Advanced Provision of Emergency Contraception: Utilizing Technology to Increase Prescription Fill Rates
1 other identifier
interventional
60
1 country
1
Brief Summary
Eighty-five percent of the 750,000 teenage pregnancies per year in the United States are unintended (Guttmacher Institute). Approximately half of all teenage pregnancies end in the birth of a child; the remaining proportion end in either abortion (30%) or miscarriage (20%). It has been estimated that if Emergency Contraception (Plan B) was used after every contraception failure, it could prevent 50% of unintended pregnancies and 60-70% of abortions annually. Previous studies have showed the effectiveness of emergency contraception decreases with time after intercourse; the sooner it is taken-even if it means a matter of hours-the more effective it is in preventing pregnancy. Based on previous studies, it is clear that relying on obtaining emergency contraception on the same day or even the day after unprotected intercourse is not guaranteed. For example, approximately 27% of pharmacies called by the adolescent mystery caller did not have the medication available the day of the call and almost all of the pharmacies not stocking the medication would take greater than 24 hours to obtain it through their ordering system. Thus, the concept of advanced provision of emergency contraception has been proposed to assure that the medication can be taken as soon as possible. Although this practice is known to be safe and has not shown any association with increased sexual risk or behaviors, it is unclear how often/if adolescents will fill a prescription for a medication that is not needed at the time of a medical encounter. The investigators propose a randomized pilot study (n=60) of a text-messaging intervention that aims to increase the rate at which prescriptions for emergency contraception are filled. Based on practice norms in the BMC Adolescent Center, sexually active female adolescents (ages 13-21) in both the control and intervention groups will be provided a prescription for emergency contraception. The intervention group, however, will receive follow-up text message on their phone reminding them to fill the prescription. Boston Medical Center Health Plan will provide prescription fill data regarding the prescriptions written at the time of enrollment. Approximately 6 weeks after enrollment, all study participants will be contacted for a follow-up survey.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2011
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedFirst Posted
Study publicly available on registry
July 25, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedJuly 10, 2012
June 1, 2011
7 months
June 21, 2011
July 6, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prescription Fill Rates
The primary outcome is whether the advanced provision prescription for emergency contraception is filled or not. This will be measured through insurance claims data obtained from BMC Health Plan a month after enrollment. Furthermore, the time to fill the prescription from the time of enrollment can be examined.
1 month
Secondary Outcomes (4)
Sexual Activity
6 weeks
Contraception Use
6 weeks
Risk of Pregnancy
6 weeks
Knowledge of Emergency Contraception
6 weeks
Study Arms (2)
Intervention Group
EXPERIMENTALSubjects in this group will receive a prescription for emergency contraception and then text-messages (on Day 1, 3 and 5 after enrollment) to their personal cell phone with a reminder to fill their prescription.
Control Group
NO INTERVENTIONSubjects in this group will receive a only a prescription for emergency contraception and no reminder text messages.
Interventions
Subjects will receive a text message on their personal cell phone on Days 1, 3 and 5 after enrollment reminding them to fill their prescription.
Eligibility Criteria
You may qualify if:
- Sexually Active
- Boston Medical Center Health Plan Insurance
- Personal Cell Phone
You may not qualify if:
- Pregnant
- Currently using a long-acting form of contraception (IUD, Depo, Implanon)
- No personal cell phone
- Insurance other than Boston Medical Center Health Plan
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Silverstein, MD, MPH
Boston Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2011
First Posted
July 25, 2011
Study Start
July 1, 2011
Primary Completion
February 1, 2012
Study Completion
May 1, 2012
Last Updated
July 10, 2012
Record last verified: 2011-06