Clinical trial NCT05013710: Evaluating the Mobile Clinic Model as a Means of Increasing Access to Reproductive and Sexual Health
Official title: Evaluating the Mobile Clinic Model as a Means of Increasing Access to Reproductive and Sexual Health
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Healthcare Disparities
Reproductive Health
Sexual Health
Program Evaluation
Health Care Quality, Access, and Evaluation
Lead sponsor: Plan A Health, Inc
Sponsor class: OTHER
Collaborators: name: Organon
First posted: 2021-08-19
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient data included in the study will be from those who:

1. Presented to mobile health clinic during the study periods AND,
2. Completed an interaction with the mobile health clinic during the study periods, on which adequate evaluative data was collected on the patient visit (e.g. staff was able to note their visit and reason for visit, the patient met with a healthcare professional, etc)

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).

Eligibility criteria: Inclusion Criteria:

* Patient at a participating mobile clinic

Exclusion Criteria:

* None

Primary outcomes:
measure: Sexual Health
timeFrame: 1 Day
measure: Vaccinations
timeFrame: 1 Day
measure: Reproductive Health
timeFrame: 1 Day
measure: Patient screening and referrals
timeFrame: 1 Day
measure: Coronavirus Disease 2019 (COVID-19)
timeFrame: 1 Day
Secondary outcomes:
measure: Patient Demographics
timeFrame: 1 Day
measure: Patient Visit
timeFrame: 1 Day
measure: Patients Assets, Risks, and Experiences
timeFrame: 1 Day
measure: Patient Satisfaction on Visit
timeFrame: 1 Day
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Mobile Outreach Clinic
state: Florida
city: Saint Paul
country: United States
facility: Just the Pill
state: Minnesota
city: Louise
country: United States
facility: Plan A Health, Inc
state: Mississippi
Study officials:
References:
citation: Choi H, Steptoe A, Heisler M, Clarke P, Schoeni RF, Jivraj S, Cho TC, Langa KM. Comparison of Health Outcomes Among High- and Low-Income Adults Aged 55 to 64 Years in the US vs England. JAMA Intern Med. 2020 Sep 1;180(9):1185-1193. doi: 10.1001/jamainternmed.2020.2802.
citation: Rosenblatt RA, Hart LG. Physicians and rural America. West J Med. 2000 Nov;173(5):348-51. doi: 10.1136/ewjm.173.5.348. No abstract available.
citation: Hill CF, Powers BW, Jain SH, Bennet J, Vavasis A, Oriol NE. Mobile health clinics in the era of reform. Am J Manag Care. 2014 Mar;20(3):261-4.
citation: Yu SWY, Hill C, Ricks ML, Bennet J, Oriol NE. The scope and impact of mobile health clinics in the United States: a literature review. Int J Equity Health. 2017 Oct 5;16(1):178. doi: 10.1186/s12939-017-0671-2.