Evaluating MyPath to Enhance Reproductive Autonomy and Liberate Decision-making

NCT04627805 | Terminated

• 1 other identifier: STUDY20010128
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Substance Use Disorders; Reproductive Issues; Contraception

Keywords

Reproductive decisions; Pregnancy planning; Contraceptive counseling

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (6)

• Number of providers reporting ease of incorporating MyPath into clinical workflow assessed by 5-point Likert scale

  Approximately one month

• Number of participants who complete all study procedures

  Approximately six months

• Mean change in reproductive health knowledge

  Approximately one month

• Mean change in self-efficacy

  Approximately one month

• Mean change in decisional conflict

  Approximately one month

Study Arms (2)

Phase 2: Usual Care

NO INTERVENTION

The investigators will enroll 33 women with SUDs 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 be asked to complete a pre-visit survey, including substance use history and current reproductive health goals, as well as questions about reproductive health knowledge, self-efficacy, and decision conflict. The participants will then attend their scheduled therapy visit with the substance use treatment provider. Following the therapy 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.

Phase 3: MyPath Pilot

EXPERIMENTAL

Following completion of the usual care arm, the investogators will enroll a second group of 33 women with SUDs 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 that they will be encouraged to use as a guide when discussing their reproductive health with their substance use treatment provider at their next scheduled therapy visit. 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.

Behavioral: MyPath tool

Interventions

MyPath tool BEHAVIORAL

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.

Phase 3: MyPath Pilot

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Society of Family Planning: collaborator

Study Sites (1)

Center for Family Planning Research

Pittsburgh, Pennsylvania, 15201, United States

Location

Related 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. Online ahead of print. No abstract available.

  PMID: 31472941 BACKGROUND

Related Links

• MyPath web-based decision support tool

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Beatrice A Chen, MD MPH

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

• Samantha J Deans, MD MPH

  University of Pittsburgh

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2020
• First Posted: November 13, 2020
• Study Start: November 20, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: July 14, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)