Protocol paper: Stepped wedge cluster randomized trial translating the ABCS into optimizing cardiovascular care for people living with HIV.

People living with HIV (PWH) are at higher risk for cardiovascular disease (CVD) and stroke in comparison to their non-infected counterparts. The ABCS (aspirin-blood pressure control-cholesterol control-smoking cessation) reduce atherosclerotic (ASCVD) risk in the general population, but little is known regarding strategies for promoting the ABCS among PWH. Guided by the Consolidated Framework for Implementation Research (CFIR), we designed multilevel implementation strategies that target PWH and their clinicians to promote appropriate use of the ABCS based on a 10-year estimated ASCVD risk. Implementation strategies include patient coaching, automated texting, peer phone support, academic detailing and audit and feedback for the patient's clinician. We are evaluating implementation through a stepped wedge cluster randomized trial based on the Reach-Effectiveness-Adoption-Maintenance/Qualitative-Evaluation-for-Systematic-Translation (RE-AIM/QuEST) mixed methods framework that integrates quantitative and qualitative assessments. The primary outcome is change in ASCVD risk. Findings will have important implications regarding strategies for reducing ASCVD risk among PWH.

Does patient time spent viewing computer-tailored colorectal cancer screening materials predict patient-reported discussion of screening with providers?

The main aim is to examine whether patients' viewing time on information about colorectal cancer (CRC) screening before a primary care physician (PCP) visit is associated with discussion of screening options during the visit. We analyzed data from a multi-center randomized controlled trial of a tailored interactive multimedia computer program (IMCP) to activate patients to undergo CRC screening, deployed in primary care offices immediately before a visit. We employed usage time information stored in the IMCP to examine the association of patient time spent using the program with patient-reported discussion of screening during the visit, adjusting for previous CRC screening recommendation and reading speed.On average, patients spent 33 minutes on the program. In adjusted analyses, 30 minutes spent using the program was associated with a 41% increase in the odds of the patient having a discussion with their PCP (1.04, 1.59, 95% CI). In a separate analysis of the tailoring modules; the modules encouraging adherence to the tailored screening recommendation and discussion with the patient's PCP yielded significant results. Other predictors of screening discussion included better self-reported physical health and increased patient activation. Time spent on the program predicted greater patient-physician discussion of screening during a linked visit.Usage time information gathered automatically by IMCPs offers promise for objectively assessing patient engagement around a topic and predicting likelihood of discussion between patients and their clinician.

Do Lung Cancer Eligibility Criteria Align with Risk among Blacks and Hispanics?

BACKGROUND: Black patients have higher lung cancer risk despite lower pack years of smoking. We assessed lung cancer risk by race, ethnicity, and sex among a nationally representative population eligible for lung cancer screening based on Medicare criteria. METHODS: We used data from the National Health and Nutrition Examination Survey, 2007-2012 to assess lung cancer risk by sex, race and ethnicity among persons satisfying Medicare age and pack-year smoking eligibility criteria for lung cancer screening. We assessed Medicare eligibility based on age (55-77 years) and pack-years (≥ 30). We assessed 6-year lung cancer risk using a risk prediction model from Prostate, Lung, Colorectal and Ovarian Cancer Screening trial that was modified in 2012 (PLCOm2012). We compared the proportions of eligible persons by sex, race and ethnicity using Medicare criteria with a risk cut-point that was adjusted to achieve comparable total number of persons eligible for screening. RESULTS: Among the 29.7 million persons aged 55-77 years who ever smoked, we found that 7.3 million (24.5%) were eligible for lung cancer screening under Medicare criteria. Among those eligible, Blacks had statistically significant higher (4.4%) and Hispanics lower lung cancer risk (1.2%) than non-Hispanic Whites (3.2%). At a cut-point of 2.12% risk for lung screening eligibility, the percentage of Blacks and Hispanics showed statistically significant changes. Blacks eligible rose by 48% and Hispanics eligible declined by 63%. Black men and Hispanic women were affected the most. There was little change in eligibility among Whites. CONCLUSION: Medicare eligibility criteria for lung cancer screening do not align with estimated risk for lung cancer among Blacks and Hispanics. Data are urgently needed to determine whether use of risk-based eligibility screening improves lung cancer outcomes among minority patients.

Activation of persons living with HIV for treatment, the great study.

