Trial Outcomes & Findings for Reducing Adolescent Pregnancy in the Emergency Department (NCT NCT04744155)
NCT ID: NCT04744155
Last Updated: 2023-09-28
Results Overview
The intervention will be deemed feasible if the median score across all items is ≥ 3. Individual responses range from 1 to 5. Higher scores indicate greater feasibility using the investigator created Feasibility Assessment.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
1 visit on day 1
Results posted on
2023-09-28
Participant Flow
Participant milestones
| Measure |
Multi-Level Intervention
All adolescents receive the Motivational Interviewing (MI) enhanced counseling and clinic referral.Those randomized to MLI will be offered immediate, ED-based contraception (i.e., oral pill, transdermal patch, vaginal ring, injection, subdermal implant) in addition to receive a warm referral (provider helping to schedule follow-up appointment) to follow-up on selected method (or to initiate in clinic, if preferred)
Multi-Level Intervention: Behavioral intervention that assesses uptake of contraception and seeks follow-up care.
|
Enhanced Standard of Care
All adolescents receive the Motivational Interviewing (MI) enhanced counseling and clinic referral. eSOC participants may obtain contraception only at the referral.
Enhanced Standard of Care: Behavioral intervention that assesses uptake of contraception from follow-up care.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
12
|
|
Overall Study
COMPLETED
|
25
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Adolescent Pregnancy in the Emergency Department
Baseline characteristics by cohort
| Measure |
Multi-Level Intervention
n=25 Participants
All adolescents receive the Motivational Interviewing (MI) enhanced counseling and clinic referral.Those randomized to MLI will be offered immediate, ED-based contraception (i.e., oral pill, transdermal patch, vaginal ring, injection, subdermal implant) in addition to receive a warm referral (provider helping to schedule follow-up appointment) to follow-up on selected method (or to initiate in clinic, if preferred)
Multi-Level Intervention: Behavioral intervention that assesses uptake of contraception and seeks follow-up care.
|
Enhanced Standard of Care
n=12 Participants
All adolescents receive the Motivational Interviewing (MI) enhanced counseling and clinic referral. eSOC participants may obtain contraception only at the referral.
Enhanced Standard of Care: Behavioral intervention that assesses uptake of contraception from follow-up care.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.5 years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
16.7 years
STANDARD_DEVIATION 1.0 • n=7 Participants
|
16.6 years
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
19 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
other
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Previous sexual activity
|
15 participants
n=5 Participants
|
9 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Previous hormonal contraception use
|
11 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 visit on day 1The intervention will be deemed feasible if the median score across all items is ≥ 3. Individual responses range from 1 to 5. Higher scores indicate greater feasibility using the investigator created Feasibility Assessment.
Outcome measures
| Measure |
Multi-level Intervention
n=16 Participants
Adolescent participants who received the counseling intervention and opportunity to start contraception at index visit
|
Enhanced Standard of Care
n=9 Participants
Received counseling but no opportunity for same day initiation, they received referral only.
|
|---|---|---|
|
Adolescent Feasibility of Intervention
|
4.5 score on a scale
Interval 4.2 to 4.8
|
4.7 score on a scale
Interval 4.6 to 5.0
|
Adverse Events
Enhanced Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Multi-level 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place