Surrogate Decision MakersNCT01751061
Improving Decision Making for Patients With Prolonged Mechanical Ventilation
A study testing Decision aid in people with Surrogate Decision Makers and Prolonged Mechanical Ventilation, run by Duke University at 4 sites in United States.
Trial summary
Deciding about prolonged life support for critically ill patients can be very difficult. Therefore, the investigators are doing a study to see if an internet-based decision aid can improve the quality of decision making for substitute decision makers of patients who are in the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surrogate Decision Makers, Prolonged Mechanical Ventilation
- What is being tested?
- Decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2013to 6 Jan 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- self-identified as participating directly in health care decision making for the incapable patient under relevant state law
Who cannot join
- do not personally know the patient
- need translation assistance because of poor English fluency (the decision aid has not been validated in other languages)
- history of clinically important neurological disorder (e.g., dementia)
- patient dies after meeting inclusion criteria but before surrogates provide consent
- Physician and nurse inclusion criteria:
- ICU attending or fellow (physicians) at the time of surrogate enrollment
- bedside ICU nurse present at the time of surrogate enrollment
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
Duke University
Durham, North Carolina, 27710
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
University of Washington
Seattle, Washington, 98195
About this study
Deciding about prolonged life support for critically ill patients can be very difficult. Therefore, the investigators are doing a study to see if an internet-based decision aid can improve the quality of decision making for substitute decision makers of patients who are in the intensive care unit (ICU).
Read the detailed description
The process of making a decision about whether or not to provide prolonged life support is seriously deficient among clinicians and the surrogate decision makers for critically ill patients. To address this problem, we propose a randomized, controlled trial to determine if an innovative web-based decision aid compared to usual care control can improve the quality of decision making (defined as clinician-surrogate concordance for prognosis, quality of communication, and medical comprehension), reduce surrogates' psychological distress (depression, anxiety, and post-traumatic stress syndrome disorder (PTSD) symptoms), and reduce patients' health care costs over 6-month follow up. We will enroll 410 surrogate decision makers for 273 patients (expected average of 1.5 surrogates per patient). This study has the potential both to improve how clinicians and surrogates interact in intensive care units and to increase the likelihood that life support decisions are aligned with patients' values.
- Being tested
- Decision aid, Usual care
- Keywords
- prolonged mechanical ventilation, chronic critical illness, decision making, decision aid, decisional support, critical illness, intensive care unit
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aidBehavioural
A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions
Usual careOther
usual ICU care
| Study group | Role | What they receive |
|---|---|---|
| Decision aid | Experimental | Web-based decision aid (decision support tool) provided to surrogate decision maker Receives: Behavioral: Decision aid |
| Usual care | Active comparator | usual care in an intensive care unit setting Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Clinician-surrogate Concordance Scale Score
Concordance is calculated as the absolute value of the difference in prognosis for 1 year patient survival between the surrogate(s) and the clinician (ICU physician), and, therefore, can range from 0 to 100.
We report pre-intervention to post-intervention difference in the CSCS.
The CSCS is calculated as the absolute value of the difference between the surrogate's response and that of either the treating ICU physician (primary outcome) or the nurse (secondary outcome) to the question, "What percent chance do you think [the patient/your loved one] has of being alive 1 year from now if the current treatment plan is continued?" Scores can range from 0 to 100 percentage points, and higher values indicate greater discordance.
Measured: ~2-7 days post-randomization
Secondary outcomes (6)
Hospital Anxiety and Depression Scale (HADS) Total Score
We report here the difference between Interview 1 (baseline) and Interview 4 (6 months post-randomization) for primary surrogate decision makers (not secondary).
HADS scores can range from 0 to 42 points; higher scores=more distress.
Measured: Pre-randomization (study day 1) and 180 days post-randomization
Post-traumatic Stress Syndrome Inventory
Here we report PTSS score differences between Interview 1 (baseline) and Interview 4 (6 months post-randomization) for primary (not secondary) surrogate decision makers.
PTSS scores can range from 10-70, with greater scores=more distress.
Measured: Pre-randomization (study day 1) and 180 days post-randomization
Patient-centeredness of Care Scale
Here we report change in patient-centeredness score between Study day 1 (Interview 1) and 180 days post-randomization (Interview 4) for primary (not secondary) surrogate decision makers.
Scores can range from 12-48 points, with higher scores=greater patient-centeredness.
Measured: Study day 1 and 180 days post-randomization
Medical Comprehension Scale Score
Here we report MCS score differences between Interview 1 (baseline) and Interview 2 (immediately post-intervention) for primary (not secondary) surrogate decision makers.
Scores can range from 0-8, with greater scores=better comprehension.
Measured: Study day 1 (pre-randomization), ~2-7
Quality of Communication Scale Score
Here we report QOC score differences between Interview 1 (baseline) and Interview 2 (immediately post-intervention) for primary (not secondary) surrogate decision makers.
Scores range from 0-110, with higher scores=better quality of communication.
Measured: Study day 1 (pre-randomization), ~2-7
Change in Clinical-surrogate Concordance Scale Score (Nurse)
Concordance is calculated as the absolute value of the difference in prognosis for 1 year patient survival between the primary surrogate decision maker and the IUC nurse, and, therefore, can range from 0 to 100.
We report pre-intervention to post-intervention difference in the CSCS.
The CSCS is calculated as the absolute value of the difference between the surrogate's response and that of the nurse to the question, "What percent chance do you think [the patient/your loved one] has of being alive 1 year from now if the current treatment plan is continued?" Scores can range from 0 to 100 percentage points, and higher values indicate greater discordance.
Measured: ~2-7 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJan 2013
- Primary completion3 May 2016
- Study completion6 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Surrogate Decision MakersStudies of the same condition, open and under way.
