Severe Life-limiting COPDPhase 2/3CHARTNCT02984124
Communication During Hospitalization About Resuscitation Trial
A Phase 2/3 study testing Informed Assent Discussion in people with Severe Life-limiting COPD and Severe Life-limiting Heart Failure, run by University of Vermont at 4 sites in United States.
Trial summary
This multicenter RCT of 200 hospitalized patients and their family members evaluates an "informed assent" approach to discussing cardiopulmonary resuscitation, compared to usual care, in older seriously ill hospitalized patients with severe life-limiting illness or severe functional impairment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Severe Life-limiting COPD, Severe Life-limiting Heart Failure, Severe Life-limiting Cirrhosis
- What is being tested?
- Informed Assent Discussion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2016to Dec 2025
- Phase
- Phase 2/3
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- >65 years old
- English speaking
- Must have one or more of the following:
- Chronic life-limiting illness with median survival <2 years defined as: 1) metastatic cancer or inoperable lung cancer; 2) COPD requiring oxygen; 3) New York Heart Association Class III or IV heart failure, 4) Child's Class C cirrhosis or MELD score of >20, 5) End-stage renal disease (must be on dialysis and ≥ 75 years old), 6) Advanced pulmonary fibrosis/interstitial lung disease, 7) Advanced pulmonary hypertension
- Severe functional impairment defined as dependence with >4 activities of daily living (ADLs) on Katz Index of Independence in ADLs.
Who cannot join
- Has already definitively chosen DNR status
- Unable to provide informed consent
- Refused consent
- Currently listed on a transplant list (awaiting transplant)
- Inappropriate for study enrollment per clinician
- Known to have a left ventricular assist device (LVAD)
- Research team unavailable
- Patient discharged from hospital prior to enrollment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Vermont
Burlington, Vermont, 05405
University of North Carolina
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Washington
Seattle, Washington, 98104
About this study
This multicenter RCT of 200 hospitalized patients and their family members evaluates an "informed assent" approach to discussing cardiopulmonary resuscitation, compared to usual care, in older seriously ill hospitalized patients with severe life-limiting illness or severe functional impairment.
Read the detailed description
Increasing evidence suggests that high quality palliative care in older patients improves quality of care, patient and family satisfaction, and costs of care. However, while some specific palliative care interventions have been investigated, exactly how we should provide this care remains unclear. One important component of high quality provider-patient communication is discussing cardiopulmonary resuscitation (CPR) within the context of the patient's values and goals of care. Unfortunately, these conversations are often rushed, focused only on the procedure rather than the patient's goals and values, and CPR is often offered as if a choice on a menu. Elderly hospitalized patients are unlikely to have made decisions about CPR prior to hospitalization, and these discussions often leave patients and families feeling burdened, stressed, and concerned. Outcomes after in-hospital CPR in chronically ill older patients continue to be very poor, despite decades of efforts toward improvement.
The investigators aim to change the paradigm of CPR discussions with older adults unlikely to benefit from CPR. This study is a randomized controlled trial comparing an innovative "informed assent" approach to discussing CPR versus usual care with attention control for older hospitalized adults with life-limiting illness or severe functional impairment, enrolling patients and family members at three different study sites. Informed assent includes: 1) eliciting values and goals, 2) explaining CPR in the context of illness, and 3) a caring statement that the patient should not receive CPR if values include avoiding burdensome therapies unlikely to provide benefit. Thus, the provider can elicit values, convey information, and state an assessment, while allowing the patient or family to disagree. The investigators hypothesize that informed assent will improve quality of and satisfaction with communication about CPR; reduce the burden of potentially harmful CPR discussions, including reduced patient and family symptoms of depression and anxiety; and reduce intensity of care and health care utilization. The intervention builds on prior work investigating CPR outcomes in older adults and performing pilot studies of the informed assent intervention in both inpatients and outpatients.
