Latino STYLE: Preliminary Findings From an HIV Prevention RCT Among Latino Youth.

OBJECTIVE: Latino STYLE is a family-centered, HIV-focused intervention (HIV) emphasizing cultural factors and parent-adolescent communication. We hypothesized that, compared with a general health promotion (HP) intervention, the HIV arm would improve caregiver and adolescent HIV knowledge, attitudes, parental monitoring, sexual communication, and family relationships after a 3-month postintervention period. This article reports on the short-term findings of the longer trial. METHODS: A single-site, two-arm, parallel, family-based, randomized, controlled trial was conducted; eligible participants were Latino adolescents aged 14-17 and their primary caregiver. The study was conducted at the University of South Florida with 227 adolescent-caregiver dyads allocated to the HIV (n = 117) or HP (n = 110) intervention after completing a baseline assessment. Interim measures at 3-month follow-up included demographics, HIV knowledge, self-efficacy, parental monitoring, sexual communication, family relationships, and adolescent sexual behavior. RESULTS: Adolescents in the HIV group reported small effects in parental permissiveness and the HP group reported small effects for family support. Caregivers in both groups reported decreases in all outcomes. Incidence of past 90-day sexual intercourse decreased in both treatment arms. Among those who were sexually active over the past 90 days, the number of sex acts decreased from baseline, particularly in the HIV group. The percentage of condom-protected sex acts increased in the HIV group and decreased in the HP group, but did not reach statistical significance. CONCLUSIONS: The HIV Latino STYLE intervention was not efficacious in improving hypothesized outcomes over a 3-month period. However, exploratory analyses revealed moderate effects for decreases in adolescent sexual risk behavior, particularly in the HIV group.

Lay navigator model for impacting cancer health disparities.

This paper recounts experiences, challenges, and lessons learned when implementing a lay patient navigator program to improve cancer care among medically underserved patients who presented in a primary care clinic with a breast or colorectal cancer abnormality. The program employed five lay navigators to navigate 588 patients. Central programmatic elements were the following: (1) use of bilingual lay navigators with familiarity of communities they served; (2) provision of training, education, and supportive activities; (3) multidisciplinary clinical oversight that factored in caseload intensity; and (4) well-developed partnerships with community clinics and social service entities. Deconstruction of healthcare system information was fundamental to navigation processes. We conclude that a lay model of navigation is well suited to assist patients through complex healthcare systems; however, a stepped care model that includes both lay and professional navigation may be optimal to help patients across the entire continuum.

Effect of patient navigation on time to diagnostic resolution among patients with colorectal cancer-related abnormalities.

The objective of this study is to evaluate whether a patient navigation (PN) program is effective in reducing delay in diagnostic resolution among medically underserved patients with colorectal cancer (CRC)-related abnormalities in Tampa Bay, Florida. This study involved ten primary care clinics randomized either to receive navigation or to serve as controls (five clinics per arm). Each clinic identified all subjects with CRC-related abnormalities in the year prior to the clinic beginning participation in the Moffitt Patient Navigator Research Program. Patients with CRC-related abnormalities were navigated from the time of a colorectal abnormality to diagnostic resolution. Control patients received usual care, and outcome information was obtained from medical record abstraction. Using a frailty Cox proportional hazard model, we examined the length of time between colorectal abnormality and definitive diagnosis. One hundred ninety-three patients were eligible for the study because of a CRC-related abnormality (75 navigated and 118 controls). Analysis of PN effect by two time periods of resolution (0-4 and >4 months) showed a lagged effect of PN. The adjusted time-varying PN effect on diagnostic resolution compared to the controls was marginally significant (adjusted hazard ratio [aHR] = 1.15, 95% confidence interval = 1.02-1.29) after controlling for insurance status. The predicted aHR at 4 months was 1.2, but showed no significant effect until 12 months. For patients having an abnormal symptom of CRC, PN appeared to have a positive effect over time and sped diagnostic resolution after 4 months. However, the small sample size limits drawing a definitive conclusion regarding the positive PN effect.

Patient navigation and time to diagnostic resolution: results for a cluster randomized trial evaluating the efficacy of patient navigation among patients with breast cancer screening abnormalities, Tampa, FL.

OBJECTIVES: The objective of this study was to evaluate a patient navigation (PN) program that attempts to reduce the time between a breast cancer screening abnormality and definitive diagnosis among medically underserved populations of Tampa Bay, Florida. METHODS: The Moffitt Patient Navigation Research Program conducted a cluster randomized design with 10 primary care clinics. Patients were navigated from time of a breast screening abnormality to diagnostic resolution. This paper examined the length of time between breast abnormality and definitive diagnosis, using a shared frailty Cox proportional hazard model to assess PN program effect. RESULTS: 1,039 patients were eligible for the study because of an abnormal breast cancer screening/clinical abnormality (494 navigated; 545 control). Analysis of PN effect by two time periods of resolution (0-3 months and > 3 months) showed a lagged effect of PN. For patients resolving in the first three months, the adjusted Hazard Ratio (aHR) was 0.85 (95% Confidence Interval [CI]: 0.64-1.13) suggesting that PN had no effect on resolution time during this period. Beyond three months, however, navigated patients resolved more quickly to diagnostic resolution compared with the control group (aHR 2.8, 95%CI: 1.30-6.13). The predicted aHR at 3 months was 1.2, which was not statistically significant, while PN had a significant positive effect beyond 4.7 months. CONCLUSIONS: PN programs may increase the timeliness of diagnostic resolution for patients with a breast cancer-related abnormality. PN did not speed diagnostic resolution during the initial three months of follow up but started to reduce time to diagnostic resolution after three months and showed a significant effect after 4.7 months. TRIAL REGISTRATION: ClinicalTrials.gov NCT00375024.

