A navigator-led ACP program was feasible and may be associated with lower rates of resource utilization near EOL.

Costs to Medicare and health care use from 2012 through 2015 declined significantly for navigated patients compared with matched comparison patients. Lay navigation programs should be expanded as health systems transition to value-based health care.

The Patient Care Connect Program (PCCP) is a lay patient navigation program, implemented by the University of Alabama at Birmingham Health System Cancer Community Network. The PCCP’s goal is to provide better health and health care, as well as to lower overall expenditures. The program focuses on enhancing the health of patients, with emphasis on patient empowerment and promoting proactive participation in health care. Navigator training emphasizes palliative care principles and includes development of skills to facilitate advance care planning conversations. Lay navigators are integrated into the health care team, with the support of a nurse supervisor, physician medical director, and administrative champion. The intervention focuses on patients with high needs to reach those with the greatest potential for benefit from supportive services. Navigator activities are guided by frequent distress assessments, which help to identify patient concerns across multiple domains, triage patients to appropriate resources, and ultimately overcome barriers to health care. In this article, we describe the PCCP’s development, infrastructure, selection and training of lay navigators, and program operations.

Objective The purpose of this study was to evaluate the safety, efficacy, and immunogenicity of a plasmid vaccine, pNGVL4a-CRT-E7(detox), administered either intradermally, intramuscularly, or directly into the cervical lesion, in patients with HPV16-associated CIN2/3. Methods Eligible patients with HPV16+ CIN2/3 were enrolled in treatment cohorts evaluating pNGVL4a-CRT-E7(detox), administered by either particle-mediated epidermal delivery (PMED), intramuscular injection (IM), or cervical intralesional injection, at study weeks 0, 4, and 8. Patients were monitored for local injection site and systemic toxicity. A standard therapeutic resection was performed at week 15. The primary endpoints were safety and tolerability. Secondary endpoints included histologic regression and change in cervical HPV viral load. Exploratory endpoints included immune responses in the blood and in the target tissue. Results Thirty-two patients with HPV16+ CIN2/3 were enrolled onto the treatment phase of the study, and were vaccinated. Twenty-two of 32 patients (69%) experienced vaccine-specific related adverse events. The most frequent vaccine-related events were constitutional and local injection site in nature, and were grade 1 or less in severity. Histologic regression to CIN 1 or less occurred in 8 of 27 (30%) patients who received all vaccinations and underwent LEEP. In subject-matched comparisons, intraepithelial CD8+ T cell infiltrates increased after vaccination in subjects in the intralesional administration cohort. Conclusion pNGVL4a-CRT-E7(detox) was well-tolerated, elicited the most robust immune response when administered intralesionally, and demonstrated preliminary evidence of potential clinical efficacy.