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Organizational and physician factors associated with patient enrollment in cancer clinical trials.

ABSTRACT: Our purpose was to identify physicians' individual characteristics, attitudes, and organizational contextual factors associated with higher enrollment of patients in cancer clinical trials among physician participants in the National Cancer Institute's Community Clinical Oncology Program (CCOP). We hypothesized that physicians' individual characteristics, such as age, medical specialty, tenure, CCOP organizational factors (i.e. policies and procedures to encourage enrollment), and attitudes toward participating in CCOP would directly determine enrollment. We also hypothesized that physicians' characteristics and CCOP organizational factors would influence physicians' attitudes toward participating in CCOP, which in turn would predict enrollment.We evaluated enrollment in National Cancer Institute-sponsored cancer clinical trials in 2011 among 481 physician participants using Structural Equation Modeling. The data sources include CCOP Annual Progress Reports, two surveys of CCOP administrators and physician participants, and the American Medical Association Masterfile.Physicians with more positive attitudes toward participating in CCOP enrolled more patients than physicians with less positive attitudes. In addition, physicians who practiced in CCOPs that had more supportive policies and practices in place to encourage enrollment (i.e. offered trainings, provided support to screen and enroll patients, gave incentives to enroll patients, instituted minimum accrual expectations) also significantly enrolled more patients. Physician status as CCOP Principal Investigator had a positive direct effect on enrollment, while physician age and non-oncology medical specialty had negative direct effects on enrollment. Neither physicians' characteristics nor CCOP organizational factors indirectly influenced enrollment through an effect on physician attitudes.We examined whether individual physicians' characteristics and attitudes, as well as CCOP organizational factors, influenced patient enrollment in cancer clinical trials among CCOP physicians. Physician attitudes and CCOP organizational factors had positive direct effects, but not indirect effects, on physician enrollment of patients. Our results could be used to develop physician-directed strategies aimed at increasing involvement in clinical research. For example, administrators may want to ensure physicians have access to support staff to help screen and enroll patients or institute minimum accrual expectations. Our results also highlight the importance of recruiting physicians for volunteer clinical research programs whose attitudes and values align with programmatic goals. Given that physician involvement is a key determinant of patient enrollment in clinical trials, these interventions could expand the overall number of patients involved in cancer research. These strategies will be increasingly important as the CCOP network continues to evolve.

SUBMITTER: Jacobs SR

PROVIDER: S-EPMC4156916 | biostudies-literature | 2014 Oct

REPOSITORIES: biostudies-literature

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Organizational and physician factors associated with patient enrollment in cancer clinical trials.

Jacobs Sara R SR Weiner Bryan J BJ Reeve Bryce B BB Weinberger Morris M Minasian Lori M LM Good Marjorie J MJ

Clinical trials (London, England) 20140605 5

<h4>Background</h4>Our purpose was to identify physicians' individual characteristics, attitudes, and organizational contextual factors associated with higher enrollment of patients in cancer clinical trials among physician participants in the National Cancer Institute's Community Clinical Oncology Program (CCOP). We hypothesized that physicians' individual characteristics, such as age, medical specialty, tenure, CCOP organizational factors (i.e. policies and procedures to encourage enrollment), ...[more]

PMID: 24902923

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Project description:ImportancePatient withdrawal of consent from a cancer clinical trial is defined as a patient's volitional cessation of participation in all matters related to a trial. It can undermine the trial's purpose, make the original sample size and power calculations irrelevant, introduce bias between trial arms, and prolong the time to trial completion.ObjectiveTo report rates of and baseline factors associated with withdrawal of consent among patients in cancer clinical trials.Design, setting, and participantsThis multisite observational cohort study was conducted through the Alliance for Clinical Trials in Oncology. Patient withdrawal was defined as a patient's voluntary termination of consent to participate anytime during trial conduct. Baseline patient- and trial-based factors were investigated for their associations with patient withdrawal within the first 2 years using logistic regression models. All patients who participated in cancer therapeutic clinical trials conducted within the Alliance for Clinical Trials in Oncology from 2013 through 2019 were included. The data lock date was January 23, 2022.Main outcomes and measuresThe percentage of patients who withdrew consent in 2 years and factors associated with withdrawal of consent.ResultsA total of 11 993 patients (median age, 62 years; 67% female) from 58 trials were included. Within 2 years, 1060 patients (9%) withdrew from their respective trials. Two-year rates of withdrawal were 5.7%, 7.6%, 8.5%, 7.8%, 8.4%, 9.5%, and 9.8% for each of the respective years from 2013 through 2019. In multivariable analyses, Hispanic ethnicity (odds ratio [OR], 1.67; 95% CI, 1.30-2.15; P < .001), randomized design with placebo (OR, 1.64; 95% CI, 1.38-1.94; P < .001), and patient age 75 years and older (OR, 1.39; 95% CI, 1.12-1.72; P = .003) were associated with higher likelihood of withdrawal by 2 years. Use of radiation was associated with patient retention (OR, 0.68; 95% CI, 0.54-0.86; P = .001).Conclusions and relevanceIn this cohort study, rates of withdrawal of consent were less than 10% and appeared consistent over time. Factors that are associated with withdrawal of consent should be considered when designing trials and should be further studied to learn how they can be favorably modified.

