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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02157168
Enrollment
2267
Registered
2014-06-05
Start date
2015-03-30
Completion date
2016-12-15
Last updated
2019-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Cancer, Contraception, Sexually Transmitted Infections

Keywords

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

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).

Detailed description

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.

Interventions

BEHAVIORALCommunity health worker

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.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
RAND
CollaboratorOTHER
University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 39 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Identify and Utilization of Primary Care Provider (PCP)6 monthsThe number and percentage of new members who had at least one visit with a primary care provider during their first 6 months of enrollment.

Secondary

MeasureTime frameDescription
The Impact of the Intervention on the Utilization of Women's Preventive Services and Other Preventive Services6 monthsThe number and percentage of new members who had at least one preventive visit (i.e., well woman visit, cervical cancer screening, sexually transmitted infection (STI) screening, STI counseling, contraception counseling or immunizations) during their first 6 months of enrollment.
The Impact of the Intervention on the Utilization of Avoidable Emergency Department (ED) Visits6 monthsThe number and percentage of new members who had avoidable emergency department (ED) visits during their first 6 months of enrollment.
The Impact of the Intervention on Preventable Hospital Stays6 monthsThe number and percentage of new members who had avoidable hospitalizations during their first 6 months of enrollment.

Other

MeasureTime frameDescription
Informed Decision Making Regarding the Healthcare System and Their HealthBaseline and 6 monthsThe short form of the Patient Activation Measure (PAM), a measure of patient engagement in their healthcare. PAM levels of engagement with Level 4 being the highest level.

Countries

United States

Participant flow

Recruitment details

Each month all newly enrolled female health plan members were randomly picked by the health plan (according to a randomization scheme provided by the study team) to be invited to work with a community health worker (CHW). Those not invited constituted the usual care control group. Recruitment began March 2015 and ended May 2016.

Participants by arm

ArmCount
Control Group (CG)
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker. Those not invited constituted the usual care control group..
746
Intervention Group (IG1)
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group. The intervention group was made up of two sub groups. The IG1 group is made up of those individuals who accept the invitation to participate in the intervention and receive it.
159
Intervention Group (IG2)
Each month all newly enrolled female health plan members had an equal chance of being randomly picked by the health plan to be invited to contact and work with a community health worker in the intervention group. The intervention group was made up of two sub groups. The IG2 group is comprised of those randomized to the intervention group but who reject the opportunity to participate.
1,362
Total2,267

Baseline characteristics

CharacteristicControl Group (CG)Intervention Group (IG1)Intervention Group (IG2)Total
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
746 Participants159 Participants1362 Participants2267 Participants
Age, Continuous27.2 years
STANDARD_DEVIATION 6
28.5 years
STANDARD_DEVIATION 5.9
27.0 years
STANDARD_DEVIATION 6.1
27.2 years
STANDARD_DEVIATION 6.1
Ethnicity (NIH/OMB)
Hispanic or Latino
218 Participants70 Participants431 Participants719 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
423 Participants62 Participants736 Participants1221 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
105 Participants27 Participants195 Participants327 Participants
Race (NIH/OMB)
American Indian or Alaska Native
41 Participants1 Participants60 Participants102 Participants
Race (NIH/OMB)
Asian
15 Participants0 Participants23 Participants38 Participants
Race (NIH/OMB)
Black or African American
61 Participants9 Participants123 Participants193 Participants
Race (NIH/OMB)
More than one race
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
105 Participants27 Participants195 Participants327 Participants
Race (NIH/OMB)
White
523 Participants122 Participants961 Participants1606 Participants
Region of Enrollment
United States
746 participants159 participants1362 participants2267 participants
Sex: Female, Male
Female
746 Participants159 Participants1362 Participants2267 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —
other
Total, other adverse events
0 / 7460 / 1590 / 1,362
serious
Total, serious adverse events
0 / 7460 / 1590 / 1,362

Outcome results

Primary

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.

