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A Patient-Directed Computerized Intervention to Address Reproductive Coercion

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University of Michigan

Status

Completed

Conditions

Feasibility Pilot Study

Treatments

Other: Educational web-based application

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06764030
HUM00259457
R21HD107619 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

156 patients

Sex

Female

Ages

18 to 29 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

156 participants in 2 patient groups

BRIDGES plus standard of care
Experimental group
Treatment:
Other: Educational web-based application
Standard of care
No Intervention group

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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