Clinical trial NCT06086054: Effect of a Childcare Resource on Cervical Cancer Prevention
Official title: Effectiveness of a Childcare Intervention on Retention in the Cervical Cancer Screening and Diagnostic Continuum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Dysplasia
Keywords: Childcare
Social determinant of health
Patient navigation
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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).


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

Primary outcomes:
measure: Show-rate for initial visit to gynecology dysplasia clinic
timeFrame: Up to 2 years
Secondary outcomes:
measure: Rate of completion of indicated diagnostic and therapeutic procedures
timeFrame: Up to 2 years
measure: Show-rate for follow-up visits in gynecology
timeFrame: Up to 2 years
measure: Rate of utilization of childcare facility during scheduled gynecology visits
timeFrame: Up to 2 years
Other outcomes:
measure: Questionnaire of patient-centered outcomes about experience in health system and in gynecology clinic
timeFrame: Up to 2 years
Locations:
city: Dallas
country: United States
facility: Parkland Health
state: Texas
Study officials:
affiliation: Parkland Health & Hospital System - - Dallas, TX
name: Anisha Ganguly, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alvarez KS, Bhavan K, Mathew S, Johnson C, McCarthy A, Garcia B, Callies M, Stovall K, Harms M, Kho KA. Addressing childcare as a barrier to healthcare access through community partnerships in a large public health system. BMJ Open Qual. 2022 Oct;11(4):e001964. doi: 10.1136/bmjoq-2022-001964.