N/A
N=416
Improving Decision Making for Patients With Prolonged Mechanical Ventilation
Surrogate Decision Makers · Prolonged Mechanical Ventilation
Bottom Line
View on ClinicalTrials.gov: NCT01751061 ↗Enrolled (actual)
416
Serious AEs
0.0%
Results posted
May 2019
Primary outcome: Primary: Change in Clinician-surrogate Concordance Scale Score — -6.6; -4.8; 33.6; 34.3 score on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Decision aid (Behavioral); Usual care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- May 2016
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 |
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).
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.