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Trial Title:
Effect of a Childcare Resource on Cervical Cancer Prevention
NCT ID:
NCT06086054
Condition:
Cervical Dysplasia
Conditions: Official terms:
Uterine Cervical Dysplasia
Conditions: Keywords:
Childcare
Social determinant of health
Patient navigation
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
Double (Participant, Care Provider)
Intervention:
Intervention type:
Behavioral
Intervention name:
Navigation and EMR referral to childcare facility
Description:
See arm description
Arm group label:
Intervention
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).
Criteria for eligibility:
Criteria:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Parkland Health
Address:
City:
Dallas
Zip:
75235
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jillian Smartt
Phone:
214-590-4049
Email:
Jillian.Smartt@phhs.org
Start date:
October 31, 2023
Completion date:
July 2025
Lead sponsor:
Agency:
University of Texas Southwestern Medical Center
Agency class:
Other
Source:
University of Texas Southwestern Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06086054
