Critical IllnessNCT04239209
Effect of Intensivist Communication on Surrogate Prognosis Interpretation
A study testing Indirect - other patients, Indirect - physiology and Redirection in people with Critical Illness, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study evaluates the effect of physician communication styles on the interpretation of prognosis by family members of chronically-ill patients. Participants were randomized to view one of four videos how depicting different physicians disclose prognosis when physicians expect an ICU patient to die. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Critical Illness
- What is being tested?
- Indirect - other patients, Indirect - physiology and Redirection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 302 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2019to 17 Oct 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- spouse/partner, sibling, or adult child of a patient with Chronic Obstructive Pulmonary Disease (COPD) on home oxygen
- over age 18
Who cannot join
- ever working in healthcare as a nurse, advanced practice provider, or physician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intensivist Communication on Prognosis Interpretation by Family Members of Patients at High Risk for Intensive Care Unit Admission: A Randomized Trial
This study evaluates the effect of physician communication styles on the interpretation of prognosis by family members of chronically-ill patients. Participants were randomized to view one of four videos how depicting different physicians disclose prognosis when physicians expect an ICU patient to die.
Read the detailed description
Intensivist-surrogate discordance about prognosis is common in the intensive care unit. Minimizing discordance and empowering families to make informed decisions about participants' loved one's care is important, but it is unclear how best to communicate prognostic information to vulnerable surrogates when a patient is expected to die. Participants are randomized to view one of 4 intensivist communication styles in response to the question "What do you think is most likely to happen?": 1) a direct response (control), 2) an indirect response comparing the patient's condition to other patients, 3) an indirect response describing physiology, or 4) redirection to a discussion of patient values and goals.
The participant will then be asked a series of questions to measure participants' interpretation of what the intensivist says.
- Conditions
- Critical Illness
- Being tested
- Indirect - other patients, Indirect - physiology, Redirection, Direct communication
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect - other patientsBehavioural
Video depicting an indirect response focusing on a comparison to other patients.
Indirect - physiologyBehavioural
Video of an indirect response focusing on the physiology of the patient.
RedirectionBehavioural
Video of a redirection towards discussing the patient's values and possible future decisions.
Direct communicationBehavioural
Video of a direct response.
| Study group | Role | What they receive |
|---|---|---|
| Direct Communication (control) | Placebo comparator | A direct response where the intensivist acknowledges that he is not certain but believes the patient will not survive hospitalization. Receives: Behavioral: Direct communication |
| Indirect - other patients | Active comparator | An indirect response describing the prognosis of other people similar to the patient in question. Receives: Behavioral: Indirect - other patients |
| Indirect - physiology | Active comparator | An indirect response describing the severe physiologic abnormalities present in the patient and potential future problems. Receives: Behavioral: Indirect - physiology |
| Redirection | Active comparator | Redirection to a conversation about the values of the patient and possible future decisions. Receives: Behavioral: Redirection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant perception of the intensivist's prognostic estimate.
Participant response to the question "If you had to guess, what do you think the doctor thinks is the chance that your loved one will survive this hospitalization?" answered on a 0-100% percentage scale. 0% signifies no chance of survival and 100% signifies definitely will survive.
Measured: approximately 5 minutes
Secondary outcomes (2)
Participant prognostic estimate.
Participant response to the question "What do you think are the chances that your loved one will survive this hospitalization?" answered on a 0-100% percentage scale. 0% signifies no chance of survival and 100% signifies definitely will survive.
Measured: approximately 5 minutes
Participant difference in belief about prognosis.
This is the difference between outcome #2 (participant prognostic estimate) and outcome #1 (participant perception of the intensivist's prognostic estimate), expressed as a difference in percentage. In other words, if for a given participant outcome #2 was a 50% chance of survival and outcome #1 was a 30% chance of survival then outcome #3 (participant difference in belief about prognosis) would be 50% - 30% = 20%.
Measured: approximately 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start27 Sep 2019
- Primary completion17 Oct 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1:1:1 ratio to view a video depicting one of four different ways intensivists answered a patient surrogate's prognostic question "What do you think is most likely to happen?" during a simulated ICU family meeting.
- Masking
- None (open label)
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Responsible party
- Sponsor
- Investigators
- Alison E Turnbull, DVM MPH PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04239209
- Sponsor's protocol ID
- IRB00204036
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 27 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan would be to share aggregate, de-identified with other researchers if requested.
Publications
Fischer S, Min SJ, Cervantes L, Kutner J. Where do you want to spend your last days of life? Low concordance between preferred and actual site of death among hospitalized adults. J Hosp Med. 2013 Apr;8(4):178-83. doi: 10.1002/jhm.2018. Epub 2013 Feb 25.
