Patient-Centered Reproductive Decision Support Tool for Women Veterans (NCT04584294) | Clinical Trial Compass
CompletedNot Applicable
Patient-Centered Reproductive Decision Support Tool for Women Veterans
United States465 participantsStarted 2021-03-01
Plain-language summary
The investigators have developed a web-based decision support tool to help women Veterans get the information and care they need to achieve their reproductive goals, whether that includes optimizing their health before desired pregnancies or birth control to avoid unwanted pregnancies. The study will test the effect of sending a weblink to the decision tool to women Veterans prior to primary care visits at the VA. Half of participants will be sent a weblink before their appointment, and half will not be sent the link. The investigators hypothesize that participants who are sent the link will be more likely to report patient-centered discussions of their reproductive needs at visits, feel confident in communicating with their health care providers, have accurate knowledge about reproductive health, and choose birth control methods that best fit their preferences and needs.
Who can participate
Age range
18 Years – 44 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Patients:
* Female sex identified in medical record
* 18 - 44 years old
* Has a scheduled VA medical appointment with an enrolled study provider
* Has at least one valid telephone number available in medical record
* Interested in receiving information or talking with their provider about pregnancy and/or birth control
Providers:
* Primary Care Provider (MD, Nurse Practitioner, Physician Assistant) at a study site
* Designated as a Women's Health Provider \[defined in VA directive 1330.01 as primary care providers who have demonstrated proficiency (e.g. pelvic exams and pap smears) in women's health and who have at least 10% of their panel comprised of women\]
* Completed appointments with at least 30 unique female patients ages 18-44 in the past year at a study site
Exclusion Criteria:
Patients:
* Currently pregnant
* Medical record or self-reported history of hysterectomy, bilateral oophorectomy; or self-report of not having a uterus
* Unable to communicate in English
* Impaired decision-making
* Used the decision tool prior to study enrollment (e.g. during pilot testing of the tool)
Providers:
* Previous involvement as a provider in MyPath pilot work (identified by the PI)
* Medical trainee
* Self-report that they have plans to leave VA, go on extended leave, retire, stop primary care practice, or change VA site in the 18 months following their enrollment
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of Reproductive Needs Discussion With Shared Decision Making (SDM)