Information Access for Birth Control

Recruiting in Palo Alto (17 mi)

Overseen by Eleanor Schwarz, MD, MS

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of California, San Francisco

Disqualifiers: Current pregnancy, Menopause, Infertility, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this study is to understand whether providing information to women with a strong desire to avoid future pregnancy about how tubal sterilization compares to long-acting reversible contraceptives improves perceived access to available contraceptives. Participants will: * Complete a baseline survey * Receive access to web-based educational resources * Complete a brief follow up survey immediately after exploring these web-based resources * Complete a follow-up survey 3 months after enrolling The investigators will compare outcomes among participants provided with access to a new website (intervention) summarizing recent patient-centered outcomes research (PCOR) comparing interval laparoscopic tubal sterilization and long-acting reversible contraception (LARC) to control participants provided with access to the existing Planned Parenthood website on tubal sterilization.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Advancing Access Website, Patient-centered Information on Permanent Contraception Website?

Research shows that patient-oriented information, like the longer informational brochure for oral contraceptives, is preferred and found useful by many women, suggesting that detailed, accessible information can positively impact understanding and decision-making about contraception. ^{1 2 3 4 5}

Is the Information Access for Birth Control treatment safe for humans?

The research highlights that many women are concerned about the safety of oral contraceptives, but balanced information about risks is important for making informed decisions. Websites and printed materials are useful tools for providing safety information and addressing common concerns like side effects. ^{2 4 5 6 7}

How is the Advancing Access Website treatment different from other birth control treatments?

The Advancing Access Website is unique because it provides patient-centered information on permanent contraception through an online platform, making it more accessible and informative compared to traditional in-person consultations. This approach is designed to empower patients with knowledge and support their decision-making process regarding permanent birth control options. ^{8 9 10 11 12}

Research Team

Eleanor Schwarz, MD, MS

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for women who do not wish to become pregnant in the future. Participants should be considering their options for permanent contraception and willing to complete surveys about their perceptions of contraceptive access after using educational websites.

Inclusion Criteria

Self-reported fertility

I speak English or Spanish.

I strongly do not want to become pregnant in the future.

Exclusion Criteria

I have gone through menopause.

Current pregnancy

Infertility

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Survey and Educational Resource Access

Participants complete a baseline survey and receive access to web-based educational resources

1 week

1 visit (virtual)

Immediate Follow-up

Participants complete a brief follow-up survey immediately after exploring web-based resources

1 week

1 visit (virtual)

3-Month Follow-up

Participants complete a follow-up survey 3 months after enrolling to assess changes in knowledge and perceived access to contraceptives

3 months

1 visit (virtual)

Treatment Details

Interventions

• Advancing Access Website (Behavioral Intervention)

Trial Overview The study tests if a new website with patient-centered information on tubal sterilization versus long-acting reversible contraceptives (LARC) affects women's views on contraceptive access, compared to an existing Planned Parenthood website.

Participant Groups

Group I: Comparative information on tubal sterilization and other long-acting contraceptives Experimental Treatment 1 Intervention

A new website comparing tubal sterilization to vasectomy and long-acting reversible contraceptives

Group II: Information on tubal sterilization Active Control 1 Intervention

Participants will be shown an existing web page developed by Planned Parenthood for people considering tubal sterilization

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Suresh Gunasekaran

University of California, San Francisco

Chief Executive Officer since 2022

MBA from Southern Methodist University

Dr. Lukejohn Day

University of California, San Francisco

Chief Medical Officer

MD from Stanford University School of Medicine

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Laura L. Sessums

Agency for Healthcare Research and Quality (AHRQ)

Chief Medical Officer

JD, MD

Arlene S. Bierman

Agency for Healthcare Research and Quality (AHRQ)

Chief Strategy Officer

MD, MS

Essential Access Health

Collaborator

Trials

7

Recruited

3,200+

Findings from Research

A nationwide survey of 2,669 women (1,720 current and 949 former oral contraceptive users) revealed that while most women received and read the patient insert with their oral contraceptives, only about one-third received the longer informational brochure from physicians, indicating a gap in comprehensive patient education.

The study found that directions for use and side effects were the most recalled pieces of information, and despite the availability of written materials, physician-patient interactions remained largely unchanged, suggesting that improving the delivery and accessibility of patient information could enhance understanding and safety in contraceptive use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A survey of the effects of oral contraceptive patient information. Morris, LA., Mazis, M., Gordon, E.[2016]

A survey of 828 women revealed that many are concerned about the safety of oral contraceptives, highlighting the need for better communication regarding their risks and benefits.

The patient-oriented package insert for oral contraceptives was generally well-received and considered useful, but there is a clear preference for receiving information from health professionals and printed materials rather than media sources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral contraceptive patient information. A questionnaire study of attitudes, knowledge, and preferred information sources. Fleckenstein, L., Joubert, P., Lawrence, R., et al.[2019]

A contraception navigator program designed for adolescents in central Indiana emphasizes the importance of building trust and addressing patient-specific barriers to contraception access, as identified through co-design sessions with 35 adolescents and 11 community stakeholders.

