Decision Aid Feasibility Trial for Families of Critically Ill Stroke Patients
Primary Purpose
Ischemic Stroke, Ischaemic Stroke With Coma, Intracerebral Hemorrhage
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Decision Aid
Sponsored by
About this trial
This is an interventional other trial for Ischemic Stroke focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
≥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)
Exclusion Criteria:
- 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
Sites / Locations
- Yale Medical School/Yale New Haven Medical Center
- University of Massachusetts, Worcester
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care (n=20)
Decision Aid (n=20)
Arm Description
Control: general information about stroke/Intracerebral Hemorrhage (ICH) from American Heart/Stroke Association
Paper Decision aid (share decision making tool) with worksheet for surrogates
Outcomes
Primary Outcome Measures
Recruitment
Consent rate
Participation
Proportion of participants who read decision aid and completed worksheet
Retention
Number of participants who complete follow-up
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT04143113
First Posted
October 24, 2019
Last Updated
March 10, 2021
Sponsor
University of Massachusetts, Worcester
Collaborators
Yale University
1. Study Identification
Unique Protocol Identification Number
NCT04143113
Brief Title
Decision Aid Feasibility Trial for Families of Critically Ill Stroke Patients
Official Title
Feasibility Trial of a Goals of Care Decision Aid for Families of Critically Ill Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study not funded
Study Start Date
July 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke, Ischaemic Stroke With Coma, Intracerebral Hemorrhage, Hemorrhagic Stroke
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
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Step-wedge design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual Care (n=20)
Arm Type
No Intervention
Arm Description
Control: general information about stroke/Intracerebral Hemorrhage (ICH) from American Heart/Stroke Association
Arm Title
Decision Aid (n=20)
Arm Type
Experimental
Arm Description
Paper Decision aid (share decision making tool) with worksheet for surrogates
Intervention Type
Other
Intervention Name(s)
Decision Aid
Intervention Description
Shared decision making tool
Primary Outcome Measure Information:
Title
Recruitment
Description
Consent rate
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.
Title
Participation
Description
Proportion of participants who read decision aid and completed worksheet
Time Frame
1-36 hours after family meeting
Title
Retention
Description
Number of participants who complete follow-up
Time Frame
3 months after goals-of-care decision
Secondary Outcome Measure Information:
Title
Impact of Events Scale-revised
Description
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.
Time Frame
Baseline, 1-36 hours after family meeting, and 3-months after goals-of-care decision
Title
Patient-Perceived Centeredness of Care Scale
Description
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.
Time Frame
1-36 hours after family meeting
Other Pre-specified Outcome Measures:
Title
Decisional Conflict Scale
Description
is a validated scale that measures the personal perception of choosing an option and factors contributing to choice uncertainty. It is a 16-item, 5-item Likert scale with sub-scores for uncertainty, feeling informed, values clarity, decision support and effective decision-making. It ranges from 0 (strongly agree) to 4 (strongly disagree).
Time Frame
1-36 hours after family meeting
Title
Surrogate Decision Regret Scale
Description
is a validated scale that measures distress or remorse after a health care decision with high internal consistency. It asks 5 questions and provides a 5-point Likert scale. It ranges between 1 (strongly agree) to 5 (strongly disagree).
Time Frame
3-months after goals of care decision
Title
Clinician-surrogate concordance scale score
Description
measures prognostic concordance between ICU clinicians and surrogates. Participants from both groups will independently estimate numerically a SABI patient's 6-month survival and return to independence. Concordance is calculated as the absolute value of the difference in prognosis between the surrogate and the clinician, and, therefore, can range from 0 (no concordance) to 100 (full concordance).
Time Frame
Baseline and 1-36 hours after family meeting
Title
AIS/Intracerebral Hemorrhage (ICH) knowledge test
Description
Medical knowledge about the goals-of-care decision in severe strokes will be assessed using the medical knowledge test, which was adapted to 17 questions about goals-of-care and severe strokes, all of which are addressed in the decision aid. The % correct will be calculated.
Time Frame
Baseline and 1-36 hours after family meeting
Title
Hospital Anxiety and Depression Scale (HADS)
Description
is a 14-item, two-domain (depression, anxiety) instrument with reliability and validity among ICU surrogates, which is recommended by consensus guidelines for the prospective measurement of psychological distress among ICU surrogates. Each of the 14 questions are scored between 0 (not at all) and 3 (most of the time), and summed up for a total HADS score, which ranges from 0 to 42, with higher scores indicating worse symptoms. Total HADS 0-7 =normal, 8-10 borderline abnormal, 11-21=abnormal, indicating high anxiety and depression.
Time Frame
Baseline,1-36 hours after family meeting, and 3-months
Title
Quality of Communications Scale
Description
is a is a validated 17-item patient-centered instrument widely used in the ICU to assess surrogates' satisfaction of clinician communication about treatments and understanding treatment decisions. It ranges between 0 (poor) to 10 (absolutely perfect). Total score is the sum of all questions and ranges from 0 to 100, with higher scores indicating better communication.
Time Frame
1-36 hours after family meeting
Title
Total number of goals-of-care family meetings
Description
Investigators will sum up the total number of goals-of-care meetings at the patient's ICU discharge.
Time Frame
Through discharge from hospital, an average of 4 weeks
Title
Cumulative duration of the goals-of-care family meetings
Description
Investigators will track the duration of each goals-of-care meeting. At the patient's ICU discharge, investigators will sum up the cumulative duration of all goals-of-care meetings [minutes].
Time Frame
Through discharge from hospital, an average of 4 weeks
Title
Patient's survival status
Description
Investigators will record whether the patient is dead or alive.
Time Frame
3-months after goals of care decision
Title
Patient's modified Rankin Scale
Description
is a validated scale that measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It ranges from 0 (no symptoms at all) to 6 (death).
Time Frame
3-months after goals of care decision
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
≥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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suzanne Muehlschlegel, MD, PhD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale Medical School/Yale New Haven Medical Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
University of Massachusetts, Worcester
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to share listed materials (below), including deidentified participant data (with data dictionaries), as long as this is approved by the IRB.
IPD Sharing Time Frame
Beginning immediately after publication and for 5 years.
IPD Sharing Access Criteria
Researchers who provide a scientifically and methodologically sound proposal to achieve the aims in the approved proposal. Proposals should be submitted by email to the PI (Dr. Muehlschlegel). To gain access, researchers will need to sign a data access agreement.
Citations:
PubMed Identifier
28685395
Citation
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.
Results Reference
background
PubMed Identifier
25561435
Citation
Muehlschlegel 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.
Results Reference
background
PubMed Identifier
30288437
Citation
Moskowitz 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.
Results Reference
background
PubMed Identifier
28962816
Citation
Khan 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.
Results Reference
background
PubMed Identifier
25990137
Citation
Cai 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.
Results Reference
background
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Decision Aid Feasibility Trial for Families of Critically Ill Stroke Patients
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