Abstract:
BACKGROUND:Colorectal cancer (CRC) screening by annual fecal immunochemical test (FIT) is an accessible and cost-effective strategy to lower CRC incidence and mortality. However, this mode of screening depends on follow-up colonoscopy after a positive FIT result. Unfortunately, nearly one-half of FIT-positive patients fail to complete this essential screening component. Patient navigation may improve follow-up colonoscopy adherence. To deliver patient navigation cost-effectively, health centers could target navigation to patients who are unlikely to complete the procedure on their own. OBJECTIVES:The Predicting and Addressing Colonoscopy Non-adherence in Community Settings (PRECISE) clinical trial will validate a risk model of follow-up colonoscopy adherence and test whether patient navigation raises rates of colonoscopy adherence overall and among patients in each probability stratum (low, moderate, and high probability of adherence without intervention). METHODS:PRECISE is a collaboration with a large community health center whose patient population is 37% Latino. Eligible patients will be aged 50-75, have an abnormal FIT result in the past month, and be due for a follow-up colonoscopy. Patients will be randomized to patient navigation or usual care. Primary outcomes will be colonoscopy completion within one year of a positive FIT result, cost, and cost-effectiveness. Secondary outcomes will include time to colonoscopy receipt, adequacy of bowel prep, and communication of results to primary care providers. Primary and secondary outcomes will be reported overall and by probability stratum. DISCUSSION:This innovative clinical trial will test the effectiveness and financial feasibility of using a precision health intervention to improve CRC screening completion in community health centers. TRIAL REGISTRATION:National Clinical Trial (NCT) Identifier: NCT03925883.
journal_name
Contemp Clin Trialsjournal_title
Contemporary clinical trialsauthors
Coronado GD,Johnson ES,Leo MC,Schneider JL,Smith D,Mummadi R,Petrik AF,Thompson JH,Jimenez Rdoi
10.1016/j.cct.2019.105920subject
Has Abstractpub_date
2020-02-01 00:00:00pages
105920eissn
1551-7144issn
1559-2030pii
S1551-7144(19)30636-6journal_volume
89pub_type
杂志文章abstract:BACKGROUND:Basic research suggests that rapid increases in circulating inflammatory and hemostatic blood markers may trigger or indicate impending plaque rupture and coronary thrombosis, resulting in acute ischemic heart disease (IHD) events. However, these associations are not established in humans. METHODS AND RESUL...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2014.03.009
更新日期:2014-05-01 00:00:00
abstract::First-time blood donors are essential to the US donor pool, providing nearly a third of all donations. Unfortunately, there are a wide variety of obstacles to repeat donation and new donors are extremely difficult to retain. Because each donor experiences a unique set of deterrents, we developed a post-donation interv...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2015.07.020
更新日期:2015-09-01 00:00:00
abstract:BACKGROUND:Despite efforts by the U.S. Department of Defense to train behavioral health (BH) providers in evidence-based psychotherapies (EBPs) for posttraumatic stress disorder (PTSD), numerous barriers limit EBP implementation. A context-tailored implementation approach called TACTICS (Targeted Assessment and Context...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106008
更新日期:2020-06-01 00:00:00
abstract:BACKGROUND:Children with sickle cell anemia (SCA) have an 11% risk of stroke by the age of 18. Chronic transfusion applied in patients detected to be at risk by transcranial Doppler allows a significant reduction of stroke risk. However, chronic transfusion exposes to several adverse events, including alloimmunization ...
journal_title:Contemporary clinical trials
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1016/j.cct.2017.08.008
更新日期:2017-11-01 00:00:00
abstract:INTRODUCTION:Many low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aim...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2015.10.006
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND:The comprehension of informed consent is an integral part of clinical trials. Though India is rapidly becoming a hub of clinical trials very few studies have dealt with the issue of comprehension of informed consent by the patients participating in these trials. METHODS:Patients who were invited to particip...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1016/j.cct.2009.03.005
更新日期:2009-09-01 00:00:00
abstract::Traumatic brain injury (TBI) often leads to immediate and chronic functional impairments that affect care partners, or those providing physical and/or emotional support to individuals with TBI. The many challenges associated with being a care partner often lead to caregiver burden and can compromise the well-being and...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2019.03.004
更新日期:2019-05-01 00:00:00
abstract:INTRODUCTION:Focal therapy offers the possibility of cancer control, without the side effect profile of radical therapies. Early single centre prospective development studies using high intensity focused ultrasound (HIFU) have demonstrated encouraging genitourinary functional preservation and short-term cancer control....
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究
doi:10.1016/j.cct.2013.06.005
更新日期:2013-09-01 00:00:00
abstract::A response-adaptive randomization (RAR) design refers to the method in which the probability of treatment assignment changes according to how well the treatments are performing in the trial. Holding the promise of treating more patients with the better treatments, RARs have been successfully implemented in clinical tr...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2014.11.006
更新日期:2015-01-01 00:00:00
abstract:INTRODUCTION:In promoting the health of chronically ill children, the hospital should help children cope both medically and psychosocially with their disease. The University Children's Hospital of Nancy proposes adapted physical activity for hospitalized children, but the practice during hospitalization is not well dev...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2009.12.003
更新日期:2010-03-01 00:00:00
abstract:BACKGROUND:African American (AA) women perform low levels of physical activity (PA) and are disproportionally burdened by cardiometabolic disease conditions when compared to White women and the U.S. population as a whole. These disparities emphasize the need for innovative and effective interventions to increase PA and...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2018.12.011
更新日期:2019-02-01 00:00:00
abstract::Assessing the probability that a Phase III clinical trial will demonstrate clinically relevant efficacy based on Phase II data is an important topic in clinical drug development. An accurate estimate of how likely a Phase III trial will succeed based on available data will inform the decision on whether to move an exp...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2010.08.008
更新日期:2010-11-01 00:00:00
abstract::The prevalence of obesity is high resulting from chronic imbalances between energy intake and expenditure. On the expenditure side, regular exercise is associated with health benefits, including enhanced brain function. The benefits of exercise are not immediate and require persistence to be realized. Brain regions as...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2013.11.007
更新日期:2014-01-01 00:00:00
abstract::Missing data is common in clinical trials. Depending on the volume and nature of missing data, it may reduce statistical power for detecting treatment difference, introduce potential bias and invalidate conclusions. Non-responder imputation (NRI), where patients with missing information to determine endpoint status ar...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2020.106226
更新日期:2020-11-22 00:00:00
abstract:PURPOSE:To describe the strategies-based on the social triad concept of a partnership of researchers, school personnel and community-employed to recruit low-income, minority parent/caregivers of kindergarten children into a school-based tooth decay prevention trial in the United States. METHODS:The study site was an u...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2011.09.012
更新日期:2012-01-01 00:00:00
abstract::Whole exome and whole genome sequencing are applications of next generation sequencing transforming clinical care, but there is little evidence whether these tests improve patient outcomes or if they are cost effective compared to current standard of care. These gaps in knowledge can be addressed by comparative effect...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2014.06.016
更新日期:2014-09-01 00:00:00
abstract::Cluster randomised controlled trials for health promotion, education, public health or organisational change interventions are becoming increasingly common to inform evidence-based policy. However, there is little published methodological evidence on recruitment strategies for primary care population clusters. In this...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2006.08.004
更新日期:2007-05-01 00:00:00
abstract::If randomized controlled trials (RCTs) are to fulfill their potential to allow health care providers to make informed inferences about the validity of the trials upon which they base their clinical practice, then the reporting of key methodological factors must improve. The revised Consolidated Standards for Reporting...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2005.02.008
更新日期:2005-08-01 00:00:00
abstract::Smokers are at high risk for oral disease. As a result, they represent an important target group for population-level, public oral health promotion efforts. While dental health professionals often address smoking with their patients, no systematic efforts have been made to offer smokers an intervention to improve thei...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.04.003
更新日期:2017-06-01 00:00:00
abstract::Among children with asthma, black children are two to four times as likely to have an emergency department (ED) visit and die from asthma, respectively, compared to white children in the United States. Despite the availability of evidence-based asthma management guidelines, minority children are less likely than white...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.03.015
更新日期:2017-06-01 00:00:00
abstract:INTRODUCTION:Juvenile neuronal ceroid lipofuscinosis (JNCL; Batten disease) is a rare, inherited, fatal lysosomal storage childhood disorder. True for many rare diseases, there are no treatments that impact the course of JNCL. The University of Rochester Batten Center's (URBC) mission is to find treatments to slow, hal...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2013.04.004
更新日期:2013-07-01 00:00:00
abstract::Benign prostatic hyperplasia (BPH) is a highly prevalent condition in aging men, which can be progressive and lead to acute urinary retention (AUR) and the need for surgery. It is commonly treated with alpha-blockers and 5alpha-reductase inhibitors (5ARIs), both of which improve the symptoms of BPH. Long-term treatmen...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.cct.2007.07.008
更新日期:2007-11-01 00:00:00
abstract::Ethically sound clinical research requires that prospective study participants provide voluntary informed consent before any study procedures begin. The original intent was to provide the participant with clear, accurate information about study specifics (e.g., risks/benefits) to aid in the decision to participate. Br...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2016.06.005
更新日期:2016-07-01 00:00:00
abstract::Double-blinding is an important and widely implemented feature of clinical trials although its success is rarely assessed. In a randomized, placebo-controlled trial of tea tree oil, an aromatic essential oil, for the treatment of recurrent herpes labialis (RHL), or cold sores, deception was used to prevent volunteers ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章
doi:10.1016/j.cct.2007.04.006
更新日期:2008-01-01 00:00:00
abstract::Determining the quality of a randomized clinical trial (RCT) is necessary for decision-makers to determine the believability and applicability of the trial findings. Issues that are likely to affect the utility of RCT evidence include issues of bias, random error and applicability. In this article we focus primarily o...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,评审
doi:10.1016/j.cct.2015.07.019
更新日期:2015-11-01 00:00:00
abstract:BACKGROUND:Atorvastatin and metformin are known energy restricting mimetic agents that act synergistically to produce molecular and metabolic changes in advanced prostate cancer (PCa). This trial seeks to determine whether these drugs favourably alter selected parameters in men with clinically-localized, aggressive PCa...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.06.014
更新日期:2016-09-01 00:00:00
abstract:BACKGROUND:Hypertension disproportionately affects African Americans compared to whites, and it is the single most common explanation for the disparity in mortality between African Americans and whites. Adherence with antihypertensive medications can help reduce risk of negative hypertension-related outcomes. Motivatio...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2006.04.002
更新日期:2007-02-01 00:00:00
abstract:BACKGROUND:Medicaid recipients with serious mental illness die 25-30 years earlier than people in the general population due to health conditions that are modifiable through lifestyle changes. Cardiovascular diseases from excess weight, smoking, and sedentary lifestyle contribute substantially to this life expectancy d...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2019.04.005
更新日期:2019-06-01 00:00:00
abstract:BACKGROUND:The addition of specialty palliative care to standard oncology care improves outcomes for patients with advanced cancer and their caregivers, but many lack access to specialty care services. Primary palliative care-meaning basic palliative care services provided by clinicians who are not palliative care spec...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2017.01.005
更新日期:2017-03-01 00:00:00
abstract:BACKGROUND:Many of the health behaviors known to contribute to cardiometabolic risk and disease (CMRD), including physical activity, diet, sleep, and screen time, begin during childhood. Given the population-wide burden of CMRD, novel ways of assessing risk and providing feedback to support behavior change are needed. ...
journal_title:Contemporary clinical trials
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.cct.2016.07.012
更新日期:2016-07-01 00:00:00