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临床试验/NCT03557801
NCT03557801已完成不适用

Assessing the Impact of a Community Health Worker on Hispanic Women's Reported Measures of Processes of Care in the Screening Mammography Setting

Vanderbilt University Medical Center2 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2018年6月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
101
试验地点
2
主要终点
Patient Reported Measures From Interpersonal Processes of Care Survey

研究概览

简要总结

Although there has been interval improvement in reducing disparity in mammography utilization in medically underserved communities since the 1990s, significant disparities persist and should be addressed. In the 40-65 year old age range, there is significant disparity in screening mammography utilization in Hispanic women compared to their white counterparts.

Culturally adapted patient-targeted healthcare interventions can help reduce ethnic inequalities in access to cancer screening programs. Promotoras, culturally appropriate patient navigators for the Hispanic community, have been shown to increase screening mammography rates in the Hispanic/Latino population.

However, there is little research exploring the interaction between these lay community health workers and community members. This proposal aims to assess this interaction by measuring the impact of a Promotora working with community members in either a group setting or individual setting. Understanding this interaction can lead to more effectively designed future community interventions. Primary outcomes in this study will include women's reported measures of interpersonal processes of care (communication and interpersonal style) during screening mammography care, trust in the healthcare system, and satisfaction with cancer screening care when compared to those receiving standard of care.

研究设计

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

入排标准

年龄范围
40 Years 至 64 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Identifying as Hispanic ethnicity
  • Age 40-64
  • Tennessee resident

排除标准

  • Personal history of breast cancer
  • Current breast symptoms (palpable mass)

研究组 & 干预措施

Standard of Care Mammography

Active Comparator

Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard of care protocol.

干预措施: Standard of Care Mammography (Other)

Mammography with Community Health Worker (individual)

Experimental

Immediately following consent and completion of the baseline assessment, women in the intervention arm 1 will participate in a 20-30 minute educational session alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.

干预措施: Mammography with Community Health Worker (individual) (Behavioral)

Mammography with Community Health Worker (group)

Experimental

Immediately following consent and completion of the baseline assessment, women in the intervention arm will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.

干预措施: Mammography with Community Health Worker (group) (Behavioral)

结局指标

主要结局

Patient Reported Measures From Interpersonal Processes of Care Survey

时间窗: Approximately 2 weeks after consent/screening mammogram.

Selected scales (communication and interpersonal style) of the Interpersonal Processes of Care Survey will be the primary outcome. A total of 18 (corrected from orginal submission) questions will be administered. The questions are scored on a scale from 1-5 with higher scores indicating higher frequencies of the construct. The compiled scores will range from 5-90. Scales with negative associations (discrimination, hurried communication) will be reversed. Thus, higher scores for all items will indicate a more positive experience.

次要结局

  • Patient Reported Measures From the Distrust in the Healthcare System Scale. Reported at Baseline and Post Intervention. Also Reported as the Change Between Baseline and Intervention.(Baseline, approximately 2 weeks after consent/screening mammogram.)
  • Patient Reported Measures From the Satisfaction With Cancer Related Care Scale.(Approximately 2 weeks after consent/screening mammogram.)

研究者

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

Lucy Spalluto

Assistant Professor

Vanderbilt University Medical Center

研究点 (2)

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