BACKGROUND: Patient empowerment represents a potent tool for addressing racial, ethnic and socioeconomic disparities in health care, particularly for chronic conditions such as HIV infection that require active patient engagement. This multimodal intervention, developed in concert with HIV patients and clinicians, aims to provide HIV patients with the knowledge, skills, attitudes and tools to become more activated patients. METHODS/DESIGN: Randomized controlled trial of a multimodal intervention designed to activate persons living with HIV. The intervention includes four components: 1) use of a web-enabled hand-held device (Apple iPod Touch) loaded with a Personal Health Record (ePHR) customized for HIV patients; 2) six 90-minute group-based training sessions in use of the device, internet and the ePHR; 3) a pre-visit coaching session; and 4) clinician education regarding how they can support activated patients. Outcome measures include pre- post changes in patient activation measure score (primary outcome), eHealth literacy, patient involvement in decision-making and care, medication adherence, preventive care, and HIV Viral Load. DISCUSSION: We hypothesize that participants receiving the intervention will show greater improvement in empowerment and the intervention will reduce disparities in study outcomes. Disparities in these measures will be smaller than those in the usual care group. Findings have implications for activating persons living with HIV and for other marginalized groups living with chronic illness. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02165735, 6/13/2014.

Impact of patient navigation in eliminating economic disparities in cancer care.

BACKGROUND: Patient navigation may reduce cancer disparities associated with socioeconomic status (SES) and household factors. This study examined whether these factors were associated with delays in diagnostic resolution among patients with cancer screening abnormalities and whether patient navigation ameliorated these delays. METHODS: This study analyzed data from 5 of 10 centers of the National Cancer Institute's Patient Navigation Research Program, which collected SES and household data on employment, income, education, housing, marital status, and household composition. The primary outcome was the time to diagnostic resolution after a cancer screening abnormality. Separate adjusted Cox proportional hazard models were fit for each SES and household factor, and an interaction between that factor and the intervention status was included. RESULTS: Among the 3777 participants (1968 in the control arm and 1809 in the navigation intervention arm), 91% were women, and the mean age was 44 years; 43% were Hispanic, 28% were white, and 27% were African American. Within the control arm, the unemployed experienced a longer time to resolution than those employed full-time (hazard ratio [HR], 0.85; P = .02). Renters (HR, 0.81; P = .02) and those with other (ie, unstable) housing (HR, 0.60; P < .001) had delays in comparison with homeowners. Never married (HR, 0.70; P < .001) and previously married participants (HR, 0.85; P = .03) had a longer time to care than married participants. There were no differences in the time to diagnostic resolution with any of these variables within the navigation intervention arm. CONCLUSIONS: Delays in diagnostic resolution exist by employment, housing type, and marital status. Patient navigation eliminated these disparities in the study sample. These findings demonstrate the value of providing patient navigation to patients at high risk for delays in cancer care.

Barriers to health care contribute to delays in follow-up among women with abnormal cancer screening: Data from the Patient Navigation Research Program.

BACKGROUND: There is limited understanding of the association between barriers to care and clinical outcomes within patient navigation programs. METHODS: Secondary analyses of data from the intervention arms of the Patient Navigation Research Program were performed, which included navigated participants with abnormal breast and cervical cancer screening tests from 2007 to 2010. Independent variables were: 1) the number of unique barriers to care (0, 1, 2, or ≥3) documented during patient navigation encounters; and 2) the presence of socio-legal barriers originating from social policy (yes/no). The median time to diagnostic resolution of index screening abnormalities was estimated using Kaplan-Meier cumulative incidence curves. Multivariable Cox proportional hazards regression examined the impact of barriers on time to resolution, controlling for sociodemographics and stratifying by study center. RESULTS: Among 2600 breast screening participants, approximately 75% had barriers to care documented (25% had 1 barrier, 16% had 2 barriers, and 34% had ≥3 barriers). Among 1387 cervical screening participants, greater than one-half had barriers documented (31% had 1 barrier, 11% had 2 barriers, and 13% had ≥3 barriers). Among breast screening participants, the presence of barriers was associated with less timely resolution for any number of barriers compared with no barriers. Among cervical screening participants, only the presence of ≥2 barriers was found to be associated with less timely resolution. Both types of barriers, socio-legal and other barriers, were found to be associated with delay among breast and cervical screening participants. CONCLUSIONS: Navigated women with barriers resolved cancer screening abnormalities at a slower rate compared with navigated women with no barriers. Further innovations in navigation care are necessary to maximize the impact of patient navigation programs nationwide.