PubMed 23440934Barnato AE, Herndon MB, Anthony DL, Gallagher PM, Skinner JS, Bynum JP, Fisher ES. Are regional variations in end-of-life care intensity explained by patient preferences?: A Study of the US Medicare Population. Med Care. 2007 May;45(5):386-93. doi: 10.1097/01.mlr.0000255248.79308.41.
PubMed 17446824Auriemma CL, Nguyen CA, Bronheim R, Kent S, Nadiger S, Pardo D, Halpern SD. Stability of end-of-life preferences: a systematic review of the evidence. JAMA Intern Med. 2014 Jul;174(7):1085-92. doi: 10.1001/jamainternmed.2014.1183.
PubMed 24861560Needham DM, Bronskill SE, Calinawan JR, Sibbald WJ, Pronovost PJ, Laupacis A. Projected incidence of mechanical ventilation in Ontario to 2026: Preparing for the aging baby boomers. Crit Care Med. 2005 Mar;33(3):574-9. doi: 10.1097/01.ccm.0000155992.21174.31.
PubMed 15753749Angus DC, Barnato AE, Linde-Zwirble WT, Weissfeld LA, Watson RS, Rickert T, Rubenfeld GD; Robert Wood Johnson Foundation ICU End-Of-Life Peer Group. Use of intensive care at the end of life in the United States: an epidemiologic study. Crit Care Med. 2004 Mar;32(3):638-43. doi: 10.1097/01.ccm.0000114816.62331.08.
PubMed 15090940Teno JM, Gozalo P, Trivedi AN, Bunker J, Lima J, Ogarek J, Mor V. Site of Death, Place of Care, and Health Care Transitions Among US Medicare Beneficiaries, 2000-2015. JAMA. 2018 Jul 17;320(3):264-271. doi: 10.1001/jama.2018.8981.
PubMed 29946682Teno JM, Gozalo P, Khandelwal N, Curtis JR, Meltzer D, Engelberg R, Mor V. Association of Increasing Use of Mechanical Ventilation Among Nursing Home Residents With Advanced Dementia and Intensive Care Unit Beds. JAMA Intern Med. 2016 Dec 1;176(12):1809-1816. doi: 10.1001/jamainternmed.2016.5964.
PubMed 27723891Wunsch H, Linde-Zwirble WT, Harrison DA, Barnato AE, Rowan KM, Angus DC. Use of intensive care services during terminal hospitalizations in England and the United States. Am J Respir Crit Care Med. 2009 Nov 1;180(9):875-80. doi: 10.1164/rccm.200902-0201OC. Epub 2009 Aug 27.
PubMed 19713448Bekelman JE, Halpern SD, Blankart CR, Bynum JP, Cohen J, Fowler R, Kaasa S, Kwietniewski L, Melberg HO, Onwuteaka-Philipsen B, Oosterveld-Vlug M, Pring A, Schreyogg J, Ulrich CM, Verne J, Wunsch H, Emanuel EJ; International Consortium for End-of-Life Research (ICELR). Comparison of Site of Death, Health Care Utilization, and Hospital Expenditures for Patients Dying With Cancer in 7 Developed Countries. JAMA. 2016 Jan 19;315(3):272-83. doi: 10.1001/jama.2015.18603.
PubMed 26784775Wright AA, Keating NL, Balboni TA, Matulonis UA, Block SD, Prigerson HG. Place of death: correlations with quality of life of patients with cancer and predictors of bereaved caregivers' mental health. J Clin Oncol. 2010 Oct 10;28(29):4457-64. doi: 10.1200/JCO.2009.26.3863. Epub 2010 Sep 13.
PubMed 20837950Halpern SD, Becker D, Curtis JR, Fowler R, Hyzy R, Kaplan LJ, Rawat N, Sessler CN, Wunsch H, Kahn JM; Choosing Wisely Taskforce; American Thoracic Society; American Association of Critical-Care Nurses; Society of Critical Care Medicine. An official American Thoracic Society/American Association of Critical-Care Nurses/American College of Chest Physicians/Society of Critical Care Medicine policy statement: the Choosing Wisely(R) Top 5 list in Critical Care Medicine. Am J Respir Crit Care Med. 2014 Oct 1;190(7):818-26. doi: 10.1164/rccm.201407-1317ST.
PubMed 25271745Silveira MJ, Kim SY, Langa KM. Advance directives and outcomes of surrogate decision making before death. N Engl J Med. 2010 Apr 1;362(13):1211-8. doi: 10.1056/NEJMsa0907901.
PubMed 20357283Turnbull AE, Hartog CS. Goal-concordant care in the ICU: a conceptual framework for future research. Intensive Care Med. 2017 Dec;43(12):1847-1849. doi: 10.1007/s00134-017-4873-2. Epub 2017 Jun 27. No abstract available.
