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Advanced Provision of Emergency Contraception: Utilizing Technology to Increase Prescription Fill Rates

Primary Purpose

Sexually Active

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Message
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Sexually Active focused on measuring Adolescents, Sexually Active, Unprotected Sex, Emergency Contraception

Eligibility Criteria

13 Years - 21 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Sexually Active
  • Boston Medical Center Health Plan Insurance
  • Personal Cell Phone

Exclusion Criteria:

  • Pregnant
  • Currently using a long-acting form of contraception (IUD, Depo, Implanon)
  • No personal cell phone
  • Insurance other than Boston Medical Center Health Plan

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention Group

Control Group

Arm Description

Subjects 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.

Subjects in this group will receive a only a prescription for emergency contraception and no reminder text messages.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sexual Activity
Each study participant will receive a follow-up telephone call to his or her personal cell phone six weeks after enrollment to complete a follow-up survey that will consist of questions related to sexual activity since enrollment.
Contraception Use
Each participant will receive a follow-up telephone survey and answer questions regarding their use of contraception (if any) and how often they utilized such methods since enrollment.
Risk of Pregnancy
Each study participant will receive a telephone survey and be asked if they have used emergency contraception (EC) since enrolling in the study or if they have taken a pregnancy test since enrolling.
Knowledge of Emergency Contraception
Each study participant will receive a follow-up telephone survey and answer questions on the time-frame and accessibility of emergency contraception.

Full Information

First Posted
June 21, 2011
Last Updated
July 6, 2012
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01401816
Brief Title
Advanced Provision of Emergency Contraception: Utilizing Technology to Increase Prescription Fill Rates
Official Title
Advanced Provision of Emergency Contraception: Utilizing Technology to Increase Prescription Fill Rates
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexually Active
Keywords
Adolescents, Sexually Active, Unprotected Sex, Emergency Contraception

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Subjects 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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Subjects in this group will receive a only a prescription for emergency contraception and no reminder text messages.
Intervention Type
Other
Intervention Name(s)
Text Message
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prescription Fill Rates
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Sexual Activity
Description
Each study participant will receive a follow-up telephone call to his or her personal cell phone six weeks after enrollment to complete a follow-up survey that will consist of questions related to sexual activity since enrollment.
Time Frame
6 weeks
Title
Contraception Use
Description
Each participant will receive a follow-up telephone survey and answer questions regarding their use of contraception (if any) and how often they utilized such methods since enrollment.
Time Frame
6 weeks
Title
Risk of Pregnancy
Description
Each study participant will receive a telephone survey and be asked if they have used emergency contraception (EC) since enrolling in the study or if they have taken a pregnancy test since enrolling.
Time Frame
6 weeks
Title
Knowledge of Emergency Contraception
Description
Each study participant will receive a follow-up telephone survey and answer questions on the time-frame and accessibility of emergency contraception.
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sexually Active Boston Medical Center Health Plan Insurance Personal Cell Phone Exclusion Criteria: Pregnant Currently using a long-acting form of contraception (IUD, Depo, Implanon) No personal cell phone Insurance other than Boston Medical Center Health Plan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Silverstein, MD, MPH
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

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Advanced Provision of Emergency Contraception: Utilizing Technology to Increase Prescription Fill Rates

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