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

391 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the MyPath Web-Based Informational and Decision Support Tool treatment?

Research on similar decision support tools, like 'My Birth Control', shows they help improve communication between patients and healthcare providers and aid in making informed choices about reproductive health. These tools are designed to make complex decisions easier by providing clear information and aligning with patient preferences. ^{1 2 3 4 5}

How is the MyPath Decision Support Tool for Reproductive Health different from other treatments?

The MyPath Decision Support Tool is unique because it focuses on improving the decision-making process for reproductive health by helping patients choose options that align with their personal values and preferences, rather than being a direct medical treatment. It is a patient-centered tool designed to enhance communication and shared decision-making between patients and healthcare providers. ^{1 5 6 7 8}

Research Team

Lisa S Callegari, MD

Principal Investigator

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

Eligibility Criteria

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 am between 18 and 44 years old.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A mixed-methods study of provider perspectives on My Birth Control: a contraceptive decision support tool designed to facilitate shared decision making. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a decision aid for early pregnancy loss: A pilot randomized controlled trial in Philadelphia, Pennsylvania. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Use of a contraceptive decision support tool in the abortion care setting. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Patient Decision Aids to Facilitate Shared Decision Making in Obstetrics and Gynecology: A Systematic Review and Meta-analysis. [2021]

5. Ireland pubmed.ncbi.nlm.nih.gov

Patient-provider communication before and after implementation of the contraceptive decision support tool My Birth Control. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Cluster randomized trial of a patient-centered contraceptive decision support tool, My Birth Control. [2020]

7. England pubmed.ncbi.nlm.nih.gov

End-user involvement in developing and field testing an online contraceptive decision aid. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Women's values in contraceptive choice: a systematic review of relevant attributes included in decision aids. [2022]