Cervical Cancer, Contraception, Sexually Transmitted Infections
Conditions
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
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
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Identify and Utilization of Primary Care Provider (PCP) | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Impact of the Intervention on the Utilization of Women's Preventive Services and Other Preventive Services | 6 months | 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. |
| The Impact of the Intervention on the Utilization of Avoidable Emergency Department (ED) Visits | 6 months | The 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 Stays | 6 months | The number and percentage of new members who had avoidable hospitalizations during their first 6 months of enrollment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Informed Decision Making Regarding the Healthcare System and Their Health | Baseline and 6 months | 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. |
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
| Arm | Count |
|---|---|
| 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 |
| Total | 2,267 |
Baseline characteristics
| Characteristic | Control Group (CG) | Intervention Group (IG1) | Intervention Group (IG2) | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 746 Participants | 159 Participants | 1362 Participants | 2267 Participants |
| Age, Continuous | 27.2 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 Participants | 70 Participants | 431 Participants | 719 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 423 Participants | 62 Participants | 736 Participants | 1221 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 105 Participants | 27 Participants | 195 Participants | 327 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 41 Participants | 1 Participants | 60 Participants | 102 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 0 Participants | 23 Participants | 38 Participants |
| Race (NIH/OMB) Black or African American | 61 Participants | 9 Participants | 123 Participants | 193 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 105 Participants | 27 Participants | 195 Participants | 327 Participants |
| Race (NIH/OMB) White | 523 Participants | 122 Participants | 961 Participants | 1606 Participants |
| Region of Enrollment United States | 746 participants | 159 participants | 1362 participants | 2267 participants |
| Sex: Female, Male Female | 746 Participants | 159 Participants | 1362 Participants | 2267 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 746 | 0 / 159 | 0 / 1,362 |
| serious Total, serious adverse events | 0 / 746 | 0 / 159 | 0 / 1,362 |
Outcome results
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
| Arm | Measure | Value (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 |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group (CG) | The Impact of the Intervention on Preventable Hospital Stays | 13 Participants |
| Intervention Group (IG1) | The Impact of the Intervention on Preventable Hospital Stays | 4 Participants |
| Intervention Group (IG2) | The Impact of the Intervention on Preventable Hospital Stays | 25 Participants |
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group (CG) | The Impact of the Intervention on the Utilization of Avoidable Emergency Department (ED) Visits | 135 Participants |
| Intervention Group (IG1) | The Impact of the Intervention on the Utilization of Avoidable Emergency Department (ED) Visits | 23 Participants |
| Intervention Group (IG2) | The Impact of the Intervention on the Utilization of Avoidable Emergency Department (ED) Visits | 220 Participants |
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group (CG) | The Impact of the Intervention on the Utilization of Women's Preventive Services and Other Preventive Services | 189 Participants |
| Intervention Group (IG1) | The Impact of the Intervention on the Utilization of Women's Preventive Services and Other Preventive Services | 52 Participants |
| Intervention Group (IG2) | The Impact of the Intervention on the Utilization of Women's Preventive Services and Other Preventive Services | 366 Participants |
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group (CG) | Informed Decision Making Regarding the Healthcare System and Their Health | 1: Believes active role important | 8 Participants |
| Control Group (CG) | Informed Decision Making Regarding the Healthcare System and Their Health | 2: Confidence and knowledge to take action | 7 Participants |
| Control Group (CG) | Informed Decision Making Regarding the Healthcare System and Their Health | 3: Taking action | 38 Participants |
| Control Group (CG) | Informed Decision Making Regarding the Healthcare System and Their Health | 4: Staying the course under stress | 48 Participants |
| Intervention Group (IG1) | Informed Decision Making Regarding the Healthcare System and Their Health | 4: Staying the course under stress | 53 Participants |
| Intervention Group (IG1) | Informed Decision Making Regarding the Healthcare System and Their Health | 1: Believes active role important | 1 Participants |
| Intervention Group (IG1) | Informed Decision Making Regarding the Healthcare System and Their Health | 3: Taking action | 41 Participants |
| Intervention Group (IG1) | Informed Decision Making Regarding the Healthcare System and Their Health | 2: Confidence and knowledge to take action | 6 Participants |
| Intervention Group (IG2) | Informed Decision Making Regarding the Healthcare System and Their Health | 4: Staying the course under stress | 65 Participants |
| Intervention Group (IG2) | Informed Decision Making Regarding the Healthcare System and Their Health | 2: Confidence and knowledge to take action | 8 Participants |
| Intervention Group (IG2) | Informed Decision Making Regarding the Healthcare System and Their Health | 3: Taking action | 36 Participants |
| Intervention Group (IG2) | Informed Decision Making Regarding the Healthcare System and Their Health | 1: Believes active role important | 2 Participants |