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

Reproductive Health Clinical Trial

— MHCE  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05013710
• Other study ID #: 01
• Status: Enrolling by invitation
• Start date: January 1, 2021
• Est. completion date: January 1, 2024

Study information

• Verified date: November 2023
• Source: Plan A Health, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10000
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patient at a participating mobile clinic

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Health Care Quality, Access, and Evaluation
• Healthcare Disparities
• Program Evaluation
• Reproductive Health
• Sexual Health

Intervention

Other:
• Complete Clinical Interaction
The intervention consists of a completed 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 an healthcare professional, etc)

Locations

Country	Name	City	State
United States	University of Florida Mobile Outreach Clinic	Gainesville	Florida
United States	Plan A Health, Inc	Louise	Mississippi
United States	Just the Pill	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Plan A Health, Inc	Organon

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sexual Health	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.	1 Day
Primary	Vaccinations	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).	1 Day
Primary	Reproductive Health	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.	1 Day
Primary	Patient screening and referrals	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.	1 Day
Primary	Coronavirus Disease 2019 (COVID-19)	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.	1 Day
Secondary	Patient Demographics	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.	1 Day
Secondary	Patient Visit	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.	1 Day
Secondary	Patients Assets, Risks, and Experiences	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.	1 Day
Secondary	Patient Satisfaction on Visit	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).	1 Day

External Links

•   Mobile Clinic Delivers Culturally Competent Services to Underserved Neighborhoods, Leading to Identification of Untreated Chronic Conditions, Better Blood Pressure Control, and Significant Return on Investment | AHRQ Health Care Innovations Exchange
•   National Healthcare Quality and Disparities Report