N/A
Completed N=416
Improving Decision Making for Patients With Prolonged Mechanical Ventilation
Surrogate Decision Makers · Prolonged mechanical ventilation
Source: ClinicalTrials.gov NCT01751061 ↗
Enrolled (actual)
416
Serious AEs
0.0%
Results posted
May 2019
Primary outcomePrimary: Change in Clinician-surrogate Concordance Scale Score — -6.6; -4.8; 33.6; 34.3 score on a scale — p=<0.05
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Clinician-surrogate Concordance Scale Score |
-6.6; -4.8; 33.6; 34.3; 27.1; 29.5 | <0.05 sig |
| SECONDARY Hospital Anxiety and Depression Scale (HADS) Total Score |
-3.8; -4.0 | <0.05 sig |
| SECONDARY Post-traumatic Stress Syndrome Inventory |
-1.7; -1.4 | <0.05 sig |
| SECONDARY Patient-centeredness of Care Scale |
42.7; 41.8 | <0.05 sig |
| SECONDARY Medical Comprehension Scale Score |
0.8; 0.5 | <0.05 sig |
| SECONDARY Quality of Communication Scale Score |
4; 7.0 | <0.05 sig |
| SECONDARY Change in Clinical-surrogate Concordance Scale Score (Nurse) |
-5.4; -6.2 | <0.05 sig |
Eligibility Criteria
Inclusion Criteria (Patient characteristics required for surrogate inclusion)
- age ≥18
- ≥10 days of mechanical ventilation interrupted by 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
Data sourced from ClinicalTrials.gov (NCT01751061). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.