Trial Outcomes & Findings for A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making (NCT NCT00122135)
NCT ID: NCT00122135
Last Updated: 2015-12-14
Results Overview
Qualitative content analysis of physician-patient encounters regarding presence of any type of discussion about end of life care goals/wishes
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
immediate
Results posted on
2015-12-14
Participant Flow
Participant milestones
| Measure |
Patients With VI
patients / surrogates who did receive the Values Inventory prior to their clinic appointment
Values history discussion w/physician \& patient/surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed.
|
Patients Without VI
Patients who did not receive the Values Inventory prior to their clinic visit
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
57
|
60
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
Patients With VI
patients / surrogates who did receive the Values Inventory prior to their clinic appointment
Values history discussion w/physician \& patient/surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed.
|
Patients Without VI
Patients who did not receive the Values Inventory prior to their clinic visit
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
Baseline Characteristics
A Culturally Sensitive Values-Guided Aid for End of Life Decision-Making
Baseline characteristics by cohort
| Measure |
Patients With VI
n=60 Participants
Patients who filled out the Values History prior to their clinic appointment
|
Patients Without VI
n=60 Participants
Patients who did not receive the Values History prior to their clinic appointment (usual care)
|
Total
n=120 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
30 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
57 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
30 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
63 Participants
n=27 Participants
|
|
Age, Continuous
|
66.4 years
n=93 Participants
|
68.4 years
n=4 Participants
|
67.4 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=93 Participants
|
60 Participants
n=4 Participants
|
120 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=93 Participants
|
60 participants
n=4 Participants
|
120 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: immediateQualitative content analysis of physician-patient encounters regarding presence of any type of discussion about end of life care goals/wishes
Outcome measures
| Measure |
Patients With VI
n=57 Participants
Patients who filled out the Values History prior to their clinic appointment
|
Patients Without VI
n=60 Participants
Patients who did not receive the Values History prior to their clinic appointment (usual care)
|
|---|---|---|
|
Presence of Discussions About End of Life Care Goals/Wishes
|
13 participants
|
8 participants
|
Adverse Events
Patients With VI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Without VI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ursula Braun
Center for Innovations in Quality, Effectiveness, and Safety (IQuESt), MEDVAMC, Houston, TX
Phone: 832 687 1645
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place