Ischemic StrokeNCT04143113
Decision Aid Feasibility Trial for Families of Critically Ill Stroke Patients
A study testing Decision Aid in people with Ischemic Stroke and Ischaemic Stroke With Coma, run by University of Massachusetts, Worcester at 2 sites in United States.
Trial summary
Severe strokes, including large artery acute ischemic stroke and intracerebral hemorrhage, continue to be the leading cause of death and disability in adults in the U.S. Due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke, Ischaemic Stroke With Coma, Intracerebral Hemorrhage
- What is being tested?
- Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2020to 30 Jun 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age; no upper age limit
- Documented health care proxy or legal next of kin of severe stroke patient admitted to the ICU with intracerebral hemorrhage or acute ischemic stroke.
- ≥3 days after insult ("stabilization period"); clinical team may ask study team to wait longer if clinically indicated
- Severe stroke patient remains "critically ill" after 3 days defined as: either intubated and mechanically ventilated, or unable to swallow, needing feeding tube beyond hospital discharge (even if not intubated)
- Surrogate is physically present in ICU to receive decision aid and participate in planned family meeting in person (not over phone)
Who cannot join
- Devastating severe stroke patient near death
- Patient will be extubated and pass swallow evaluation (as deemed by clinical team)
- Surrogate is non-English speaking and no interpreter available to translate decision aid (no available validated, translated decision aid version)
- Surrogate is illiterate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale Medical School/Yale New Haven Medical Center
New Haven, Connecticut, 06520
University of Massachusetts, Worcester
Worcester, Massachusetts, 01655
About this study
Official title: Feasibility Trial of a Goals of Care Decision Aid for Families of Critically Ill Stroke Patients
Severe strokes, including large artery acute ischemic stroke and intracerebral hemorrhage, continue to be the leading cause of death and disability in adults in the U.S. Due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is the most common cause of death in severe strokes, but occurs at a highly variable rate. Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. The investigators have developed a pilot DA for goals-of-care decisions for surrogates of severe, critically ill stroke patients. This was developed through qualitative research using semi-structured interviews in surrogate decision makers of traumatic brain injury patients and physicians, and adapted to severe strokes. The investigators now propose to pilot-test a DA for surrogates of critically ill severe stroke patients in a feasibility trial.
Read the detailed description
Severe strokes, including large artery acute ischemic stroke and intracerebral hemorrhage, continue to be the leading cause of death and disability in adults in the U.S, accounting for more than 200,000 of the acute brain injury-related deaths in the U.S. annually. Patients with severe strokes are critically ill and most commonly require mechanical ventilation and supportive medical care with artificial nutrition to ensure survival. However, due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is by far the most common cause of death in severe strokes but occurs at a highly variable rate at different stroke centers. Shared decision making is a collaborative process that enhances patients' and surrogates' understanding about prognosis, encourages them to actively weigh the risks and benefits of a treatment, and to match them to patient preferences, thereby decreasing decisional conflict and improving decision quality and health related outcomes. Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. No DA currently exists for goals-of-care decisions in critically ill severe stroke patients. Such a patient- and family-centered DA has the potential to improve decision-making for critically ill severe stroke patients by ensuring proxies receive consistent, evidence-based prognostication while also addressing patients' preferences and values. The investigators have developed a pilot DA for goals of care decisions by surrogates of critically ill severe stroke patients using qualitative research using semi-structured interviews in surrogate decision makers of traumatic brain injury patients and physicians, followed by an iterative feedback process with feedback by surrogates, physicians, and other stakeholders (ICU nurses), and adaptation to large artery acute ischemic and hemorrhagic stroke. The investigators now propose to pilot-test a DA for surrogates of critically ill severe stroke patients in a feasibility trial.
- Being tested
- Decision Aid
- Keywords
- stroke, hemorrhagic stroke, shared decision making, neurocritical care, decision aid, goals of care, palliative care, family communication, end of life, critical care, neuroICU, patient-centered care
- Medical subject headings
- Ischemic Stroke, Cerebral Hemorrhage, Hemorrhagic Stroke, Stroke, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidOther
Shared decision making tool
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (n=20) | No intervention | Control: general information about stroke/Intracerebral Hemorrhage (ICH) from American Heart/Stroke Association |
| Decision Aid (n=20) | Experimental | Paper Decision aid (share decision making tool) with worksheet for surrogates Receives: Other: Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Consent rate
Measured: From date of approaching surrogate decision maker for consent until the date of the first documented goals-of-care family meeting, assessed up to 1 month after admission.
Participation
Proportion of participants who read decision aid and completed worksheet
Measured: 1-36 hours after family meeting
Retention
Number of participants who complete follow-up
Measured: 3 months after goals-of-care decision
Secondary outcomes (2)
Impact of Events Scale-revised
is a is a validated 15-item instrument, measuring post-traumatic stress disorder (PTSD) symptoms. Total score is the sum of all questions and ranges from 0 to 88, with higher scores indicating worse PTSD symptoms.
