Effect of a Childcare Resource on Cervical Cancer Prevention
- Conditions
- Cervical Dysplasia
- Interventions
- Behavioral: Navigation and EMR referral to childcare facility
- Registration Number
- NCT06086054
- Lead Sponsor
- University of Texas Southwestern Medical Center
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 200
- All women with abnormal cervical cancer screening referred to Parkland gynecology dysplasia clinic as a new patient
- Pregnant women
- Patients <18 years of age
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Navigation and EMR referral to childcare facility 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.
- Primary Outcome Measures
Name Time Method Show-rate for initial visit to gynecology dysplasia clinic Up to 2 years Show-rate assessed via EMR
- Secondary Outcome Measures
Name Time Method Show-rate for follow-up visits in gynecology Up to 2 years Show-rate assessed via EMR
Rate of utilization of childcare facility during scheduled gynecology visits Up to 2 years Rate of utilization assessed by health system's dashboard for childcare facility
Rate of completion of indicated diagnostic and therapeutic procedures Up to 2 years May include colposcopy, biopsies, and cervical excisional procedures, including hysterectomy, in the clinic and operating room (OR). Will vary based on clinical indication and assessment during initial appointment.
Trial Locations
- Locations (1)
Parkland Health
🇺🇸Dallas, Texas, United States