Clinical trial NCT04627805: Evaluating MyPath to Enhance Reproductive Autonomy and Liberate Decision-making
Official title: Reproductive Decision Support Tool for Women With Substance Use Disorders: A Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Substance Use Disorders
Reproductive Issues
Contraception
Keywords: Reproductive decisions
Pregnancy planning
Contraceptive counseling
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2020-11-13
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This is a pilot study to evaluate the acceptability and feasibility of incorporating a patient-facing reproductive decision support tool, MyPath, into existing clinical pathways in a SUD treatment program. This study will be conducted virtually in partnership with a single substance use treatment program within the University of Pittsburgh Medical Center (UPMC).

Aim 1: Assess the feasibility and acceptability of incorporating a patient-facing reproductive decision support tool (MyPath) into existing clinical pathways in a substance use treatment program.

Aim 2: Assess preliminary efficacy of MyPath on reproductive health knowledge, self-efficacy, and decisional conflict as compared to usual care, as well comparisons between receipt of reproductive health services during the usual care period versus after implementing the intervention.

The investigators hypothesize that the MyPath tool is acceptable and feasible for participants and their providers within a SUD treatment program. They also anticipate that preliminary efficacy data will show a positive correlation between the MyPath intervention and receipt of reproductive services, as well as increased knowledge and self-efficacy with decreased decision conflict. This pilot study will lay the groundwork for future larger trials in order to measure efficacy of this tool in substance use treatment settings.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* Female
* Aged 18-45 years
* Enrolled in a substance use treatment program
* English-speaking
* Interested in discussing their reproductive health with their substance use provider
* Willing and able to participate in a virtual study using video and/or phone

Exclusion Criteria:

* Currently pregnant
* History of female sterilization, hysterectomy, bilateral oophorectomy, or monogamous with a partner with vasectomy
* Previously enrolled in the study

Primary outcomes:
measure: Number of participants reporting satisfaction with reproductive discussions assessed by 5-point Likert scale
timeFrame: Approximately 2 weeks
measure: Number of providers reporting comfort with reproductive discussions assessed by 5-point Likert scale
timeFrame: Approximately one month
measure: Number of participants reporting satisfaction with MyPath assessed by 5-point Likert scale
timeFrame: Approximately 2 weeks
measure: Number of providers reporting satisfaction with MyPath assessed by 5-point Likert scale
timeFrame: Approximately one month
Secondary outcomes:
measure: Number of providers reporting ease of incorporating MyPath into clinical workflow assessed by 5-point Likert scale
timeFrame: Approximately one month
measure: Number of participants who complete all study procedures
timeFrame: Approximately six months
measure: Mean change in reproductive health knowledge
timeFrame: Approximately one month
measure: Mean change in self-efficacy
timeFrame: Approximately one month
measure: Mean change in decisional conflict
timeFrame: Approximately one month
measure: Number of participants who received reproductive health services
timeFrame: Approximately four months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Center for Family Planning Research
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Beatrice A Chen, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Samantha J Deans, MD MPH
role: STUDY_DIRECTOR
References:
citation: Teal S, Haider S, Harris L, Hubacher D, Raine-Bennett T. Scientific abstracts: Featured research at the 2019 Society of Family Planning Annual Meeting. Contraception. 2019 Jul 23:303-304. doi: 10.1016/j.contraception.2019.07.007. Online ahead of print. No abstract available.