Bedsider.Org in Post-abortion Contraceptive Counseling: A Mixed Methods Study

NCT ID: NCT02532946

Last Updated: 2017-04-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-12-31

Brief Summary

This is a mixed methods study, incorporating a randomized controlled trial and a qualitative provider focus group, to evaluate contraceptive counseling aided by www.Bedsider.org in patients seeking first-trimester abortion. The primary outcome is the uptake of long-acting reversible contraception in women seeking induced abortion.

Detailed Description

Nearly half of pregnancies among American women are unintended, and about 4 in 10 of these are terminated by abortion. Unmet need for family planning is the cause for induced abortion, and those women seeking induced abortion are a high risk for repeat abortion. Family planning services are of paramount importance to this population, and evidence shows that high-quality family planning counseling and provision of methods prior to discharge from a care facility improve uptake and continuation of methods. In a recent study, oral contraceptive pills, a transdermal patch, or a vaginal ring had a risk of contraceptive failure that was 20 times as high as the risk among those using long-acting reversible contraception (IUD or implant).

We plan to randomize preoperative clinic days to either provider counseling aided by Bedsider.org or routine provider counseling, and compare the types of contraceptive methods that are chosen in each group, with the primary outcome being uptake of long-acting reversible contraception (intrauterine device or implant). The secondary outcome is satisfaction with contraceptive counseling in both groups.

We also plan to conduct a qualitative focus group study of provider perspectives of this counseling tool after completion of the randomized trial. Materials related to the qualitative portion of the study will be submitted in a separate amendment. No Follow-up is needed.

EXPECTED OUTCOMES AND DISSEMINATION OF FINDINGS The goal of the study is to assess the feasibility and effectiveness of using a web-based contraception tool in a unique family planning clinic serving high-risk patients with expert family planning providers. After assessing feasibility, utility, and effectiveness in our practice setting, we hope to spread the use of bedsider.org to the entirety of the outpatient clinic, which includes general obstetrics and gynecology patients and providers.

After completion of the study, we plan to submit our findings for presentation at a national meeting, and submit a manuscript for publication in a peer-reviewed journal.

Conditions

Contraception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Bedsider counseling group

Women exposed to: Bedsider.org counseling will be offered a computer or tablet at check-in to clinic. The outcome measure is measured at the patient's surgical abortion procedure appointment, or at medical abortion follow-up, which can range up to 10 days after enrollment

Group Type: EXPERIMENTAL

Bedsider.org counseling

Intervention Type: BEHAVIORAL

Contraceptive counseling was done while women kept the computer/tablet throughout their visit to facilitate discussion of website information with their providers.

Routine counseling group

Women were given counseling in the providers' usual practice style. They were given a card with Bedsider.org's web address along with the counseling.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Bedsider.org counseling

Contraceptive counseling was done while women kept the computer/tablet throughout their visit to facilitate discussion of website information with their providers.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• English speaking
• Seeking medical or surgical pregnancy termination
• 12 weeks gestation or less

Exclusion Criteria

• Early pregnancy failure
• Medical contraindications to any contraceptive methods as based on CDC Medical Eligibility Criteria

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarita Soanlkar, MD MPH

Role: PRINCIPAL_INVESTIGATOR

Hospital of the University of Pennsylvania Department of Obstetrics and Gynecology

Related Links

https://bedsider.org/

Bedsider site

Other Identifiers

H-31382

Identifier Type: -

Identifier Source: org_study_id