Measured: Baseline, 1-36 hours after family meeting, and 3-months after goals-of-care decision
Patient-Perceived Centeredness of Care Scale
is a is a validated 14-item, 4-point Likert scale based test. Its version adapted to surrogates has shown responsiveness in a recent trial of a nurse-driven communication intervention for surrogates in the ICU. It ranges between 1 (very well) to 4 (not at all), and median score is calculated from all questions. Median scores range from 1 to 4, with lower scores indicating more patient- and family-centered care.
Measured: 1-36 hours after family meeting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Jul 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Why it stopped: Study not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Step-wedge design
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University
- Responsible party
- Principal investigator, Susanne Muehlschlegel, University of Massachusetts, Worcester
- Investigators
- Suzanne Muehlschlegel, MD, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04143113
- Sponsor's protocol ID
- H00015764
- Status last verified
- Mar 2021
- First submitted
- 24 Oct 2019
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share listed materials (below), including deidentified participant data (with data dictionaries), as long as this is approved by the IRB.
Publications
Quinn T, Moskowitz J, Khan MW, Shutter L, Goldberg R, Col N, Mazor KM, Muehlschlegel S. What Families Need and Physicians Deliver: Contrasting Communication Preferences Between Surrogate Decision-Makers and Physicians During Outcome Prognostication in Critically Ill TBI Patients. Neurocrit Care. 2017 Oct;27(2):154-162. doi: 10.1007/s12028-017-0427-2.
PubMed 28685395Muehlschlegel S, Shutter L, Col N, Goldberg R. Decision Aids and Shared Decision-Making in Neurocritical Care: An Unmet Need in Our NeuroICUs. Neurocrit Care. 2015 Aug;23(1):127-30. doi: 10.1007/s12028-014-0097-2.
PubMed 25561435Moskowitz J, Quinn T, Khan MW, Shutter L, Goldberg R, Col N, Mazor KM, Muehlschlegel S. Should We Use the IMPACT-Model for the Outcome Prognostication of TBI Patients? A Qualitative Study Assessing Physicians' Perceptions. MDM Policy Pract. 2018 Mar 26;3(1):2381468318757987. doi: 10.1177/2381468318757987. eCollection 2018 Jan-Jun.
PubMed 30288437Khan MW, Muehlschlegel S. Shared Decision Making in Neurocritical Care. Neurol Clin. 2017 Nov;35(4):825-834. doi: 10.1016/j.ncl.2017.06.014.
PubMed 28962816Cai X, Robinson J, Muehlschlegel S, White DB, Holloway RG, Sheth KN, Fraenkel L, Hwang DY. Patient Preferences and Surrogate Decision Making in Neuroscience Intensive Care Units. Neurocrit Care. 2015 Aug;23(1):131-41. doi: 10.1007/s12028-015-0149-2.
PubMed 25990137
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Trial of a Goals of Care Decision Aid for Families of Critically Ill Stroke Patients
- ClinicalTrials.gov ID
- NCT04143113
- Acronym / sponsor ID
- H00015764
- Keywords
- stroke, hemorrhagic stroke, shared decision making, neurocritical care, decision aid, goals of care, palliative care, family communication
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Yale University
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 29 Oct 2019 (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.
Severe strokes, including large artery acute ischemic stroke and intracerebral hemorrhage, continue to be the leading cause of death and disability in adults in the U.S. Due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is the most common cause of death in severe strokes, but occurs at a highly variable rate. Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. The investigators have developed a pilot DA for goals-of-care decisions for surrogates of severe, critically ill stroke patients. This was developed through qualitative research using semi-structured interviews in surrogate decision makers of traumatic brain injury patients and physicians, and adapted to severe strokes. The investigators now propose to pilot-test a DA for surrogates of critically ill severe stroke patients in a feasibility trial.
Detailed description
Severe strokes, including large artery acute ischemic stroke and intracerebral hemorrhage, continue to be the leading cause of death and disability in adults in the U.S, accounting for more than 200,000 of the acute brain injury-related deaths in the U.S. annually. Patients with severe strokes are critically ill and most commonly require mechanical ventilation and supportive medical care with artificial nutrition to ensure survival. However, due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is by far the most common cause of death in severe strokes but occurs at a highly variable rate at different stroke centers. Shared decision making is a collaborative process that enhances patients' and surrogates' understanding about prognosis, encourages them to actively weigh the risks and benefits of a treatment, and to match them to patient preferences, thereby decreasing decisional conflict and improving decision quality and health related outcomes. Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. No DA currently exists for goals-of-care decisions in critically ill severe stroke patients. Such a patient- and family-centered DA has the potential to improve decision-making for critically ill severe stroke patients by ensuring proxies receive consistent, evidence-based prognostication while also addressing patients' preferences and values. The investigators have developed a pilot DA for goals of care decisions by surrogates of critically ill severe stroke patients using qualitative research using semi-structured interviews in surrogate decision makers of traumatic brain injury patients and physicians, followed by an iterative feedback process with feedback by surrogates, physicians, and other stakeholders (ICU nurses), and adaptation to large artery acute ischemic and hemorrhagic stroke. The investigators now propose to pilot-test a DA for surrogates of critically ill severe stroke patients in a feasibility trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Step-wedge design
| Arm | Type | Receives |
|---|---|---|
| Usual Care (n=20) | No intervention | –Control: general information about stroke/Intracerebral Hemorrhage (ICH) from American Heart/Stroke Association |
| Decision Aid (n=20) | Experimental | Other: Decision AidPaper Decision aid (share decision making tool) with worksheet for surrogates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age; no upper age limit
- Documented health care proxy or legal next of kin of severe stroke patient admitted to the ICU with intracerebral hemorrhage or acute ischemic stroke.