PubMed 28656453Committee on Approaching Death: Addressing Key End of Life Issues; Institute of Medicine. Dying in America: Improving Quality and Honoring Individual Preferences Near the End of Life. Washington (DC): National Academies Press (US); 2015 Mar 19. Available from http://www.ncbi.nlm.nih.gov/books/NBK285681/
PubMed 25927121Lee Char SJ, Evans LR, Malvar GL, White DB. A randomized trial of two methods to disclose prognosis to surrogate decision makers in intensive care units. Am J Respir Crit Care Med. 2010 Oct 1;182(7):905-9. doi: 10.1164/rccm.201002-0262OC. Epub 2010 Jun 10.
PubMed 20538959
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intensivist Communication on Prognosis Interpretation by Family Members of Patients at High Risk for Intensive Care Unit Admission: A Randomized Trial
- ClinicalTrials.gov ID
- NCT04239209
- Acronym / sponsor ID
- IRB00204036
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 27 Jan 2020 (actual)
- 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 study evaluates the effect of physician communication styles on the interpretation of prognosis by family members of chronically-ill patients. Participants were randomized to view one of four videos how depicting different physicians disclose prognosis when physicians expect an ICU patient to die.
Detailed description
Intensivist-surrogate discordance about prognosis is common in the intensive care unit. Minimizing discordance and empowering families to make informed decisions about participants' loved one's care is important, but it is unclear how best to communicate prognostic information to vulnerable surrogates when a patient is expected to die. Participants are randomized to view one of 4 intensivist communication styles in response to the question "What do you think is most likely to happen?": 1) a direct response (control), 2) an indirect response comparing the patient's condition to other patients, 3) an indirect response describing physiology, or 4) redirection to a discussion of patient values and goals.
The participant will then be asked a series of questions to measure participants' interpretation of what the intensivist says.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants are randomized in a 1:1:1:1 ratio to view a video depicting one of four different ways intensivists answered a patient surrogate's prognostic question "What do you think is most likely to happen?" during a simulated ICU family meeting.
| Arm | Type | Receives |
|---|---|---|
| Direct Communication (control) | Placebo comparator | Behavioral: Direct communicationA direct response where the intensivist acknowledges that he is not certain but believes the patient will not survive hospitalization. |
| Indirect - other patients | Active comparator | Behavioral: Indirect - other patientsAn indirect response describing the prognosis of other people similar to the patient in question. |
| Indirect - physiology | Active comparator | Behavioral: Indirect - physiologyAn indirect response describing the severe physiologic abnormalities present in the patient and potential future problems. |
| Redirection | Active comparator | Behavioral: RedirectionRedirection to a conversation about the values of the patient and possible future decisions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- spouse/partner, sibling, or adult child of a patient with Chronic Obstructive Pulmonary Disease (COPD) on home oxygen
- over age 18
Key exclusion criteria (1 listed)
- ever working in healthcare as a nurse, advanced practice provider, or physician
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 |
|---|---|---|
| Indirect - other patientsVideo depicting an indirect response focusing on a comparison to other patients. | Behavioural | Indirect - other patients |
| Indirect - physiologyVideo of an indirect response focusing on the physiology of the patient. | Behavioural | Indirect - physiology |
| RedirectionVideo of a redirection towards discussing the patient's values and possible future decisions. | Behavioural | Redirection |
| Direct communicationVideo of a direct response. | Behavioural | Direct Communication (control) |
Primary outcome
Participant perception of the intensivist's prognostic estimate.
Time frame: approximately 5 minutes
Participant response to the question "If you had to guess, what do you think the doctor thinks is the chance that your loved one will survive this hospitalization?" answered on a 0-100% percentage scale. 0% signifies no chance of survival and 100% signifies definitely will survive.
2 secondary outcomes
Participant prognostic estimate.
Time frame: approximately 5 minutes
Participant difference in belief about prognosis.
Time frame: approximately 5 minutes
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 27 Jan 2020.
- Background: PubMed 23440934Fischer S, Min SJ, Cervantes L, Kutner J. Where do you want to spend your last days of life? Low concordance between preferred and actual site of death among hospitalized adults. J Hosp Med. 2013 Apr;8(4):178-83. doi: 10.1002/jhm.2018. Epub 2013 Feb 25.
- Background: PubMed 17446824Barnato AE, Herndon MB, Anthony DL, Gallagher PM, Skinner JS, Bynum JP, Fisher ES. Are regional variations in end-of-life care intensity explained by patient preferences?: A Study of the US Medicare Population. Med Care. 2007 May;45(5):386-93. doi: 10.1097/01.mlr.0000255248.79308.41.
- Background: PubMed 24861560Auriemma CL, Nguyen CA, Bronheim R, Kent S, Nadiger S, Pardo D, Halpern SD. Stability of end-of-life preferences: a systematic review of the evidence. JAMA Intern Med. 2014 Jul;174(7):1085-92. doi: 10.1001/jamainternmed.2014.1183.
