Evaluating MyPath to Enhance Reproductive Autonomy and Liberate Decision-making

Contraception Clinical Trial

— EMERALD  

Official title:

Reproductive Decision Support Tool for Women With Substance Use Disorders: A Pilot Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04627805
• Other study ID #: STUDY20010128
• Status: Terminated
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: July 2022
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception
• Reproductive Issues
• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• MyPath tool
MyPath is a reproductive decision support tool that utilizes a patient-centered approach to help women frame their reproductive decisions in the context of their goals, preferences, and health needs. This tool was developed by Dr. Lisa Callegari with funding from the Veterans Administration (VA) Health Services Research & Development to be used in primary care settings with women veterans. It is conceptually grounded in Self-Determination Theory, which postulates that health care that meets patients' psychological needs in three key domains - autonomy, competence, and relatedness - will result in improved health behaviors and health outcomes. This is particularly relevant in reproductive health care, given the highly individualized and personal nature of these decisions, and the importance of centering a woman's aspirations and goals in her health care decision making.

Locations

Country	Name	City	State
United States	Center for Family Planning Research	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Society of Family Planning

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants reporting satisfaction with reproductive discussions assessed by 5-point Likert scale	Number of participants that report they are somewhat satisfied or very satisfied with reproductive discussions as assessed on a Likert scale from 1 (very dissatisfied) to 5 (very satisfied)	Approximately 2 weeks
Primary	Number of providers reporting comfort with reproductive discussions assessed by 5-point Likert scale	Number of providers that report they are comfortable or very comfortable with reproductive discussions as assessed on a Likert scale from 1 (very uncomfortable) to 5 (very comfortable)	Approximately one month
Primary	Number of participants reporting satisfaction with MyPath assessed by 5-point Likert scale	Number of participants that report they agree or strongly agree with satisfaction statements about MyPath as assessed on a Likert scale from 1 (strongly disagree) to 5 (strongly agree)	Approximately 2 weeks
Primary	Number of providers reporting satisfaction with MyPath assessed by 5-point Likert scale	Number of providers that report they agree or strongly agree with satisfaction statements about MyPath as assessed on a Likert scale from 1 (strongly disagree) to 5 (strongly agree)	Approximately one month
Secondary	Number of providers reporting ease of incorporating MyPath into clinical workflow assessed by 5-point Likert scale	Likert scale Number of providers that report they agree or strongly agree with ease of incorporation statements about MyPath as assessed on a Likert scale from 1 (strongly disagree) to 5 (strongly agree)	Approximately one month
Secondary	Number of participants who complete all study procedures	Number of participants who enroll and complete all study procedures, including enrollment visit, pre- and post-surveys, and MyPath tool	Approximately six months
Secondary	Mean change in reproductive health knowledge	Mean change in reproductive health knowledge defined as the difference in the number of correct responses to a set of reproductive health knowledge questions from surveys administered before and after the study visit	Approximately one month
Secondary	Mean change in self-efficacy	Mean change in self-efficacy, as assessed on a 5-point Likert scale from 1 (not confident at all) to 5 (very confident) by a set of self-efficacy statements from surveys administered before and after the study visit	Approximately one month
Secondary	Mean change in decisional conflict	Mean change in decisional conflict, as assessed on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree) by a set of decision statements from surveys administered before and after the study visit	Approximately one month
Secondary	Number of participants who received reproductive health services	Number of participants who received reproductive health services as assessed by medical chart review at three month follow-up	Approximately four months

External Links

•   MyPath web-based decision support tool