- ≥3 days after insult ("stabilization period"); clinical team may ask study team to wait longer if clinically indicated
- Severe stroke patient remains "critically ill" after 3 days defined as: either intubated and mechanically ventilated, or unable to swallow, needing feeding tube beyond hospital discharge (even if not intubated)
- Surrogate is physically present in ICU to receive decision aid and participate in planned family meeting in person (not over phone)
Key exclusion criteria (4 listed)
- Devastating severe stroke patient near death
- Patient will be extubated and pass swallow evaluation (as deemed by clinical team)
- Surrogate is non-English speaking and no interpreter available to translate decision aid (no available validated, translated decision aid version)
- Surrogate is illiterate
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 AidShared decision making tool | Other | Decision Aid (n=20) |
Primary outcome
Recruitment
Time frame: From date of approaching surrogate decision maker for consent until the date of the first documented goals-of-care family meeting, assessed up to 1 month after admission.
Consent rate
Participation
Time frame: 1-36 hours after family meeting
Proportion of participants who read decision aid and completed worksheet
Retention
Time frame: 3 months after goals-of-care decision
Number of participants who complete follow-up
2 secondary outcomes
Impact of Events Scale-revised
Time frame: Baseline, 1-36 hours after family meeting, and 3-months after goals-of-care decision
Patient-Perceived Centeredness of Care Scale
Time frame: 1-36 hours after family meeting
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2021.
- Background: PubMed 28685395Quinn T, Moskowitz J, Khan MW, Shutter L, Goldberg R, Col N, Mazor KM, Muehlschlegel S. What Families Need and Physicians Deliver: Contrasting Communication Preferences Between Surrogate Decision-Makers and Physicians During Outcome Prognostication in Critically Ill TBI Patients. Neurocrit Care. 2017 Oct;27(2):154-162. doi: 10.1007/s12028-017-0427-2.
- Background: PubMed 25561435Muehlschlegel S, Shutter L, Col N, Goldberg R. Decision Aids and Shared Decision-Making in Neurocritical Care: An Unmet Need in Our NeuroICUs. Neurocrit Care. 2015 Aug;23(1):127-30. doi: 10.1007/s12028-014-0097-2.
- Background: PubMed 30288437Moskowitz J, Quinn T, Khan MW, Shutter L, Goldberg R, Col N, Mazor KM, Muehlschlegel S. Should We Use the IMPACT-Model for the Outcome Prognostication of TBI Patients? A Qualitative Study Assessing Physicians' Perceptions. MDM Policy Pract. 2018 Mar 26;3(1):2381468318757987. doi: 10.1177/2381468318757987. eCollection 2018 Jan-Jun.
- Background: PubMed 28962816Khan MW, Muehlschlegel S. Shared Decision Making in Neurocritical Care. Neurol Clin. 2017 Nov;35(4):825-834. doi: 10.1016/j.ncl.2017.06.014.
- Background: PubMed 25990137Cai X, Robinson J, Muehlschlegel S, White DB, Holloway RG, Sheth KN, Fraenkel L, Hwang DY. Patient Preferences and Surrogate Decision Making in Neuroscience Intensive Care Units. Neurocrit Care. 2015 Aug;23(1):131-41. doi: 10.1007/s12028-015-0149-2.
- Individual participant dataSharing planned: Yes. We plan to share listed materials (below), including deidentified participant data (with data dictionaries), as long as this is approved by the IRB.
Related trials for Ischemic Stroke
RecruitingObservational study
Natural History of Stroke: Cause and Development
Brain Disease, Ischemic Attack, Transient
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
Not yet recruitingPhase 3
Cilostazol for Prevention of Recurrent Stroke Trial
Stroke Recurrence, Myocardial Infarction
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
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.
Suzanne Muehlschlegel, MD, PhD principal investigator
University of Massachusetts, Worcester
2 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 Ischemic Stroke and Ischaemic Stroke With Coma, run by University of Massachusetts, Worcester at 2 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 4 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: withdrawn, as of the sponsor's last update on 15 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 was withdrawn before enrolling participants, so there are no results.
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?
Recruitment (time frame: From date of approaching surrogate decision maker for consent until the date of the first documented goals-of-care family meeting, assessed up to 1 month after admission.). The study lists 3 primary outcomes in all. 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 NCT04143113, which also lists 5 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 15 Mar 2021; AzTrials last refreshed its copy on 26 Oct 2026.