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

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.

Study Overview

• Status: Completed
• Conditions: Contraception
• Intervention / Treatment: Behavioral: Bedsider.org counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 346
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 29 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Behavioral: 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.
NO_INTERVENTION: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uptake, as measured by questionnaire, of long-acting reversible contraception (LARC) in 18-29 women seeking induced abortion	Decision on contraceptive tool selected: LARC - Yes or No	Up to 10 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with a web based tool as measured by a Likert scale	Short Questionnaire with likeret scale	Up to 10 days

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Investigators: Principal Investigator: Sarita Soanlkar, MD MPH, Hospital of the University of Pennsylvania Department of Obstetrics and Gynecology

Publications and helpful links

Helpful Links

• Bedsider site

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: March 9, 2015
• First Submitted That Met QC Criteria: August 24, 2015
• First Posted (ESTIMATE): August 26, 2015

Study Record Updates

• Last Update Posted (ACTUAL): April 13, 2017
• Last Update Submitted That Met QC Criteria: April 12, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: H-31382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Publication in peer-reviewed journal