COPDNCT01817686
Study of Default Options in Advance Directives
A study testing Comfort Default AD forms, Life Extension Default AD forms and Standard Default AD forms in people with COPD and Severe or Very Severe Airflow Obstruction and/or Receiving or Eligible to Receive Long-term Oxygen Therapy, run by Corporal Michael J. Crescenz VA Medical Center at 1 site in United States.
Trial summary
Default options represent the events or conditions that are set into place if no alternatives are actively chosen. The setting of default options has well-established effects on a broad range of human decisions, but its influence on patients' preferences for end-of-life care is only beginning to be understood. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Severe or Very Severe Airflow Obstruction and/or Receiving or Eligible to Receive Long-term Oxygen Therapy, Idiopathic Pulmonary Fibrosis
- What is being tested?
- Comfort Default AD forms, Life Extension Default AD forms and Standard Default AD forms
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jun 2015
- 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
- Age > 18 years
- Chronic Obstructive Pulmonary Disease (COPD) with severe or very severe airflow obstruction on pulmonary function testing and or receiving or eligible to receive long-term oxygen therapy AND/OR
- Idiopathic Pulmonary Fibrosis (IPF) AND/OR
- Other interstitial lung disease without curative therapy AND/OR
- Any stage 3B or 4 solid tumor AND/OR
- Congestive Heart Failure (CHF) either New York Heart Association NYHA) class IV or NYHA class III plus 1 hospitalization in the past year
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- No previously signed advance directive in the medical record
- Neither listed for nor considering lung or heart transplantation
- High anticipated risk for critical illness in the next 2 years based on clinical judgment
- Interest in thinking about filling out an Advance Directive
Who cannot join
- Diseases for which life-extending medical therapies may be available
- Inability to speak and/or read English proficiently
- New clinic patients meeting the clinic provider for the first time
- Patients being actively evaluated or already listed for transplants
- Patients already having an AD
- Cognitive impairment necessitating proxy consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Philadelphia Veterans Affairs Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Default Options in Advance Directives for Veterans With Serious Illnesses: A Randomized Clinical Trial
Default options represent the events or conditions that are set into place if no alternatives are actively chosen. The setting of default options has well-established effects on a broad range of human decisions, but its influence on patients' preferences for end-of-life care is only beginning to be understood.
This is a 3-armed randomized clinical trial in Veterans at high risk for critical illness, assessing the impact of Advance Directive (AD) forms framed with different default options. The central goals are to assess how default options in ADs influence the end-of-life care choices made by patients at risk for critical care, and these patients' hospital and ICU utilization.
The investigators hypothesize that setting defaults in real ADs will increase the proportion of Veterans selecting comfort-oriented plans of care, decrease selections of life-extending therapies such as mechanical ventilation and dialysis, and reduce the proportion of time during follow-up that Veterans spend in the hospital and/or ICU, without affecting patient satisfaction with end-of-life care planning.
- Conditions
- COPD, Severe or Very Severe Airflow Obstruction and/or Receiving or Eligible to Receive Long-term Oxygen Therapy, Idiopathic Pulmonary Fibrosis, Other Interstitial Lung Disease Without Curative Therapy, Congestive Heart Failure, NYHA Class IV or NYHA Class III Plus 1 Hospitalization in the Past Year
- Being tested
- Comfort Default AD forms, Life Extension Default AD forms, Standard Default AD forms
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Idiopathic Pulmonary Fibrosis, Heart Failure, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comfort Default AD formsOther
Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, the patients will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.
Life Extension Default AD formsOther
Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, the patients will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.
Standard Default AD formsOther
Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, the patients will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| Comfort Default | Experimental | ADs with pre-selected defaults that focus on providing comfort at end-of-life. Receives: Other: Comfort Default AD forms |
| Life Extension Default | Experimental | ADs with pre-selected defaults that focus on extending life. Receives: Other: Life Extension Default AD forms |
| Standard Default | Experimental | ADs without pre-selected defaults. Receives: Other: Standard Default AD forms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate how the setting of defaults influences the proportion of Veterans selecting comfort-oriented plans of care in real ADs
The primary outcome is the proportion of patients in each of the 3 groups who select a general plan of care that prioritizes comfort over life extension.
