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临床试验/NCT04162184
NCT04162184已完成不适用

Increasing Linkage to Family Planning Care for Individuals With Substance Use Disorder

Denver Health and Hospital Authority2 个研究点 分布在 1 个国家目标入组 199 人开始时间: 2019年12月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
199
试验地点
2
主要终点
Intervention sessions completed.

研究概览

简要总结

This study will utilize mixed methods to develop and assess the feasibility and acceptability of a health educator intervention designed to connect patients in recovery from substance use disorder to reproductive health education and services.

详细描述

Developing effective reproductive health interventions for individuals in treatment for substance use disorder is an important public health priority. In the US nearly half (45%) of all pregnancies are unplanned and studies have consistently found this rate to be much higher among individuals in substance treatment, almost 90%. There is a paucity of research on interventions to support the family planning care of this population. The primary goal of this project is to identify an innovative delivery model to address the family planning needs of individuals of reproductive age in treatment for substance use disorder at an urban integrated safety-net health system. Through the use of mixed methods this study will address the following objectives: 1) To describe the family planning experiences and needs of individuals in treatment for substance use disorders (SUD) in a representative sample of patients and 2) To assess the feasibility and acceptability of the intervention among study participants. If found to be acceptable, efficacy should be assessed in a randomized controlled trial. A navigator model such as this is generalizable and could be easily integrated into a variety of settings.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 44 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • In treatment for substance use disorder at one of the participating clinics; 18-44 years of age; English-speaking; not currently pregnant; able to become pregnant (e.g., no history of hysterectomy, tubal ligation, hysterectomy, menopause); not planning to leave the Denver area in the next 3 months.

排除标准

  • currently pregnant; intoxicated or mentally impaired to the point that one is unable to voluntarily consent to participate and/or respond to the surveys.

结局指标

主要结局

Intervention sessions completed.

时间窗: up to 3 months

Intervention acceptability will be measured by the number of sessions completed by the health educator among participants enrolled in the study.

Self-reported satisfaction with intervention.

时间窗: up to 3 months

Intervention acceptability will be assessed by participant self-reported satisfaction with the intervention (via surveys) among those who complete the intervention sessions. Satisfaction will be assessed with 8 items on a 4-point scale describing how strongly participants agree with each statement. The response scale is coded so that a higher score reflects higher satisfaction and therefore a better outcome. Reported as mean overall score (range 1-32).

次要结局

未报告次要终点

研究者

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

Deborah Rinehart

Research Scientist

Denver Health and Hospital Authority

研究点 (2)

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