Clinical trial NCT02508363: Randomized Controlled Trial Examining Health Care Access Interventions for Taxi Drivers
Official title: Taxi HAILL: A Three-Arm Cluster Randomized Controlled Trial Examining Health Care Access Interventions for Taxi Drivers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Healthcare Access for Taxi Drivers
Keywords: Taxi drivers
Health care access
15-163
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: SOUTH ASIAN COUNCIL FOR SOCIAL SERVICES
First posted: 2015-07-24
Enrollment: 756
Sex: MALE
Minimum age (years): 21
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to compare the effectiveness of providing the usual health fair service and follow-up alone plus additional interventions of Navigation Case Management (NCM) or mobile text messaging (mTECH) and Taxi health Improvement Promoter (TIP). The addition of NCM or mTECH and TIP to the usual follow-up could prove to be more effective in finding the best way to make sure taxi drivers go to important medical appointments and have a regular doctor to help with their health problems. This study will help researchers find out whether the different approaches are better, the same as, or worse than the usual approach.

In the event that participants are unable to meet in person for biometric measurements, staff will accept their self-reported weight, blood pressure, and waist circumference over the phone. Staff may mail blood pressure machines (to participants who did not receive them at baseline), scales, and measuring tapes to participants to assist in the completion of self-reported biometric measures. Along with supplies, participants may also receive a letter asking for the confirmation of supply receipt.


Eligibility criteria: Inclusion Criteria:

Garage/Enrollment Site Inclusion:

* Located in the NYC Borough of Manhattan, Queens, Brooklyn, or the Bronx
* Has a roster of at least 100 drivers or is a site frequented by drivers

Driver Inclusion:

* Male
* Between 21 to 85 years of age (We are selecting participants older than three years past the legal driving age of 18, as younger drivers tend to change jobs more often)
* Planning on remaining in NYC for at least 1 year, (with no vacations or trips to exceed two months)
* Licensed taxi driver for at least three months
* Affillated with a NYC garage or frequents at a study enrollment site
* Speaks English, Bengali, Urdu, Spanish, or French
* Owns a cell phone that can receive text messages and is willing to receive text messages for this study.
* Does not have a usual primary care provider(PCP) at baseline
* Has not seen a doctor for an annual physical within the last year not including annual required physical for work at baseline

TIPs Inclusion:

* Between 21 to 85 years of age
* Male
* Planning on remaining in NYC for at least 1 year, (with no vacations or trips to exceed one month)
* Licensed taxi driver for at least two years
* Affilliated with a NYC garage or frequents at a study enrollment site
* Speaks English, (English proficiency required for TIPs training)
* Willing and able to attend in person TIPs training sessions
* As per study team judgment, based upon the TIPs screening tool, is socially active among fellow taxi drivers, cares about health issues, and wants to help others improve their health

Exclusion Criteria:

Garage/Site Exclusion:

* Does not agree to holding screening health fairs on location (e.g. does not sign enrollment form, or send email confirming agreement, or verbally agree to study team management)

Driver Exclusion:

* Part-time driver (drives fewer than 30 hours per week) Although it is highly unlikely for NYC taxi drivers to work for multiple garages at study baseline, drivers may switch jobs and/or their garage base affiliation while participating in this study. New jobs and/or garage base affiliations will be tracked during follow-up assessments and noted for potential limitations with study retention and intervention contamination. Drivers will be allowed to continue the study even if they are no longer working with the initial garage base.

Primary outcomes:
measure: Number of drivers that have a primary care provider (pcp)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Francesca Gany, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: