Connecting Healthy Women: Examining the Effect of an Intervention From the Effect of Being Reachable

NCT02157168 | Completed Results

• 1 other identifier: IHS-1306-04356
• Study Type: interventional
• Target: 2,267
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators propose to test a community-developed and targeted intervention that employs community health workers (CHWs) as aides to newly Medicaid-insured women. These women face the challenges of engaging with their healthcare and health and of making highly personal and socioculturally embedded decisions about reproductive health-related preventive services (e.g., contraception, STI and cancer screening).

Conditions

Contraception; Sexually Transmitted Infections; Cervical Cancer

Keywords

Affordable Care Act; Medically underserved minorities; Community health workers; Health disparities among Mexican origin

Outcome Measures

Primary Outcomes (1)

• Identify and Utilization of Primary Care Provider (PCP)

  The number and percentage of new members who had at least one visit with a primary care provider during their first 6 months of enrollment.

  6 months

Secondary Outcomes (3)

• The Impact of the Intervention on the Utilization of Women's Preventive Services and Other Preventive Services

  6 months

• The Impact of the Intervention on the Utilization of Avoidable Emergency Department (ED) Visits

  6 months

• The Impact of the Intervention on Preventable Hospital Stays

  6 months

Other Outcomes (1)

• Informed Decision Making Regarding the Healthcare System and Their Health

  Baseline and 6 months

Study Arms (2)

Control Group

NO INTERVENTION

Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan (according to a randomization scheme provided by the study team) to be invited to contact and work with a Community health worker. Those not invited will constitute the usual care control group.

Intervention Group

OTHER

Each month all newly enrolled female health plan members will have an equal chance of being randomly picked by the health plan (according to a randomization scheme provided by the study team) to be invited to contact and work with a Community health worker in the intervention group. The intervention group will be made up of two sub groups. The group of individuals who accept the invitation to participate (IG1) in the intervention and receive it, and those randomized to the intervention group but who reject the opportunity to participate (IG2).

Behavioral: Community health worker

Interventions

Community health worker BEHAVIORAL

Community health workers (CHWs) in Hispanic communities, often referred to as "promotoras," are members of the community who use "resource sharing, partnership development, education, outreach, health promotion, and disease prevention strategies to improve the health" of their communities. IG1: The intervention itself consists of a 45-minute one-on-one presentation and tailored planning session delivered by a CHW in a community setting of the new member's choosing. Presentations (in English or Spanish) will be delivered using a tablet computer or a hand held flipchart. Two booster telephone interactions will be performed at 2 and 4 months. At month 6, the participant will receive a call from the telephone interviewer to administer the informed patient choice survey.

Also known as: Promotoras

Intervention Group

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women between the ages of 18 and 39
• Women newly enrolled in one of the state-wide Medicaid health plans (University Family Care)
• Women who are ambulatory
• Women who are community-dwelling

You may not qualify if:

• Women not between the ages of 18 and 39
• Women not newly enrolled in one of the state wide Medicaid health plans (University Family Care)
• Women who are not ambulatory
• Women who are not community dwelling

Sponsors & Collaborators

• University of Arizona: lead
• Patient-Centered Outcomes Research Institute: collaborator
• RAND: collaborator

Study Sites (1)

University of Arizona

Tucson, Arizona, 85721-0477, United States

Location

MeSH Terms

Conditions

Sexually Transmitted Diseases; Uterine Cervical Neoplasms

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Limitations and Caveats

The health plan was unable to contact the majority of the population to make the offer of CHW services, and the young, generally healthy population made impacts on avoidable ED visits and hospitalizations difficult to detect within a 6 month period.

Results Point of Contact

• Title: Dr. Ada Wilkinson-Lee, Co-Investigator
• Organization: University of Arizona

adaw@email.arizona.edu

(520) 626-7766

Study Officials

• Franciso AR Garcia, MD, MPH

  University of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2014
• First Posted: June 5, 2014
• Study Start: March 30, 2015
• Primary Completion: December 15, 2016
• Study Completion: December 15, 2016
• Last Updated: April 5, 2019
• Results First Posted: January 29, 2018

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)