Trial Outcomes & Findings for Computerized Contraceptive Decision Aid (NCT NCT01479985)
NCT ID: NCT01479985
Last Updated: 2020-09-29
Results Overview
Pre-Visit, Post-Visit and change in Decisional Conflict Scale (DCS) Score between Post-Visit (immediately following visit) and Pre-Visit (immediately prior to visit). The Decisional Conflict Scale scores range from 0 to 100; 0 represents no decisional conflict and 100 represents high decisional conflict.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
253 participants
Primary outcome timeframe
Pre-Visit and Post-Visit (same day)
Results posted on
2020-09-29
Participant Flow
Participant milestones
| Measure |
CDM Tool
participants will be randomized to completing the CDM tool
CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers
|
Control
Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out
|
|---|---|---|
|
Overall Study
STARTED
|
167
|
86
|
|
Overall Study
Baseline Survey
|
166
|
85
|
|
Overall Study
COMPLETED
|
161
|
80
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
CDM Tool
participants will be randomized to completing the CDM tool
CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers
|
Control
Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out
|
|---|---|---|
|
Overall Study
Tablet malfunction, no data saved
|
1
|
1
|
|
Overall Study
No decisional conflict scale responses
|
0
|
2
|
|
Overall Study
No post-visit survey
|
5
|
3
|
Baseline Characteristics
Computerized Contraceptive Decision Aid
Baseline characteristics by cohort
| Measure |
CDM Tool
n=166 Participants
participants will be randomized to completing the CDM tool
CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers
|
Control
n=85 Participants
Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.5 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
28.4 years
STANDARD_DEVIATION 6.2 • n=7 Participants
|
28.5 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
166 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
62 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
84 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
166 participants
n=5 Participants
|
85 participants
n=7 Participants
|
251 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre-Visit and Post-Visit (same day)Population: 8 subjects did not complete the post-visit survey, so a post-visit DCS score and change in DCS score could not be calculated
Pre-Visit, Post-Visit and change in Decisional Conflict Scale (DCS) Score between Post-Visit (immediately following visit) and Pre-Visit (immediately prior to visit). The Decisional Conflict Scale scores range from 0 to 100; 0 represents no decisional conflict and 100 represents high decisional conflict.
Outcome measures
| Measure |
CDM Tool
n=166 Participants
participants will be randomized to completing the CDM tool
CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers
|
Control
n=83 Participants
Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out
|
|---|---|---|
|
Decisional Conflict Scale Score
Pre-Visit Score
|
15 score on a scale
Interval 0.0 to 80.0
|
10 score on a scale
Interval 0.0 to 85.0
|
|
Decisional Conflict Scale Score
Post-Visit Score
|
0 score on a scale
Interval 0.0 to 70.0
|
0 score on a scale
Interval 0.0 to 35.0
|
|
Decisional Conflict Scale Score
Change in Score
|
-10 score on a scale
Interval -80.0 to 25.0
|
-10 score on a scale
Interval -60.0 to 5.0
|
SECONDARY outcome
Timeframe: Post-visit (immediately after visit)Contraceptive method chosen at end of visit with healthcare provider as reported on the post-visit survey
Outcome measures
| Measure |
CDM Tool
n=161 Participants
participants will be randomized to completing the CDM tool
CDM Tool: Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers
|
Control
n=80 Participants
Participants will fill out a computer survey similar to CDM tool without the decisive factors and computer print out
|
|---|---|---|
|
Contraceptive Method Chosen
LNG-IUS
|
45 Participants
|
21 Participants
|
|
Contraceptive Method Chosen
Copper IUD
|
9 Participants
|
3 Participants
|
|
Contraceptive Method Chosen
Implant
|
9 Participants
|
6 Participants
|
|
Contraceptive Method Chosen
DMPA
|
19 Participants
|
4 Participants
|
|
Contraceptive Method Chosen
Pills
|
57 Participants
|
29 Participants
|
|
Contraceptive Method Chosen
Contraceptive patch
|
1 Participants
|
0 Participants
|
|
Contraceptive Method Chosen
Vaginal ring
|
8 Participants
|
5 Participants
|
|
Contraceptive Method Chosen
Sterilization
|
0 Participants
|
3 Participants
|
|
Contraceptive Method Chosen
Condoms
|
7 Participants
|
4 Participants
|
|
Contraceptive Method Chosen
Other
|
1 Participants
|
3 Participants
|
|
Contraceptive Method Chosen
No method/undecided
|
5 Participants
|
2 Participants
|
Adverse Events
CDM Tool
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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. Tessa Madden, MD, MPH
Washington University in St. Louis
Phone: 314-747-6495
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place