search
Back to results

Effect of a Childcare Resource on Cervical Cancer Prevention

Primary Purpose

Cervical Dysplasia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Navigation and EMR referral to childcare facility
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cervical Dysplasia focused on measuring Childcare, Social determinant of health, Patient navigation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    No Intervention

    Arm Label

    Intervention

    Standard Care

    Arm Description

    The intervention is comprised of two components to link randomized patients to our health system childcare facility: 1) navigation by the research assistant to the childcare facility and 2) placement of the facility EMR referral. Navigation will occur an eligible patient is randomized to the intervention group. Navigation will consist of the research assistant educating the patient about the childcare facility and providing information about how to access the childcare facility during the telephone contact and via mailed written materials.

    Patients randomized to the control group will undergo current standard of care with regards to childcare, which currently consists of passive sources of information about our childcare facility (Parkland website, signage in the hospital, or via word of mouth). Currently, there is no formalized mechanism for patients referred to gynecology from primary care to receive information about childcare aside from the above passive sources of information.

    Outcomes

    Primary Outcome Measures

    Show-rate for initial visit to gynecology dysplasia clinic
    Show-rate assessed via EMR

    Secondary Outcome Measures

    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.
    Show-rate for follow-up visits in gynecology
    Show-rate assessed via EMR
    Rate of utilization of childcare facility during scheduled gynecology visits
    Rate of utilization assessed by health system's dashboard for childcare facility

    Full Information

    First Posted
    September 14, 2023
    Last Updated
    October 10, 2023
    Sponsor
    University of Texas Southwestern Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT06086054
    Brief Title
    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

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    July 2024 (Anticipated)
    Study Completion Date
    July 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Texas Southwestern Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Dysplasia
    Keywords
    Childcare, Social determinant of health, Patient navigation

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    200 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Active Comparator
    Arm Description
    The intervention is comprised of two components to link randomized patients to our health system childcare facility: 1) navigation by the research assistant to the childcare facility and 2) placement of the facility EMR referral. Navigation will occur an eligible patient is randomized to the intervention group. Navigation will consist of the research assistant educating the patient about the childcare facility and providing information about how to access the childcare facility during the telephone contact and via mailed written materials.
    Arm Title
    Standard Care
    Arm Type
    No Intervention
    Arm Description
    Patients randomized to the control group will undergo current standard of care with regards to childcare, which currently consists of passive sources of information about our childcare facility (Parkland website, signage in the hospital, or via word of mouth). Currently, there is no formalized mechanism for patients referred to gynecology from primary care to receive information about childcare aside from the above passive sources of information.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Navigation and EMR referral to childcare facility
    Intervention Description
    See arm description
    Primary Outcome Measure Information:
    Title
    Show-rate for initial visit to gynecology dysplasia clinic
    Description
    Show-rate assessed via EMR
    Time Frame
    Up to 2 years
    Secondary Outcome Measure Information:
    Title
    Rate of completion of indicated diagnostic and therapeutic procedures
    Description
    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.
    Time Frame
    Up to 2 years
    Title
    Show-rate for follow-up visits in gynecology
    Description
    Show-rate assessed via EMR
    Time Frame
    Up to 2 years
    Title
    Rate of utilization of childcare facility during scheduled gynecology visits
    Description
    Rate of utilization assessed by health system's dashboard for childcare facility
    Time Frame
    Up to 2 years
    Other Pre-specified Outcome Measures:
    Title
    Questionnaire of patient-centered outcomes about experience in health system and in gynecology clinic
    Description
    Designed questions in a follow-up survey administered via telephone after initial appointment
    Time Frame
    Up to 2 years

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jillian Smartt, BSN
    Phone
    214-590-4049
    Email
    Jillian.Smartt@phhs.org
    First Name & Middle Initial & Last Name or Official Title & Degree
    Anisha Ganguly, MD, MPH
    Phone
    469-419-9795
    Email
    Anisha.Ganguly@phhs.org

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    This is not permitted under our system's Office of Research Administration policies with regards to this type of collected patient data.
    Citations:
    PubMed Identifier
    36261213
    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.
    Results Reference
    background

    Learn more about this trial

    Effect of a Childcare Resource on Cervical Cancer Prevention

    We'll reach out to this number within 24 hrs