Decision Aid Feasibility Trial for Families of Critically Ill Stroke Patients

NCT04143113 | Withdrawn

• 1 other identifier: H00015764
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Impact of Events Scale-revised

  Baseline, 1-36 hours after family meeting, and 3-months after goals-of-care decision

• Patient-Perceived Centeredness of Care Scale

  1-36 hours after family meeting

Other Outcomes (10)

• Decisional Conflict Scale

  1-36 hours after family meeting

• Surrogate Decision Regret Scale

  3-months after goals of care decision

• Clinician-surrogate concordance scale score

  Baseline and 1-36 hours after family meeting

Study Arms (2)

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

Other: Decision Aid

Interventions

Decision Aid OTHER

Shared decision making tool

Decision Aid (n=20)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Yale University: collaborator

Study Sites (2)

Yale Medical School/Yale New Haven Medical Center

New Haven, Connecticut, 06520, United States

Location

University of Massachusetts, Worcester

Worcester, Massachusetts, 01655, United States

Location

Related Publications (5)

• 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.

  PMID: 28685395 BACKGROUND

• 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.

  PMID: 25561435 BACKGROUND

• 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.

  PMID: 30288437 BACKGROUND

• 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.

  PMID: 28962816 BACKGROUND

• 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.

  PMID: 25990137 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Cerebral Hemorrhage; Hemorrhagic Stroke; Stroke; Death

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Intracranial Hemorrhages; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Suzanne Muehlschlegel, MD, PhD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Neurocritical Care

Model Details: Step-wedge design

Study Record Dates

• First Submitted: October 24, 2019
• First Posted: October 29, 2019
• Study Start: July 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: March 15, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning immediately after publication and for 5 years.
• 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.

Locations

US (2)