Skip to main content
Clinical Trials/NCT06086054
NCT06086054TerminatedNot Applicable

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

University of Texas Southwestern Medical Center2 sites in 1 country65 target enrollmentStarted: October 31, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
65
Locations
2
Primary Endpoint
Show-rate for initial visit to gynecology dysplasia clinic

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Health Services Research
Masking
Double (Participant, Care Provider)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts 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

Outcomes

Primary Outcomes

Show-rate for initial visit to gynecology dysplasia clinic

Time Frame: Up to 2 years

Show-rate assessed via EMR

Secondary Outcomes

  • 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)
  • Rate of completion of indicated diagnostic and therapeutic procedures(Up to 2 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Robert Martin

Assistant Professor

University of Texas Southwestern Medical Center

Study Sites (2)

Loading locations...

Similar Trials