Trial Outcomes & Findings for Reducing Adolescent Pregnancy (NCT NCT04120376)
NCT ID: NCT04120376
Last Updated: 2023-02-03
Results Overview
Intention to initiate contraception at Emergency Department (ED) or follow-up visit from survey responses
COMPLETED
NA
144 participants
up to 8 weeks
2023-02-03
Participant Flow
Adolescents and APPs were enrolled from Emergency Departments of two geographically distinct urban pediatric hospitals.
Participant milestones
| Measure |
Contraception Counseling in ED
APPs administer contraception counseling to adolescents.
Adolescents complete survey and follow up data, and APP completes feasibility data.
|
APP Contraception Counseling Training
APPs are trained to conduct a brief contraception counseling session with adolescents in the ED.
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
27
|
|
Overall Study
COMPLETED
|
99
|
27
|
|
Overall Study
NOT COMPLETED
|
9
|
0
|
Reasons for withdrawal
| Measure |
Contraception Counseling in ED
APPs administer contraception counseling to adolescents.
Adolescents complete survey and follow up data, and APP completes feasibility data.
|
APP Contraception Counseling Training
APPs are trained to conduct a brief contraception counseling session with adolescents in the ED.
|
|---|---|---|
|
Overall Study
Determined to be ineligible or there was no APP to perform the counseling.
|
9
|
0
|
Baseline Characteristics
Please note, no baseline measures were collected for APP participants.
Baseline characteristics by cohort
| Measure |
Adolescent Counseling Intervention
n=96 Participants
All adolescent participants will receive contraception counseling.
Contraception Counseling: Each participant will receive a 10 minute confidential contraception counseling session with an Advanced Practice Provider(APP) in the Emergency Department
Please note, no baseline measures were collected for APP participants.
|
APP Contraception Counseling Training
All adolescent participants will receive contraception counseling.
Contraception Counseling: Each participant will receive a 10 minute confidential contraception counseling session with an Advanced Practice Provider(APP) in the Emergency Department
Please note, no baseline measures were collected for APP participants.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
96 Participants
n=99 Participants • Please note, no baseline measures were collected for APP participants.
|
0 Participants
n=107 Participants • Please note, no baseline measures were collected for APP participants.
|
96 Participants
n=206 Participants • Please note, no baseline measures were collected for APP participants.
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants • Please note, no baseline measures were collected for APP participants.
|
0 Participants
n=107 Participants • Please note, no baseline measures were collected for APP participants.
|
0 Participants
n=206 Participants • Please note, no baseline measures were collected for APP participants.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants • Please note, no baseline measures were collected for APP participants.
|
0 Participants
n=107 Participants • Please note, no baseline measures were collected for APP participants.
|
0 Participants
n=206 Participants • Please note, no baseline measures were collected for APP participants.
|
|
Age, Continuous
|
16.8 years
n=99 Participants • Please note, no baseline measures were collected for APP participants.
|
—
|
16.8 years
n=206 Participants • Please note, no baseline measures were collected for APP participants.
|
|
Sex: Female, Male
Female
|
96 Participants
n=99 Participants • Please note, no baseline measures were collected for APP participants.
|
0 Participants
n=107 Participants • Please note, no baseline measures were collected for APP participants.
|
96 Participants
n=206 Participants • Please note, no baseline measures were collected for APP participants.
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants • Please note, no baseline measures were collected for APP participants.
|
0 Participants
n=107 Participants • Please note, no baseline measures were collected for APP participants.
|
0 Participants
n=206 Participants • Please note, no baseline measures were collected for APP participants.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=99 Participants • Please note, no baseline measures were collected for APP participants.
|
0 Participants
n=107 Participants • Please note, no baseline measures were collected for APP participants.
|
16 Participants
n=206 Participants • Please note, no baseline measures were collected for APP participants.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=99 Participants • Please note, no baseline measures were collected for APP participants.
|
0 Participants
n=107 Participants • Please note, no baseline measures were collected for APP participants.