Measured: 18 months
Secondary outcomes (2)
Assess the influence of default options in ADs on Veterans' selections of specific life-extending therapies
The proportions of patients electing to receive each of the 5 specific life-extending interventions
Measured: 18 months
Determine whether setting defaults in ADs influences the proportion of time during follow-up that Veterans spend in the hospital or ICU
The proportion of time during a 6-18 month follow-up (median 1 year) that patients spend in the hospital or ICU for each AD group
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporal Michael J. Crescenz VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Joshua B. Kayser, Corporal Michael J. Crescenz VA Medical Center
- Investigators
- Joshua B Kayser, MD, MPH, Principal investigator, Corporal Michael J. Crescenz VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01817686
- Sponsor's protocol ID
- 01381
- Status last verified
- Jun 2015
- First submitted
- 19 Mar 2013
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Default Options in Advance Directives for Veterans With Serious Illnesses: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01817686
- Acronym / sponsor ID
- 01381
- Conditions
- COPD, Severe or Very Severe Airflow Obstruction and/or Receiving or Eligible to Receive Long-term Oxygen Therapy, Idiopathic Pulmonary Fibrosis, Other Interstitial Lung Disease Without Curative Therapy, Congestive Heart Failure, NYHA Class IV or NYHA Class III Plus 1 Hospitalization in the Past Year
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Corporal Michael J. Crescenz VA Medical CenterUS federal agency
- Study start
- Mar 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Mar 2013 (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.
Default options represent the events or conditions that are set into place if no alternatives are actively chosen. The setting of default options has well-established effects on a broad range of human decisions, but its influence on patients' preferences for end-of-life care is only beginning to be understood.
This is a 3-armed randomized clinical trial in Veterans at high risk for critical illness, assessing the impact of Advance Directive (AD) forms framed with different default options. The central goals are to assess how default options in ADs influence the end-of-life care choices made by patients at risk for critical care, and these patients' hospital and ICU utilization.
The investigators hypothesize that setting defaults in real ADs will increase the proportion of Veterans selecting comfort-oriented plans of care, decrease selections of life-extending therapies such as mechanical ventilation and dialysis, and reduce the proportion of time during follow-up that Veterans spend in the hospital and/or ICU, without affecting patient satisfaction with end-of-life care planning.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Comfort Default | Experimental | Other: Comfort Default AD formsADs with pre-selected defaults that focus on providing comfort at end-of-life. |
| Life Extension Default | Experimental | Other: Life Extension Default AD formsADs with pre-selected defaults that focus on extending life. |
| Standard Default | Experimental | Other: Standard Default AD formsADs without pre-selected defaults. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 18 years
- Chronic Obstructive Pulmonary Disease (COPD) with severe or very severe airflow obstruction on pulmonary function testing and or receiving or eligible to receive long-term oxygen therapy AND/OR
- Idiopathic Pulmonary Fibrosis (IPF) AND/OR
- Other interstitial lung disease without curative therapy AND/OR
- Any stage 3B or 4 solid tumor AND/OR
Key exclusion criteria (6 listed)
- Diseases for which life-extending medical therapies may be available
- Inability to speak and/or read English proficiently
- New clinic patients meeting the clinic provider for the first time
- Patients being actively evaluated or already listed for transplants
- Patients already having an AD
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 |
|---|---|---|
| Comfort Default AD formsConsenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, the patients will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire. | Other | Comfort Default |
| Life Extension Default AD formsConsenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, the patients will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire. | Other | Life Extension Default |
| Standard Default AD formsConsenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, the patients will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire. | Other | Standard Default |
Primary outcome
Evaluate how the setting of defaults influences the proportion of Veterans selecting comfort-oriented plans of care in real ADs
Time frame: 18 months
The primary outcome is the proportion of patients in each of the 3 groups who select a general plan of care that prioritizes comfort over life extension.
2 secondary outcomes
Assess the influence of default options in ADs on Veterans' selections of specific life-extending therapies
Time frame: 18 months
Determine whether setting defaults in ADs influences the proportion of time during follow-up that Veterans spend in the hospital or ICU
Time frame: 18 months
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 30 Jun 2015.
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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.
Joshua B Kayser, MD, MPH principal investigator
Corporal Michael J. Crescenz VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comfort Default AD forms, Life Extension Default AD forms and Standard Default AD forms in people with COPD and Severe or Very Severe Airflow Obstruction and/or Receiving or Eligible to Receive Long-term Oxygen Therapy, run by Corporal Michael J. Crescenz VA Medical Center at 1 site 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 10 inclusion and 6 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 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Evaluate how the setting of defaults influences the proportion of Veterans selecting comfort-oriented plans of care in real ADs (time frame: 18 months). 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 30 Jun 2015.