Cervical Dysplasia
Conditions
Keywords
Childcare, Social determinant of health, Patient navigation
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).
Interventions
BEHAVIORALNavigation and EMR referral to childcare facility
See arm description
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All women with abnormal cervical cancer screening referred to Parkland gynecology dysplasia clinic as a new patient
Exclusion criteria
* Pregnant women * Patients \<18 years of age
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Show-rate for initial visit to gynecology dysplasia clinic | Up to 2 years | Show-rate assessed via EMR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Questionnaire of patient-centered outcomes about experience in health system and in gynecology clinic | Up to 2 years | Designed questions in a follow-up survey administered via telephone after initial appointment |
Countries
United States
Outcome results
None listed