A descriptive analysis of deferred consent in a study of diaphragm activity in mechanically ventilated patients in the intensive care unit (ICU)
CCCF ePoster library. Sandhu G. Oct 4, 2017; 198216; 85
Gyan Sandhu
Gyan Sandhu
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Abstract
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A descriptive analysis of deferred consent in a study of diaphragm activity in mechanically ventilated patients in the intensive care unit (ICU)

Sandhu, Gyan1; Junhasavasdikul, Detajin1,2; Hodder, Jennifer1; Salway, Kurtis3; Smith, Orla1,2; Brochard, Laurent1,2

1 Department of Critical Care, St. Michael's Hospital, Toronto, Canada; 2 Interdepartmental Division of Critical Care Medicine, University of Toronto, Toronto, Canada; 3 Department of Respiratory Therapy, St. Michael's Hospital, Toronto, Canada


Introduction:
Patient eligibility for research in the intensive care unit (ICU) can occur at any time of day or week. Deferred consent, consent from the patient or substitute decision-maker (SDM) after research has commenced, is a common alteration in the ICU when conducting observational research or studying low risk, time-sensitive interventions or transient phenomenon (1). Utilization of a deferred approach can overcome challenges experienced as a result of patient incapacity and SDM availability. SDMs and patients have endorsed deferred consent as an acceptable mechanism for research consent in the ICU (2, 3). Herein we describe time to deferred consent from SDMs in an observational study of diaphragm activity in mechanically ventilated patients.

Objectives:
To describe consent outcomes, including timing, in an observational study of diaphragm activity in mechanically ventilated patients in the ICU.

Methods:
DIVIP, Assessing Diaphragm Muscle Inactivity in Mechanically Ventilated ICU Patients, is an observational study which involves serial recording of electrical activity of the diaphragm and daily diaphragm ultrasound (NCT02434016) for up to 5 days. The first ultrasound must be performed within 24 hours of mechanical ventilation. The Research Ethics Board at St. Michael’s Hospital approved the use of a deferred consent model for patient enrollment in the study and for the conduct of the first ultrasound. The research team has up to 5 days after enrollment to assess the patient for capacity and/or identify and contact an SDM (in-person or by phone) for consent for continued participation and the completion of up to 5 ultrasounds. Data from our local screening log was reviewed to identify outcomes and timing of our deferred consent approach.

Results:
From April 2016 to the end of July 2017, we enrolled 29 patients into the study. Deferred consent was obtained from SDMs in 15 patients (52%). Most consents (11/15; 73%) occurred within 24 hours, allowing us to obtain the maximum number of ultrasounds in these patients. Consent for continued participation could not be obtained for 14 patients with the most common cause being no identifiable SDM (6/14; 43%), followed by patient extubation prior to consent (29%). In only one patient was the absence of consent the result of a designated SDM not being reachable within the 5-day study window. Considering all patients with an identified SDM, consent rates of 81% (13/16) and 94% (15/16) were possible with time windows of 48 hours and 5 days respectively.

Conclusion:
A deferred consent model supported patient enrollment in our observational study. For patients with identifiable SDMs, a less restrictive window to make contact permitted SDM involvement in the majority of consents. Our experience in utilizing a deferred consent approach has informed the design of consent approaches in other studies by our group and may be useful to others conducting low risk, time-sensitive research in the ICU.

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