A cluster randomized trial evaluating the efficacy of patient navigation in improving quality of diagnostic care for patients with breast or colorectal cancer abnormalities.

BACKGROUND: This study examines efficacy of a lay patient navigation (PN) program aimed to reduce time between a cancer abnormality and definitive diagnosis among racially/ethnically diverse and medically underserved populations of Tampa Bay, Florida. METHODS: Using a cluster randomized design, the study consisted of 11 clinics (six navigated; five control). Patients were navigated from time of a breast or colorectal abnormality to diagnostic resolution, and to completion of cancer treatment. Using a generalized mixed-effects model to assess intervention effects, we examined: (i) length of time between abnormality and definitive diagnosis, and (ii) receipt of definitive diagnosis within the 6-month minimum follow-up period. RESULTS: A total of 1,267 patients participated (588 navigated; 679 control). We also included data from an additional 309 chart abstractions (139 navigated arm; 170 control arm) that assessed outcomes at baseline. PN did not have a significant effect on time to diagnostic resolution in multivariable analysis that adjusted for race-ethnicity, language, insurance status, marital status, and cancer site (P = 0.16). Although more navigated patients achieved diagnostic resolution by 180 days, results were not statistically significant (74.5% navigated vs. 68.5% control, P = 0.07). CONCLUSIONS: PN did not impact the overall time to completion of diagnostic care or the number of patients who reached diagnostic resolution of a cancer abnormality. Further evaluation of PN programs applied to other patient populations across the cancer continuum is necessary to gain a better perspective on its effectiveness. IMPACT: PN programs may not impact timely resolution of an abnormality suspicious of breast or colorectal cancer.

Diagnostic resolution of cancer screening abnormalities at community health centers.

BACKGROUND: Few studies have examined timeliness of diagnostic evaluation of abnormal cancer screening tests in community health centers. METHODS: Using medical record review, timeliness of diagnosis was assessed among 317 people having either breast or colorectal-related abnormalities. RESULTS: For 241 subjects (76.0%) who reached clinical resolution, the median time to diagnostic resolution was 37 days. People with breast abnormalities had more than twice the odds (adjusted odds ratio: 2.84) of reaching diagnostic resolution within 180 days compared with patients with colorectal abnormalities. We found, however, no evidence of disparate outcomes according to patient race/ethnicity, insurance status, or spoken language. CONCLUSIONS: Diagnostic evaluations are often either not completed or are delayed after a cancer-related abnormality is discovered. Further research is needed to understand the patient, provider, and health care system factors that contribute to these delays. There was no evidence of cancer disparities in the community health centers studied.

Navigation and palliative care.

Patient navigation represents an opportunity to further the integration of palliative care with standard cancer care. This article defines palliative and hospice care and describes some of the current challenges of integrating palliative care into other forms of care. It also considers outcomes that navigation might be expected to improve for patients receiving palliative care or enrolled in hospice. These outcomes include symptom relief; communication efficacy; transitions of care; and access to palliative care, hospice, and bereavement care for families. Although these outcomes may not have been specifically assessed in patients in cancer navigation programs, they represent important outcomes for patients receiving palliative care and their families. It is recognized that the types of outcomes that are important to track for patients and families receiving palliative care should be consistent with outcomes at other stages of illness.

Innovative approaches to reducing cancer health disparities: the Moffitt Cancer Center Patient Navigator Research Program.

The Moffitt Cancer Center Patient Navigation Research Program (Moffitt PNRP) is evaluating the efficacy of patient navigation in reducing delays from screening abnormality to diagnostic resolution of a breast or colorectal abnormality. The Moffitt PNRP was conducted in three phases: (1) developing an acceptable, appealing, and culturally appropriate patient navigation program; (2) conducting a group randomized controlled trial to evaluate the patient navigation program; and (3) disseminating research findings and Moffitt PNRP intervention model. The patient navigation program was developed through significant formative research, input from the Moffitt PNRP Community Advisory Board, and through a close collaboration with the Tampa Bay Community Cancer Network. 1367 patients were enrolled in the Phase 2 group randomized trial of the Moffitt PNRP. Most Moffitt PNRP group randomized trial participants are Hispanic, female, and Spanish speaking, with minimal education and income. Analyses are currently being conducted to evaluate efficacy of the Moffitt PNRP.

Estimating maternal mortality in Monseñor Nouel Province, Dominican Republic.

OBJECTIVES: Maternal deaths are estimated by the World Health Organization at over 500,000 annually. Various methods of calculating mortality ratios have been utilized throughout the world, but many are inaccurate. The purpose of this study was to measure maternal mortality by using a sibling survivorship survey and by recording and tracking death certificates. METHODS: The data for the survey were collected within a specific province in the Dominican Republic that represents predominately rural communities. Interviews with 2,180 women and data from their 17,807 siblings were recorded, 9,723 of which were sisters. The Death Certificate data were obtained by tracking 3,430 records at the local government office in the same province. RESULTS: The results from the rural sibling survey show a maternal mortality ratio significantly higher than other national estimates (348/100,000 live births versus 72-250/100,000). Data collection methods are discussed, including government record keeping and potential sources of inaccuracy. CONCLUSION: Reported maternal mortality ratios may not portray the true magnitude of the poor health status of women in developing countries.