Effect of a Childcare Resource on Cervical Cancer Prevention

Cervical Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06086054
• Other study ID #: STU-2021-03-09
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2023
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: University of Texas Southwestern Medical Center
• Contact: Jillian Smartt, BSN
• Phone: 214-590-4049
• Email: Jillian.Smartt[@]phhs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2025
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Dysplasia
• Uterine Cervical Dysplasia

Intervention

Behavioral:
• Navigation and EMR referral to childcare facility
See arm description

Locations

Country	Name	City	State
United States	Parkland Health	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questionnaire of patient-centered outcomes about experience in health system and in gynecology clinic	Designed questions in a follow-up survey administered via telephone after initial appointment	Up to 2 years
Primary	Show-rate for initial visit to gynecology dysplasia clinic	Show-rate assessed via EMR	Up to 2 years
Secondary	Rate of completion of indicated diagnostic and therapeutic procedures	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.	Up to 2 years
Secondary	Show-rate for follow-up visits in gynecology	Show-rate assessed via EMR	Up to 2 years
Secondary	Rate of utilization of childcare facility during scheduled gynecology visits	Rate of utilization assessed by health system's dashboard for childcare facility	Up to 2 years