跳至主要内容
临床试验/NCT06086054
NCT06086054终止不适用

Effectiveness of a Childcare Intervention on Retention in the Cervical Cancer Screening and Diagnostic Continuum

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2023年10月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
入组人数
65
试验地点
1
主要终点
Show-rate for initial visit to gynecology dysplasia clinic

研究概览

简要总结

Aim 1: Determine the prevalence of unmet childcare needs among women with abnormal cervical cancer screening and establish the relevance of childcare as a social determinant of health in the context of cervical dysplasia.

Aim 2: Conduct a pilot pragmatic patient-randomized control trial (RCT) to evaluate the effectiveness of an intervention linking eligible patients to our childcare facility compared to standard of care on retention in care, defined as show-rate for the initial visit in the gynecology dysplasia clinic. The intervention will consist of 1) patient navigation to our childcare facility prior to the initial visit in the gynecology dysplasia clinic and 2) placement of an electronic medical record (EMR) referral to our childcare facility.

Hypothesis: The study team hypothesizes that women receiving the intervention will have increased retention in care compared to women randomized to standard of care among women with abnormal cervical cancer screening referred to gynecology for diagnostic work-up.

These two aims will demonstrate the significance of childcare as a social determinant of health in the cervical cancer screening and diagnostic continuum by assessing the burden of unmet childcare needs among women with cervical dysplasia and measuring the effect of health system-integrated childcare as an intervention for unmet childcare needs on retention in care and subsequent completion of diagnostic work-up among women with cervical dysplasia. This study will rigorously provide the first evidence illustrating the effect of health systems' investment in addressing unmet childcare needs on preventive care like cervical cancer screening. The findings of this proposed pilot study will be utilized to develop future large-scale studies with extramural funding, building a longitudinal program of research on addressing childcare as a social determinant of health in this and other similar clinical contexts (e.g., breast cancer screening and treatment).

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
Double (Participant, Care Provider)

入排标准

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

入选标准

  • •All women with abnormal cervical cancer screening referred to Parkland gynecology dysplasia clinic as a new patient

排除标准

  • •Pregnant women
  • •Patients <18 years of age

研究组 & 干预措施

Intervention

Active Comparator

The intervention is comprised of two components to link randomized patients to our health system childcare facility: 1) navigation by the research assistant to the childcare facility and 2) placement of the facility EMR referral. Navigation will occur an eligible patient is randomized to the intervention group. Navigation will consist of the research assistant educating the patient about the childcare facility and providing information about how to access the childcare facility during the telephone contact and via mailed written materials.

干预措施: Navigation and EMR referral to childcare facility (Behavioral)

Standard Care

No Intervention

Patients randomized to the control group will undergo current standard of care with regards to childcare, which currently consists of passive sources of information about our childcare facility (Parkland website, signage in the hospital, or via word of mouth). Currently, there is no formalized mechanism for patients referred to gynecology from primary care to receive information about childcare aside from the above passive sources of information.

结局指标

主要结局

Show-rate for initial visit to gynecology dysplasia clinic

时间窗: Up to 2 years

Show-rate assessed via EMR

次要结局

  • Rate of completion of indicated diagnostic and therapeutic procedures(Up to 2 years)
  • Show-rate for follow-up visits in gynecology(Up to 2 years)
  • Rate of utilization of childcare facility during scheduled gynecology visits(Up to 2 years)

研究者

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

Robert Martin

Assistant Professor

University of Texas Southwestern Medical Center

研究点 (1)

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