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



Status:Completed
Conditions:Cervical Cancer, Cervical Cancer, Cancer, Contraception, Contraception, Infectious Disease, Women's Studies
Therapuetic Areas:Immunology / Infectious Diseases, Oncology, Reproductive
Healthy:No
Age Range:18 - 39
Updated:4/6/2019
Start Date:March 30, 2015
End Date:December 15, 2016

Use our guide to learn which trials are right for you!

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 contacted by the health
plan's call center. A brief verbal overview of the intervention including time requirement
and content to be covered will be provided. The potential participants who have been randomly
assigned to the intervention group will then be offered the opportunity to set up an
individual confidential appointment with a community health worker (CHW) at her earliest
convenience.

The call center will provide the research office a list of interested participants and their
contact information. Once that list is received by the research office, a CHW will be
assigned to each potential participant. The assigned CHW will call to introduce herself, to
answer lingering questions about the intervention and proposed encounter and to confirm the
participant's acceptance into the intervention. At that time, the CHW will confirm language
and location preference, date/ time of proposed meeting, and the contact information for the
research office for any questions. 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 used 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.

The call center will administer a similar 6-month survey by phone to a sample of the group
randomized to invitation, but who did not accept the invitation (IG2) and the group not
invited (CG). A $30 gift card incentive will be offered to complete this survey.

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
We found this trial at
1
site
Tucson, Arizona 85721
(520) 621-2211
Principal Investigator: Francisco Garcia, M.D., MPH
Phone: 520-626-8539
University of Arizona The University of Arizona is a premier, public research university. Established in...
?
mi
from
Tucson, AZ
Click here to add this to my saved trials