Improving Decision Making for Patients With Prolonged Mechanical Ventilation



Status:Active, not recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:8/12/2016
Start Date:January 2013
End Date:January 2017

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Deciding about prolonged life support for critically ill patients can be very difficult.
Therefore, the investigators are doing a study to see if an internet-based decision aid can
improve the quality of decision making for substitute decision makers of patients who are in
the intensive care unit (ICU).

The process of making a decision about whether or not to provide prolonged life support is
seriously deficient among clinicians and the surrogate decision makers for critically ill
patients. To address this problem, we propose a randomized, controlled trial to determine if
an innovative web-based decision aid compared to usual care control can improve the quality
of decision making (defined as clinician-surrogate concordance for prognosis, quality of
communication, and medical comprehension), reduce surrogates' psychological distress
(depression, anxiety, and post-traumatic stress syndrome disorder (PTSD) symptoms), and
reduce patients' health care costs over 6-month follow up. We will enroll 410 surrogate
decision makers for 273 patients (expected average of 1.5 surrogates per patient). This
study has the potential both to improve how clinicians and surrogates interact in intensive
care units and to increase the likelihood that life support decisions are aligned with
patients' values.

Inclusion Criteria (Patient characteristics required for surrogate inclusion)

- age ≥18

- ≥10 days of mechanical ventilation interrupted by <96 continuous hours of unassisted
breathing (including invasive and non-invasive ventilation)

- no anticipation of imminent (24 hours) death or extubation by the attending.

Exclusion Criteria (Patient characteristics that will exclude surrogates from study
enrollment):

- possession of decisional capacity

- no identifiable surrogate, surrogate is unavailable for study procedures such as
interviews

- imminent organ transplantation

- chronic neuromuscular disease

- physician refuses permission to approach family and/or patient for consent

- admission for severe burns

- admission for high cervical spine injury

- ventilation for >21 days.

Inclusion criteria for surrogate decision makers:

- age ≥18

- self-identified as participating directly in health care decision making for the
incapable patient under relevant state law

Exclusion criteria for surrogate decision makers:

- do not personally know the patient

- need translation assistance because of poor English fluency (the decision aid has not
been validated in other languages)

- history of clinically important neurological disorder (e.g., dementia)

- patient dies after meeting inclusion criteria but before surrogates provide consent

Physician and nurse inclusion criteria:

- ICU attending or fellow (physicians) at the time of surrogate enrollment

- bedside ICU nurse present at the time of surrogate enrollment
We found this trial at
4
sites
Seattle, Washington 98104
(206) 543-2100
Principal Investigator: Catherine L Hough, MD MSc
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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Durham, North Carolina 27710
(919) 684-8111
Principal Investigator: Christopher E Cox, MD MPH
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
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4200 Fifth Ave
Pittsburgh, Pennsylvania 15260
(412) 624-4141
Principal Investigator: Douglas B White, MD MS
University of Pittsburgh The University of Pittsburgh is a state-related research university, founded as the...
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Shannon S Carson, MD
Univ of North Carolina Carolina’s vibrant people and programs attest to the University’s long-standing place...
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Chapel Hill, NC
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