Randomized Controlled Trial Examining Health Care Access Interventions for Taxi Drivers

October 4, 2023 updated by: Memorial Sloan Kettering Cancer Center

Taxi HAILL: A Three-Arm Cluster Randomized Controlled Trial Examining Health Care Access Interventions for Taxi Drivers

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

756

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Health Fair Alone (Control)

No Follow Up Participant does not require referrals or assistance and was not advised to see a provider in the next three months.

Regular follow-up call within two weeks of health fair by IHCD intern or staff. Participant has abnormal values, requires referrals or assistance or was advised to see a provider in the next three months.

Up to 3 call attempts to get participant into needed care. Further contact only by participant request.

Urgent follow-up call or in-person assistance within 1 day of health fair by IHCD intern or staff Participant advised to seek urgent care within one week.

Three total call or in-person attempts to get participant into needed care. Further contact only by participant request The follow up call attempts may extend up to 3 months past the date of health fair to complete any needs the driver may have.

Experimental: Health Fair + Navigator Case Management

• Follow-up call or further in-person assistance within one day for urgent follow-up, or call within two weeks for regular needs. Three call attempts.

Navigator Case Management by trained staff

  • Tailored assistance for any health needs a minimum of once a month 12 months. Assistance includes pre-appointment reminder calls, post-appointment follow up calls, and health promotion reminders.
  • NCM case management will continue follow-up at a minimum of once per month or as requested by the participant for the study duration and will consistently offer appointment reminders and follow-ups.
Experimental: Health Fair + Taxi Health Improvement Promoters

Health Fair standard services Follow-up call or further in-person assistance within one day for urgent follow-up, or call within two weeks for regular needs. Three call attempts.

Taxi health Improvement Promoters (TIPs)

  • Weekly check-ins with each participant, in person or by phone, about scheduling of, and attendance at, primary care appointments along with other health or study questions Mosio Text Messaging Program
  • Send primary care provider recommendations to participant up to three times
  • Two pre-appointment reminders & one post-appointment check-in
  • Twice weekly health promotion reminders after primary care appointment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of drivers that have a primary care provider (pcp)
Time Frame: 12 months
This primary outcome will be determined through the use of three Medical Expenditure Panel Survey questions (AC05, AC11 and AC22), considered the standard in determining existence of a usual PCP by the AHRQ (11).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Francesca Gany, MD, MS, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

July 23, 2015

First Submitted That Met QC Criteria

July 23, 2015

First Posted (Estimated)

July 24, 2015

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 15-163

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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