Critical IllnessPEINCT02721810
Patient Engagement Initiative
A study testing Consideration of 3-month functional prognosis in people with Critical Illness, run by Johns Hopkins University at 1 site in United States.
Trial summary
A no-cost intervention may improve adherence with a recommendation for higher-quality, lower-cost care for patients with critical illness endorsed by a collaborative of critical care societies. The investigators propose prompting consideration of functional outcomes. Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Consideration of 3-month functional prognosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 19 Mar 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Licensed physicians
- At least 4 weeks of clinical work in an I.C.U. in the U.S.A. during the past 12 months
Who cannot join
- <25 years old
- Non-English speaking
- Primarily practicing medicine outside the U.S.A.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Engaging Surrogates and Physicians to Ensure Concordant Critical Care
A no-cost intervention may improve adherence with a recommendation for higher-quality, lower-cost care for patients with critical illness endorsed by a collaborative of critical care societies. The investigators propose prompting consideration of functional outcomes. This trial will help establish the impact of the intervention on practice patterns including proxy engagement and elements of shared decision-making.
- Conditions
- Critical Illness
- Being tested
- Consideration of 3-month functional prognosis
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consideration of 3-month functional prognosisBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Prompts standard to rounds or electronic medical records. |
| Prompting Intervention | Experimental | Prompting consideration of 3-month functional outcome. Receives: Behavioral: Consideration of 3-month functional prognosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of acceptable treatment option as assessed by a checklist completed by clinical colleges.
Measured: 0 to 5 minutes after prompting an intervention
Secondary outcomes (9)
Level of conflict with proxy with a previously validated single question
Measured: 0 to 5 minutes after prompting an intervention
Level of shared decision-making measured using CollaboRATE scale
Measured: 0 to 5 minutes after prompting an intervention
Prevalence of communication skills for involving ICU proxies in treatment decisions assessed by a checklist completed by clinical colleges
Measured: 0 to 5 minutes after prompting an intervention
Medical interactions assessed using the Roter Interaction Analysis System (RIAS)
Measured: 0 to 5 minutes after prompting an intervention
Prevalence of the discussed option of stopping life support as assessed by blinded assessors
Measured: 0 to 5 minutes after prompting an intervention
Prevalence of conveying prognosis as assessed by blinded assessors
Measured: 0 to 5 minutes after prompting an intervention
Level of shared decision-making measured using CollaboRATE scale as assessed by blinded assessors
Measured: 0 to 5 minutes after prompting an intervention
The Observer OPTIONS5 measure completed by blinded assessors
Measured: 0 to 5 minutes after prompting an intervention
Consulting services requested by study participants
Measured: 0 to 5 minutes after prompting an intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startOct 2016
- Primary completionFeb 2018
- Study completion19 Mar 2019
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 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 116 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, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721810
- Sponsor's protocol ID
- IRB00082272
- Acronym
- PEI
- Status last verified
- May 2019
- First submitted
- 23 Mar 2016
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Abshire MA, Li X, Basyal PS, Teply ML, Singh AL, Hayes MM, Turnbull AE. Actor feedback and rigorous monitoring: Essential quality assurance tools for testing behavioral interventions with simulation. PLoS One. 2020 May 29;15(5):e0233538. doi: 10.1371/journal.pone.0233538. eCollection 2020.
PubMed 32469920Turnbull AE, Hayes MM, Brower RG, Colantuoni E, Basyal PS, White DB, Curtis JR, Needham DM. Effect of Documenting Prognosis on the Information Provided to ICU Proxies: A Randomized Trial. Crit Care Med. 2019 Jun;47(6):757-764. doi: 10.1097/CCM.0000000000003731.
PubMed 30882479
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Surrogates and Physicians to Ensure Concordant Critical Care
- ClinicalTrials.gov ID
- NCT02721810
- Acronym / sponsor ID
- PEI / IRB00082272
- Conditions
- Critical Illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Gordon and Betty Moore Foundation
- Study start
- Oct 2016
- Primary completion
- Feb 2018 (actual)
- Study completion
- 19 Mar 2019 (actual)
- First posted
- 29 Mar 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.
A no-cost intervention may improve adherence with a recommendation for higher-quality, lower-cost care for patients with critical illness endorsed by a collaborative of critical care societies. The investigators propose prompting consideration of functional outcomes. This trial will help establish the impact of the intervention on practice patterns including proxy engagement and elements of shared decision-making.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Prompts standard to rounds or electronic medical records. |
| Prompting Intervention | Experimental | Behavioral: Consideration of 3-month functional prognosisPrompting consideration of 3-month functional outcome. |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Licensed physicians
- At least 4 weeks of clinical work in an I.C.U. in the U.S.A. during the past 12 months
Key exclusion criteria (3 listed)
- <25 years old
- Non-English speaking
- Primarily practicing medicine outside the U.S.A.
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 |
|---|---|---|
| Consideration of 3-month functional prognosis | Behavioural | Prompting Intervention |
Primary outcome
Presence of acceptable treatment option as assessed by a checklist completed by clinical colleges.
Time frame: 0 to 5 minutes after prompting an intervention
9 secondary outcomes
Level of conflict with proxy with a previously validated single question
Time frame: 0 to 5 minutes after prompting an intervention
Level of shared decision-making measured using CollaboRATE scale
Time frame: 0 to 5 minutes after prompting an intervention
Prevalence of communication skills for involving ICU proxies in treatment decisions assessed by a checklist completed by clinical colleges
Time frame: 0 to 5 minutes after prompting an intervention
Medical interactions assessed using the Roter Interaction Analysis System (RIAS)
Time frame: 0 to 5 minutes after prompting an intervention
Prevalence of the discussed option of stopping life support as assessed by blinded assessors
Time frame: 0 to 5 minutes after prompting an intervention
Prevalence of conveying prognosis as assessed by blinded assessors
Time frame: 0 to 5 minutes after prompting an intervention
Level of shared decision-making measured using CollaboRATE scale as assessed by blinded assessors
Time frame: 0 to 5 minutes after prompting an intervention
The Observer OPTIONS5 measure completed by blinded assessors
Time frame: 0 to 5 minutes after prompting an intervention
Consulting services requested by study participants
Time frame: 0 to 5 minutes after prompting an intervention
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 20 May 2019.
- Derived from this study: PubMed 32469920Abshire MA, Li X, Basyal PS, Teply ML, Singh AL, Hayes MM, Turnbull AE. Actor feedback and rigorous monitoring: Essential quality assurance tools for testing behavioral interventions with simulation. PLoS One. 2020 May 29;15(5):e0233538. doi: 10.1371/journal.pone.0233538. eCollection 2020.
- Derived from this study: PubMed 30882479Turnbull AE, Hayes MM, Brower RG, Colantuoni E, Basyal PS, White DB, Curtis JR, Needham DM. Effect of Documenting Prognosis on the Information Provided to ICU Proxies: A Randomized Trial. Crit Care Med. 2019 Jun;47(6):757-764. doi: 10.1097/CCM.0000000000003731.
- Individual participant dataSharing planned: No
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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 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 Consideration of 3-month functional prognosis 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 3 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 20 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 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?
Presence of acceptable treatment option as assessed by a checklist completed by clinical colleges. (time frame: 0 to 5 minutes after prompting an intervention). 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 NCT02721810, 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 20 May 2019.