Preliminary validation of a scale to measure patient perceived similarity to their navigator.

OBJECTIVE: A central premise in deployment of community health workers (CHW) is that CHWs share key characteristics with their patients. We sought to develop a scale to measure this construct called the Perceived Navigator Similarity (PNS) questionnaire. METHODS: We adopted items from a similarly developed scale, patient perceived similarity to their physicians, and examined its psychometric properties among 51 patients who were navigated for cancer care by a CHW. RESULTS: Principal component analysis revealed two main factors: personal and ethnic. The scale was associated with greater satisfaction with navigation (p < 0.005) and cancer care (p < 0.05). CONCLUSION: The PNS shows promise for further validation in larger samples assessing navigator-patient similarity from the patient perspective.

Design of, and enrollment in, the palliative care communication research initiative: a direct-observation cohort study.

BACKGROUND: Understanding the characteristics of communication that foster patient-centered outcomes amid serious illness are essential for the science of palliative care. However, epidemiological cohort studies that directly observe clinical conversations can be challenging to conduct in the natural setting. We describe the successful enrollment, observation and data collection methods of the ongoing Palliative Care Communication Research Initiative (PCCRI). METHODS: The PCCRI is a multi-site cohort study of naturally occurring inpatient palliative care consultations. The 6-month cohort data includes directly observed and audio-recorded palliative care consultations (up to first 3 visits); patient/proxy/clinician self-report questionnaires both before and the day after consultation; post-consultation in-depth interviews; and medical/administrative records. RESULTS: One hundred fourteen patients or their proxies enrolled in PCCRI during Enrollment Year One (of Three). Seventy percent of eligible patients/proxies were invited to hear about a communication research study (188/269); 60% of them ultimately enrolled in the PCCRI (114/188), resulting in a 42% sampling proportion (114/269 eligible). All PC clinicians at study sites were invited to participate; all 45 participated. CONCLUSIONS: Epidemiologic study of patient-family-clinician communication in palliative care settings is feasible and acceptable to patients, proxies and clinicians. We detail the successful PCCRI methods for enrollment, direct observation and data collection for this complex "field" environment.

Goal Communication in Palliative Care Decision-Making Consultations.

CONTEXT: Palliative care (PC) promotes patient-centered outcomes, but the mechanisms underlying these effects remain poorly understood. Identifying, clarifying, and prioritizing patients' goals are conceptually fundamental to the process of patient-centeredness and are the main reasons for PC referral. However, very little is empirically known about the content or process of goal expression in the natural setting of PC. OBJECTIVES: To describe the frequency, types, and determinants of goal expression in PC consultations. METHODS: This was a cross-sectional direct observational study of 72 audiorecorded PC consultations with hospitalized patients (and families) referred for PC goals of care clarification or end-of-life decision making. We coded digital audio files using reliable methods and linked conversation codes to clinical record and brief clinician interview data. RESULTS: Goal expressions occurred frequently in PC consultations and addressed both length-of-life and quality-of-life domains. The presence of existential suffering in the conversation was associated with substantially more expressions and types of goals. CONCLUSION: Goal communication is common in PC decision-making settings and strongly influenced by existential suffering.

Barriers reported among patients with breast and cervical abnormalities in the patient navigation research program: impact on timely care.

BACKGROUND: Patient navigation (PN) is a system-level strategy to decrease cancer mortality rates by reducing barriers to cancer care. Barriers to resolution among participants in the PN intervention arm with a breast or cervical abnormality in the Patient Navigation Research Program and navigators' actions to address those barriers were examined. METHODS: Data from seven institutions (2005-2010) included 1,995 breast and 1,194 cervical patients. A stratified Cox proportional hazards regression model was used to examine the effects of barriers on time to resolution of an abnormal screening test or clinical finding. FINDINGS: The range of unique barriers was 0 to 12 and 0 to 7 among participants with breast and cervical abnormalities, respectively. About two thirds of breast and one half of cervical participants had at least one barrier resulting in longer time to diagnostic resolution among breast (adjusted hazard ratio [HR], 0.744; p < .001) and cervical (adjusted HR, 0.792; p < .001) participants. Patient- and system-level barriers were most common. Frequent navigator actions were making arrangements, scheduling appointments, referrals, and education. CONCLUSIONS: Having a barrier resulted in a delay in diagnostic resolution of an abnormal screening test or clinical finding. Health care systems can use these findings to improve existing PN programs or when developing new programs.

Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life.

BACKGROUND: Patient navigation is a promising intervention to ameliorate cancer health disparities. This study objective was to measure patient navigation effects on cancer-specific quality of life (QOL) among patients with newly diagnosed cancer. METHODS: A randomized controlled trial of patient navigation was conducted in Rochester, NY. Patients with breast cancer and colorectal cancer were randomly assigned to receive a patient navigation intervention or usual care. QOL was measured at baseline and four subsequent time points, using the validated Functional Assessment of Cancer Therapy (FACT-B, FACT-C) instruments. RESULTS: Among 319 randomized patients (165 patient navigation, 154 control), median age was 57 years and 32.5% were from minority race/ethnicity groups. Patient navigation and control groups were comparable on baseline factors, except home ownership versus renting (more home ownership among controls, P = 0.05) and race (more whites among controls, P = 0.05). Total and subscale FACT scores did not differ between groups when analyzed as a change from baseline to 3 months, or at various time points. The emotional well-being subscale change from baseline approached significance (better change among patient navigation group, P = 0.05). Time trends of QOL measures did not differ significantly between groups. Adjustment for baseline patient factors did not reveal a benefit of patient navigation on QOL. CONCLUSIONS: In this randomized trial of patient navigation, there was no statistically significant effect on disease-specific QOL. IMPACT: These results suggest that patient navigation may not affect QOL during cancer treatment, that social/medical support are adequate in this study's setting, or that the trial failed to target patients likely to experience QOL benefit from patient navigation.

Patient navigation from the paired perspectives of cancer patients and navigators: a qualitative analysis.

OBJECTIVE: Patient navigation for cancer care assesses and alleviates barriers to health care services. We examined paired perspectives of cancer patients and their navigators to examine the process of patient navigation. We explored the strengths, limitations, and our own lessons learned about adopting the novel methodology of multiperspective analysis. METHODS: As part of a larger RCT, patients and navigators were interviewed separately. We reviewed interviews with 18 patient-navigator dyads. Dyad summaries were created that explicitly incorporated both patient and navigator perspectives. Emerging themes and verbatim quotations were reflected in the summaries. RESULTS: Paired perspectives were valuable in identifying struggles that arose during navigation. These were represented as imbalanced investment and relational amelioration. Patients and navigators had general consensus about important patient needs for cancer care, but characterized these needs differently. CONCLUSION: Our experience with multiperspective analysis revealed a methodology that delivers novel relational findings, but is best conducted de novo rather than as part of a larger study. PRACTICE IMPLICATIONS: Multiperspective analysis should be more widely adopted with clear aims and analytic strategy that strengthen the ability to reveal relational dynamics. Navigation training programs should anticipate navigator struggles and provide navigators with tools to manage them.

Understanding the processes of patient navigation to reduce disparities in cancer care: perspectives of trained navigators from the field.

Patient navigation (PN) programs are being widely implemented to reduce disparities in cancer care for racial/ethnic minorities and the poor. However, few systematic studies cogently describe the processes of PN. We qualitatively analyzed 21 transcripts of semistructured exit interviews with three navigators about their experiences with patients who completed a randomized trial of PN. We iteratively discussed codes/categories, reflective remarks, and ways to focus/organize data and developed rules for summarizing data. We followed a three-stage analysis model: reduction, display, and conclusion drawing/verification. We used ATLAS.ti_5.2 for text segmentation, coding, and retrieval. Four categories of factors affecting cancer care outcomes emerged: patients, navigators, navigation processes, and external factors. These categories formed a preliminary conceptual framework describing ways in which PN processes influenced outcomes. Relationships between processes and outcomes were influenced by patient, navigator, and external factors. The process of PN has at its core relationship-building and instrumental assistance. An enhanced understanding of the process of PN derived from our analyses will facilitate improvement in navigators' training and rational design of new PN programs to reduce disparities in cancer-related care.