- More trials run by Duke 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, University of Pittsburgh, University of Washington, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Christopher E Cox, MD MPH, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751061
- Sponsor's protocol ID
- Pro00021965
- Other IDs
- R01HL109823-01A1
- Status last verified
- Apr 2019
- First submitted
- 13 Dec 2012
- Last updated
- 2 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Cox CE, Lewis CL, Hanson LC, Hough CL, Kahn JM, White DB, Song MK, Tulsky JA, Carson SS. Development and pilot testing of a decision aid for surrogates of patients with prolonged mechanical ventilation. Crit Care Med. 2012 Aug;40(8):2327-34. doi: 10.1097/CCM.0b013e3182536a63.
PubMed 22635048Cox CE, White DB, Hough CL, Jones DM, Kahn JM, Olsen MK, Lewis CL, Hanson LC, Carson SS. Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial. Ann Intern Med. 2019 Mar 5;170(5):285-297. doi: 10.7326/M18-2335. Epub 2019 Jan 29.
PubMed 30690645
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Decision Making for Patients With Prolonged Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT01751061
- Acronym / sponsor ID
- Pro00021965
- Keywords
- prolonged mechanical ventilation, chronic critical illness, decision making, decision aid, decisional support, critical illness, intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, University of Pittsburgh, University of Washington, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2013 (actual)
- Primary completion
- 3 May 2016 (actual)
- Study completion
- 6 Jan 2017 (actual)
- First posted
- 17 Dec 2012 (estimated)
- Results
- Posted 2 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Deciding about prolonged life support for critically ill patients can be very difficult. Therefore, the investigators are doing a study to see if an internet-based decision aid can improve the quality of decision making for substitute decision makers of patients who are in the intensive care unit (ICU).
Detailed description
The process of making a decision about whether or not to provide prolonged life support is seriously deficient among clinicians and the surrogate decision makers for critically ill patients. To address this problem, we propose a randomized, controlled trial to determine if an innovative web-based decision aid compared to usual care control can improve the quality of decision making (defined as clinician-surrogate concordance for prognosis, quality of communication, and medical comprehension), reduce surrogates' psychological distress (depression, anxiety, and post-traumatic stress syndrome disorder (PTSD) symptoms), and reduce patients' health care costs over 6-month follow up. We will enroll 410 surrogate decision makers for 273 patients (expected average of 1.5 surrogates per patient). This study has the potential both to improve how clinicians and surrogates interact in intensive care units and to increase the likelihood that life support decisions are aligned with patients' values.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decision aid | Experimental | Behavioral: Decision aidWeb-based decision aid (decision support tool) provided to surrogate decision maker |
| Usual care | Active comparator | Other: Usual careusual care in an intensive care unit setting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age ≥18
- self-identified as participating directly in health care decision making for the incapable patient under relevant state law
Key exclusion criteria (7 listed)
- do not personally know the patient
- need translation assistance because of poor English fluency (the decision aid has not been validated in other languages)
- history of clinically important neurological disorder (e.g., dementia)
- patient dies after meeting inclusion criteria but before surrogates provide consent
- ICU attending or fellow (physicians) at the time of surrogate enrollment
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 |
|---|---|---|
| Decision aidA web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions | Behavioural | Decision aid |
| Usual careusual ICU care | Other | Usual care |
Primary outcome
Change in Clinician-surrogate Concordance Scale Score
Time frame: ~2-7 days post-randomization
Concordance is calculated as the absolute value of the difference in prognosis for 1 year patient survival between the surrogate(s) and the clinician (ICU physician), and, therefore, can range from 0 to 100. We report pre-intervention to post-intervention difference in the CSCS. The CSCS is calculated as the absolute value of the difference between the surrogate's response and that of either the treating ICU physician (primary outcome) or the nurse (secondary outcome) to the question, "What percent chance do you think [the patient/your loved one] has of being alive 1 year from now if the current treatment plan is continued?" Scores can range from 0 to 100 percentage points, and higher values indicate greater discordance.
6 secondary outcomes
Hospital Anxiety and Depression Scale (HADS) Total Score
Time frame: Pre-randomization (study day 1) and 180 days post-randomization
Post-traumatic Stress Syndrome Inventory
Time frame: Pre-randomization (study day 1) and 180 days post-randomization
Patient-centeredness of Care Scale
Time frame: Study day 1 and 180 days post-randomization
Medical Comprehension Scale Score
Time frame: Study day 1 (pre-randomization), ~2-7
Quality of Communication Scale Score
Time frame: Study day 1 (pre-randomization), ~2-7
Change in Clinical-surrogate Concordance Scale Score (Nurse)
Time frame: ~2-7 days post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22635048Cox CE, Lewis CL, Hanson LC, Hough CL, Kahn JM, White DB, Song MK, Tulsky JA, Carson SS. Development and pilot testing of a decision aid for surrogates of patients with prolonged mechanical ventilation. Crit Care Med. 2012 Aug;40(8):2327-34. doi: 10.1097/CCM.0b013e3182536a63.
- Derived from this study: PubMed 30690645Cox CE, White DB, Hough CL, Jones DM, Kahn JM, Olsen MK, Lewis CL, Hanson LC, Carson SS. Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial. Ann Intern Med. 2019 Mar 5;170(5):285-297. doi: 10.7326/M18-2335. Epub 2019 Jan 29.
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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.
Christopher E Cox, MD MPH principal investigator
Duke University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid in people with Surrogate Decision Makers and Prolonged Mechanical Ventilation, run by Duke University 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 2 inclusion and 7 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 2 May 2019. 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?
Yes. Results are posted in the registry (first posted 2 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Clinician-surrogate Concordance Scale Score (time frame: ~2-7 days post-randomization). 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 NCT01751061, 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 2 May 2019.