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Evaluating the Mobile Clinic Model as a Means of Increasing Access to Reproductive and Sexual Health

Conditions
Healthcare Disparities
Reproductive Health
Sexual Health
Health Care Quality, Access, and Evaluation
Program Evaluation
Interventions
Other: Complete Clinical Interaction
Registration Number
NCT05013710
Lead Sponsor
Plan A Health, Inc
Brief Summary

The mobile health clinic evaluation study examines the impact of mobile health clinics on access reproductive and sexual healthcare services in underserved communities. Multiple mobile clinics operating throughout the U.S. are participating by implementing the same evaluation plan for their programs and contributing de-identified data into a shared database. This allows the investigators to both determine the impact of individual programs and to compare and contrast their impact across different programs, states, population densities (rural, urban, suburban), and populations.

Detailed Description

The purpose of this prospective/retrospective cohort study is to evaluate the effectiveness of each individual participating mobile health clinic in improving their community's health and access to care, and to compare each clinic's performance and reach within their respective communities. This Institutional Review Board (IRB)-exempt study is a descriptive review of de-identified evaluation, clinical, and operations data, including staff and patient surveys, patient metrics, and clinic operations metrics. The investigators anticipate that additional mobile clinic programs will submit de-identified data from evaluations done under local IRB exemption. The study will utilize data already collected or to be collected by each mobile health clinic as a part of its clinical and operational activities. Each mobile health clinic will decide which indicators from the evaluation instrument it will use for its own evaluation, and which will be reported to the shared database, depending on the specific services provided and population served. Data will be tracked on a per-patient-visit level or per-operational day, whichever is more relevant to the variable at hand. Data will be sourced from each mobile health clinic's current evaluation sources, including patient intake records (for demographic information, clinic visit dates, clinic procedures done), time and budget tracking software (for hours/patient and cost/patient spent), patient questionnaires (for patient satisfaction and attitudes about their mobile health clinic visit), patient post-visit follow-up questionnaires (for simple referral or prescription follow-up), and clinic operational records (for distance traveled).

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
10000
Inclusion Criteria
  • Patient at a participating mobile clinic
Exclusion Criteria
  • None

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Just the PillComplete Clinical InteractionJust The Pill offers telemedicine appointments by phone or online for sexual and reproductive health needs that is delivered to the patient's home. The organization is also opening a mobile health clinic that will deliver care directly to communities.
Plan A HealthComplete Clinical InteractionFounded in 2018, Plan A Health, Inc seeks to address health care disparities in rural communities by improving access to reproductive and sexual care. Beginning April 2021, the first Plan A mobile health clinic opened, serving five counties in the Mississippi Delta. The care team in the clinic includes a community health worker, nurse practitioner, volunteer providers, residents, and a collaborating physician.
University of Florida Mobile Outreach ClinicComplete Clinical InteractionThe mission of the Mobile Outreach Clinic is to reduce health disparities by providing best practice, flexible, low-barrier primary care at no cost to patients unable to access the healthcare system. They focus on addressing the social barriers that drive health inequities and educating health professions students in an environment that equips them to become the socially conscious medical providers of the future.
Primary Outcome Measures
NameTimeMethod
Vaccinations1 Day

Completed if patient received human papilloma virus (HPV) vaccine or if HPV vaccination status was recorded AND/OR if the patient received any other routine, non-COVID-19 vaccine(s).

Reproductive Health1 Day

Completed if patient received a pregnancy test AND/OR reported patient pregnancy status and history, prior pregnancy information, and provision of pregnancy and related referrals by the Mobile Health Clinic AND/OR if the patient received a pap smear during the visit or provided their pap smear history AND/OR if the mobile health clinic offered and provided contraception counseling and collected patient's current contraception status and contraception history AND/OR if patient requested for specific contraception or change in method AND/OR if patient received condoms AND/OR if patient received emergency contraception.

Coronavirus Disease 2019 (COVID-19)1 Day

Completed if the mobile health clinic collected the patient's history on COVID-19 testing and history of COVID-19 AND/OR if the patient has been able to access COVID-19 testing AND/OR if the patient has been able to access the COVID-19 vaccination(s) and their vaccination status.

Patient screening and referrals1 Day

Completed if mobile health clinic collected patient's self-reported level of health AND/OR if the patient received primary care screenings (Chol, BP, Blood sugar, A1C) AND/OR if the patient was screened for sexual assault, depression, domestic violence, and drug use, AND/OR if the patient received referrals for social services, additional health services (including specialty services), AND/OR financial or health insurance-related assistance AND/OR if the patient attended ther referral appointment AND/OR if the patient received any prescription(s) for medication, AND/OR if the mobile health clinic registered the patient to vote, AND/OR if the patient used any of the telehealth hotspot to connect with alternate providers AND/OR if the mobile health clinic staff supported the telehealth visit.

Sexual Health1 Day

Completed if patient received human immunodeficiency virus (HIV) status, HIV testing, education, and/or Pre-exposure prophylaxis (PrEP) AND/OR if patient received Sexually transmitted disease (STD) status, STD testing, education, and/or medication.

Secondary Outcome Measures
NameTimeMethod
Patient Satisfaction on Visit1 Day

Information on how the patient heard about the clinic, patient satisfaction on a Likert scale including reason(s) for dissatisfaction (if any), any services that were wanted but not provided, the patient's likelihood to refer the clinic to others, and the patient's alternative sources of care (e.g., regular doctor, hospital/ER, urgent care).

Patient Visit1 Day

Completed if mobile health clinic collected information on date of patient visit, time of arrival, time of departure, how the patient travelled to the mobile health clinic (e.g. walk, drive, public transport), how patient learned about the mobile health clinic, the approximate distance from the mobile health clinic (in miles), whether the mobile health clinic or the brick and mortar site was preferred, the mobile health clinic location at time of visit, whether the appointment was through telehealth or in- person, the patient's main reason for the visit, the type of care provided, the services that the patient wanted but could not receive, the patient's health insurance type (private, public etc.), and the cost of services provided.

Patient Demographics1 Day

Completed if mobile health clinic collected data on patient's gender, transgender identity, age, sexual orientation, ethnic or racial group, highest attained education, current employment status, marital status, and new patient status.

Patients Assets, Risks, and Experiences1 Day

Completed if the mobile health clinic collected information on patient's family size, patient's approximate income bracket and %federal poverty level (FPL), whether the patient has been able to access basic and necessary goods (e.g., food, clothing, etc.), whether the patient has been able to maintain a healthy diet, the patient's history of any chronic disease (e.g., obesity, diabetes, high BP). Whether the patient has access to transportation, healthcare services, and/or medications, if the patient has delayed services, the patient's current housing situation, the patient's history of incarceration or criminal proceedings, the patient's psychosocial circumstances related to partner or living situation, and the patient's veteran status.

Trial Locations

Locations (3)

University of Florida Mobile Outreach Clinic

🇺🇸

Gainesville, Florida, United States

Just the Pill

🇺🇸

Saint Paul, Minnesota, United States

Plan A Health, Inc

🇺🇸

Louise, Mississippi, United States

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