A Pilot Feasibility Study of a Patient-Directed Computerized Intervention to Address Reproductive Coercion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Level of agreement that the BRIDGES website was acceptable
研究概览
简要总结
The goal of this clinical trial is to evaluate the feasibility and acceptability of "BRIDGES" (Building Reproductive Decision-Making, Empowerment, & Support), a new patient-directed educational website (bridges4support.org). BRIDGES aims to improve family planning (FP) patients' understanding of reproductive coercion (RC) and harm-reduction strategies, as well as their ability to discuss RC-related issues with healthcare providers if they so choose. Designed to be integrated into routine FP clinical care and pre-visit materials, this brief (5-10 minute) educational website includes 1) education on reproductive coercion and (un)healthy relationships, 2) harm-reduction and safety planning strategies, and 3) patient activation messages to encourage patients to actively engage with their healthcare provider. Four study clinics were selected from Planned Parenthood of Michigan (PPMI) clinics based on patient volume and number of clinics. Two of the four chosen clinics will be randomly assigned to receive BRIDGES, with 40 participants per clinic, and the other two clinics will be randomly assigned to receive the standard of care, also with 40 participants per clinic. Control clinics will receive the standard of care, which includes the typical support and counseling provided at these centers for FP patients, and the intervention clinics will receive BRIDGES plus standard of care. Research staff will recruit FP patients ages 18-29 (N=160) through patient portal messages. Participants will complete online, self-directed Qualtrics surveys at three time points: pre-appointment, post-appointment, and 3-months. Survey data will be used to assess differences in patient knowledge, self-efficacy, and behavior between patients attending intervention clinics and patients attending control FP clinics (i.e., receiving standard-of-care FP services). Feasibility, implementation, and pilot outcome data will be used to further refine the intervention towards the goal of conducting a future larger-scale study of BRIDGES within FP clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 29 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Family planning patients at study clinics, including women, transgender men, non-binary, and other gender-diverse people
- •Ages 18-29
- •Able to participate in English
- •Has an upcoming birth control appointment (telemedicine or in-clinic) scheduled at a study clinic during the enrollment period (November 2024-June 2025). Appointments must be scheduled for at least 24 hours after study enrollment.
- •Has access to PPMI MyChart (i.e., study clinic patient portal)
- •Participants who complete the Pre-Appointment Survey and attend the scheduled birth control appointment or a rescheduled (up to 3x) appointment are eligible for the Post-Appointment Survey
- •Participants who complete the Pre-Appointment Survey are eligible for the 3-Month Survey, regardless of whether they complete the Post-Appointment Survey
排除标准
- •Previously exposed to the intervention (e.g., participated in user testing during September and October 2024)
- •Does not have a valid email address
研究组 & 干预措施
BRIDGES plus standard of care
干预措施: Educational web-based application (Other)
Standard of care
结局指标
主要结局
Level of agreement that the BRIDGES website was acceptable
时间窗: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statements: The BRIDGES website is an acceptable way to learn about each of the following (reproductive coercion, birth control methods that other people are less able to control, things to discuss with a healthcare provider, resources, and use of the patient portal for the invitation to the study). Reponse options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Level of agreement that the user liked BRIDGES
时间窗: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: I like the bridges website. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Level of agreement that BRIDGES was helpful
时间窗: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: Overall, the BRIDGES website helped me. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Level of agreement that the user was comfortable using BRIDGES
时间窗: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: I felt uncomfortable when viewing the BRIDGES website. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Level of agreement that the user felt safe using BRIDGES
时间窗: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: I felt unsafe when viewing the BRIDGES website. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Level of agreement that BRIDGES was easy to use
时间窗: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: The BRIDGES website was easy to use. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Level of agreement that the BRIDGES website helped them talk to their healthcare provider about their intimate relationships
时间窗: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: The BRIDGES website helped me talk to my healthcare provider about my intimate relationships. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Level of agreement that the BRIDGES website helped them talk to their healthcare provider about their preferred birth control method
时间窗: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: The BRIDGES website helped me talk to my healthcare provider about my preferred birth control method. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Level of agreement that the BRIDGES website helped them choose a birth control method that works best for them
时间窗: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: The BRIDGES website helped me choose a birth control method that works best for me. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Level of agreement that the BRIDGES website influenced their decision about which birth control method they wanted
时间窗: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: The BRIDGES website influenced my decision about which birth control method I wanted. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Level of agreement that the BRIDGES website will help them talk to their friends and family about reproductive coercion
时间窗: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: The BRIDGES website will help me talk to my friends and family about reproductive coercion. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Level of agreement that the user would share the BRIDGES website with a friend or family member who needed support
时间窗: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: I would share the BRIDGES website with a friend or family member who needed support. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
Level of agreement that the user would use the BRIDGES website if the user were not in the study
时间窗: Up to five days after appointment
In a self-administered survey, patients at the treatment clinic are asked the extent to which they agree with the following statement: If I was not in this research study, I would use the BRIDGES website. Response options for each statement ranged from strongly disagree (1) to strongly agree (5) such that a higher score would signify agreement with the statement.
次要结局
- Knowledge about which birth control methods can be kept private(Pre-appointment)
- Change in knowledge about which birth control methods can be kept private(Three months after appointment)
- Knowledge about what reproductive coercion is(Pre-appointment)
- Change in knowledge about what reproductive coercion is(Three months after appointment)
- Knowledge about the role of healthcare providers(Pre-appointment)
- Change in knowledge about the role of healthcare providers(Three months after appointment)
- Confidence in their ability to ask with their healthcare providers about issues related to reproductive coercion(Three months after appointment)
- Change in level of reproductive autonomy(Three months after appointment)
研究者
Yasamin Yoko Kusunoki
Associate Professor
University of Michigan