Improving Transportation Assets and the Effects on Wellness Metrics (ACTiN)

ACTiN and Health Metrics: Improving Transportation Assets as a Critical Social Determinant of Health and the Effects on Wellness and Chronic Disease Metrics.

1. Implementation of an Advanced Connected Transportation Network (ACTiN), a novel, collaborative multinetwork transportation model for small cities and rural areas.
2. Evaluation of effectiveness in improving transportation assets for clients of a community-based nonprofit specializing in addressing social determinants of health (Lighthouse Community Health Services in Lynchburg, VA).
3. Simultaneous evaluation of wellness metrics based on the standards of the CMS Annual Wellness Visit and metrics associated with common chronic diseases.

Study Overview

• Status: Not yet recruiting
• Conditions: Social Determinants of Health
• Intervention / Treatment: Behavioral: Transportation service

Detailed Description

1. Implementation of a community transportation solution The project will be managed by Unified Potential, Inc., a 501c3 tax-exempt organization for transportation.

   • The solution requires implementation of four separate transportation "networks"
   • Public / Contracted / For-Hire Transportation
   • Workforce Transportation Network
   • Community Rideshare Network
   • Volunteer Transportation Network

2. Assessment of Personal Transportation Assets

   • Subjects asked to complete a survey upon intake, at six months, and at one year
   • Digital survey:
   • Can be completed by individual using provided smartphone app or at onsite desktop kiosk
   • Can be facilitated by a caregiver or other provider not involved in data analysis

3. Assessment of health and wellness metrics and chronic disease metrics if applicable

   • Dataset based on metrics assessed in the Center for Medicare and Medicaid Services (CMS) Annual Wellness Visit
   • All metrics quantified via either binary (yes/no) or through use of a validated scale (see below)
   • Data collected electronically at onsite or in-home provider visits at intake, six months, and one year

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John Salmon, MD; Phone Number: 434-847-5050; Email: john@unifiedpotential.org
• Study Contact Backup: Name: Martha Brown; Phone Number: 434-847-5050; Email: marthabrown@lhchs.com

Study Locations

• United States
  • Virginia
    • Lynchburg, Virginia, United States, 24504
      • Lighthouse Community Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adult resident of the City of Lynchburg, Virginia
• Under-resourced at trial entry as defined by meeting eligibility for welfare, food stamps/SNAP, Medicaid, Housing Choice Voucher program, or income at or below 200% of the Federal Poverty Threshold.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study arm; Low resource, high risk individuals with limited transportation options as a social determinant of health.	Behavioral: Transportation service; Improved transportation assets applied to all aspects of subjects life

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rides completed	Total number of rides for test subject per week, averaged over previous 6 months, measured at intake, 6 months, and 1 year.	1 year
Cost of transportation	Total cost per mile of transportation, averaged over previous 6 months, measured at intake, 6 months, and 1 year.	1 year
Untreated disease(s)	Total number of attributed disease diagnoses that are not being treated, measured at intake, 6 months, and 1 year.	1 year
Cancer screening success	Number of eligible cancer screening exams not performed (lung, colon, breast), measured at intake, 6 months, and 1 year.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unmet transportation needs	Total number of rides per week that test subject is unable to complete, averaged over 6 previous 6 months, measured at intake, 6 months, and 1 year.	1 year
Unmet medical transportation needs	Total number of medical (including mental health) appointments missed due to transportation, averaged over previous 6 months, measured at intake, 6 months, and 1 year.	1 year
Prescribed medications	Total number of prescribed medications, measured at intake, 6 months, and 1 year.	1 year
Prescribed medications not utilized	Total number of prescribed medications that are not being utilized (all cause), averaged over previous 6 months, measured at intake, 6 months, and 1 year.	1 year
Weight	Weight in pounds, measured at intake, 6 months, and 1 year.	1 year
BMI	Body mass index, measured at intake, 6 months, and 1 year.	1 year
Blood Pressure	Blood Pressure (mmHg), measured at intake, 6 months, and 1 year.	1 year
Hgb A1c	Hemoglobin A1c, measured at intake, 6 months, and 1 year.	1 year
ADL	Activities of daily living (Barthel index), measured at intake, 6 months, and 1 year.	1 year
IADL	Instrumental activities of daily living (Lawton scale), measured at intake, 6 months, and 1 year.	1 year
Physical activity	Physical activity / exercise assessment (Modified Kaiser physical activity survey), measured at intake, 6 months, and 1 year.	1 year
Psychosocial assessment	Psychosocial assessment (PAT, Briggs Health), measured at intake, 6 months, and 1 year.	1 year
Cognitive function	Cognitive function test (CPCOG), measured at intake, 6 months, and 1 year.	1 year
Depression screening	Depression screening and/or assessment (MHA depression screening tool), measured at intake, 6 months, and 1 year.	1 year
Other mental health conditions	Other mental health conditions (MHA screening and assessment tools), measured at intake, 6 months, and 1 year.	1 year
Smoking assessment	Smoking / tobacco / nicotine use (No/Yes, with yes triggering LDCT assessment), measured at intake, 6 months, and 1 year.	1 year
Substance use	Substance use or abuse (CAGE), measured at intake, 6 months, and 1 year.	1 year

Collaborators and Investigators

• Sponsor: John M. Salmon IV, MD
• Investigators: Study Director: John Salmon, MD, Medical Director, Lighthouse Community Health Center

Publications and helpful links

General Publications

• Hood CM, Gennuso KP, Swain GR, Catlin BB. County Health Rankings: Relationships Between Determinant Factors and Health Outcomes. Am J Prev Med. 2016 Feb;50(2):129-35. doi: 10.1016/j.amepre.2015.08.024. Epub 2015 Oct 31.
• Bradley EH, Elkins BR, Herrin J, Elbel B. Health and social services expenditures: associations with health outcomes. BMJ Qual Saf. 2011 Oct;20(10):826-31. doi: 10.1136/bmjqs.2010.048363. Epub 2011 Mar 29.
• Solberg LI. Theory vs Practice: Should Primary Care Practice Take on Social Determinants of Health Now? No. Ann Fam Med. 2016 Mar;14(2):102-3. doi: 10.1370/afm.1918. No abstract available.

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: August 10, 2022
• First Submitted That Met QC Criteria: August 19, 2022
• First Posted (Actual): August 22, 2022

Study Record Updates

• Last Update Posted (Actual): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 4212.081022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data from all three datasets
• IPD Sharing Time Frame: Available July 2024 (2 years)
• IPD Sharing Access Criteria: Government entity; Healthcare system
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No