Clinical trial NCT01751061: Improving Decision Making for Patients With Prolonged Mechanical Ventilation
Official title: Improving Decision Making for Patients With Prolonged Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surrogate Decision Makers
Prolonged Mechanical Ventilation
Keywords: prolonged mechanical ventilation
chronic critical illness
decision making
decision aid
decisional support
critical illness
intensive care unit
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
name: University of Pittsburgh
name: University of Washington
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-12-17
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Change in Clinician-surrogate Concordance Scale Score
timeFrame: ~2-7 days post-randomization
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS) Total Score
timeFrame: Pre-randomization (study day 1) and 180 days post-randomization
measure: Post-traumatic Stress Syndrome Inventory
timeFrame: Pre-randomization (study day 1) and 180 days post-randomization
measure: Patient-centeredness of Care Scale
timeFrame: Study day 1 and 180 days post-randomization
measure: Medical Comprehension Scale Score
timeFrame: Study day 1 (pre-randomization), ~2-7
measure: Quality of Communication Scale Score
timeFrame: Study day 1 (pre-randomization), ~2-7
measure: Change in Clinical-surrogate Concordance Scale Score (Nurse)
timeFrame: ~2-7 days post-randomization
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Duke University
name: Christopher E Cox, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cox CE, Lewis CL, Hanson LC, Hough CL, Kahn JM, White DB, Song MK, Tulsky JA, Carson SS. Development and pilot testing of a decision aid for surrogates of patients with prolonged mechanical ventilation. Crit Care Med. 2012 Aug;40(8):2327-34. doi: 10.1097/CCM.0b013e3182536a63.
citation: Cox CE, White DB, Hough CL, Jones DM, Kahn JM, Olsen MK, Lewis CL, Hanson LC, Carson SS. Effects of a Personalized Web-Based Decision Aid for Surrogate Decision Makers of Patients With Prolonged Mechanical Ventilation: A Randomized Clinical Trial. Ann Intern Med. 2019 Mar 5;170(5):285-297. doi: 10.7326/M18-2335. Epub 2019 Jan 29.