Decision Aid Feasibility Trial for Families of Critically Ill Stroke Patients

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.

Study Overview

• Status: Withdrawn
• Conditions: Ischemic Stroke; Hemorrhagic Stroke; Intracerebral Hemorrhage; Ischaemic Stroke With Coma
• Intervention / Treatment: Other: Decision Aid

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale Medical School/Yale New Haven Medical Center
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts, Worcester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care (n=20); Control: general information about stroke/Intracerebral Hemorrhage (ICH) from American Heart/Stroke Association
Experimental: Decision Aid (n=20); Paper Decision aid (share decision making tool) with worksheet for surrogates	Other: Decision Aid; Shared decision making tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment	Consent rate	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	1-36 hours after family meeting
Retention	Number of participants who complete follow-up	3 months after goals-of-care decision

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1-36 hours after family meeting
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.	Baseline, 1-36 hours after family meeting, and 3-months after goals-of-care decision

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinician-surrogate concordance scale score	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).	Baseline and 1-36 hours after family meeting
Decisional Conflict Scale	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).	1-36 hours after family meeting
Hospital Anxiety and Depression Scale (HADS)	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.	Baseline,1-36 hours after family meeting, and 3-months
Quality of Communications Scale	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.	1-36 hours after family meeting
Patient's survival status	Investigators will record whether the patient is dead or alive.	3-months after goals of care decision
Patient's modified Rankin Scale	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).	3-months after goals of care decision
Surrogate Decision Regret Scale	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).	3-months after goals of care decision
AIS/Intracerebral Hemorrhage (ICH) knowledge test	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.	Baseline and 1-36 hours after family meeting
Total number of goals-of-care family meetings	Investigators will sum up the total number of goals-of-care meetings at the patient's ICU discharge.	Through discharge from hospital, an average of 4 weeks
Cumulative duration of the goals-of-care family meetings	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].	Through discharge from hospital, an average of 4 weeks

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Yale University
• Investigators: Principal Investigator: Suzanne Muehlschlegel, MD, PhD, University of Massachusetts, Worcester

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: October 24, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2021
• Last Update Submitted That Met QC Criteria: March 10, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: palliative care; critical care; stroke; shared decision making; patient-centered care; hemorrhagic stroke; decision aid; end of life; neurocritical care; family communication; neuroICU; goals of care
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Infarction; Brain Infarction; Intracranial Hemorrhages; Stroke; Ischemic Stroke; Ischemia; Hemorrhage; Cerebral Infarction; Cerebral Hemorrhage; Hemorrhagic Stroke
• Other Study ID Numbers: H00015764

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No