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Control Group (CG)Identify and Utilization of Primary Care Provider (PCP)426 Participants
Intervention Group (IG1)Identify and Utilization of Primary Care Provider (PCP)114 Participants
Intervention Group (IG2)Identify and Utilization of Primary Care Provider (PCP)771 Participants
Comparison: CG and IG (IG1+IG2)p-value: 0.624Chi-squared
p-value: 0.001Chi-squared
Secondary

The Impact of the Intervention on Preventable Hospital Stays

The number and percentage of new members who had avoidable hospitalizations during their first 6 months of enrollment.

Time frame: 6 months

Population: Members who had a hospital visit during the first 6 months of enrollment.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Control Group (CG)The Impact of the Intervention on Preventable Hospital Stays13 Participants
Intervention Group (IG1)The Impact of the Intervention on Preventable Hospital Stays4 Participants
Intervention Group (IG2)The Impact of the Intervention on Preventable Hospital Stays25 Participants
Comparison: CG and IG (IG1+IG2)p-value: 0.741Chi-squared
p-value: 0.966Chi-squared
Secondary

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

The number and percentage of new members who had avoidable emergency department (ED) visits during their first 6 months of enrollment.

Time frame: 6 months

Population: Members who had an ED visit during the first 6 months of their enrollment.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Control Group (CG)The Impact of the Intervention on the Utilization of Avoidable Emergency Department (ED) Visits135 Participants
Intervention Group (IG1)The Impact of the Intervention on the Utilization of Avoidable Emergency Department (ED) Visits23 Participants
Intervention Group (IG2)The Impact of the Intervention on the Utilization of Avoidable Emergency Department (ED) Visits220 Participants
Comparison: CG and IG (IG1+IG2)p-value: 0.889Chi-squared
p-value: 0.691Chi-squared
Secondary

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

The number and percentage of new members who had at least one preventive visit (i.e., well woman visit, cervical cancer screening, sexually transmitted infection (STI) screening, STI counseling, contraception counseling or immunizations) during their first 6 months of enrollment.

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Control Group (CG)The Impact of the Intervention on the Utilization of Women's Preventive Services and Other Preventive Services189 Participants
Intervention Group (IG1)The Impact of the Intervention on the Utilization of Women's Preventive Services and Other Preventive Services52 Participants
Intervention Group (IG2)The Impact of the Intervention on the Utilization of Women's Preventive Services and Other Preventive Services366 Participants
Comparison: CG and IG (IG1+IG2)p-value: 0.278Chi-squared
p-value: 0.056Chi-squared
Other Pre-specified

Informed Decision Making Regarding the Healthcare System and Their Health

The short form of the Patient Activation Measure (PAM), a measure of patient engagement in their healthcare. PAM levels of engagement with Level 4 being the highest level.

Time frame: Baseline and 6 months

Population: IG1 group members that completed the baseline and 6-month survey and CG and IG2 group members that complete the 6-month survey.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Control Group (CG)Informed Decision Making Regarding the Healthcare System and Their Health1: Believes active role important8 Participants
Control Group (CG)Informed Decision Making Regarding the Healthcare System and Their Health2: Confidence and knowledge to take action7 Participants
Control Group (CG)Informed Decision Making Regarding the Healthcare System and Their Health3: Taking action38 Participants
Control Group (CG)Informed Decision Making Regarding the Healthcare System and Their Health4: Staying the course under stress48 Participants
Intervention Group (IG1)Informed Decision Making Regarding the Healthcare System and Their Health4: Staying the course under stress53 Participants
Intervention Group (IG1)Informed Decision Making Regarding the Healthcare System and Their Health1: Believes active role important1 Participants
Intervention Group (IG1)Informed Decision Making Regarding the Healthcare System and Their Health3: Taking action41 Participants
Intervention Group (IG1)Informed Decision Making Regarding the Healthcare System and Their Health2: Confidence and knowledge to take action6 Participants
Intervention Group (IG2)Informed Decision Making Regarding the Healthcare System and Their Health4: Staying the course under stress65 Participants
Intervention Group (IG2)Informed Decision Making Regarding the Healthcare System and Their Health2: Confidence and knowledge to take action8 Participants
Intervention Group (IG2)Informed Decision Making Regarding the Healthcare System and Their Health3: Taking action36 Participants
Intervention Group (IG2)Informed Decision Making Regarding the Healthcare System and Their Health1: Believes active role important2 Participants
p-value: 0.117Chi-squared
p-value: 0.638Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026