Institute's Community Clinical Oncology Research Articles

Determining the predictors of innovation implementation in healthcare: a quantitative analysis of implementation effectiveness

BackgroundThe failure rates for implementing complex innovations in healthcare organizations are high. Estimates range from 30% to 90% depending on the scope of the organizational change involved, the definition of failure, and the criteria to judge it. The innovation implementation framework offers a promising approach to examine the organizational factors that determine effective implementation. To date, the utility of this framework in a healthcare setting has been limited to qualitative studies and/or group level analyses. Therefore, the goal of this study was to quantitatively examine this framework among individual participants in the National Cancer Institute’s Community Clinical Oncology Program using structural equation modeling.MethodsWe examined the innovation implementation framework using structural equation modeling (SEM) among 481 physician participants in the National Cancer Institute’s Community Clinical Oncology Program (CCOP). The data sources included the CCOP Annual Progress Reports, surveys of CCOP physician participants and administrators, and the American Medical Association Physician Masterfile.ResultsOverall the final model fit well. Our results demonstrated that not only did perceptions of implementation climate have a statistically significant direct effect on implementation effectiveness, but physicians’ perceptions of implementation climate also mediated the relationship between organizational implementation policies and practices (IPP) and enrollment (p <0.05). In addition, physician factors such as CCOP PI status, age, radiological oncologists, and non-oncologist specialists significantly influenced enrollment as well as CCOP organizational size and structure, which had indirect effects on implementation effectiveness through IPP and implementation climate.ConclusionsOverall, our results quantitatively confirmed the main relationship postulated in the innovation implementation framework between IPP, implementation climate, and implementation effectiveness among individual physicians. This finding is important, as although the model has been discussed within healthcare organizations before, the studies have been predominately qualitative in nature and/or at the organizational level. In addition, our findings have practical applications. Managers looking to increase implementation effectiveness of an innovation should focus on creating an environment that physicians perceive as encouraging implementation. In addition, managers should consider instituting specific organizational IPP aimed at increasing positive perceptions of implementation climate. For example, IPP should include specific expectations, support, and rewards for innovation use.

Provider-based research networks and diffusion of surgical technologies among patients with early-stage kidney cancer.

Provider-based research networks such as the National Cancer Institute's Community Clinical Oncology Program (CCOP) have been shown to facilitate the translation of evidence-based cancer care into clinical practice. This study compared the utilization of laparoscopy and partial nephrectomy among patients with early-stage kidney cancer according to their exposure to CCOP-affiliated providers. With linked Surveillance, Epidemiology, and End Results-Medicare data, patients with T1aN0M0 kidney cancer who had been treated with nephrectomy from 2000 to 2007 were identified. For each patient, the receipt of care from a CCOP physician or hospital and treatment with laparoscopy or partial nephrectomy were determined. Adjusted for patient characteristics (eg, age, sex, and marital status) and other organizational features (eg, community hospital and National Cancer Institute-designated cancer center), multivariate logistic regression was used to estimate the association between each surgical innovation and CCOP affiliation. During the study interval, 1578 patients (26.8%) were treated by a provider with a CCOP affiliation. Trends in the utilization of laparoscopy and partial nephrectomy remained similar between affiliated and nonaffiliated providers (P ≥ .05). With adjustments for patient characteristics, organizational features, and clustering, no association was noted between CCOP affiliation and the use of laparoscopy (odds ratio [OR], 1.11; 95% confidence interval [CI], 0.81-1.53) or partial nephrectomy (OR, 1.04; 95% CI, 0.82-1.32) despite the more frequent receipt of these treatments in academic settings (P < .05). At a population level, patients treated by providers affiliated with CCOP were no more likely to receive at least 1 of 2 surgical innovations for treatment of their kidney cancer, indicating perhaps a more limited scope to provider-based research networks as they pertain to translational efforts in cancer care.

Provider-based research networks may improve early access to innovative colon cancer treatment for African Americans treated in the community.

