Chronic Critical IllnessNCT01230099
Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT)
A study testing Supportive Information Team Group in people with Chronic Critical Illness and Prolonged Mechanical Ventilation, run by Icahn School of Medicine at Mount Sinai at 4 sites in United States.
Trial summary
The purpose of this study is to test a communication intervention to support family decision-making for patients with chronic critical illness. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Chronic Critical Illness, Prolonged Mechanical Ventilation
- What is being tested?
- Supportive Information Team Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 622 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2010to Oct 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mechanically ventilated ≥ 7 days
- Mechanically ventilated without > 96 hour interruption
- Age ≥ 21 years
- ICU MD does not expect patient will die within 72 hours
- ICU MD does not expect patient will be liberated from the ventilator within 72 hours.
Who cannot join
- Previous admission to study ICU this hospitalization Mechanically ventilated at outside hospital for > 7 days before transfer
- Chronic Neuromuscular (NM) Disease
- Trauma
- Burn
- Previous palliative care consultation in this hospitalization
- No family or other surrogate decision-maker
Show all 9Show fewer
- Family not available
- Surrogate lacks English proficiency
- Physician refused permission for research staff to approach the family
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of North Carolina School of Medicine
Chapel Hill, North Carolina, 27599
Durham Regional Medical Center
Durham, North Carolina, 27704
Duke University School of Medicine
Durham, North Carolina, 27710
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
The purpose of this study is to test a communication intervention to support family decision-making for patients with chronic critical illness.
Read the detailed description
Increasing use of intensive care therapies by an aging population has created a new medical syndrome - "chronic critical illness" - encompassing multi-system derangements, recurrent complications, and protracted/permanent dependence on mechanical ventilation and other life-supports. Numbering >100,000 at any point in time, the chronically critically ill are a growing population of older adults and a serious national health problem. Annual expenditures for these patients are estimated at $24 billion, mostly for patients ≥ 65 years old. Yet 6-month mortality rates exceed those for most malignancies, impairments are severe among survivors, and return to the community is rare. Descriptive research has identified domains of information that are important for decision-making by patients/families about continuation of treatment in the chronic phase of critical illness, but has also revealed that decisions are often made without this information or patient goals of care as a context. In acute critical illness, scheduled, structured meetings and printed informational aids are effective for Intensive Care Unit (ICU) families, but no study has tested an intervention to inform and support decision-making about chronic critical illness. This study is a randomized, controlled, multi-center clinical trial of such an intervention. Specific Aims are: (1) To evaluate the impact on family- and patient-focused outcomes of a proactive program of protocolized, interdisciplinary, informational support meetings led by a palliative care physician, plus a printed informational aid, for families of chronically critically ill patients; and (2) To evaluate the impact of this intervention on utilization of critical care resources for the chronically critically ill. We hypothesize that as compared to usual care plus the printed aid, this intervention will effectively inform decision-making, improve family well-being, promote discussion of preferences for patient goals of care, and optimize critical care resource utilization, without increasing patient mortality.
- Being tested
- Supportive Information Team Group
- Keywords
- Critical Illness, Mechanical Ventilation, Palliative Care, Caregivers
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supportive Information Team GroupBehavioural
Also called SIT
A minimum of two protocolized, interdisciplinary, informational support meetings led by palliative care clinicians will be arranged with family members or other patient surrogates who participate in decision-making for individual chronically critically ill patients.
| Study group | Role | What they receive |
|---|---|---|
| Supportive Information Team Group | Experimental | Protocolized information and support meetings led by palliative care clinicians Receives: Behavioral: Supportive Information Team Group |
| Usual Care Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale
Measured: Day 90
Secondary outcomes (11)
Hospital Anxiety and Depression Scale
Measured: Day 18-20
Impact of Events Scale-Revised
Measured: Day 90
Discussion of Preferences for Patients Goals of Care
Subscale of Center for Gerontology and Health Care Research Toolkit
Measured: Day 18-20
Quality of Communication
Curtis Measure
Measured: Day 18-20
Family Satisfaction in the Intensive Care Unit (ICU) Survey
Measured: Day 90
Modified Center for Gerontology and Health Care Research (CHCR) Tool
Measured: Day 90
Limitation of Intensive Care Unit (ICU) Therapy
Percent of patients with mechanical ventilation, renal replacement, vasopressors, or artificial nutrition withheld or withdrawn
Measured: Average of 60 days
Hospital Length of Stay
Days since randomization
Measured: Average of 60 days
Mortality
Measured: Day 90
Physician-Surrogate Discordance Score
Measured: day 18-20
Discussion of Preferences for Patients Goals of Care
Subscale of Center for Gerontology and Health Care Research Toolkit
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Critical IllnessStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 622 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of North Carolina, Duke University
- Responsible party
- Sponsor
- Investigators
- Judith Nelson, MD, JD, Principal investigator, Icahn School of Medicine at Mount SinaiShannon Carson, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230099
- Sponsor's protocol ID
- 08-0601 0001 01 ME
- Other IDs
- R01NR012413-01A1
- Status last verified
- Oct 2015
- First submitted
- 22 Oct 2010
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nelson JE, Hanson LC, Keller KL, Carson SS, Cox CE, Tulsky JA, White DB, Chai EJ, Weiss SP, Danis M. The Voice of Surrogate Decision-Makers. Family Responses to Prognostic Information in Chronic Critical Illness. Am J Respir Crit Care Med. 2017 Oct 1;196(7):864-872. doi: 10.1164/rccm.201701-0201OC.
