Overview

This trial is active, not recruiting.

Conditions surrogate decision makers, prolonged mechanical ventilation
Treatments decision aid, usual care
Sponsor Duke University
Collaborator University of North Carolina, Chapel Hill
Start date January 2013
End date May 2016
Trial size 421 participants
Trial identifier NCT01751061, Pro00021965, R01HL109823-01A1

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Web-based decision aid (decision support tool) provided to surrogate decision maker
decision aid
A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions
(Active Comparator)
usual care in an intensive care unit setting
usual care
usual ICU care

Primary Outcomes

Measure
Clinician-surrogate concordance scale score
time frame: ~2-7 days post-randomization

Secondary Outcomes

Measure
Hospital anxiety and depression scale (HADS) score
time frame: Pre-randomization (study day 1) and post-randomization days ~2-7, 90, 180
post-traumatic stress syndrome inventory
time frame: Pre-randomization (study day 1) and post-randomization days ~2-7, 90, 180
total health care costs
time frame: over duration of study period (180 days)
patient-centeredness of care scale
time frame: ~2-7, 90, and 180 days post-randomization
Medical comprehension scale score
time frame: Study day 1 (pre-randomization), ~2-7
Quality of communication scale score
time frame: Study day 1 (pre-randomization), ~2-7

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Improving Decision Making for Patients With Prolonged Mechanical Ventilation
Principal investigator Christopher E Cox, MD MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Duke University.