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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Contraception

Intervention / Treatment
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* Behavioral: Bedsider.org counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 29 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bedsider counseling group<br>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<br>* Contraceptive counseling was done while women kept the computer/tablet throughout their visit to facilitate discussion of website information with their providers.<br>|
| No Intervention: Routine counseling group<br>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?
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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 |