Clinical trial NCT06764030: A Patient-Directed Computerized Intervention to Address Reproductive Coercion
Official title: A Pilot Feasibility Study of a Patient-Directed Computerized Intervention to Address Reproductive Coercion
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Feasibility Pilot Study
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-01-08
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The intervention group will interact with BRIDGES in addition to receiving standard of care while the control group will receive standard of care.
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Previously exposed to the intervention (e.g., participated in user testing during September and October 2024)
* Does not have a valid email address

Primary outcomes:
measure: Level of agreement that the BRIDGES website was acceptable
timeFrame: Up to five days after appointment
measure: Level of agreement that the user liked BRIDGES
timeFrame: Up to five days after appointment
measure: Level of agreement that BRIDGES was helpful
timeFrame: Up to five days after appointment
measure: Level of agreement that the user was comfortable using BRIDGES
timeFrame: Up to five days after appointment
measure: Level of agreement that the user felt safe using BRIDGES
timeFrame: Up to five days after appointment
measure: Level of agreement that BRIDGES was easy to use
timeFrame: Up to five days after appointment
measure: Level of agreement that the BRIDGES website helped them talk to their healthcare provider about their intimate relationships
timeFrame: Up to five days after appointment
measure: Level of agreement that the BRIDGES website helped them talk to their healthcare provider about their preferred birth control method
timeFrame: Up to five days after appointment
measure: Level of agreement that the BRIDGES website helped them choose a birth control method that works best for them
timeFrame: Up to five days after appointment
measure: Level of agreement that the BRIDGES website influenced their decision about which birth control method they wanted
timeFrame: Up to five days after appointment
measure: Level of agreement that the BRIDGES website will help them talk to their friends and family about reproductive coercion
timeFrame: Up to five days after appointment
measure: Level of agreement that the user would share the BRIDGES website with a friend or family member who needed support
timeFrame: Up to five days after appointment
measure: Level of agreement that the user would use the BRIDGES website if the user were not in the study
timeFrame: Up to five days after appointment
Secondary outcomes:
measure: Knowledge about which birth control methods can be kept private
timeFrame: Pre-appointment
measure: Change in knowledge about which birth control methods can be kept private
timeFrame: Three months after appointment
measure: Knowledge about what reproductive coercion is
timeFrame: Pre-appointment
measure: Change in knowledge about what reproductive coercion is
timeFrame: Three months after appointment
measure: Knowledge about the role of healthcare providers
timeFrame: Pre-appointment
measure: Change in knowledge about the role of healthcare providers
timeFrame: Three months after appointment
measure: Confidence in their ability to ask with their healthcare providers about issues related to reproductive coercion
timeFrame: Three months after appointment
measure: Change in level of reproductive autonomy
timeFrame: Three months after appointment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References: