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临床试验/NCT04627805
NCT04627805终止不适用

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

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2020年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
1
试验地点
2
主要终点
Number of providers reporting comfort with reproductive discussions assessed by 5-point Likert scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Number of providers reporting comfort with reproductive discussions assessed by 5-point Likert scale

时间窗: Approximately one month

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)

Number of providers reporting satisfaction with MyPath assessed by 5-point Likert scale

时间窗: Approximately one month

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)

Number of participants reporting satisfaction with reproductive discussions assessed by 5-point Likert scale

时间窗: Approximately 2 weeks

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)

Number of participants reporting satisfaction with MyPath assessed by 5-point Likert scale

时间窗: Approximately 2 weeks

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)

次要结局

  • Number of providers reporting ease of incorporating MyPath into clinical workflow assessed by 5-point Likert scale(Approximately one month)
  • Mean change in self-efficacy(Approximately one month)
  • Number of participants who complete all study procedures(Approximately six months)
  • Mean change in decisional conflict(Approximately one month)
  • Mean change in reproductive health knowledge(Approximately one month)
  • Number of participants who received reproductive health services(Approximately four months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Beatrice Chen

Associate Professor

University of Pittsburgh

研究点 (2)

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