Randomized Trial of Provider-Assisted Versus Patient-Initiated Enrollment in the Bedsider.Org Online Contraceptive Reminder Tool

September 22, 2015 updated by: Ashlyn H. Savage, MD, Medical University of South Carolina
The broad objective of this research is to determine whether a quick, simple intervention will increase utilization of contraceptive reminders and adherence to short-term contraceptive regimens. Such an intervention could be implemented easily with no additional resources into a busy clinical practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The specific aims of the study are to:

  1. Measure the difference in reminder utilization over three months between patients who are assisted with initiating the reminder system during their office visit versus those who are encouraged to self-initiate after the visit.
  2. Assess whether provider-assisted enrollment in the online reminder system improves adherence to a short-term contraceptive regimen compared to self- initiated enrollment after the visit.

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • MUSC Women's Health- Cannon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 29 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female, 18-29 years old

  2. Prescribed one of the following birth control:

    Oral contraceptive pills, vaginal ring, transdermal patch, or Depo Provera

  3. Able to provide consent
  4. Have regular access to a computer, Ipad, or a hand-held device such as a smartphone.
  5. Women must be able to read and speak English(Bedsider website in not translated into Spanish)

Exclusion Criteria:

  1. Male
  2. Over the age of 30 years old
  3. Non-English Speaking
  4. Limited or no access to computer, Ipad or hand-held device(smartphone)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Office enrollment in the online contraceptive reminder system
Members of this arm were enrolled in the reminder system during their visit.
Other: enrollment in online reminder system
Study personnel enrolled members in the online reminder system during their office visit.
No Intervention: Control
Members in the control group were not enrolled in the reminder system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients using the online reminder tool three months after enrollment
Time Frame: 3 months
Measure the difference in reminder utilization over three months between patients who are assisted with initiating the reminder system during their office visit versus those who are encouraged to self-initiate after the visit. The primary outcome, which is proportion of reminder users, will be assessed three months after enrollment
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess whether provider-assisted enrollment in the online reminder system improves adherence to a short-term contraceptive regimen compared to self- initiated enrollment after the visit.
Time Frame: 3 months
Assess whether provider-assisted enrollment in the online reminder system improves adherence to a short-term contraceptive regimen compared to self- initiated enrollment after the visit. This data will be collected three months after enrollment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Collaborators

American College of Obstetricians and Gynecologists

Investigators

  • Principal Investigator: Ashlyn Savage, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

November 11, 2013

First Submitted That Met QC Criteria

November 15, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Estimate)

September 23, 2015

Last Update Submitted That Met QC Criteria

September 22, 2015

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Besider

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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