- Conditions
- Severe Life-limiting COPD, Severe Life-limiting Heart Failure, Severe Life-limiting Cirrhosis, Severe Life-limiting Malignancy, Severe Functional Impairment, End Stage Renal Disease
- Being tested
- Informed Assent Discussion, Usual Care with Attention Control
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informed Assent DiscussionBehavioural
Participants randomized to the intervention arm will participate in a discussion about CPR with a study doctor that follows these steps:
- Patient's values and preferences for therapies and outcomes elicited from patient and family; overall therapeutic goals formulated
- Description of CPR and dying process provided
- Personalized explanation provided about probable lack of achieving any reasonable therapeutic goal with CPR (i.e. why s/he is a poor candidate for CPR due to underlying illness)
- Patient and family informed that due to severe underlying illness and high likelihood that CPR will be burdensome/harmful and will not provide benefit, CPR will not be offered unless they disagree (except in rare circumstance where overall therapeutic goals from step 1 are to preserve life regardless of quality of that life) Assessment of patient's and family's understanding of issues discussed; patients may actively disagree and request CPR be performed, but CPR not explicitly offered
Usual Care with Attention ControlBehavioural
Participants who are randomized to the usual care arm will receive a friendly visit in the hospital from research personnel to ask if they have any questions or concerns. Follow up assessments and time windows will be explained. Importance of their participation in the study will be emphasized.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Participants (n= approximately 100 plus family members) who are randomized to the intervention arm of the study will participate in a discussion about CPR with a study doctor. Receives: Behavioral: Informed Assent Discussion |
| Usual Care with Attention Control | Placebo comparator | Participants (n= approximately 100 plus family members) who are randomized to the usual care arm will receive a friendly visit in the hospital from research personnel to ask if they have any questions or concerns. Follow up assessments and time windows will be explained. Importance of their participation in the study will be emphasized. Receives: Behavioral: Usual Care with Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation
Patient-Assessed Quality of Communication about CPR
Measured: Study day 5 +/- 1 or hospital discharge, whichever is earlier
Secondary outcomes (16)
Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation
Family-Assessed Quality of Communication about CPR
Measured: Study day 5 +/- 1 or hospital discharge, whichever is earlier
5-question communication domain of the CANHELP Questionnaire, slightly modified to focus on communication about cardiopulmonary resuscitation
Patient-Assessed Satisfaction with Communication about CPR
Measured: Study day 5 +/- 1 or hospital discharge, whichever is earlier
5-question communication domain of the CANHELP Questionnaire, slightly modified to focus on communication about cardiopulmonary resuscitation
Family-Assessed Satisfaction with Communication about CPR
Measured: Study day 5 +/- 1 or hospital discharge, whichever is earlier
Hospital Anxiety and Depression Survey (HADS)
Patient Depressive and Anxiety Symptoms
Measured: Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months
Hospital Anxiety and Depression Survey (HADS)
Family Depressive and Anxiety Symptoms
Measured: Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months
Do-Not-Resuscitate Orders (yes/no)
Measured: Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months
Time to Do-Not-Resuscitate Orders
Measured: To 6 months post-randomization
Admission to the intensive care unit (ICU) 9yes/no)
Measured: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
ICU length of stay (days)
Measured: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Tracheostomy placement (yes/no)
Measured: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Gastrostomy tube placement (yes/no)
Measured: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Receipt of mechanical ventilation (yes/no)
Measured: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Receipt of renal replacement therapy (yes/no)
Measured: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Receipt of cardiopulmonary resuscitation (yes/no)
Measured: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Cost of health care after initial hospitalization
Repeat hospital admissions, ICU admissions, nursing home says, hospice care stays, and use of home health care will be assessed, and if they occurred, duration will be recorded. A standardized value (costs, not charges) will be applied to these measures to determine overall cost.
Measured: 3 months and 6 months post-randomization
Mortality (dead or alive)
Measured: To 6 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2023
- Study completionDec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Life-limiting 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 2/3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Medical University of South Carolina, University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Renee Stapleton, University of Vermont
- Investigators
- Renee Stapleton, MD PhD, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984124
- Sponsor's protocol ID
- CHRMS 16-227
- Acronym
- CHART
- Status last verified
- Feb 2025
- First submitted
- 28 Nov 2016
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: This study includes quantitative data that the investigators plan to share with other researchers with interests in the quality of care provided to older hospitalized seriously ill patients and their families. De-identified questionnaire data, medical record data, and administrative data will be made available in the form of datasets with no personally identifying characteristics retained, to protect the identity of the respondents.
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication During Hospitalization About Resuscitation Trial
- ClinicalTrials.gov ID
- NCT02984124
- Acronym / sponsor ID
- CHART / CHRMS 16-227
- Conditions
- Severe Life-limiting COPD, Severe Life-limiting Heart Failure, Severe Life-limiting Cirrhosis, Severe Life-limiting Malignancy, Severe Functional Impairment, End Stage Renal Disease
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- University of Washington, Medical University of South Carolina, University of North Carolina, Chapel Hill
- Study start
- Dec 2016 (actual)
- Primary completion
- Mar 2023 (actual)
- Study completion
- Dec 2025 (actual)
- First posted
- 6 Dec 2016 (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.
This multicenter RCT of 200 hospitalized patients and their family members evaluates an "informed assent" approach to discussing cardiopulmonary resuscitation, compared to usual care, in older seriously ill hospitalized patients with severe life-limiting illness or severe functional impairment.
Detailed description
Increasing evidence suggests that high quality palliative care in older patients improves quality of care, patient and family satisfaction, and costs of care. However, while some specific palliative care interventions have been investigated, exactly how we should provide this care remains unclear. One important component of high quality provider-patient communication is discussing cardiopulmonary resuscitation (CPR) within the context of the patient's values and goals of care. Unfortunately, these conversations are often rushed, focused only on the procedure rather than the patient's goals and values, and CPR is often offered as if a choice on a menu. Elderly hospitalized patients are unlikely to have made decisions about CPR prior to hospitalization, and these discussions often leave patients and families feeling burdened, stressed, and concerned. Outcomes after in-hospital CPR in chronically ill older patients continue to be very poor, despite decades of efforts toward improvement.
The investigators aim to change the paradigm of CPR discussions with older adults unlikely to benefit from CPR. This study is a randomized controlled trial comparing an innovative "informed assent" approach to discussing CPR versus usual care with attention control for older hospitalized adults with life-limiting illness or severe functional impairment, enrolling patients and family members at three different study sites. Informed assent includes: 1) eliciting values and goals, 2) explaining CPR in the context of illness, and 3) a caring statement that the patient should not receive CPR if values include avoiding burdensome therapies unlikely to provide benefit. Thus, the provider can elicit values, convey information, and state an assessment, while allowing the patient or family to disagree. The investigators hypothesize that informed assent will improve quality of and satisfaction with communication about CPR; reduce the burden of potentially harmful CPR discussions, including reduced patient and family symptoms of depression and anxiety; and reduce intensity of care and health care utilization. The intervention builds on prior work investigating CPR outcomes in older adults and performing pilot studies of the informed assent intervention in both inpatients and outpatients.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Informed Assent DiscussionParticipants (n= approximately 100 plus family members) who are randomized to the intervention arm of the study will participate in a discussion about CPR with a study doctor. |
| Usual Care with Attention Control | Placebo comparator | Behavioral: Usual Care with Attention ControlParticipants (n= approximately 100 plus family members) who are randomized to the usual care arm will receive a friendly visit in the hospital from research personnel to ask if they have any questions or concerns. Follow up assessments and time windows will be explained. Importance of their participation in the study will be emphasized. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- >65 years old
