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Randomized Controlled Trial Examining Health Care Access Interventions for Taxi Drivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02508363
Recruitment Status : Active, not recruiting
First Posted : July 24, 2015
Last Update Posted : November 2, 2022
Sponsor:
Collaborator:
SOUTH ASIAN COUNCIL FOR SOCIAL SERVICES
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Healthcare Access for Taxi Drivers Behavioral: questionnaires Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 756 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Taxi HAILL: A Three-Arm Cluster Randomized Controlled Trial Examining Health Care Access Interventions for Taxi Drivers
Study Start Date : July 2015
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2023
Arms and Interventions
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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.

 Behavioral: questionnaires
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.
 Behavioral: questionnaires
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
 Behavioral: questionnaires


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02508363


Locations
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United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
SOUTH ASIAN COUNCIL FOR SOCIAL SERVICES
Investigators
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Principal Investigator: Francesca Gany, MD, MS Memorial Sloan Kettering Cancer Center
  Study Documents (Full-Text)

Documents provided by Memorial Sloan Kettering Cancer Center:
Informed Consent Form  [PDF] October 28, 2020

More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02508363    
Other Study ID Numbers: 15-163
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: November 2, 2022
Last Verified: November 2022
Keywords provided by Memorial Sloan Kettering Cancer Center:
Taxi drivers
Health care access
15-163