Decision Aid Feasibility Trial for Families of Critically Ill Stroke Patients

NCT ID: NCT04143113

Last Updated: 2021-03-15

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-06-30

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.

Conditions

Ischemic Stroke; Ischaemic Stroke With Coma; Intracerebral Hemorrhage; Hemorrhagic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Usual Care (n=20)

Control: general information about stroke/Intracerebral Hemorrhage (ICH) from American Heart/Stroke Association

Group Type: NO_INTERVENTION

No interventions assigned to this group

Decision Aid (n=20)

Paper Decision aid (share decision making tool) with worksheet for surrogates

Group Type: EXPERIMENTAL

Decision Aid

Intervention Type: OTHER

Shared decision making tool

Interventions

Decision Aid

Shared decision making tool

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Susanne Muehlschlegel

Associate Professor of Neurocritical Care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzanne Muehlschlegel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts, Worcester

Locations

Yale Medical School/Yale New Haven Medical Center

New Haven, Connecticut, United States

University of Massachusetts, Worcester

Worcester, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 28685395 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25561435 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30288437 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28962816 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25990137 (View on PubMed)

Other Identifiers

H00015764

Identifier Type: -

Identifier Source: org_study_id