PubMed 28387538Carson SS, Cox CE, Wallenstein S, Hanson LC, Danis M, Tulsky JA, Chai E, Nelson JE. Effect of Palliative Care-Led Meetings for Families of Patients With Chronic Critical Illness: A Randomized Clinical Trial. JAMA. 2016 Jul 5;316(1):51-62. doi: 10.1001/jama.2016.8474.
PubMed 27380343
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Informing Decisions in Chronic Critical Illness: A Randomized Control Trial (RCT)
- ClinicalTrials.gov ID
- NCT01230099
- Acronym / sponsor ID
- 08-0601 0001 01 ME
- Keywords
- Critical Illness, Mechanical Ventilation, Palliative Care, Caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 622 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR), University of North Carolina, Duke University
- Study start
- Oct 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 28 Oct 2010 (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.
The purpose of this study is to test a communication intervention to support family decision-making for patients with chronic critical illness.
Detailed description
Increasing use of intensive care therapies by an aging population has created a new medical syndrome - "chronic critical illness" - encompassing multi-system derangements, recurrent complications, and protracted/permanent dependence on mechanical ventilation and other life-supports. Numbering >100,000 at any point in time, the chronically critically ill are a growing population of older adults and a serious national health problem. Annual expenditures for these patients are estimated at $24 billion, mostly for patients ≥ 65 years old. Yet 6-month mortality rates exceed those for most malignancies, impairments are severe among survivors, and return to the community is rare. Descriptive research has identified domains of information that are important for decision-making by patients/families about continuation of treatment in the chronic phase of critical illness, but has also revealed that decisions are often made without this information or patient goals of care as a context. In acute critical illness, scheduled, structured meetings and printed informational aids are effective for Intensive Care Unit (ICU) families, but no study has tested an intervention to inform and support decision-making about chronic critical illness. This study is a randomized, controlled, multi-center clinical trial of such an intervention. Specific Aims are: (1) To evaluate the impact on family- and patient-focused outcomes of a proactive program of protocolized, interdisciplinary, informational support meetings led by a palliative care physician, plus a printed informational aid, for families of chronically critically ill patients; and (2) To evaluate the impact of this intervention on utilization of critical care resources for the chronically critically ill. We hypothesize that as compared to usual care plus the printed aid, this intervention will effectively inform decision-making, improve family well-being, promote discussion of preferences for patient goals of care, and optimize critical care resource utilization, without increasing patient mortality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supportive Information Team Group | Experimental | Behavioral: Supportive Information Team GroupProtocolized information and support meetings led by palliative care clinicians |
| Usual Care Group | No intervention | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mechanically ventilated ≥ 7 days
- Mechanically ventilated without > 96 hour interruption
- Age ≥ 21 years
- ICU MD does not expect patient will die within 72 hours
- ICU MD does not expect patient will be liberated from the ventilator within 72 hours.
Key exclusion criteria (9 listed)
- Previous admission to study ICU this hospitalization Mechanically ventilated at outside hospital for > 7 days before transfer
- Chronic Neuromuscular (NM) Disease
- Trauma
- Burn
- Previous palliative care consultation in this hospitalization
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 |
|---|---|---|
| Supportive Information Team GroupAlso: SITA minimum of two protocolized, interdisciplinary, informational support meetings led by palliative care clinicians will be arranged with family members or other patient surrogates who participate in decision-making for individual chronically critically ill patients. | Behavioural | Supportive Information Team Group |
Primary outcome
Hospital Anxiety and Depression Scale
Time frame: Day 90
11 secondary outcomes
Hospital Anxiety and Depression Scale
Time frame: Day 18-20
Impact of Events Scale-Revised
Time frame: Day 90
Discussion of Preferences for Patients Goals of Care
Time frame: Day 18-20
Quality of Communication
Time frame: Day 18-20
Family Satisfaction in the Intensive Care Unit (ICU) Survey
Time frame: Day 90
Modified Center for Gerontology and Health Care Research (CHCR) Tool
Time frame: Day 90
Limitation of Intensive Care Unit (ICU) Therapy
Time frame: Average of 60 days
Hospital Length of Stay
Time frame: Average of 60 days
Mortality
Time frame: Day 90
Physician-Surrogate Discordance Score
Time frame: day 18-20
Discussion of Preferences for Patients Goals of Care
Time frame: Day 90
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 Oct 2015.
- Derived from this study: PubMed 28387538Nelson JE, Hanson LC, Keller KL, Carson SS, Cox CE, Tulsky JA, White DB, Chai EJ, Weiss SP, Danis M. The Voice of Surrogate Decision-Makers. Family Responses to Prognostic Information in Chronic Critical Illness. Am J Respir Crit Care Med. 2017 Oct 1;196(7):864-872. doi: 10.1164/rccm.201701-0201OC.
- Derived from this study: PubMed 27380343Carson SS, Cox CE, Wallenstein S, Hanson LC, Danis M, Tulsky JA, Chai E, Nelson JE. Effect of Palliative Care-Led Meetings for Families of Patients With Chronic Critical Illness: A Randomized Clinical Trial. JAMA. 2016 Jul 5;316(1):51-62. doi: 10.1001/jama.2016.8474.
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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.
Judith Nelson, MD, JD principal investigator
Icahn School of Medicine at Mount Sinai
Shannon Carson, MD principal investigator
University of North Carolina, Chapel Hill
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supportive Information Team Group in people with Chronic Critical Illness and Prolonged Mechanical Ventilation, run by Icahn School of Medicine at Mount Sinai 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 9 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 Oct 2015. 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. 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?
Hospital Anxiety and Depression Scale (time frame: Day 90). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01230099, which also lists 2 linked publications.
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 Oct 2015.