Skip to main content
OpenTrials
Completed

NCT Number: NCT03833375

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Craniocerebral Trauma Hemorrhage Intracerebral Hemorrhage Intracranial Hemorrhages Ischemic Stroke Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Medical School/Yale New Haven Medical Center, New Haven, Connecticut, United States

Loading trial locations.

About this study

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, accounting for more than 200,000 of the acute brain injury-related deaths in the U.S. annually. Patients with SABI 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 SABI but occurs at a highly variable rate (for example in TBI 45-90%) at different trauma 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 SABI. Such a patient- and family-centered DA has the potential to improve decision-making for SABI 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 SABI patients using qualitative research using semi-structured interviews in surrogate decision makers of TBI patients and physicians, followed by an iterative feedback process with feedback by surrogates, physicians, and other stakeholders (ICU nurses). The investigators now propose to pilot-test a DA for surrogates of SABI patients in a feasibility trial.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥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)

Exclusion criteria

  • 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

Treatment and study plan

Decision Aid

Other

Shared-decision making tool

Primary outcomes

  1. Recruitment

    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.

    Consent rate

  2. Participation

    Time frame: 1-36 hours after family meeting

    Proportion of participants who read decision aid and completed worksheet

  3. Retention

    Time frame: 3 months

    Number of participants who complete follow-up

Secondary outcomes

  1. Clinician-surrogate concordance scale score

    Time frame: Baseline and 1-36 hours after family meeting

    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).

  2. Decision Self-Efficacy Scale

    Time frame: 1-36 hours after family meeting

    is a validated scale that measures self-confidence in making an informed choice using a 5-point Likert scale ranging from 0 (not at all confident) to 4 (very confident).

  3. Decisional Conflict Scale

    Time frame: 1-36 hours after family meeting

    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).

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

    Time frame: Baseline and 1-36 hours after family meeting

    Medical knowledge about the goals-of-care decision in SABI will be assessed using the medical knowledge test, which was adapted to 17 questions about goals-of-care and SABI, all of which are addressed in the decision aid. The % correct will be calculated.

  5. Hospital Anxiety and Depression Scale (HADS)

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

    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.

  6. Impact of Events Scale-revised

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

    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.

  7. Quality of Communications Scale

    Time frame: 1-36 hours after family meeting

    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.

  8. Patient-Perceived Centeredness of Care Scale

    Time frame: 1-36 hours after family meeting

    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.

  9. Cumulative duration of the goals-of-care family meetings

    Time frame: 1-36 hours after family meeting

    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].

  10. Total number of goals-of-care family meetings

    Time frame: 1-36 hours after family meeting

    Investigators will sum up the total number of goals-of-care meetings at the patient's ICU discharge.

  11. Patient's survival status

    Time frame: 3-months after goals of care decision

    Investigators will record whether the patient is dead or alive.

  12. Patient's Glasgow Outcome Scale

    Time frame: 3-months after goals of care decision

    The Glasgow Outcome Score (GOS) is a validated 5-point scale given to traumatic brain injury or other brain injury patients at some point in their recovery. It is a very general assessment of the general functioning of the person who suffered a head injury or other neurological injury. It ranges from 1-5 (higher scores indicating better functional status): 1=death, 2=Vegetative State, 3=Severely Disabled (conscious but the patient requires others for daily support due to disability), 4=Moderately Disabled (the patient is independent but disabled), 5=Good Recovery (the patient has resumed most normal activities but may have minor residual problems).

  13. Patient's modified Rankin Scale

    Time frame: 3-months after goals of care decision

    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).

  14. Surrogate Decision Regret Scale

    Time frame: 3-months after goals of care decision

    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).

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Florida
  • Yale University

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 7, 2019
Registry last updated
Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.