Project description:ObjectiveTo examine the extent to which medical group and market factors are related to individual primary care physician (PCP) performance on patient experience measures.Data sourcesThis study employs Clinician and Group CAHPS survey data (n=105,663) from 2,099 adult PCPs belonging to 34 diverse medical groups across California. Medical group directors were interviewed to assess the magnitude and nature of financial incentives directed at individual physicians and the adoption of patient experience improvement strategies. Primary care services area (PCSA) data were used to characterize the market environment of physician practices.Study designWe used multilevel models to estimate the relationship between medical group and market factors and physician performance on each Clinician and Group CAHPS measure. Models statistically controlled for respondent characteristics and accounted for the clustering of respondents within physicians, physicians within medical groups, and medical groups within PCSAs using random effects.Principal findingsCompared with physicians belonging to independent practice associations, physicians belonging to integrated medical groups had better performance on the communication ( p=.007) and care coordination ( p=.03) measures. Physicians belonging to medical groups with greater numbers of PCPs had better performance on all measures. The use of patient experience improvement strategies was not associated with performance. Greater emphasis on productivity and efficiency criteria in individual physician financial incentive formulae was associated with worse access to care ( p=.04). Physicians located in PCSAs with higher area-level deprivation had worse performance on the access to care ( p=.04) and care coordination ( p<.001) measures.ConclusionsPhysicians from integrated medical groups and groups with greater numbers of PCPs performed better on several patient experience measures, suggesting that organized care processes adopted by these groups may enhance patients' experiences. Physicians practicing in markets with high concentrations of vulnerable populations may be disadvantaged by constraints that affect performance. Future studies should clarify the extent to which performance deficits associated with area-level deprivation are modifiable.

Project description:BACKGROUND:Cancer clinical trials are essential for testing new treatments and represent state-of-the-art cancer treatment, but only a small percentage of patients ever enroll in a trial. Under-enrollment is an even greater problem among minorities, particularly African Americans, representing a racial/ethnic disparity in cancer care. One understudied cause is patient-physician communication, which is often of poor quality during clinical interactions between African-American patients and non-African-American physicians. Partnering Around Cancer Clinical Trials (PACCT) involves a transdisciplinary theoretical model proposing that patient and physician individual attitudes and beliefs and their interpersonal communication during racially discordant clinical interactions influence outcomes related to patients' decisions to participate in a trial. The overall goal of the study is to test a multilevel intervention designed to increase rates at which African-American and White men with prostate cancer make an informed decision to participate in a clinical trial. METHODS/DESIGN:Data collection will occur at two NCI-designated comprehensive cancer centers. Participants include physicians who treat men with prostate cancer and their African-American and White patients who are potentially eligible for a clinical trial. The study uses two distinct research designs to evaluate the effects of two behavioral interventions, one focused on patients and the other on physicians. The primary goal is to increase the number of patients who decide to enroll in a trial; secondary goals include increasing rates of physician trial offers, improving the quality of patient-physician communication during video recorded clinical interactions in which trials may be discussed, improving patients' understanding of trials offered, and increasing the number of patients who actually enroll. Aims are to 1) determine the independent and combined effects of the two interventions on outcomes; 2) compare the effects of the interventions on African-American versus White men; and 3) examine the extent to which patient-physician communication mediates the effect of the interventions on the outcomes. DISCUSSION:PACCT has the potential to identify ways to increase clinical trial rates in a diverse patient population. The research can also improve access to high quality clinical care for African American men bearing the disproportionate burden of disparities in prostate and other cancers. TRIAL REGISTRATION:Clinical Trials.gov registration number: NCT02906241 (September 8, 2016).

Project description:ImportanceConsolidation among physician practices and between hospitals and physician practices has accelerated in the past decade, resulting in higher prices in commercial markets. The resulting integration of health care across clinicians and participation in alternative payment models (APMs), which aim to improve quality while constraining spending, are cited as reasons for consolidation, but little is known about the association between integration and APM participation.ObjectiveTo examine the association of organizational characteristics, ownership, and integration with intensity of participation in APMs among physician practices.Design, setting, and participantsA cross-sectional descriptive study, adjusted for sampling and nonresponse weights, was conducted in US physician practice respondents to the National Survey of Healthcare Organizations and Systems conducted between June 16, 2017, and August 17, 2018; of 2333 responses received (response rate, 46.9%) and after exclusion of ineligible and incomplete responses, the number of practices included in the analysis was 2061. Data analysis was performed from April 1, 2019, to August 31, 2019.ExposuresSelf-reported physician practice characteristics, including ownership, integration (clinical, cultural, financial, and functional), care delivery capabilities, activities, and environmental factors.Main outcomes and measuresParticipation in APMs: (1) bundled payments, (2) comprehensive primary care and medical home programs, (3) pay-for-performance programs, (4) capitated contracts with commercial health plans, and (5) accountable care organization contracts.ResultsA total of 49.2% of the 2061 practices included reported participating in 3 or more APMs; most participated in pay-for-performance and accountable care organization models. Covariate-adjusted analyses suggested that operating within a health care system (odds ratio [OR] for medical group: 2.35; 95% CI, 1.70-3.25; P < .001; simple health system: 1.46; 95% CI, 1.08-1.97; P = .02; and complex health system: 1.76; 95% CI, 1.25-2.47; P = .001 relative to independent practices), greater clinical (OR, 4.68; 95% CI, 2.28-9.59; P < .001) and functional (OR, 4.24; 95% CI, 2.00-8.97; P < .001) integration, and being located in the Northeast (OR for Midwest: 0.47; 95% CI, 0.34-0.65; P < .001; South: 0.47; 95% CI, 0.34-0.66; P < .001; and West: 0.64; 95% CI, 0.46-0.91; P = .01) were associated with greater APM participation.Conclusions and relevanceGreater APM participation appears to be supported by integration and system ownership.

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Organizational and physician factors associated with patient enrollment in cancer clinical trials.

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Organizational and physician factors associated with patient enrollment in cancer clinical trials.

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