跳至主要内容
临床试验/NCT04939012
NCT04939012招募中不适用

Implementation of a Patient-centered, Reproductive Planning Decision Support Tool (MyPath) Among Women With Substance Use Disorder in the Immediate Postpartum Period

University of Pittsburgh1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2022年10月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
400
试验地点
1
主要终点
Contraceptive method continuation

研究概览

简要总结

This is a study to determine the effect of a novel patient-centered, reproductive planning decision support tool developed by the research team called MyPath on postpartum contraceptive decision-making among women with SUDs.

详细描述

The reproductive health needs of women with substance use disorders (SUDs) are unmet. Over 80% of pregnancies among women with SUDs are unintended, compared to 45% of the general population, and over 20% of women with SUDs have had a short interpregnancy interval (i.e. ≤ 18 months after a previous birth). Adverse reproductive health outcomes are perpetuated by contraceptive decisions that are inconsistent with women's reproductive goals. In an evaluation of women in opioid use disorder (OUD) treatment, only half of sexually active women not wanting to get pregnant used contraception, with condoms the most frequent method used. Pregnancy is a unique opportunity to address contraceptive needs due to increased healthcare access and expanded Medicaid eligibility, increased access to highly effective methods such as long-acting reversible contraception (LARC) and enhanced motivation to avoid rapid, repeat pregnancy. Despite this, over 75% of women with OUD do not use postpartum contraception and less than 2% receive LARC.

Currently, there are no effective strategies to improve postpartum contraceptive decision-making for women with SUDs. As an initial step to address this gap, the investigators conducted an observational study of postpartum contraceptive choices among 194 women with OUD at our maternity hospital (Plan NOW). Per usual care, women were provided with information about all contraceptive options, consistent with "information-based" counseling, and access to all methods including immediate postpartum LARC. Several findings informed this proposal. First, women's postpartum contraceptive decisions were often inconsistent with their childbearing goals. Among women who did not want another child, 36% did not choose a highly effective method and 10% had a repeat pregnancy within one year. Second, women had limited contraceptive knowledge and frequent misconceptions about their fertility and vulnerability to pregnancy. Third, women's decisional autonomy regarding sex and contraception was often threatened due to ongoing illicit drug use and reproductive coercion by partners. Fourth, women who wanted another baby did not feel supported and often felt pressured to choose a highly effective method. Therefore, failure to frame contraceptive decisions within the larger reproductive health context of women with OUD was a major barrier to high quality decision-making.

The goal of this research is to help women with SUDs make informed decisions about their reproductive health that align with their preferences, values and reproductive goals. Our objective in this application is to determine the effect of a novel patient-centered, reproductive planning decision support tool developed by the research team called MyPath on postpartum contraceptive decision-making among women with SUDs. Designed to facilitate high-quality decisions regarding pregnancy and contraception, MyPath helps women a) review their thoughts about pregnancy and children, b) learn about fertility and preconception health and c) prioritize their preferences for various contraceptive method characteristics (e.g. effectiveness, side effects). As such, MyPath uses a patient-centered approach to help women frame their contraceptive decisions in the context of their goals and health and is a critical first step towards addressing reproductive health inequities among women with SUDs. Our overarching hypothesis is that patient-centered, reproductive planning decision support will facilitate high quality decision-making and thus improve postpartum contraceptive utilization and reproductive health outcomes among women with SUDs. To test this hypothesis, the investigators propose a hybrid type 1 effectiveness-implementation randomized controlled trial, guided by the following aims:

Aim 1: Assess the effect of patient-centered, reproductive planning decision support (MyPath) on postpartum contraceptive utilization and reproductive health outcomes among women with SUDs

Aim 2: Determine if the relationship between MyPath and contraceptive utilization is mediated by decision quality. Decision quality will be measured using four patient-centered components of decision-making: knowledge, values concordance, decisional conflict and involvement. The investigators hypothesize that improvements in decision quality will mediate the relationship between MyPath and contraceptive utilization.

研究设计

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

入排标准

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

入选标准

  • Prenatal Cohort:
  • Be greater than or equal to 18 years of age.
  • Be pregnant with an EGA of 22 to 37 weeks at enrollment.
  • Plan to deliver at research site.
  • Meet DSM-5 criteria for a SUD (i.e., opioid, stimulant or other use disorder) and/or have a diagnosis code for a substance use disorder in their medical record.
  • Postpartum Cohort:
  • Be greater than or equal to 18 years of age.
  • Be 0-9 days postpartum at enrollment.
  • Have delivered at research site.
  • Meet DSM-5 criteria for a SUD (i.e., opioid, stimulant or other use disorder) and/or have a diagnosis code for a substance use disorder in their medical record.

排除标准

  • Have had a fetal or neonatal death with their current pregnancy.
  • Be currently in jail or prison as required by court of law. Persons on probation or in residential facilities do not need to be excluded.
  • Have any other condition (social or medical) which, in the opinion of the Investigator, would make study participation unsafe, make study participation difficult, and/or complicate data interpretation.
  • PPC ONLY: Documented tubal ligation or hysterectomy procedures at time of delivery hospitalization

研究组 & 干预措施

MyPath Intervention

Experimental

At the first visit participants randomized to this arm receive MyPath contraceptive decision tool.

干预措施: MyPath Intervention (Behavioral)

Standard of Care

Active Comparator

At the first visit participants randomized to this arm receive standard of care contraceptive counseling.

干预措施: Usual care (Behavioral)

结局指标

主要结局

Contraceptive method continuation

时间窗: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery

Contraceptive method continuation as measured at each postpartum follow-up assessment by participants use of the same contraceptive method as she did at the previous timepoint.

Continuous contraceptive use

时间窗: Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery

Continuous contraceptive use as measured by participants continuously using any moderately (i.e., pill, patch, or ring, injection) or highly effective (i.e., long-acting reversible contraceptive (LARC), tubal ligation) method at consecutive timepoints. Reasons for stopping or switching methods will also be obtained.

次要结局

  • Unintended pregnancy(Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery)
  • Decisional Conflict(Enrollment (22 - 37 weeks pregnant) to 18 months post delivery)
  • Knowledge(Enrollment (22 - 37 weeks pregnant) to 18 months post delivery)
  • Use of moderate or highly effective method(Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery)
  • Interpregnancy interval(Delivery (Immediate Post-delivery Inpatient Visit) to 18 months post delivery)
  • Values concordance(Enrollment (22 - 37 weeks pregnant) to 18 months post delivery)
  • Involvement(Enrollment (22 - 37 weeks pregnant) to 18 months post delivery)

研究者

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

Elizabeth Krans, MD

Assistant Professor

University of Pittsburgh

研究点 (1)

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