University of Michigan
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT06764030
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.
Looking for future studies?
Notify Me18 year–29 year
Female
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BRIDGES is a patient-directed computerized universal education on RC that is delivered within the FP setting, and that does not require the patient to disclose RC experiences to learn about RC.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-appointment
In a self-administered survey, all patients are asked: Imagine you wanted to keep your birth control private. Which of the following birth control methods are more difficult for other people (like a partner) to mess with or control? (select all that apply). Seven types of birth control methods are provided. The correct answers include birth control implant, injectable birth control, intrauterine device, and sterilization. Incorrect answers include birth control pills, condoms, and withdrawal.
Time frame: Three months after appointment
In a self-administered survey, all patients are asked: Imagine you wanted to keep your birth control private. Which of the following birth control methods are more difficult for other people (like a partner) to mess with or control? (select all that apply). Seven types of birth control methods are provided. The correct answers include birth control implant, injectable birth control, intrauterine device, and sterilization. Incorrect answers include birth control pills, condoms, and withdrawal. A measure of change will be created by subtracting the number of correct methods 3 months after interacting with BRIDGES minus the number of correct methods before interacting with BRIDGES. A value of 0 will signify that knowledge remained the same; a positive value will signify that knowledge increased; a negative value will signify that knowledge decreased.
Time frame: Pre-appointment
In a self-administered survey, all patients are asked: TRUE or FALSE: Pressuring a partner to become pregnant when they don't want to be can be a sign of an unhealthy relationship. The correct answer is true.
Time frame: Three months after appointment
In a self-administered survey, all patients are asked: TRUE or FALSE: Pressuring a partner to become pregnant when they don't want to be can be a sign of an unhealthy relationship. The correct answer is true. A measure of change will be created that compares the answer to this question before and three months after interacting with BRIDGES. If the response is true at both time points or was false before and true after, it would signify an improvement in knowledge.
Time frame: Pre-appointment
In a self-administered survey, all patients are asked: TRUE or FALSE: Healthcare providers can support people who feel controlled in their reproductive decisions. The correct answer is true.
Time frame: Three months after appointment
In a self-administered survey, all patients are asked: TRUE or FALSE: Healthcare providers can support people who feel controlled in their reproductive decisions. The correct answer is true. A measure of change will be created that compares the answer to this question before and three months after their appointment. If the response is false before and true after, it would signify an improvement in knowledge.
Time frame: Three months after appointment
In a self-administered survey, all patients are asked the extent to which they agree with being confident in asking their healthcare provider about issues related to 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. The responses to this question will be compared between the treatment and control.
Time frame: Three months after appointment
In a self-administered survey, all patients are asked about their level of reproductive autonomy based on a validated 14-item measure which included three subscales that encompass reproductive autonomy including communication, freedom from coercion, and decision-making. Mean scores were calculated for each subscale by adding the value of the response choice for each item on the subscale and dividing this value by the number of items on the subscale. Higher scores on each subscale represented higher levels of RA (score ranges from 0 to 14). A measure of change will be created that compares the answer to this question before and three months after their appointment.
University of Michigan
Other
A Pilot Feasibility Study of a Patient-Directed Computerized Intervention to Address Reproductive Coercion
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06635005
Behavior, Breast Diseases
Columbus, Ohio, United States
View Trial DetailsNCT06673277
Adverse Effects, Cryotherapy
Winchester, Hampshire, United Kingdom
View Trial DetailsNCT07541794
Feasibility Pilot Study, Post Prandial Blood Glucose
View Trial DetailsNCT07106125
Antibiotic Prophylaxis, Feasibility Pilot Study
San Francisco, California, United States
View Trial Details