Frederick R. Snyder

Impact of Patient Navigation on Timely Cancer Care: The Patient Navigation Research Program

BACKGROUND Patient navigation is a promising intervention to address cancer disparities but requires a multisite controlled trial to assess its effectiveness. METHODS The Patient Navigation Research Program compared patient navigation with usual care on time to diagnosis or treatment for participants with breast, cervical, colorectal, or prostate screening abnormalities and/or cancers between 2007 and 2010. Patient navigators developed individualized strategies to address barriers to care, with the focus on preventing delays in care. To assess timeliness of diagnostic resolution, we conducted a meta-analysis of center- and cancer-specific adjusted hazard ratios (aHRs) comparing patient navigation vs usual care. To assess initiation of cancer therapy, we calculated a single aHR, pooling data across all centers and cancer types. We conducted a metaregression to evaluate variability across centers. All statistical tests were two-sided. RESULTS The 10521 participants with abnormal screening tests and 2105 with a cancer or precancer diagnosis were predominantly from racial/ethnic minority groups (73%) and publically insured (40%) or uninsured (31%). There was no benefit during the first 90 days of care, but a benefit of navigation was seen from 91 to 365 days for both diagnostic resolution (aHR = 1.51; 95% confidence interval [CI] = 1.23 to 1.84; P < .001)) and treatment initiation (aHR = 1.43; 95% CI = 1.10 to 1.86; P < .007). Metaregression revealed that navigation had its greatest benefits within centers with the greatest delays in follow-up under usual care. CONCLUSIONS Patient navigation demonstrated a moderate benefit in improving timely cancer care. These results support adoption of patient navigation in settings that serve populations at risk of being lost to follow-up.

Impact of patient navigation in eliminating economic disparities in cancer care

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.

Racial and ethnic differences in patient navigation: Results from the Patient Navigation Research Program

Patient navigation was developed to address barriers to timely care and reduce cancer disparities. The current study explored navigation and racial and ethnic differences in time to the diagnostic resolution of a cancer screening abnormality.

Analysis of combined data from heterogeneous study designs: an applied example from the patient navigation research program

Background The Patient Navigation Research Program (PNRP) is a cooperative effort of nine research projects, with similar clinical criteria but with different study designs. To evaluate projects such as PNRP, it is desirable to perform a pooled analysis to increase power relative to the individual projects. There is no agreed-upon prospective methodology, however, for analyzing combined data arising from different study designs. Expert opinions were thus solicited from the members of the PNRP Design and Analysis Committee. Purpose To review possible methodologies for analyzing combined data arising from heterogeneous study designs. Methods The Design and Analysis Committee critically reviewed the pros and cons of five potential methods for analyzing combined PNRP project data. The conclusions were based on simple consensus. The five approaches reviewed included the following: (1) analyzing and reporting each project separately, (2) combining data from all projects and performing an individual-level analysis, (3) pooling data from projects having similar study designs, (4) analyzing pooled data using a prospective meta-analytic technique, and (5) analyzing pooled data utilizing a novel simulated group-randomized design. Results Methodologies varied in their ability to incorporate data from all PNRP projects, to appropriately account for differing study designs, and to accommodate differing project sample sizes. Limitations The conclusions reached were based on expert opinion and not derived from actual analyses performed. Conclusions The ability to analyze pooled data arising from differing study designs may provide pertinent information to inform programmatic, budgetary, and policy perspectives. Multisite community-based research may not lend itself well to the more stringent explanatory and pragmatic standards of a randomized controlled trial design. Given our growing interest in community-based population research, the challenges inherent in the analysis of heterogeneous study design are likely to become more salient. Discussion of the analytic issues faced by the PNRP and the methodological approaches we considered may be of value to other prospective community-based research programs.

Relation of comorbidities and patient navigation with the time to diagnostic resolution after abnormal cancer screening

Whether patient navigation improves outcomes for patients with comorbidities is unknown. The aims of this study were to determine the effect of comorbidities on the time to diagnostic resolution after an abnormal cancer screening test and to examine whether patient navigation improves the timeliness and likelihood of diagnostic resolution for patients with comorbidities in comparison with no navigation.

