A Web-based Contraceptive Decision Support Tool for Individuals With Health Conditions: A Cluster Randomized Controlled Trial With Mixed Methods
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 795
- 试验地点
- 30
- 主要终点
- Proportion of participants who report contraceptive nonuse at 3 months
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 治疗
- 盲法
- 单盲 (结局评估者)
盲法说明
The lead biostatistician will generate the allocation sequence and assign clinics to the intervention arm or usual care arm. To prevent unequal distribution of clinics that have greater expertise in contraceptive care, clinics with family planning specialists will be balanced between the two arms. Because of the cluster RCT design, allocation concealment is impractical. To minimize the risk of recruitment bias, differential dropouts, and bias, group assignments will be revealed to patient and clinician participants only after they have been consented and taken the baseline survey. The study team and statistical team will be blinded to group assignment when evaluating outcomes. This approach is consistent with the Ottawa Statement on the Ethical Design and Conduct of Cluster Randomized Trials.
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 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
排除标准
- 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
研究组 & 干预措施
Usual Contraceptive Care
Participants will receive usual contraceptive care from a licensed provider (CNM, DO, MD, NP, PA).
干预措施: Usual Contraceptive Care (Behavioral)
My Health, My Choice Contraceptive Decision Tool
Participants in the intervention arm will use a web-based, password-protected contraceptive decision support tool (My Health My Choice) prior to a clinic visit with a licensed clinician who provides contraceptive care (CNM, DO, MD, NP, PA).
干预措施: My Health, My Choice Web-Based Contraceptive Decision Tool (Behavioral)
结局指标
主要结局
Proportion of participants who report contraceptive nonuse at 3 months
时间窗: Baseline, 1 month, and 3 months after the clinic visit
This is a binary outcome (yes/no) that will be assessed at baseline, 1 month, and 3 months after the clinic visit. Participants will report use or nonuse of a contraceptive method in the last month. Contraceptive methods include all non-prescription methods, prescription methods, intrauterine devices (IUDs), the implant, tubal ligation/surgery, and vasectomy of their partner. If patients report use of the cervical cap, condoms, diaphragm, spermicides, vaginal gel, or withdrawal, their outcome will be determined by whether they used the method at last intercourse in the prior month. Only patients who did not want to get pregnant in the last month will be included in the calculation of this outcome.
次要结局
- Medical Eligibility Risk (MER) Category among participants who report contraceptive method use(Baseline, 1 month, and 3 months)
研究者
研究点 (30)
标识符
- NCT 编号
- NCT07075536
- 其他研究编号
- HUM00234187, 5R01HD110570-02
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 是
- 是否有结果
- 否
All quantitative IPD collected during the trial will be de-identified and made available per the time frame and access criteria described below. The full study protocol and statistical analysis plan will also be published in an open-access peer reviewed journal and made available upon request at FAMMED-BirthControlStudy@med.umich.edu.