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临床试验/NCT03012659
NCT03012659Unknown不适用

Contraceptive Equity Study

Planned Parenthood Federation of America2 个研究点 分布在 1 个国家目标入组 1,015 人开始时间: 2016年12月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
1,015
试验地点
2
主要终点
Contraceptive Continuation

研究概览

简要总结

The purpose of this study is to assess the impact of a provider counseling training on patient contraceptive behaviors and satisfaction in a clustered randomized trial among 10 Planned Parenthood health centers.

详细描述

This study builds upon prior research on a contraceptive counseling protocol and training developed and studied by partners at New York University and Planned Parenthood Federation of America. This contraceptive counseling protocol is informed by the literature on contraceptive behavior, expertise in decision and communication science, and formative qualitative research with Planned Parenthood providers and patients. Jaccard et al. (in press) conducted a cluster randomized control study of the counseling intervention with 10 Planned Parenthood health centers, where staff at intervention sites participated in a one-day training on the counseling protocol followed by a day of in-clinic shadowing. Patients were enrolled on-site and contacted for follow-up at six months and 12 months.

Results of this study indicated that patients at intervention sites were more satisfied with their contraceptive counseling and method choice, and at one or both follow-ups there were fewer gaps in contraceptive protection, more dual method use, and less non-use of birth control. There was no significant difference in accurate use of birth control pills.

Planned Parenthood Federation of America (PPFA) adapted and piloted training in this contraceptive counseling protocol during 2016 with 18 Planned Parenthood affiliated organizations across the country. This training was integrated into a one-day event that also included a provider training to address barriers in access to intrauterine devices and implants. A mixed-methods implementation evaluation was conducted to assess outcomes for staff and patients and identify challenges in implementation. Preliminary findings from the program pilot year demonstrated positive trends for outcome measures, produced lessons learned on implementation challenges, and provided support for new adaptations to the training program and counseling protocol. The previous pilot year evaluation was designed to assess patient satisfaction and method choice before and after the training, but could not answer questions about continued impact on other outcomes of interest. The current study will use a cluster randomized control design with 10 Planned Parenthood health centers to assess patient outcomes. Five health centers randomized to the intervention will receive the contraceptive counseling training. As the control group, the other five health centers will conduct usual care. Women will be enrolled onsite at the health center and then contacted for follow-up at approximately 30 and 90 days post-enrollment. Target enrollment is 100 women per site (1000 total).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Females who have received contraceptive counseling at participating health centers.
  • Ability to understand written and spoken English.

排除标准

  • Non-English speakers

研究组 & 干预措施

Intervention Arm

Experimental

Full-day contraceptive counseling training for health center staff

干预措施: Contraceptive Counseling Training (Behavioral)

Control Arm

No Intervention

Usual care

结局指标

主要结局

Contraceptive Continuation

时间窗: 3 months

Patient-reported contraceptive continuation

次要结局

  • Patient experience of counseling best practices during their visit(Baseline)
  • Method Satisfaction(1 month and 3 months)
  • Dual-Use(1 month and 3 months)
  • Missed Pills(1 month and 3 months)
  • Method Switching(1 month and 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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