A Web-Based Tool to Help People With Health Conditions Make Contraceptive Decisions

A Web-based Contraceptive Decision Support Tool for Individuals With Health Conditions: A Cluster Randomized Controlled Trial With Mixed Methods

Among people who do not want to get pregnant, some do not use any birth control. This is also called contraceptive nonuse. Common reasons for contraceptive nonuse include concerns about birth control safety or side effects. People with health conditions, such as diabetes or high blood pressure, also report worries about how different birth control methods might affect their health condition or medicines.

The goal of this clinical trial is to learn if a web tool called My Health, My Choice helps people with health conditions understand their birth control options and choose birth control that is right for them. The study will also look at the medical safety of birth control methods that participants decide to use. The main questions it aims to answer are:

• Does the My Health My Choice tool lower the number of participants who do not use any birth control method? (contraceptive nonuse)

In other words, does the My Health My Choice tool increase the number of participants who use any birth control method? (contraceptive use)

Participants who use the My Health, My Choice tool before a clinic visit with their clinician (Intervention Group) will be compared to participants who only go to a clinic visit with their clinician (Usual Care Group).

For this study, a "clinician" is any licensed health care provider who counsels about birth control, prescribes birth control, and/or inserts birth control devices.

All participants will:

• Complete 4-5 online surveys that take 5-10 minutes each, over a 3 month time period
• Be asked to go to a scheduled clinic visit with their health care provider
• A small group of participants (about 30) will be invited to a 1 hour exit interview

Participants in the intervention arm will be asked to:

• Use the My Health My Choice tool before their clinic visit

Fourteen outpatient clinics in the United States that provide birth control services, including primary care and obstetrics and gynecology clinics, will be enrolled. Each clinic will be randomly assigned to the My Health My Choice Group (intervention group) or the Usual Care group. Only patients who receive health care at enrolled clinics are eligible for study participation.

Participants must be aged 18-49 years, read English, fertile (able to get pregnant), have at least one index health condition, characteristic or medication usage (full list of 60+ eligible conditions, characteristics, and 50+ medications available upon request); and want to talk about birth control at an upcoming clinic visit with their clinician.

Eligible participants will be enrolled over the phone. Enrolled participants will complete a baseline electronic survey about their demographics, health history, contraceptive use, and contraceptive knowledge before learning which study group they are in.

Study Activities for Participants in the Intervention Arm Only:

• Before their scheduled clinic visit, open and use the My Health My Choice tool via a password-protected weblink on a mobile device, computer
• Complete a brief electronic survey about their experience using the My Health My Choice web tool.

Study Activities for All Participants:

• Go to their scheduled clinic visit with their clinician
• Complete a survey shortly after the clinic visit
• Complete a survey 1 month after the clinic visit
• Complete a survey 3 months after the clinic visit

All surveys take about 5-10 minutes to complete. About 30 participants across all clinic sites will be asked to do an optional 1 hour exit interview by phone or teleconference.

Clinicians who provide contraceptive care, including residents who have finished their intern year, are eligible to participate. Eligible clinicians include doctors, nurse practitioners, physician assistants, and certified nurse midwives. Enrolled clinicians will complete a brief baseline and exit survey about their contraceptive counseling, the type of contraceptive methods they provide, and their contraceptive knowledge.

Activities for All Clinicians

• Complete a baseline survey
• Complete an exit survey
• Provide care to enrolled patients at their scheduled visits
• Complete a brief survey after each visit with an enrolled patient

Activities for Clinicians in the Intervention Arm Only

• Before or during the scheduled clinic visit, open and use Clinician Version of the My Health My Choice tool via a password-protected weblink on a mobile device, computer

The Clinician Version of the My Health My Choice has information to help clinicians counsel patients with health conditions about the safety of different birth control methods. Clinicians can also review the "Birth Control Summary" of enrolled patients before or during the clinic visit.

All clinician surveys take 3-10 minutes to complete. About 30 clinician participants across all clinic sites will be asked to participate in an optional 1 hour exit interview by phone or teleconference.

After patients exit the study, an electronic health record (EHR) review will be done to find out if participants got birth control prescriptions or birth control devices during the study. The EHR review also includes checking if participants report plans to get permanent birth control (tubal sterilization for themselves or vasectomy for their partners).

The primary and secondary outcomes are patient-reported or patient-related outcomes. There are no primary or secondary outcomes for clinicians.

The study aims to enroll 725 patients and 70 clinicians (795 in total).

Patient Inclusion Criteria:

• Between the ages of 18 and 49
• Assigned female sex at birth, regardless of gender identity
• Presumed to be fertile (have an intact uterus/tube/ovary; premenopausal)
• Have at least one index health condition, characteristic or medication usage (full list of 60+ eligible conditions, characteristics, and 50+ medications available upon request); and want to talk about birth control at an upcoming clinic visit with their clinician
• Able to read in English
• Access to mobile phone, computer, or tablet with internet capabilities
• Not currently pregnant
• Desire to talk to their clinician about starting, switching, or adding a contraceptive method for the purpose of preventing pregnancy

Patient Exclusion Criteria:

• Trying to get pregnant in the next 12 months
• Presumed infertile for any surgical or medical reason (e.g., postmenopausal, hysterectomy, chemotherapy)

There are additional clarifications regarding patient eligibility, such as a full list of eligible medical diagnoses and medicines, that can be found in the protocol.

Clinician Inclusion Criteria:

• Any licensed clinician who provides contraceptive care at a participating clinic, including physicians, physician assistants, certified nurse midwives, nurse practitioners. (For clinicians, there are no restrictions based upon age, gender identify or sex).

Clinician Exclusion Criteria:

• Physician interns (PGY-1) are not eligible