African American (AA) patients with colon cancer (CC) experience worse outcomes than whites partly due to differential treatment. The National Cancer Institute's Community Clinical Oncology Program (CCOP), a provider-based research network, adopts and diffuses innovative CC treatments quickly. The authors hypothesized that CCOP participation would lessen racial differences in the receipt of oxaliplatin, an innovative treatment for CC, among patients with stage III CC in the community. Using Surveillance, Epidemiology, and End Results (SEER)-Medicare data, the authors performed a population-based retrospective cohort study of AA and white individuals aged ≥66 years who were diagnosed with AJCC stage III CC from 2003 through 2005. Generalized estimating equations were used to calculate the odds of receiving an oxaliplatin-containing regimen. Predicted probabilities of oxaliplatin receipt for race-CCOP combinations were calculated. The absolute difference in oxaliplatin receipt between races was estimated using the interaction contrast ratio. Of 2971 included individuals, 36% received oxaliplatin, 29.5% were CCOP-affiliated, and 7.6% were AA. On multivariate analysis, early diffusion of oxaliplatin was not found to be associated with race or CCOP participation. The probability of receiving oxaliplatin for AAs participating in a CCOP (0.46) was nearly double that of AAs who were not participating in a CCOP (0.25; P <.05). For white individuals, the probabilities of receiving oxaliplatin did not differ by CCOP participation. For oxaliplatin receipt, the joint effects assessment suggested a greater benefit of CCOP participation among AAs (interaction contrast ratio, 1.7). Among older patients with stage III CC, there is a differential impact of race on oxaliplatin receipt depending on CCOP participation. AAs treated by CCOPs were more likely to receive oxaliplatin than AAs treated elsewhere. Provider-based research networks may facilitate early access to innovative treatment for AAs with stage III CC.

The business case for provider participation in clinical trials research

Provider-based research networks (PBRNs) make clinical trials available in community-based practice settings, where most people receive their care, but provider participation requires both financial and in-kind contributions. The aim of this study was to explore whether providers believe there is a business case for participating in PBRNs and what factors contribute to the business case. We use a multiple case study methodology approach to examine the National Cancer Institute's community clinical oncology program, a long-standing federally funded PBRN. Interviews with 41 key informants across five sites, selected on the basis of organizational maturity, were conducted using a semistructured interview guide. We analyzed interview transcripts using an iterative, deductive process to identify themes and subthemes in the data. We found that a business case for provider participation in PBRNs may exist if both direct and indirect financial benefits are identified and included in the analysis and if the time horizon is long enough to allow those benefits to be realized. We identified specific direct and indirect financial benefits that were perceived as important contributors to the business case and the perceived length of time required for a positive return to accrue. As the lack of a business case may result in provider reluctance to participate in PBRNs, knowledge of the benefits we identified may be crucial to encouraging and sustaining participation, thereby preserving patient access to innovative community-based treatments. The results are also relevant to federally funded PBRNs outside of oncology or to providers considering participation in any clinical trials research.

Achieving high cancer control trial enrollment in the community setting: An analysis of the Community Clinical Oncology Program

Determining the factors that lead to successful enrollment of patients in cancer control clinical trials is essential as cancer patients are often burdened with side effects such as pain, nausea, and fatigue. One promising intervention for increasing enrollment in cancer control trials is the National Cancer Institute's Community Clinical Oncology Program (CCOP). In this article, we examined CCOP staffing, policies, and procedures associated with enrollment in control trials. Data were obtained from three sources: the online CCOP, MB-CCOP, and Research Base Management System, CCOP Annual Progress Reports, and a survey of CCOP Administrators conducted in 2011. We analyzed cancer control trial accrual in 2011 among 46 CCOPs using multivariate regression. Three factors were significant predictors of accrual. First, having a team of staff dedicated to enrolling patients in control and prevention trials, compared to having no dedicated staff, was associated on average with an additional 30 patients enrolled in control trials (p<0.05). Second, CCOPs that recognized physicians for enrolling a large number of patients compared to CCOPs that did not recognize high enrolling physicians enrolled on average an additional 25 patients in control trials (p<0.05). Lastly, the number of cancer control trials available was also associated with enrollment (β=5.50, p<0.00). Our results indicate that CCOPs looking to increase enrollment in control trials should consider dedicating a team of staff to enroll patients in these types of trials. In addition, CCOPs or other volunteer research systems looking to increase physician participation should consider recognizing high enrolling physicians.

