Improving Decision Making for Patients With Prolonged Mechanical Ventilation

Duke University

Status: Completed

Conditions: Surrogate Decision Makers; Prolonged Mechanical Ventilation

Treatments: Other: Usual care; Behavioral: Decision aid

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01751061

Pro00021965

R01HL109823-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 416 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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416 participants in 2 patient groups

Decision aid

Experimental group

Description:

Web-based decision aid (decision support tool) provided to surrogate decision maker

Treatment:

Behavioral: Decision aid

Usual care

Active Comparator group

Description:

usual care in an intensive care unit setting

Treatment:

Other: Usual care