Pregnancy at a Time That Is Happy and Healthy for You
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Participant Satisfaction with Shared Decision Making
研究概览
简要总结
In an effort reduce maternal and infant mortality and health disparities overall, PATH4YOU (Pregnancy At a Time that's Healthy and Happy for You) will be implemented starting in Marion County, and will ultimately be a statewide comprehensive contraceptive access program that ensures that patient-centered counseling and same-day access to no (or low) cost contraception are delivered to women across the state. The goal of this project is to partner with community stakeholders to tailor and implement a patient-centered, comprehensive contraceptive access intervention, the PATH4YOU Bundle.
The health center level intervention will consist of three key principles:
- Pregnancy Intention Screening: Provide training for health care providers and assist in health center implementation of a patient-centered pregnancy intention screening strategy within clinical settings
- Contraception and Reproductive Health Counseling: Implement the use of a pre-visit patient-centered decision-aid for all patients presenting to a health center for reproductive health care.
- Same-Day Access to Contraception: Provide training for health care providers and logistical assistance to health centers to implement care consistent with providing patients with their chosen method of contraception the day of patient contact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •for Clinic Level Analysis:
- •women age 18-49
- •presenting for care at PATH4YOU clinic site
排除标准
- •history of hysterectomy or sterilization, or post-menopausal
研究组 & 干预措施
PATH4YOU County
干预措施: PATH4YOU (Behavioral)
Matched-Pair Control County
结局指标
主要结局
Participant Satisfaction with Shared Decision Making
时间窗: Within 2-4 weeks of PATH4YOU service visit
Participant satisfaction is measured by the validated CollaboRATE scale, which is a 3 question survey. Each question is rated on a 5 point Likert scale with a response range of "every effort was made" (1) to "no effort was made" (5).
Unintended pregnancy rate
时间窗: 3 months, 6 months, and 12 months
The number of unintended pregnancies within 1 year of enrollment will be assessed. Participants will be surveyed at 3 months, 6 months and 12 months after the PATH4YOU service visit.
Quality of family planning services
时间窗: Within 2-4 weeks of PATH4YOU service visit
Quality of family planning services will be evaluated through the validated Patient Centered Contraceptive Counseling (PCCC) Measure. The PCCC is a 4 question survey. Each question is rated on a 5 point Likert scale with responses ranging from poor (1) to excellent (5). Individual participant scores may range from 4 to 20 (with higher scores reflecting higher quality of care). A proportion of patient responses (80%) is used to determine overall quality of services. Participants will be asked to complete the PCCC one time, within 2-4 weeks after they have received care through the PATH4YOU program. Total responses will then be aggregated to determine overall quality of services upon final participant completion, approximately 3 years after project initiation.
Participant reported Pregnancy Intention
时间窗: 3 months, 6 months, and 12 months
Participants will complete the Parenting Attitudes Timing and How important (PATH) validated scale on pregnancy intention. The scale askes participants to express an opinion about having children (yes/no), to rate the importance of pregnancy on a 5 point Likert scale (from very important as a 1 to not at all important as a 5), and to estimate the timeframe in which intend to be pregnant (ranging from within 6 months to more than 5 years from now). Participants will be surveyed at 3 months, 6 months and 12 months after the PATH4YOU service visit.
Participant Satisfaction with Same Day Contraception
时间窗: Within 2-4 weeks of PATH4YOU service visit
Participants will be asked to respond to a single question of whether they received their desired contraception on the day of the visit. Responses will be either yes or no.
Receipt of Pre-Visit Birth Control Decision Aid
时间窗: Within 2-4 weeks of PATH4YOU service visit
Participants will be asked whether they received the decision aid and whether they used it prior to the visit.
Continuation of Contraceptive Method
时间窗: 3 months, 6 months, and 12 months
Participants will be asked whether they are satisfied with, and continuation of, contraceptive method. Participants will be surveyed at 3 months, 6 months and 12 months after the PATH4YOU service visit.
次要结局
- Number of women receiving PATH4YOU bundle(3 years)
- Impact of demographics and reproductive characteristics(3 years)
- Contraceptive choice(3 years)
研究者
Tracey Wilkinson
Associate Professor, Department of Obstetrics & Gynecology
Indiana University