Why providers participate in clinical trials: Considering the National Cancer Institute's Community Clinical Oncology Program

BackgroundThe translation of research evidence into practice is facilitated by clinical trials such as those sponsored by the National Cancer Institute's Community Clinical Oncology Program (CCOP) that help disseminate cancer care innovations to community-based physicians and provider organizations. However, CCOP participation involves unsubsidized costs and organizational challenges that raise concerns about sustained provider participation in clinical trials. ObjectivesThis study was designed to improve our understanding of why providers participate in the CCOP in order to inform the decision-making process of administrators, clinicians, organizations, and policy-makers considering CCOP participation. Research methodsWe conducted a multi-site qualitative study of five provider organizations engaged with the CCOP. We interviewed 41 administrative and clinician key informants, asking about what motivated CCOP participation, and what benefits they associated with involvement. We deductively and inductively analyzed verbatim interview transcripts, and explored themes that emerged. ResultsInterviewees expressed both “altruistic” and “self-interested” motives for CCOP participation. Altruistic reasons included a desire to increase access to clinical trials and feeling an obligation to patients. Self-interested reasons included the desire to enhance reputation, and a need to integrate disparate cancer care activities. Perceived benefits largely matched expressed motives for CCOP participation, and included internal and external benefits to the organization, and quality of care benefits for both patients and participating physicians. ConclusionThe motives and benefits providers attributed to CCOP participation are consistent with translational research goals, offering evidence that participation can contribute value to providers by expanding access to innovative medical care for patients in need.

Why providers participate in clinical trials: Considering the National Cancer Institute's Community Clinical Oncology Program

Why providers participate in clinical trials: Considering the National Cancer Institute's Community Clinical Oncology Program

Sustainability and performance of the National Cancer Institute's Community Clinical Oncology Program

Sustainability and performance of the National Cancer Institute's Community Clinical Oncology Program

A method for analyzing the business case for provider participation in the National Cancer Institute's Community Clinical Oncology Program and similar federally funded, provider-based research networks: Analyzing the Business Case for Research

A method for analyzing the business case for provider participation in the National Cancer Institute's Community Clinical Oncology Program and similar federally funded, provider-based research networks: Analyzing the Business Case for Research

A method for analyzing the business case for provider participation in the National Cancer Institute's Community Clinical Oncology Program and similar federally funded, provider‐based research networks

The Community Clinical Oncology Program (CCOP) plays an essential role in the efforts of the National Cancer Institute (NCI) to increase enrollment in clinical trials. Currently, there is little practical guidance in the literature to assist provider organizations in analyzing the return on investment (ROI), or business case, for establishing and operating a provider-based research network (PBRN) such as the CCOP. In this article, the authors present a conceptual model of the business case for PBRN participation, a spreadsheet-based tool and advice for evaluating the business case for provider participation in a CCOP organization. A comparative, case-study approach was used to identify key components of the business case for hospitals attempting to support a CCOP research infrastructure. Semistructured interviews were conducted with providers and administrators. Key themes were identified and used to develop the financial analysis tool. Key components of the business case included CCOP start-up costs, direct revenue from the NCI CCOP grant, direct expenses required to maintain the CCOP research infrastructure, and incidental benefits, most notably downstream revenues from CCOP patients. The authors recognized the value of incidental benefits as an important contributor to the business case for CCOP participation; however, currently, this component is not calculated. The current results indicated that providing a method for documenting the business case for CCOP or other PBRN involvement will contribute to the long-term sustainability and expansion of these programs by improving providers' understanding of the financial implications of participation.

Sustainability and performance of the National Cancer Institute's Community Clinical Oncology Program

Introduction The National Cancer Institute's (NCI) Community Clinical Oncology Program (CCOP) contributes one third of NCI treatment trial enrollment (“accrual”) and most cancer prevention and control (CP/C) trial enrollment. Prior research indicated that the local clinical environment influenced CCOP accrual performance during the 1990s. As the NCI seeks to improve the operations of the clinical trials system following critical reports by the Institute of Medicine and the NCI Operational Efficiency Working Group, the current relevance of the local environmental context on accrual performance is unknown. Materials and methods This longitudinal quasi-experimental study used panel data on 45 CCOPs nationally for years 2000–2007. Multivariable models examine organizational, research network, and environmental factors associated with accrual to treatment trials, CP/C trials, and trials overall. Results For total trial accrual and treatment trial accrual, the number of active CCOP physicians and the number of trials were associated with CCOP performance. Factors differ for CP/C trials. CCOPs in areas with fewer medical school-affiliated hospitals had greater treatment trial accrual. Conclusions Findings suggest a shift in the relevance of the clinical environment since the 1990s, as well as changes in CCOP structure associated with accrual performance. Rather than a limited number of physicians being responsible for the preponderance of trial accrual, there is a trend toward accrual among a larger number of physicians each accruing relatively fewer patients to trial. Understanding this dynamic in the context of CCOP efficiency may inform and strengthen CCOP organization and physician practice.

