The sample population consisted of patients who received services from California’s Family Planning, Access, Care and Treatment (Family PACT) program), which provides free reproductive health services to low-income residents of California who have no other source of family planning coverage. Enrolled Family PACT providers are Medicaid providers, serving predominantly underserved populations, including communities of color [30].
This cross-sectional study was conducted as part of an evaluation of a patient education tool which was administered in a clustered randomized study of Family PACT clinics from January 2015 to December 2016 [31]. Participating clinics served at least 200 female clients under 30 years of age per year since the tool was specifically targeting this age group. Seven of 14 clinics were randomized to incorporate a patient education tool into clinic visits. At sites randomized to the tool, the tool was administered prior to the patient’s visit with the provider. For all women, the survey was administered after their provider visit but prior to their leaving the clinic.
Development of the Patient Education Tool
We designed the patient education tool using a community engaged process, in which we collaborated with community stakeholders and experts in the field, including the National Cervical Cancer Coalition, Latina Contra Cancer, the California Office of Family Planning, and the American Society for Colposcopy and Cervical Pathology. We also conducted focus groups and cognitive interviews with women recruited from our patient stakeholders. We held three focus groups in English and one in Spanish (total n = 25). Participants’ experiences varied from having had no previous cervical cancer screening, having had a history of normal or abnormal cytology, to being a cervical cancer survivor. Women were asked to identify fears, concerns, and areas of uncertainty around cervical cancer screening and the new recommendations, as well as potential messages that could be used to address these issues.
Themes expressed by patients included fear of missing a cancer diagnosis, concern that the decrease in the recommended frequency of screening being due to a desire to cut cost at expense of patient safety, misconceptions regarding the relationship between cervical cancer screening and testing for sexually transmitted infections (STIs). Messages identified by the women as important to convey in the educational tool included details on the screening procedure, review of reproductive anatomy, HPV’s relationship with cervical cancer, reasons for the update to screening intervals, information on the HPV vaccine, and clarification about the fact that screening for STIs screening is distinct from cervical cancer screening.
We used these identified themes to develop a paper prototype for an education tool regarding cervical cancer screening and treatment. In developing the tool, we were informed by the Shared Decision Making model of patient-provider communication, which is increasingly being used as a means to engage in patient-centered communication, especially around reproductive health decisions. In particular, we sought to ensure that patients had adequate information about their ability to participate in a shared decision making process regarding whether Pap tests or colposcopies following an abnormal Pap test was the appropriate management approach for them. Another major feature was to emphasize that the tool could enhance women’s ability to and comfort with communicating with their provider about decisions related to cervical cancer prevention and treatment [32, 33]. Three cognitive testing series were then performed, with iterative improvement of the tool between each series to ensure the tool addressed the informational needs of the target population. These cognitive interviews were conducted with 17 women aged 21 to 29 years. This feedback was used to inform development of an interactive, on-line tool with multimedia components and the option for audio, which then underwent a final round of cognitive testing in both English and Spanish among women attending the participating clinics. Based on patient input, the tool presented information to two target audiences: (a) women at a well-woman visit and (b) women with an abnormal cervical cytology result. We adjusted syntax and vocabulary to a sixth-grade literacy level, and made revisions for accuracy, cultural competency, and health literacy. The tool was audio-enabled to be accessible for the visually impaired [34].
The final web-version of the tool was reviewed and approved by patient and provider stakeholders. Further piloting was performed at each of the clinics randomized to the patient education tool. After viewing the tool, patients were asked a series of questions on clarity and messaging. Final changes were then made to the tool.
Survey Measures and Administration
We developed a survey that included 15 items to address three of the goals of the tool: (1) increased knowledge of cervical cancer prevention, covering reproductive anatomy, natural history of HPV and HPV vaccine protection (4 items), (2) increased understanding of cervical cancer screening recommendations (5 items), and (3) increased comfort in communicating with providers about reproductive health topics (6 items). Participants were asked to indicate their agreement with statements related to these issues on a 5-point Likert scale ranging from strongly agree to strongly disagree. Additional questions assessed sociodemographic information and health care use (15 items). Women in the intervention group were also asked about their experience with the educational tool and their desire to continue with annual screening (9 items).
We administered the paper survey during project site visits from February 2016 to June 2016. Timing of site visits to the intervention and control sites were based on clinic availability and scheduling by clinic staff. Staff approached all women at the time of check in. to assess eligibility and willingness to participate. Staff were not asked to document number of women who refused to be approached. With patient’s consent, research staff proceeded with project orientation and written consent. All 229 women approached by research staff consented to participate in the study.
In clinics randomized to the intervention arm, the education tool was provided to the woman prior to consultation with their providers. In both arms, surveys were self-administered in a private setting within the clinic after the patient’s consultation with their providers.
The study was approved by the University of California Los Angeles and the University of California San Francisco Institutional Review Boards, California's Committee for the Protection of Human Subjects, and the Data Research Committee of the California Department of Health Care Services.
Statistical Analysis
We summarized quantitative variables on the Likert scales using means and standard deviations, and categorical variables using frequencies and percentages. We grouped responses from Likert scales to create binary scores based on responses by strongly agree and agree versus neither agree nor disagree, disagree, and strongly disagree. We made group comparisons between study arms (intervention versus control), primary language (English versus Spanish), and women who did and did not still want annual Pap smears.
We compiled composite scores on the three themes (knowledge of cervical cancer prevention, understanding of screening guidelines and comfort with provider communication). The items are listed in Table 3. Variables were compared between groups using logistic regression models with robust standard errors, with clustering at the clinic level. Treatment effect heterogeneity was evaluated by testing the interaction between group and primary language using these models. P-values less than 0.05 were considered statistically significant. Analyses were performed using SAS® version 9.4 [35].