Improving Decision Making for Patients With Prolonged Mechanical Ventilation

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Improving Decision Making for Patients With Prolonged Mechanical Ventilation

Conditions
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Surrogate Decision Makers, Prolonged Mechanical Ventilation

Intervention / Treatment
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* Behavioral: Decision aid
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decision aid<br>Web-based decision aid (decision support tool) provided to surrogate decision maker | Behavioral: Decision aid<br>* A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions<br>|
| Active Comparator: Usual care<br>usual care in an intensive care unit setting | Other: Usual care<br>* usual ICU care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinician-surrogate Concordance Scale Score | Concordance is calculated as the absolute value of the difference in prognosis for 1 year patient survival between the surrogate(s) and the clinician (ICU physician), and, therefore, can range from 0 to 100. We report pre-intervention to post-intervention difference in the CSCS. The CSCS is calculated as the absolute value of the difference between the surrogate's response and that of either the treating ICU physician (primary outcome) or the nurse (secondary outcome) to the question, What percent chance do you think [the patient/your loved one] has of being alive 1 year from now if the current treatment plan is continued? Scores can range from 0 to 100 percentage points, and higher values indicate greater discordance. |  2-7 days post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale (HADS) Total Score | We report here the difference between Interview 1 (baseline) and Interview 4 (6 months post-randomization) for primary surrogate decision makers (not secondary). HADS scores can range from 0 to 42 points; higher scores=more distress. | Pre-randomization (study day 1) and 180 days post-randomization | 
| Post-traumatic Stress Syndrome Inventory | Here we report PTSS score differences between Interview 1 (baseline) and Interview 4 (6 months post-randomization) for primary (not secondary) surrogate decision makers. PTSS scores can range from 10-70, with greater scores=more distress. | Pre-randomization (study day 1) and 180 days post-randomization | 
| Patient-centeredness of Care Scale | Here we report change in patient-centeredness score between Study day 1 (Interview 1) and 180 days post-randomization (Interview 4) for primary (not secondary) surrogate decision makers. Scores can range from 12-48 points, with higher scores=greater patient-centeredness. | Study day 1 and 180 days post-randomization | 
| Medical Comprehension Scale Score | Here we report MCS score differences between Interview 1 (baseline) and Interview 2 (immediately post-intervention) for primary (not secondary) surrogate decision makers. Scores can range from 0-8, with greater scores=better comprehension. | Study day 1 (pre-randomization),  2-7 | 
| Quality of Communication Scale Score | Here we report QOC score differences between Interview 1 (baseline) and Interview 2 (immediately post-intervention) for primary (not secondary) surrogate decision makers. Scores range from 0-110, with higher scores=better quality of communication. | Study day 1 (pre-randomization),  2-7 | 
| Change in Clinical-surrogate Concordance Scale Score (Nurse) | Concordance is calculated as the absolute value of the difference in prognosis for 1 year patient survival between the primary surrogate decision maker and the IUC nurse, and, therefore, can range from 0 to 100. We report pre-intervention to post-intervention difference in the CSCS. The CSCS is calculated as the absolute value of the difference between the surrogate's response and that of the nurse to the question, What percent chance do you think [the patient/your loved one] has of being alive 1 year from now if the current treatment plan is continued? Scores can range from 0 to 100 percentage points, and higher values indicate greater discordance. |  2-7 days post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prolonged mechanical ventilation, chronic critical illness, decision making, decision aid, decisional support, critical illness, intensive care unit