|
79 Participants
n=206 Participants • Please note, no baseline measures were collected for APP participants.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants • Please note, no baseline measures were collected for APP participants.
|
0 Participants
n=107 Participants • Please note, no baseline measures were collected for APP participants.
|
1 Participants
n=206 Participants • Please note, no baseline measures were collected for APP participants.
|
|
Region of Enrollment
United States
|
96 Participants
n=99 Participants • Three of participants enrolled initially were not included in study analysis due to enrollment eligibility errors or having not received contraception counseling. Among the 96 participants remaining who completed study measures and were included in analysis, 45 were enrolled at cmh (site 2). Please note, no baseline measures were collected for APP participants.
|
0 Participants
n=107 Participants • Three of participants enrolled initially were not included in study analysis due to enrollment eligibility errors or having not received contraception counseling. Among the 96 participants remaining who completed study measures and were included in analysis, 45 were enrolled at cmh (site 2). Please note, no baseline measures were collected for APP participants.
|
96 Participants
n=206 Participants • Three of participants enrolled initially were not included in study analysis due to enrollment eligibility errors or having not received contraception counseling. Among the 96 participants remaining who completed study measures and were included in analysis, 45 were enrolled at cmh (site 2). Please note, no baseline measures were collected for APP participants.
|
PRIMARY outcome
Timeframe: up to 8 weeksPopulation: Those who reported "high intention" to initiate contraception
Intention to initiate contraception at Emergency Department (ED) or follow-up visit from survey responses
Outcome measures
| Measure |
Adolescent Counseling Intervention
n=96 Participants
All participants will receive contraception counseling.
Contraception Counseling: Each participant will receive a 10 minute confidential contraception counseling session with an Advanced Practice Provider in the Emergency Department
|
|---|---|
|
Intention to Initiate Contraception
|
59 Participants
|
SECONDARY outcome
Timeframe: up to 8 weeksParticipants completed a referral visit for any contraception care
Outcome measures
| Measure |
Adolescent Counseling Intervention
n=96 Participants
All participants will receive contraception counseling.
Contraception Counseling: Each participant will receive a 10 minute confidential contraception counseling session with an Advanced Practice Provider in the Emergency Department
|
|---|---|
|
Contraceptive Care Referral Completion
|
35 Participants
|
SECONDARY outcome
Timeframe: up to 12 weeksParticipant has started contraception as evidenced by electronic medical record view and follow-up phone calls or surveys
Outcome measures
| Measure |
Adolescent Counseling Intervention
n=96 Participants
All participants will receive contraception counseling.
Contraception Counseling: Each participant will receive a 10 minute confidential contraception counseling session with an Advanced Practice Provider in the Emergency Department
|
|---|---|
|
Initiation of Contraception
|
32 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 12 weeksPopulation: The total number of unique themes for all participants was reported based on qualitative analysis. 28 adolescents participated in interviews out of the total number of adolescents enrolled in the study. This portion of the study was optional.
Semistructured interviews were conducted and analyzed using grounded theory to elucidate the factors that affect decision-making around contraception initiation. Only a subset of enrolled adolescents participated in interviews which were optional (28 participants). Factors were based on a theoretical framework called eTPB, the ecologically expanded theory of planned behavior, relying on attitudes, subjective norms, community, health care and perceived behavioral control factors to explain behavior. Interview analysis yielded the following factors: concerns about contraception side effects and safety, previous experiences with contraception, reasons for using contraception, peer, family and partner influence, social media, pregnancy rates, and access to contraception eduction, provider encounters, confidence in contraception decision making and knowledge, and the ED session characteristics; all of the above factors corresponded with a construct from eTPB.
Outcome measures
| Measure |
Adolescent Counseling Intervention
n=28 Participants
All participants will receive contraception counseling.
Contraception Counseling: Each participant will receive a 10 minute confidential contraception counseling session with an Advanced Practice Provider in the Emergency Department
|
|---|---|
|
Number of Unique Themes Affecting Decision-Making
|
6 themes
|
Adverse Events
Counseling Intervention
APP Contraception Counseling Training
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