Preference (time frame: Within couple of hours before the intervention and immediately (up to 2 days) after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.