Randomized Controlled Trial Examining Health Care Access... | NCT02508363

NCT02508363

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
SOUTH ASIAN COUNCIL FOR SOCIAL SERVICES	UNKNOWN

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Health Fair Alone (Control)	Active Comparator	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
Health Fair + Navigator Case Management	Experimental	• 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
Health Fair + Taxi Health Improvement Promoters	Experimental	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

Name	Type	Description	Arm Group Labels	Other Names
questionnaires	Behavioral		Health Fair + Navigator Case Management Health Fair + Taxi Health Improvement Promoters Health Fair Alone (Control)

Measure	Description	Time Frame
Number of drivers that have a primary care provider (pcp)	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

Eligibility Module

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.

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms