Patient navigation and clinical trial participation: A randomized controlled trial design.
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ABSTRACT: Background
To our knowledge, no published studies utilizing a randomized controlled design have examined the efficacy of patient navigation for improving clinical trial enrollment.Methods
This patient navigation and clinical trial participation study is a randomized controlled trial to assess the effect of a patient navigator on enrollment into therapeutic cancer clinical trials. Participants are randomly assigned to high intensity, patient navigator-delivered patient educational materials (PEM) and needs assessment vs. low intensity patient navigation (patient navigator-delivered patient educational materials [PEM] alone). Discussion: Effective enrollment strategies may include utilization of patient navigators as away to meet individual needs, barriers, and concerns of participants enrolled in clinical trials.
SUBMITTER: Uveges MK
PROVIDER: S-EPMC6197623 | biostudies-literature | 2018 Dec
REPOSITORIES: biostudies-literature
Publications
Patient navigation and clinical trial participation: A randomized controlled trial design.
Uveges Melissa Kurtz MK Lansey Dina George DG Mbah Olive O Gray Tamryn T Sherden Lisa L Wenzel Jennifer J
Contemporary clinical trials communications 20180922
<h4>Background</h4>To our knowledge, no published studies utilizing a randomized controlled design have examined the efficacy of patient navigation for improving clinical trial enrollment.<h4>Methods</h4>This patient navigation and clinical trial participation study is a randomized controlled trial to assess the effect of a patient navigator on enrollment into therapeutic cancer clinical trials. Participants are randomly assigned to high intensity, patient navigator-delivered patient educational ...[more]
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Project description:OBJECTIVES/HYPOTHESIS:To assess the efficacy of a patient navigator intervention to decrease nonadherence to obtain audiological testing following failed screening, compared to those receiving the standard of care. METHODS:Using a randomized controlled design, guardian-infant dyads, in which the infants had abnormal newborn hearing screening, were recruited within the first week after birth. All participants were referred for definitive audiological diagnostic testing. Dyads were randomized into a patient navigator study arm or standard of care arm. The primary outcome was the percentage of patients with follow-up nonadherence to obtain diagnostic testing. Secondary outcomes were parental knowledge of infant hearing testing recommendations and barriers in obtaining follow-up testing. RESULTS:Sixty-one dyads were enrolled in the study (patient navigator arm?=?27, standard of care arm?=?34). The percentage of participants nonadherent to diagnostic follow-up during the first 6 months after birth was significantly lower in the patient navigator arm compared with the standard of care arm (7.4% vs. 38.2%) (P?=?.005). The timing of initial follow-up was significantly lower in the navigator arm compared with the standard of care arm (67.9 days after birth vs. 105.9 days, P?=?.010). Patient navigation increased baseline knowledge regarding infant hearing loss diagnosis recommendations compared with the standard of care (P?=?.004). CONCLUSIONS:Patient navigation decreases nonadherence rates following abnormal infant hearing screening and improves knowledge of follow-up recommendations. This intervention has the potential to improve the timeliness of delivery of infant hearing healthcare; future research is needed to assess the cost and feasibility of larger scale implementation. LEVEL OF EVIDENCE:1b. Laryngoscope, 127:S1-S13, 2017.
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Project description:Demonstrating clinical utility for diagnostic tests and securing coverage and reimbursement requires high quality and, ideally, randomized controlled trial (RCT) data. Traditional RCTs are often too costly, slow, and cumbersome for diagnostic firms. Alternative data options are needed. We evaluated four RCTs using virtual patients to demonstrate clinical utility. Each study used a similar pre-post intervention, two round design to facilitate comparison. Representative samples of physicians were recruited and randomized into control and intervention arms. All physicians were asked to care for their virtual patients during two assessment rounds, separated by a multi-week time interval. Between rounds, intervention physicians reviewed educational materials on the diagnostic test. All physician responses were scored against evidence-based care criteria. RCTs using virtual patients can demonstrate clinical utility for a variety of diagnostic test types, including: (1) an advanced multi-biomarker blood test, (2) a chromosomal microarray, (3) a proteomic assay analysis, and (4) a multiplex immunofluorescence imaging platform. In two studies, utility was demonstrated for all targeted patient populations, while in the other two studies, utility was only demonstrated for a select sub-segment of the intended patient population. Of these four tests, two received positive coverage decisions from Palmetto, one utilized the study results to support commercial payer adjudications, and the fourth company went out of business. RCTs using virtual patients are a cost-effective approach to demonstrate the presence or absence of clinical utility.
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Project description:Cancer health disparities affecting low-income and minority patients are well documented. Root-causes are multifactorial, including diagnostic and treatment delays, social and financial barriers, and poor communication. Patient navigation and communication coaching (activation) are potential interventions to address disparities in cancer treatment. The purpose of this clinical trial is to test the effectiveness of an intervention combining patient navigation and activation to improve cancer treatment.The Rochester Patient Navigation Research Program (PNRP) is a National Cancer Institute-sponsored, patient-level randomized trial (RCT) of patient navigation and activation, targeting newly-diagnosed breast and colorectal cancer patients in Rochester, NY. The goal of the program is to decrease cancer health disparities by addressing barriers to receipt of cancer care and promoting patient self-efficacy. The intervention uses trained, paraprofessional patient navigators recruited from the target community, and a detailed training and supervisory program. Recruited patients are randomly assigned to receive either usual care (except for baseline and follow-up questionnaires and interviews) or intervention. The intervention patients receive tailored assistance from their patient navigators, including phone calls, in-person meetings, and behind-the-scenes coordination of care. A total of 344 patients have been recruited. Outcomes measured at three month intervals include timeliness of care, patient adherence, patient satisfaction, quality of life, self-efficacy, health literacy, and cancer knowledge.This unique intervention combining patient navigation and patient activation is designed to address the multifactorial problem of cancer health disparities. If successful, this study will affect the design and implementation of patient navigation programs.clinicaltrials.gov identifier NCT00496678.
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Project description:Latino Medicare enrollees report suboptimal rates of colorectal cancer screening (CRCS) despite Medicare policies designed to improve CRCS access for older persons. Patient navigation (PN) may address many underlying barriers to CRCS, yet little is known about the effectiveness of PN to increase CRCS adherence among Latino Medicare enrollees.Using a randomized controlled trial study design, we evaluated tailored PN delivered outside of primary care settings as an intervention to increase CRCS adherence in this population. Intervention participants (n = 135) received tailored PN services which included education, counseling, and logistical support administered in their language of choice. Comparison participants (n = 168) received mailed cancer education materials. We compared CRCS rates between interventions and used multivariable logistic regression to assess the odds of CRCS adherence for PN versus comparison groups after adjusting for covariates of interest.More navigated than non-navigated participants became CRCS adherent during the study period (43.7 vs. 32.1%, p = 0.04). The odds of CRCS adherence were significantly higher for PN relative to comparison participants before and after adjusting for covariates (unadjusted OR 1.64, p = 0.04; adjusted OR 1.82, p = 0.02). Higher CRCS adherence rates were observed primarily in the uptake of endoscopic screening methods.This study demonstrates that PN delivered outside of the primary care environment is modestly effective in increasing CRCS adherence among Latino Medicare enrollees. This intervention strategy should be further evaluated as a complement to primary care-based PN and other care coordination strategies to increase adherence with CRCS and other evidence-based screenings among older Latinos.
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Project description:BackgroundPatient 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.MethodsA 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.ResultsAmong 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.ConclusionsIn this randomized trial of patient navigation, there was no statistically significant effect on disease-specific QOL.ImpactThese 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.
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Project description:To describe the rationale and design of an NIH funded randomized controlled trial: the Patient Activation after DXA Result Notification (PAADRN) study. The aim of this trial is to evaluate the effect that a direct mailing of Dual-Energy X-ray Absorptiometry (DXA) results from bone density testing centers to patients will have on patients' knowledge, treatment and self-efficacy.We will enroll approximately 7500 patients presenting for DXA at three study sites, the University of Iowa, the University of Alabama at Birmingham, and Kaiser Permanente of Atlanta, Georgia. We will randomize providers (and their respective patients) to either the intervention arm or usual care. Patients randomized to the intervention group will receive a letter with their DXA results and an educational brochure, while those randomized to usual care will receive their DXA results according to standard practice. The seven discrete outcomes are changes from baseline to 12-weeks and/or 52-weeks post-DXA in: (1) guideline concordant pharmacologic and non-pharmacologic therapy; (2) knowledge of DXA results; (3) osteoporosis-specific knowledge; (4) general health-related quality of life; (5) satisfaction with bone-related health care, (6) patient activation; and, (7) osteoporosis-specific self-efficacy.This trial will offer evidence of the impact of a novel approach-direct-to-patient mailing of test results-to improve patient activation in their bone health care. The results will inform clinical practice for the communication of DXA and other test results.
| S-EPMC3525745 | biostudies-other
Project description:PurposeStudies have shown an association between socioeconomic status (SES) and quality of oncology care, but less is known about the impact of patient SES on clinical trial participation.Patients and methodsWe assessed clinical trial participation patterns according to important SES (income, education) and demographic factors in a large sample of patients surveyed via an Internet-based treatment decision tool. Logistic regression, conditioning on type of cancer, was used. Attitudes toward clinical trials were assessed using prespecified items about treatment, treatment tolerability, convenience, and cost.ResultsFrom 2007 to 2011, 5,499 patients were successfully surveyed. Forty percent discussed clinical trials with their physician, 45% of discussions led to physician offers of clinical trial participation, and 51% of offers led to clinical trial participation. The overall clinical trial participation rate was 9%. In univariate models, older patients (P = .002) and patients with lower income (P = .001) and education (P = .02) were less likely to participate in clinical trials. In a multivariable model, income remained a statistically significant predictor of clinical trial participation (odds ratio, 0.73; 95% CI, 0.57 to 0.94; P = .01). Even in patients age ? 65 years, who have universal access to Medicare, lower income predicted lower trial participation. Cost concerns were much more evident among lower-income patients (P < .001).ConclusionLower-income patients were less likely to participate in clinical trials, even when considering age group. A better understanding of why income is a barrier may help identify ways to make clinical trials better available to all patients and would increase the generalizability of clinical trial results across all income levels.
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