Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Contraception
  • Reproductive Issues
  • Substance Use Disorders
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: The investigators will enroll the first 33 participants to the usual care group, to evaluate the baseline occurrence of family planning discussions and referrals. Following the completion of the usual care group, the investigators will then enroll 33 participants to the MyPath intervention. This allocation scheme was chosen so as to not contaminate the baseline group by rolling out the intervention simultaneously. Providers will be recruited at the conclusion of the study to complete an exit survey if they interacted with at least one Phase 3 participant.Masking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 45 years
Gender
Only males

Description

The study will be completed in four phases. Phase 1 (Preparation): First, a sample of women with SUDs (n=5) will be recruited through a separate MAT program in the UPMC system to pre-test the surveys for patient participants to ensure clarity and understandability of these assessments. A sample of s...

The study will be completed in four phases. Phase 1 (Preparation): First, a sample of women with SUDs (n=5) will be recruited through a separate MAT program in the UPMC system to pre-test the surveys for patient participants to ensure clarity and understandability of these assessments. A sample of substance use treatment providers (n=3) will also be recruited to pre-test the surveys for provider participants. To ensure that participants who want contraceptive services can receive them, the investigators will create a referral pathway that can be used to link participants interested in receiving reproductive health services to an appropriate provider. Through the electronic medical record system of UPMC, providers at NATP will be able to place referrals for reproductive health services for interested participants. Additionally, given the recent increase in use of telemedicine during the COVID-19 pandemic, participants will have the option of attending a telemedicine video visit with a family planning provider through UPMC Magee-Womens Hospital's Family Planning clinic. These various options will allow participants to choose the route that is easiest for them and therefore will further decrease barriers to care. Phase 2 (Usual Care): Thirty three women with SUDs will be recruited from the NATP to evaluate baseline family planning discussions and referrals to women's health providers in SUD treatment settings. To establish usual care practice patterns, MyPath will not be administered to this group of participants. Participants will first complete a pre-visit survey. This will include demographics, substance use history, and current reproductive health goals, as well as questions about knowledge, self-efficacy, and decision conflict. The participants will then attend their scheduled visit with the substance use treatment provider, whether virtual or in-person. Following the provider visit, they will complete the post-visit survey, which will include the same knowledge, efficacy, and decision conflict survey questions as the pre-visit survey. Occurrence of reproductive health discussions, prescriptions or referrals, and satisfaction with reproductive health services will be measured following the visit as well. All surveys will be administered online through REDCap. Patient participants will be compensated for their time with a gift card after they complete the post-visit survey. Phase 3 (MyPath Pilot): Following completion of the usual care arm, a second group of 33 women with SUDs will be recruited from the NATP to participate in the MyPath intervention arm. Participants will complete the same pre-visit survey as the usual care group. In addition, they will be provided a website link to navigate through the online MyPath tool. Following completion of MyPath, participants will receive a summary page (see Appendix A for a sample summary) that they will be encouraged to share with their substance use treatment provider at their next scheduled visit, whether virtual or in-person. After the visit, they will complete the post-visit survey. In addition to satisfaction with reproductive health services, the intervention group will be asked specific questions about their perception of the MyPath tool. All surveys will be administered online through REDCap. Patient participants will be compensated for their time with a gift card after they complete the post-visit survey. Phase 4 (Provider Assessment): Following study completion for patient participants, provider participants will be asked to complete an exit survey to assess feasibility of incorporating MyPath into their clinical work flow and their comfort with reproductive counseling and referring. This will be an anonymous survey administered online and will be sent to all providers identified as engaging with at least one patient participant during the MyPath intervention. Phase 5 (Follow-up): Three months following study completion, a chart review will be performed for each patient participant through UPMC's electronic medical record. This will allow for the collection of information for completion of placed referrals and receipt of desired reproductive services.

Tracking Information

NCT #
NCT04627805
Collaborators
Society of Family Planning
Investigators
Principal Investigator: Samantha J Deans, MD University of Pittsburgh