Key elements of the program include providing various communication methods and support for understanding contraceptive side effects, which are crucial for making the process of obtaining contraception less intimidating for young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Youth Contraception Navigator Program: A Human-Centered Design Approach. Wilkinson, TA., Hawryluk, B., Moore, C., et al.[2023]

Patients found the Bedsider online contraceptive support tool to be trustworthy, accessible, and empowering, indicating a positive reception among sexually active women interested in contraception.

In contrast, clinic providers and staff expressed concerns about the tool's legitimacy and applicability, which may hinder their willingness to recommend it, highlighting a disconnect between patient and provider perspectives on contraceptive information tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and provider perspectives on Bedsider.org, an online contraceptive information tool, in a low income, racially diverse clinic population. Gressel, GM., Lundsberg, LS., Illuzzi, JL., et al.[2015]

The EngagedMD multimedia platform significantly enhances patient understanding and satisfaction regarding IVF and OI-IUI treatments, with 88% of patients feeling better prepared to consent and 83% reporting increased satisfaction with their care.

Providers also recognized the platform's benefits, with 63% agreeing it improved patient learning and standardized information dissemination, indicating its effectiveness in the informed consent process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the EngagedMD multimedia platform to improve informed consent for ovulation induction, intrauterine insemination, and in vitro fertilization. Madeira, JL., Rehbein, J., Christianson, MS., et al.[2019]

The integration of Bedsider.org, a web-based contraceptive decision support tool, into university health clinic visits was well-received by female students, with positive feedback on the information provided during their appointments.

After using Bedsider, there was an increase in the use of more effective contraceptive methods among sexually active participants, with 11% initiating or planning to receive long-acting reversible contraceptives (LARCs).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of using a web-based contraceptive support tool in a university health clinic. Giho, Y., Jones, KA., Dick, RN., et al.[2021]

A scoping review of 306 webpages about long-acting reversible contraception (LARC) revealed that while most provided key information, only half mentioned efficacy, and many lacked details on costs and access, which are crucial for informed decision-making.

Descriptions of side effects varied significantly across webpages, leading to potential confusion for users; this inconsistency highlights the need for comprehensive and reliable online health information to aid individuals in choosing contraceptive methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Googling long-acting reversible contraception: A scoping review examining the information available online about intrauterine devices and contraceptive implants. Caddy, C., Coombe, J.[2023]

The Choose Well initiative in South Carolina significantly improved perceptions of contraceptive access at federally qualified health centers (FQHCs) by enhancing training and funding for IUDs and implants, as reported by 34 staff members interviewed in 2018 and 2019.

Key factors for success included increased capacity for contraceptive counseling, streamlined workflows, and strong organizational buy-in, while challenges such as device costs and insurance coverage posed threats to sustainability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contraceptive Access at Federally Qualified Health Centers During the South Carolina Choose Well Initiative: A Qualitative Analysis of Staff Perceptions and Experiences. Ventura, LM., Beatty, KE., Khoury, AJ., et al.[2022]

Public comments on pharmacist-prescribed hormonal contraception were largely positive, highlighting benefits like increased access to healthcare and reduced unintended pregnancies, based on a review of 1060 comments from online articles.

However, there were concerns about the role of pharmacists and logistical challenges that need to be addressed for successful implementation, indicating a need for careful planning in expanding pharmacists' roles in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Public perception of pharmacist-prescribed self-administered non-emergency hormonal contraception: An analysis of online social discourse. Irwin, AN., Stewart, OC., Nguyen, VQ., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

A survey of the effects of oral contraceptive patient information. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Oral contraceptive patient information. A questionnaire study of attitudes, knowledge, and preferred information sources. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Developing a Youth Contraception Navigator Program: A Human-Centered Design Approach. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Patient and provider perspectives on Bedsider.org, an online contraceptive information tool, in a low income, racially diverse clinic population. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Using the EngagedMD multimedia platform to improve informed consent for ovulation induction, intrauterine insemination, and in vitro fertilization. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Surfing on the morning after: analysis of an emergency contraception website. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Patient attitudes about two forms of printed oral contraceptive information. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Feasibility and acceptability of using a web-based contraceptive support tool in a university health clinic. [2021]

9. Ireland pubmed.ncbi.nlm.nih.gov

Patient-provider communication before and after implementation of the contraceptive decision support tool My Birth Control. [2020]

10. Australia pubmed.ncbi.nlm.nih.gov

Googling long-acting reversible contraception: A scoping review examining the information available online about intrauterine devices and contraceptive implants. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Contraceptive Access at Federally Qualified Health Centers During the South Carolina Choose Well Initiative: A Qualitative Analysis of Staff Perceptions and Experiences. [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Public perception of pharmacist-prescribed self-administered non-emergency hormonal contraception: An analysis of online social discourse. [2022]