What Makes Patient Navigation Most Effective: Defining Useful Tasks and Networks

Abstract:Given the momentum in adopting patient navigation into cancer care, there is a need to understand the contribution of specific navigator activities to improved clinical outcomes. A mixed-methods study combined direct observations of patient navigators within the Patient Navigation Research Program and outcome data from the trial. We correlated the frequency of navigator tasks with the outcome of rate of diagnostic resolution within 365 days among patients who received the intervention relative to controls. A focused content analysis examined those tasks with the strongest correlations between navigator tasks and patient outcomes. Navigating directly with specific patients (r = 0.679), working with clinical providers to facilitate patient care (r = 0.643), and performing tasks not directly related to their diagnostic evaluation for patients were positively associated with more timely diagnosis (r = 0.714). Using medical records for non-navigation tasks had a negative association (r = –0.643). Content analysis revealed service provision directed at specific patients improved care while systems-focused activities did not.

The impact of patient navigation on receipt of quality breast cancer treatment in the national patient navigation research program.

72 Background: The discrepancy in breast cancer outcomes for underserved populations has been linked to lack of receipt of quality treatment. Patient navigation programs are being rapidly adopted as a model to improve cancer outcomes for these vulnerable populations, yet the effect of navigation on their quality of cancer care is unknown. METHODS We conducted a secondary analysis of the National Patient Navigation Research Program (PNRP) data to assess the impact of navigation on receipt of quality care among women diagnosed with breast cancer. Data pooled from 7 PRNP sites were used to determine the proportion of newly diagnosed cancer patients whose care met National Comprehensive Cancer Network (NCCN) quality metrics: 1) hormonal therapy for HR+ patients 2) post-lumpectomy radiation therapy; and 3) chemotherapy for hormone negative, >1cm tumors, in patients <70 years of age. Chi-square tests were performed to compare probability of receiving recommended care among navigated and control patients. RESULTS A total of 1,006 breast cancer patients eligible for treatment were enrolled across all sites: 491 (49%) in the intervention arm, 515 (51%) in the control arm (mean age: 56 years; 38% African American, 23% Hispanic; 13% uninsured and 38% Medicaid). Among those eligible for hormone therapy, 283/357 (79%) navigated patients received hormonal therapy compared to 237/371 (64%) of controls (p < 0.001). Among those eligible for radiation therapy post lumpectomy, 235/277 (85%) of navigated patients received radiation compared to 270/324 (83%) of controls (p=0.62). Among those eligible for chemotherapy, 79/122 (65%) of navigated patients received chemotherapy compared to 81/100 (81%) of controls (p < 0.007). Logistic regression models to determine the odds of receiving recommended care for navigated and non-navigated patients, adjusting for patient demographics, will be conducted. CONCLUSIONS Navigation had a positive effect for receipt of hormonal therapy, but not for radiation therapy and chemotherapy. Future studies are needed to assess the role navigation may play in ensuring quality care for the most vulnerable.

Abstract PL06-02: Patient navigation and timeliness of diagnostic evaluation: Results from the Patient Navigation Research Program

Background: Patient navigation has been proposed as a means to reduce cancer health disparities, through the addition of a trained navigator to the health care team. Patient navigators help patients to identify barriers to receiving needed care, and to develop individually targeted plans to overcome these barriers. The Patient Navigation Research Program is a nine-site program to evaluate the benefit of patient navigation among underserved populations from diverse socioeconomic and geographic locations within the United States. Methods: Patients with breast, cervical, colorectal or prostate screening abnormalities were eligible for enrollment. The primary outcome was time to diagnostic resolution of the screening abnormality, assessed dichotomously as resolved or not within 365 days, and analyzed using survival curves and Cox proportional hazards models of time to resolution by 12 months. Due to the differing study designs at the 9 sites (RCT, Group randomized, and non randomized group allocation) we calculated an effect size for each cancer type for each site, and utilized a meta-analysis to assess an overall effect size. Models were adjusted for age, race, insurance and marital status. Results: There were 10,513 subjects (5,055 Navigated and 5,458 Non-navigated) recruited from the 9 sites, 64% with breast cancer screening abnormalities. The study population was diverse with 74% from minority groups (32% African American, 39% Latino, 4% other), and low income with 17% Medicaid insured, and 32% with no insurance. In the control population, 62% to 95% of the participants did not reach diagnostic resolution after their abnormal screening result within 12 months. Those in the navigation arm were more likely to reach resolution after an abnormal test in 13 of the 15 cancer sites, (89 to 99% resolved). Of the 15 hazard rate ratios, 11 showed a statistically significant positive effect of the navigation intervention, 3 others showed a non statistically significant benefit of navigation, and 1 showed a negative effect of navigation on time to diagnostic resolution, (effect sizes ranging from an adjusted HR of 0.38 to 3.94, with a higher HR favoring the navigation arm). Implications: Compared to non-navigated subjects, participants with an abnormal cancer screening test who were allocated to receive a patient navigation intervention were more likely to receive timely diagnostic resolution of their abnormal screening test. Patient navigation for vulnerable populations may be beneficial in reducing cancer disparities. Citation Information: Cancer Epidemiol Biomarkers Prev 2011;20(10 Suppl):PL06-02.

