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Trial Outcomes & Findings for Testing of a Tool to Elicit Patient Preferences for CTS (NCT NCT03532373)

NCT ID: NCT03532373

Last Updated: 2024-07-03

Results Overview

The Decisional Conflict Scale measures uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. The survey consists of 16 statements with 5 response categories. Scoring: total scale-0 (no decisional conflict) to 100 (extreme decisional conflict). Lower values indicate lower decisional conflict- i.e. a better outcome for use of the tool. Calculation: Summed, divided by # of items, multiplied by 25

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

49 participants

Primary outcome timeframe

Immediately after using tool (up to 5 minutes to complete survey)

Results posted on

2024-07-03

Participant Flow

Participant milestones

Participant milestones
Measure
Control
None- normal care
Intervention
Patients use a preference elicitation tool to determine their preferences for diagnosis and treatment of CTS
Overall Study
STARTED
19
30
Overall Study
COMPLETED
19
30
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Testing of a Tool to Elicit Patient Preferences for CTS

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control
n=19 Participants
None- normal care
Intervention
n=30 Participants
Patients use a preference elicitation tool to determine their preferences for diagnosis and treatment of CTS
Total
n=49 Participants
Total of all reporting groups
Age, Continuous
57.3 years
STANDARD_DEVIATION 17.9 • n=5 Participants
54.6 years
STANDARD_DEVIATION 18.5 • n=7 Participants
55.5 years
STANDARD_DEVIATION 18.0 • n=5 Participants
Sex: Female, Male
Female
10 Participants
n=5 Participants
18 Participants
n=7 Participants
28 Participants
n=5 Participants
Sex: Female, Male
Male
9 Participants
n=5 Participants
12 Participants
n=7 Participants
21 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
3 Participants
n=7 Participants
4 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
2 Participants
n=5 Participants
1 Participants
n=7 Participants
3 Participants
n=5 Participants
Race (NIH/OMB)
White
12 Participants
n=5 Participants
18 Participants
n=7 Participants
30 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=5 Participants
4 Participants
n=7 Participants
7 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants
n=5 Participants
4 Participants
n=7 Participants
5 Participants
n=5 Participants
Region of Enrollment
United States
19 Participants
n=5 Participants
30 Participants
n=7 Participants
49 Participants
n=5 Participants
CTS-6
18.2 units on a scale
STANDARD_DEVIATION 5.9 • n=5 Participants
18.1 units on a scale
STANDARD_DEVIATION 3.8 • n=7 Participants
18.2 units on a scale
STANDARD_DEVIATION 4.7 • n=5 Participants

PRIMARY outcome

Timeframe: Immediately after using tool (up to 5 minutes to complete survey)

The Decisional Conflict Scale measures uncertainty in choosing options; modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice. The survey consists of 16 statements with 5 response categories. Scoring: total scale-0 (no decisional conflict) to 100 (extreme decisional conflict). Lower values indicate lower decisional conflict- i.e. a better outcome for use of the tool. Calculation: Summed, divided by # of items, multiplied by 25

Outcome measures

Outcome measures
Measure
Control
n=19 Participants
None- normal care
Intervention
n=30 Participants
Patients use a preference elicitation tool to determine their preferences for diagnosis and treatment of CTS
Decisional Conflict Scale
1.77 score on a scale
Standard Deviation 4.6
4.41 score on a scale
Standard Deviation 10.3

Adverse Events

Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Intervention

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

Robin Kamal

Stanford University

Phone: 650-721-7629

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place