Nicotine patch vs. nicotine lozenge for smoking cessation: An effectiveness trial coordinated by the Community Clinical Oncology Program

Background Nicotine replacement therapies are efficacious for treating nicotine dependence. However, limited data exist on benefits of different NRTs and predictors of treatment outcome. This study compared the effectiveness of transdermal nicotine vs. nicotine lozenge for smoking cessation and identified predictors of treatment response. Methods A randomized, open-label effectiveness trial was conducted at 12 medical sites participating in the National Cancer Institute's Community Clinical Oncology Program. The sample consisted of 642 treatment-seeking smokers randomized to 12 weeks of transdermal nicotine or nicotine lozenge. Results Smoker characteristics were assessed at baseline, and 24-h point prevalence abstinence confirmed with breath carbon monoxide (CO) was evaluated at end of treatment (EOT) and at a 6-month follow-up. There was a trend for higher quit rates for transdermal nicotine vs. nicotine lozenge at EOT (24.3% vs. 18.7%, p = .10) and 6 months (15.6% vs. 10.9%, p = .10). A logistic regression model of EOT quit rates showed smokers who preferred transdermal nicotine, were not reactive to smoking cues, and did not use nicotine to alleviate distress or stimulate cognitive function had higher quit rates on transdermal nicotine. A logistic regression model of 6-month quit rates showed smokers who preferred transdermal nicotine had higher quit rates on transdermal nicotine, and smokers who used nicotine to alleviate distress or stimulate cognitive processes had lower quit rates on nicotine lozenge. Conclusions Transdermal nicotine may be more effective than nicotine lozenge for smokers who prefer transdermal nicotine and do not smoke to alleviate emotional distress or stimulate cognitive function.

A Phase II/III Randomized, Placebo-Controlled, Double-Blind Clinical Trial of Ginger (Zingiber officinale) for Nausea Caused by Chemotherapy for Cancer: A Currently Accruing URCC CCOP Cancer Control Study

Despite the widespread use of 5-HT3 receptor antagonist antiemetics such as ondansetron and granistron, up to 70% of patients with cancer receiving highly emetogenic chemotherapy agents experience postchemotherapy nausea and vomiting. Delayed postchemotherapy nausea (nausea that occurs ≥ 24 hours after chemotherapy administration) and anticipatory nausea (nausea that develops before chemotherapy administration, in anticipation of it) are poorly controlled by currently available antiemetic agents. Scientific studies suggest that ginger (Zingiber officinale) might have beneficial effects on nausea and vomiting associated with motion sickness, surgery, and pregnancy. In 2 small studies of patients with cancer receiving chemotherapy, addition of ginger to standard antiemetic medication further reduced the severity of postchemotherapy nausea. This article describes a phase II/III randomized, dose-finding, placebo-controlled, double-blind clinical trial to assess the efficacy of ginger for nausea associated with chemotherapy for cancer. The study is currently being conducted by private practice oncology groups that are funded by the National Cancer Institute's Community Clinical Oncology Program and affiliated with the University of Rochester Cancer Center Community Clinical Oncology Program Research Base.

The Effects of Managed Care and Competition on Community-Based Clinical Research

The National Institutes of Health is developing practice-based clinical research networks (PBRNs) to expedite the pace of scientific discovery and improve care quality. Anecdotal evidence suggests managed care penetration and provider competition negatively affect PBRN clinical research. The objective of this study is to examine the effects of environmental factors on clinical research performance in the National Cancer Institute's Community Clinical Oncology Program (CCOP). This study examined 49 CCOPs in 34 states using longitudinal (1991-2001) generalized least-squares regression including fixed effects, using secondary data from the National Cancer Institute, Group Health Association of America, InterStudy, American Hospital Association, Area Resource Files, and the Current Population Survey. Performance was measured as CCOP-level accrual in treatment trials, cancer prevention and control (CP/C) trials, and all trials combined. HMO penetration served as a proxy for managed care penetration. Competition measures included both hospital competition and physician competition. Managed care penetration was positively associated with accrual in areas of low to moderate penetration and negative in the areas of high penetration. Compared with areas with 5% penetration, areas with 15% penetration had 21% more treatment accrual and 66% more CP/C accrual. Compared with areas with 40% penetration, areas with 50% penetration had 11% lower treatment accrual and 3% lower CP/C accrual. CP/C accrual was more positively affected than treatment accrual. Greater hospital competition was associated with a decline in trial enrollment. The healthcare environment appears to have a significant effect on accrual into community-based cancer treatment and CP/C clinical trials. Findings for treatment and CP/C accrual suggest each type of accrual is distinct and requires different strategies and administrative methods.