Connections for Healthy Women
Conditions
Contraception - Sexually Transmitted Infections - Cervical Cancer
Conditions: official terms
Sexually Transmitted Diseases - Uterine Cervical Neoplasms
Conditions: Keywords
Affordable Care Act, Medically underserved minorities, Community health workers, Health disparities among Mexican origin
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Intervention
Name: Community health worker
Type: Behavioral
Overall Status
Recruiting
Summary
The investigators propose to develop, deliver, and test a novel personalized education intervention that engages female Medicaid beneficiaries in making decisions about age-appropriate evidence-based utilization of women's preventive services.
Detailed Description
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).

All newly enrolled women in one of Arizona's state-wide Medicaid health plans (University Family Care) who are ambulatory and community-dwelling, and between the ages of 18-39, will be identified by the health plan on a monthly basis as eligible for this study. For at least the first month, these new health plan members will be randomized 2 to 1 (intervention to usual care control). Each month the health plan will provide the study team with the number of new members. A study team member will then provide the health plan with a list of numbers (1's and 0's) generated using the biased coin design to apply to those new members. To avoid bias, health plan staff will not be aware of members study arm.

All new health plan enrollees (as per current standard health plan practice) receive a series of welcome communications (by mail and electronically) from the health plan shortly after enrollment. These are designed to apprise new members of health plan policies and procedures related to covered benefits, facilitate the selection of a primary care provider, and provide general preventive health resources and information. This is followed by a second mailing at 3-months post enrollment, as well as a nurse follow-up call. The latter is designed to answer questions about covered services, finding a primary care provider, and/or otherwise provide support. Both intervention and control group member will receive identical communications from the health plan up to this point. Potential participants will be given a confidential dedicated telephone number, email and website to contact for participation that they may use should they elect to participate in the study.

When the potential participant contacts the research office she will be provided with a brief verbal overview of the intervention including time requirement and content to be covered. She will then be offered the opportunity to set up an individual confidential appointment with a community health worker (CHW) at her earliest convenience. At that time, basic contact and demographic information will be collected, language and location preference, date/time of proposed meeting, and the contact information for the research office for any questions. Additionally, a packet of information will be mailed to the participant explaining the nature and content of the intervention as well as a copy of the informed consent document. At 48 to 72 hours prior to the appointed time, the assigned CHW will call to introduce herself, to answer lingering questions about the proposed encounter, and to confirm the time and location of the intervention appointment. The CHW will meet with the subject and complete the informed consent process. Also, the baseline informed patient choice survey will be performed using a touch tablet device (to ascertain baseline knowledge, patient preferences, informed decision making, and health literacy). The CHW will tailor the individual education session to meet the unique needs of the participant (e.g., an individual who discloses a history of surgical sterilization will not receive information about contraception). The 45-minute intervention will be delivered as described above. The patient will be asked to personally assess her needs with regard to reproductive health-related issues. The CHW will work with the participant to develop a personalized plan to access the relevant targeted preventive services. This may involve assistance with contacting the Health Plan and assistance with identifying or making an appointment with a primary care provider. At the conclusion of the intervention, the patient will be encouraged to reach out to the CHW by telephone or electronically if she has any subsequent questions or concerns, and appointments for the two booster telephone calls will be scheduled. Finally, in consideration for her time and participation, the participant will be provided with a $40 gift card.

Booster telephone support calls will occur at 2 and 4 months post intervention. A telephone call guide will be designed to reinforce and clarify key concepts from the initial intervention encounter as well as to help clients formulate relevant questions related to specific women's preventive services and other health concerns in anticipation of their next primary care provider (PCP) visit. Participants will also be queried specifically about any issues related to interactions with the health plan and/or contacting her primary care provider. The patient will be assisted with connecting to the health plan or her PCP's office for those issues that cannot be easily addressed by the CHW. Whenever possible, every effort will be made by the CHW to connect the patient to the appropriate outreach staff at that PCP's office (if such staff is available). Again the availability of the CHW by telephone or electronically for interval questions will be emphasized. At month 6, the participant will receive a call from the telephone interviewer to administer the 6-month informed patient choice survey identical to the survey that was completed at baseline. A $40 gift card incentive will be offered to complete this survey.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: 39 Years
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
Location
University of Arizona
Tucson, Arizona, United States
Status: Recruiting
Contact: Francisco Garcia, M.D., MPH - 520-626-8539 - fcisco@u.arizona.edu
Start Date
June 2014
Completion Date
April 2017
Sponsors
University of Arizona
Source
University of Arizona
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page