Shared Decision Making to Improve Goals-of-Care Decisions for Families of Severe Acute Brain Injury Patients

NCT03833375 | Completed

• 2 other identifiers: H00004724/H000157645K23HD080971
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 2

Brief Summary

Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury 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 SABI, but occurs at a highly variable rate (for example in Traumatic Brain Injury (TBI) 45-89%). 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 SABI patients. This was developed through qualitative research using semi-structured interviews in surrogate decision makers of TBI patients and physicians. The investigators now propose to pilot-test a DA for surrogates of SABI patients in a feasibility trial.

Conditions

Traumatic Brain Injury; Ischemic Stroke; Intracerebral Hemorrhage

Keywords

TBI; stroke; ICH; AIS; decision aid; shared decision making; neurocritical care; SABI; surrogate

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

Secondary Outcomes (14)

• Clinician-surrogate concordance scale score

  Baseline and 1-36 hours after family meeting

• Decision Self-Efficacy Scale

  1-36 hours after family meeting

• Decisional Conflict Scale

  1-36 hours after family meeting

• AIS/Intracerebral Hemorrhage (ICH)/Traumatic Brain Injury (TBI) knowledge test

  Baseline and 1-36 hours after family meeting

• Hospital Anxiety and Depression Scale (HADS)

  Baseline,1-36 hours after family meeting, and 3-months

Study Arms (2)

Usual Care (n=20)

NO INTERVENTION

Control: general information about TBI from Center for Disease Control (CDC)/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 admitted SABI patient with traumatic brain injury, intracerebral hemorrhage or acute ischemic stroke.
• ≥3 days after insult ("stabilization period"); clinical team may ask study team to wait longer if clinically indicated
• SABI 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 SABI 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
• University of Florida: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

Yale Medical School/Yale New Haven Medical Center

New Haven, Connecticut, 06520, United States

Location

University of Massachusetts Medical School

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

• 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

• 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

• 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

• Muehlschlegel S, Goostrey K, Flahive J, Zhang Q, Pach JJ, Hwang DY. Pilot Randomized Clinical Trial of a Goals-of-Care Decision Aid for Surrogates of Patients With Severe Acute Brain Injury. Neurology. 2022 Oct 3;99(14):e1446-e1455. doi: 10.1212/WNL.0000000000200937.

  PMID: 35853748 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic; Ischemic Stroke; Cerebral Hemorrhage; Stroke

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Dr. Susanne Muehlschlegel, MD, MPH

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Open-label, usual-care-controlled feasibility trial comparing decision aid intervention prior to the goals-of-care family meeting to standard of care (no intervention prior to family meeting).

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 7, 2019
• Study Start: February 11, 2018
• Primary Completion: December 2, 2019
• Study Completion: March 9, 2020
• Last Updated: June 17, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)