Analysis of Combined Data from Heterogeneous Study Designs: A Methodological Proposal from the Patient Navigation Research program

Background The Patient Navigation Research Program (PNRP) is a cooperative effort of nine research projects, with similar clinical criteria but with different study designs. To evaluate projects such as PNRP, it is desirable to perform a pooled analysis to increase power relative to the individual projects. There is no agreed-upon prospective methodology, however, for analyzing combined data arising from different study designs. Expert opinions were thus solicited from the members of the PNRP Design and Analysis Committee. Purpose To review possible methodologies for analyzing combined data arising from heterogeneous study designs. Methods The Design and Analysis Committee critically reviewed the pros and cons of five potential methods for analyzing combined PNRP project data. The conclusions were based on simple consensus. The five approaches reviewed included the following: (1) analyzing and reporting each project separately, (2) combining data from all projects and performing an individual-level analysis, (3) pooling data from projects having similar study designs, (4) analyzing pooled data using a prospective meta-analytic technique, and (5) analyzing pooled data utilizing a novel simulated group-randomized design. Results Methodologies varied in their ability to incorporate data from all PNRP projects, to appropriately account for differing study designs, and to accommodate differing project sample sizes. Limitations The conclusions reached were based on expert opinion and not derived from actual analyses performed. Conclusions The ability to analyze pooled data arising from differing study designs may provide pertinent information to inform programmatic, budgetary, and policy perspectives. Multisite community-based research may not lend itself well to the more stringent explanatory and pragmatic standards of a randomized controlled trial design. Given our growing interest in community-based population research, the challenges inherent in the analysis of heterogeneous study design are likely to become more salient. Discussion of the analytic issues faced by the PNRP and the methodological approaches we considered may be of value to other prospective community-based research programs.

Analysis of combined data from heterogeneous study designs

Background The Patient Navigation Research Program (PNRP) is a cooperative effort of nine research projects, with similar clinical criteria but with different study designs. To evaluate projects such as PNRP, it is desirable to perform a pooled analysis to increase power relative to the individual projects. There is no agreed-upon prospective methodology, however, for analyzing combined data arising from different study designs. Expert opinions were thus solicited from the members of the PNRP Design and Analysis Committee. Purpose To review possible methodologies for analyzing combined data arising from heterogeneous study designs. Methods The Design and Analysis Committee critically reviewed the pros and cons of five potential methods for analyzing combined PNRP project data. The conclusions were based on simple consensus. The five approaches reviewed included the following: (1) analyzing and reporting each project separately, (2) combining data from all projects and performing an individual-level analysis, (3) pooling data from projects having similar study designs, (4) analyzing pooled data using a prospective meta-analytic technique, and (5) analyzing pooled data utilizing a novel simulated group-randomized design. Results Methodologies varied in their ability to incorporate data from all PNRP projects, to appropriately account for differing study designs, and to accommodate differing project sample sizes. Limitations The conclusions reached were based on expert opinion and not derived from actual analyses performed. Conclusions The ability to analyze pooled data arising from differing study designs may provide pertinent information to inform programmatic, budgetary, and policy perspectives. Multisite community-based research may not lend itself well to the more stringent explanatory and pragmatic standards of a randomized controlled trial design. Given our growing interest in community-based population research, the challenges inherent in the analysis of heterogeneous study design are likely to become more salient. Discussion of the analytic issues faced by the PNRP and the methodological approaches we considered may be of value to other prospective community-based research programs.