- English speaking
- Must have one or more of the following:
Key exclusion criteria (8 listed)
- Has already definitively chosen DNR status
- Unable to provide informed consent
- Refused consent
- Currently listed on a transplant list (awaiting transplant)
- Inappropriate for study enrollment per clinician
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 Assent DiscussionParticipants randomized to the intervention arm will participate in a discussion about CPR with a study doctor that follows these steps: 1. Patient's values and preferences for therapies and outcomes elicited from patient and family; overall therapeutic goals formulated 2. Description of CPR and dying process provided 3. Personalized explanation provided about probable lack of achieving any reasonable therapeutic goal with CPR (i.e. why s/he is a poor candidate for CPR due to underlying illness) 4. Patient and family informed that due to severe underlying illness and high likelihood that CPR will be burdensome/harmful and will not provide benefit, CPR will not be offered unless they disagree (except in rare circumstance where overall therapeutic goals from step 1 are to preserve life regardless of quality of that life) Assessment of patient's and family's understanding of issues discussed; patients may actively disagree and request CPR be performed, but CPR not explicitly offered | Behavioural | Intervention |
| Usual Care with Attention ControlParticipants who are randomized to the usual care arm will receive a friendly visit in the hospital from research personnel to ask if they have any questions or concerns. Follow up assessments and time windows will be explained. Importance of their participation in the study will be emphasized. | Behavioural | Usual Care with Attention Control |
Primary outcome
Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation
Time frame: Study day 5 +/- 1 or hospital discharge, whichever is earlier
Patient-Assessed Quality of Communication about CPR
16 secondary outcomes
Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation
Time frame: Study day 5 +/- 1 or hospital discharge, whichever is earlier
5-question communication domain of the CANHELP Questionnaire, slightly modified to focus on communication about cardiopulmonary resuscitation
Time frame: Study day 5 +/- 1 or hospital discharge, whichever is earlier
5-question communication domain of the CANHELP Questionnaire, slightly modified to focus on communication about cardiopulmonary resuscitation
Time frame: Study day 5 +/- 1 or hospital discharge, whichever is earlier
Hospital Anxiety and Depression Survey (HADS)
Time frame: Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months
Hospital Anxiety and Depression Survey (HADS)
Time frame: Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months
Do-Not-Resuscitate Orders (yes/no)
Time frame: Study day 5 +/- 1 or hospital discharge (whichever is earlier), 3 months, and 6 months
Time to Do-Not-Resuscitate Orders
Time frame: To 6 months post-randomization
Admission to the intensive care unit (ICU) 9yes/no)
Time frame: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
ICU length of stay (days)
Time frame: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Tracheostomy placement (yes/no)
Time frame: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Gastrostomy tube placement (yes/no)
Time frame: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Receipt of mechanical ventilation (yes/no)
Time frame: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Receipt of renal replacement therapy (yes/no)
Time frame: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Receipt of cardiopulmonary resuscitation (yes/no)
Time frame: Measured at the time hospital discharge, which will likely occur at an average of 6 days after admission, but will be assessed for up to 6 months.
Cost of health care after initial hospitalization
Time frame: 3 months and 6 months post-randomization
Mortality (dead or alive)
Time frame: To 6 months post-randomization
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 29 May 2026.
- Individual participant dataSharing planned: Yes. This study includes quantitative data that the investigators plan to share with other researchers with interests in the quality of care provided to older hospitalized seriously ill patients and their families. De-identified questionnaire data, medical record data, and administrative data will be made available in the form of datasets with no personally identifying characteristics retained, to protect the identity of the respondents.
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.
Renee Stapleton, MD PhD principal investigator
University of Vermont
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Informed Assent Discussion in people with Severe Life-limiting COPD and Severe Life-limiting Heart Failure, run by University of Vermont at 4 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 5 inclusion and 8 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 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quality of Communication Questionnaire (QOCQ), slightly modified to focus on communication about cardiopulmonary resuscitation (time frame: Study day 5 +/- 1 or hospital discharge, whichever is earlier). 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 29 May 2026.