- Background: PubMed 15753749Needham DM, Bronskill SE, Calinawan JR, Sibbald WJ, Pronovost PJ, Laupacis A. Projected incidence of mechanical ventilation in Ontario to 2026: Preparing for the aging baby boomers. Crit Care Med. 2005 Mar;33(3):574-9. doi: 10.1097/01.ccm.0000155992.21174.31.
- Background: PubMed 15090940Angus DC, Barnato AE, Linde-Zwirble WT, Weissfeld LA, Watson RS, Rickert T, Rubenfeld GD; Robert Wood Johnson Foundation ICU End-Of-Life Peer Group. Use of intensive care at the end of life in the United States: an epidemiologic study. Crit Care Med. 2004 Mar;32(3):638-43. doi: 10.1097/01.ccm.0000114816.62331.08.
- Background: PubMed 29946682Teno JM, Gozalo P, Trivedi AN, Bunker J, Lima J, Ogarek J, Mor V. Site of Death, Place of Care, and Health Care Transitions Among US Medicare Beneficiaries, 2000-2015. JAMA. 2018 Jul 17;320(3):264-271. doi: 10.1001/jama.2018.8981.
- Background: PubMed 27723891Teno JM, Gozalo P, Khandelwal N, Curtis JR, Meltzer D, Engelberg R, Mor V. Association of Increasing Use of Mechanical Ventilation Among Nursing Home Residents With Advanced Dementia and Intensive Care Unit Beds. JAMA Intern Med. 2016 Dec 1;176(12):1809-1816. doi: 10.1001/jamainternmed.2016.5964.
- Background: PubMed 19713448Wunsch H, Linde-Zwirble WT, Harrison DA, Barnato AE, Rowan KM, Angus DC. Use of intensive care services during terminal hospitalizations in England and the United States. Am J Respir Crit Care Med. 2009 Nov 1;180(9):875-80. doi: 10.1164/rccm.200902-0201OC. Epub 2009 Aug 27.
- Background: PubMed 26784775Bekelman JE, Halpern SD, Blankart CR, Bynum JP, Cohen J, Fowler R, Kaasa S, Kwietniewski L, Melberg HO, Onwuteaka-Philipsen B, Oosterveld-Vlug M, Pring A, Schreyogg J, Ulrich CM, Verne J, Wunsch H, Emanuel EJ; International Consortium for End-of-Life Research (ICELR). Comparison of Site of Death, Health Care Utilization, and Hospital Expenditures for Patients Dying With Cancer in 7 Developed Countries. JAMA. 2016 Jan 19;315(3):272-83. doi: 10.1001/jama.2015.18603.
- Background: PubMed 20837950Wright AA, Keating NL, Balboni TA, Matulonis UA, Block SD, Prigerson HG. Place of death: correlations with quality of life of patients with cancer and predictors of bereaved caregivers' mental health. J Clin Oncol. 2010 Oct 10;28(29):4457-64. doi: 10.1200/JCO.2009.26.3863. Epub 2010 Sep 13.
- Background: PubMed 25271745Halpern SD, Becker D, Curtis JR, Fowler R, Hyzy R, Kaplan LJ, Rawat N, Sessler CN, Wunsch H, Kahn JM; Choosing Wisely Taskforce; American Thoracic Society; American Association of Critical-Care Nurses; Society of Critical Care Medicine. An official American Thoracic Society/American Association of Critical-Care Nurses/American College of Chest Physicians/Society of Critical Care Medicine policy statement: the Choosing Wisely(R) Top 5 list in Critical Care Medicine. Am J Respir Crit Care Med. 2014 Oct 1;190(7):818-26. doi: 10.1164/rccm.201407-1317ST.
- Background: PubMed 20357283Silveira MJ, Kim SY, Langa KM. Advance directives and outcomes of surrogate decision making before death. N Engl J Med. 2010 Apr 1;362(13):1211-8. doi: 10.1056/NEJMsa0907901.
- link to pubmed abstract for this pmid 23440934Link provided by the sponsor.
- link to pubmed abstract for this pmid 17446824Link provided by the sponsor.
- link to pubmed abstract for this pmid 24861560Link provided by the sponsor.
- link to pubmed abstract for this pmid 15753749Link provided by the sponsor.
- link to pubmed abstract for this pmid 15090940Link provided by the sponsor.
- link to pubmed abstract for this pmid 29946682Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Plan would be to share aggregate, de-identified with other researchers if requested.
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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.
Alison E Turnbull, DVM MPH PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirect - other patients, Indirect - physiology and Redirection in people with Critical Illness, run by Johns Hopkins University 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 2 inclusion and 1 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 27 Jan 2020. 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. 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.
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?
Participant perception of the intensivist's prognostic estimate. (time frame: approximately 5 minutes). 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 NCT04239209, which also lists 32 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 27 Jan 2020.