MyPath Decision Support Tool for Reproductive Health

(MyPath Trial)

Recruiting at 11 trial locations

Overseen By Lisa S Callegari, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Pregnancy, Hysterectomy, Oophorectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

465 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a web-based tool designed to help women Veterans make informed decisions about their reproductive health. The tool, called the MyPath Web-Based Informational and Decision Support Tool, provides information and support for women planning pregnancies or seeking birth control options. Researchers aim to determine if sending a link to this tool before a medical appointment improves the quality of discussions with doctors and helps women feel more confident and informed. Women Veterans who are not currently pregnant and wish to discuss pregnancy or birth control with their doctor may be suitable for this trial. As an unphased trial, this study offers women Veterans the chance to contribute to research that could enhance reproductive health decision-making tools.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using a decision support tool for reproductive health, so it's unlikely to require changes to your medications.

What prior data suggests that this decision support tool is safe for use in reproductive health?

Studies have shown that the MyPath web-based decision support tool is safe to use. Research on MyPath's development and initial testing shows that it helps people understand their reproductive health choices without any physical risks. The tool provides information and support for decisions about reproductive goals, such as planning for pregnancy or choosing birth control.

Researchers have tested this tool in various settings, including Veterans Affairs (VA) primary care. They focused on its effectiveness and ease of use, not on safety concerns, because it doesn't involve medications or physical procedures. So far, studies of MyPath have reported no negative effects. It offers information and guidance, making it very low risk for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MyPath Decision Support Tool because it provides personalized reproductive health information in a web-based format, which is a fresh approach compared to the usual in-person consultations. Unlike the traditional one-size-fits-all guidance, MyPath tailors information to individual needs, empowering patients with knowledge and helping them make informed decisions before their medical visits. This proactive and accessible tool leverages modern technology to enhance patient engagement and streamline the decision-making process in reproductive health care.

What evidence suggests that the MyPath decision support tool is effective for reproductive health?

Research has shown that tools like MyPath, available to participants in this trial, can help people make informed health decisions. MyPath supports women Veterans by offering information and guidance tailored to their reproductive goals. Early results suggest that using MyPath leads to better conversations with doctors and increased confidence in communicating with health care providers. Users of the tool are likely to gain more knowledge about reproductive health and select birth control methods that align with their preferences and needs. This indicates that MyPath could effectively enhance reproductive health for women Veterans. ^{2 6 7 8 9}

Who Is on the Research Team?

Lisa S Callegari, MD

Principal Investigator

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Are You a Good Fit for This Trial?

This trial is for women Veterans aged 18-44 who want information or to discuss pregnancy and birth control with their provider. They must have a scheduled VA appointment, be proficient in English, and not currently pregnant or without reproductive organs due to surgery.

Inclusion Criteria

My medical record includes a valid phone number.

My medical records identify me as female.

I want to discuss pregnancy or birth control with my doctor.

Exclusion Criteria

Providers: Previous involvement as a provider in MyPath pilot work (identified by the PI)

I have difficulty making decisions due to my condition.

Patients: Used the decision tool prior to study enrollment (e.g. during pilot testing of the tool)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a weblink to the decision support tool prior to their primary care visit

1 week

1 visit (in-person)

Follow-up

Participants are monitored for outcomes such as reproductive needs discussions and contraceptive use

6 months

Follow-up assessments at 3 and 6 months

What Are the Treatments Tested in This Trial?

Interventions

• MyPath Web-Based Informational and Decision Support Tool

Trial Overview The study tests a web-based tool designed to support reproductive decisions. Participants are randomly divided: one group receives a weblink to the tool before their VA appointment; the other does not. The goal is better patient-provider communication and informed choices.

How Is the Trial Designed?

Group I: Intervention (MyPath) Experimental Treatment 1 Intervention

Patients scheduled to see providers randomized to this arm will receive a weblink to the decision tool via text message after study enrollment and prior to their scheduled visit.

Group II: Usual Care Active Control 1 Intervention

Patients scheduled to see providers randomized to the usual care arm will receive no intervention and will receive usual primary care.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

An online contraceptive decision aid was developed through a qualitative study involving 17 female students in the Netherlands, which included a needs assessment and field testing to ensure it met user preferences.

Participants reported that the decision aid increased their knowledge and awareness of various contraceptive methods, suggesting it could enhance informed decision-making and consultation preparation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

End-user involvement in developing and field testing an online contraceptive decision aid. Hooiveld, T., Molenaar, JM., van der Heijde, CM., et al.[2023]

The My Birth Control decision support tool did not significantly improve contraceptive continuation rates after 7 months, with continuation rates of 56.6% for the intervention group and 59.6% for the control group.

However, the tool enhanced the quality of the contraceptive counseling experience, leading to higher scores in interpersonal quality, informed decision-making, and contraceptive knowledge among users compared to those receiving usual care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cluster randomized trial of a patient-centered contraceptive decision support tool, My Birth Control. Dehlendorf, C., Fitzpatrick, J., Fox, E., et al.[2020]

The use of the 'My Birth Control' decision support tool in contraceptive counseling led to more patient-centered discussions, with providers focusing on multiple methods of interest rather than just directing patients to one option.

Patients reported gaining knowledge from the tool, indicating its effectiveness in enhancing understanding and engagement during counseling sessions, without requiring extensive training for providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-provider communication before and after implementation of the contraceptive decision support tool My Birth Control. Holt, K., Kimport, K., Kuppermann, M., et al.[2020]

Citations

1. pcrhp.ucsf.edu pcrhp.ucsf.edu/mypath

MyPath - Person Centered Reproductive Health Program MyPath is an online tool designed to empower individuals to get the information and support they need to achieve their reproductive goals.

2. withpower.com withpower.com/trial/phase-2-2021-7b8a3

MyPath Decision Support Tool for Reproductive Health What data supports the effectiveness of the MyPath Web-Based Informational and Decision Support Tool treatment? Research on similar decision support tools ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36179982/

Protocol for a pragmatic cluster randomized trial Evaluating the MyPath web-based reproductive decision support tool in VA primary care: Protocol for a pragmatic cluster randomized trial.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171442200266X

Evaluating the MyPath web-based reproductive decision ... Evaluating the MyPath web-based reproductive decision support tool in VA primary care: Protocol for a pragmatic cluster randomized trial · Background · Discussion.

5. hsrd.research.va.gov hsrd.research.va.gov/publications/vets_perspectives/1019-Improving-Reproductive-Planning-Services-for-Women-Veterans-The-MyPath-Intervention.cfm

Improving Reproductive Planning Services for Women Veterans The MyPath tool provides interactive education and decision support to empower women to make high-quality decisions and to help them communicate ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8481447/

Development and Pilot Testing of a Patient-Centered Web ... We developed and piloted MyPath, a novel web-based decision support tool integrating reproductive goals assessment, information about optimizing health before ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33538956/

Development and Pilot Testing of a Patient-Centered Web ... We developed and piloted MyPath, a novel web-based decision support tool integrating reproductive goals assessment, information about optimizing health before ...

8. researchgate.net researchgate.net/publication/364082272_Evaluating_the_MyPath_web-based_reproductive_decision_support_tool_in_VA_primary_care_Protocol_for_a_pragmatic_cluster_randomized_trial

Evaluating the MyPath web-based reproductive decision ... ... web-based reproductive health decision support tool (MyPath). VA ... system through a retrospective analysis using VA administrative data ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1569199323009244

Feasibility Testing of a Web-Based Reproductive Decision ... ... reproductive decision support tool and assessed its implementation in CF care. ... These tools—MyPath for reproductive preferences, prepregnancy health, and ...