Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Lung Neoplasms

Breast Neoplasms

Carcinoma, Hepatocellular

Urinary Bladder Neoplasms

Liver Neoplasms

Carcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Each cluster starts receiving the intervention in sequence per cluster randomized control trial designs. Each cluster will participate in attending monthly coaching calls and compare their data on test results from pre-intervention to receiving the intervention.

When the cluster is not in active intervention, they are in the non-intervention period. The amount of time that each site contributes to the intervention depends on which cluster they belong to.

SAFER Change Package delivered using a Virtual Breakthrough Series \[VBTS\] Collaborative supplemented with automated surveillance data on test results.

SAFER TRACKS Intervention

Hardeep Singh, MD MPH

Improving communication is foundational to improving patient safety. Electronic health records (EHRs) can improve communication, but also introduce unique vulnerabilities. Failure to follow-up abnormal test results (missed results) is a key preventable factor in diagnosis and treatment delays in the VHA and often involves EHR-based communication breakdowns. Effective methods are needed to detect diagnostic delays and intervene appropriately. Manual techniques to detect care delays, such as spontaneous reporting and random chart reviews, have limited effectiveness, due in part to bias and lack of provider awareness of delays. They are also inefficient and cost-prohibitive when applied to large numbers of patients.

Diagnostic errors are considered harder to tackle, in part because they are difficult to measure. Rigorous measurement of diagnostic safety is essential and should be prioritized given the increasing amount of electronically available data. To create an effective measurement and learning program researchers must (1) ensure teams know how to take actionable steps on data and have assistance in doing so and (2) prioritize diagnostic safety at the organizational level by securing commitment from local VA leadership and clinical operations personnel. This will ensure that safety measurement will translate into action. The proposed study focuses on creating a novel program to develop and evaluate multifaceted socio-technical tools and strategies to help prevent, detect, mitigate, and ameliorate breakdowns in EHR-based communication that often lead to "missed" test results in the VHA.

The goal of this study is to develop and evaluate a new program for surveillance and improvement of test results-related diagnostic safety. The investigators will use a multifaceted measurement approach, the Virtual Breakthrough Series (VBTS) model, to account for processes of care and work systems issues as well as outcomes and implement change.

This is for Aim 2 of the study which was approved under IRB Protocol Number: H-45450. This study will implement the Change Package which was developed in the research team's recent work (Aim1, prior IRB Protocol Number: H-43661 from October 2018 - September 2019) via Virtual Breakthrough Series using a stepped-wedge cluster-randomized control trial. The study design involves random and sequential crossover of clusters from control to intervention until all clusters are exposed. A Change Package is a catalogue of evidence-based practices, change concepts, and action steps/strategies that help guide improvement efforts. VBTS involves monthly learning sessions where participants are provided with education/review of a specific component of a Change Package along with reviewing de-identified data, and having a facilitated discussion about successes, challenges, and implementation progress related to needed changes. The intervention will consist of coached implementation of the SAFER Change Package using a VBTS Collaborative, plus automated near real-time surveillance data on potentially missed test results through monthly data extraction within the Corporate Data Warehouse (CDW) platform.

The study's outcome measures will be the rate of missed test results, determined through random manual medical record review conducted nationally as part of the VHA performance-measurement system, known as the External Peer Review Program (EPRP) which has been collecting facility-level data on timeliness of communication of test results to patients within the time periods specified by VHA Directive 1088, as well as automated indicators (Triggers) of missed test results. Electronic surveillance will be made possible through the use of the research team's trigger algorithms which will determine the number of patients potentially lost to follow-up for the specified condition based on a previously validated timeframe. The triggers use the national EHR data warehouse (VINCI/CDW) to identify patients at risk for delays or patients who may have fallen through the cracks. For data surveillance, the investigators will apply five triggers to the medical record data contained within the CDW for the participating facilities during the Intervention Phase along with evaluating EPRP data. The research team hypothesizes there will be fewer missed test results in participating sites during the SAFER TRACKS Intervention as compared to during the pre-intervention period.

It's a cluster randomized control trial where 12 sites are randomized in groups of 4 in 3 clusters each.

VBTS participants, providers, and outcome assessors know about the intervention and in which conditions sites are in and when.

Measuring and Improving the Safety of Test Result Follow-Up

Number of missed test results determined by electronic indicators

Percentage of patients notified of actionable test results within seven days via EPRP

Michael E. DeBakey VA Medical Center

Baylor College of Medicine

Birmingham Veterans Affairs Health Care System

VA Office of Research and Development

Rare Diseases

Small Cell Lung Carcinoma

Carcinoma, Non-Small-Cell Lung

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Small Cell Lung Cancer

1. Aged 40 to 75 years;
2. Male smoker (≥400 cig/year), female smoker or non-smoker;
3. Visible lung nodule lesion in the chest (based on local CT result);
4. Without the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.

1. Aged 40 to 75 years;
2. Male smoker (≥400 cig/year), female smoker or non-smoker;
3. Visible lung cancer lesion in the chest (based on local CT result);
4. With the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery.

Chunxue Bai, Prof.

The purpose of this study is to verify clinical utility of a simple blood test comprising of four protein- based markers for risk stratification of patients presenting symptoms related to lung cancer.

The study is a multicenter, prospective case-control research. Totally 1,200 cases will be collected in the hospitals, with 600 cases in control group, which are not suspected as lung cancer from chest CT, and other 600 in suspected group. When inclusion into the two groups, clinical information and 10mL blood sample of the patient will be recorded and tested for cancer biomarkers, biochemical detection and cardiovascular disease biomarkers, etc. The correlation between cancer biomarker panel, CT scan result and clinical pathological diagnosis will be investigated through cases follow up. The sample size estimated above was set up according to sensitivity and specificity of biomarkers in pre-study, based on lung cancer incidence of the population. To compare the diagnostic accuracy among different cancer biomarkers through T-test, Mann-Whitney U and receiver operating characteristic (ROC) curve with SPSS 15.0 software. In statistic analysis, 0.05 is set as the p value for significance. Effectiveness of the four biomarkers panel in lung cancer diagnoses and staging will be analyzed.

10mL blood sample of the patient will be tested for cancer biomarkers, biochemical detection and cardiovascular disease biomarkers, etc.

Risk Stratification of Patients Using the Lung Cancer Biomarker Panel in China

Multicenter Study for Risk Stratification of Patients Presenting With Symptoms Related to Lung Cancer Using the Lung Cancer Biomarker Panel (LCBP) in China

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Measuring and Improving the Safety of Test Result Follow-Up	NCT04166240	Lung Cancer Breast Cancer Colon Cancer Bladder Cancer Hepatocellular ...	SAFER TRACKS In...	18 Years - 65 Years	VA Office of Research and Development
Measuring and Improving the Safety of Test Result Follow-Up	NCT04166240	Lung Cancer Breast Cancer Colon Cancer Bladder Cancer Hepatocellular ...	SAFER TRACKS In...	18 Years - 65 Years	VA Office of Research and Development
Risk Stratification of Patients Using the Lung Cancer Biomarker Panel in China	NCT01928836	Lung Neoplasms		40 Years - 75 Years	Chinese Alliance Against Lung Cancer
Risk Stratification of Patients Using the Lung Cancer Biomarker Panel in China	NCT01928836	Lung Neoplasms		40 Years - 75 Years	Chinese Alliance Against Lung Cancer
Measuring and Improving the Safety of Test Result Follow-Up	NCT04166240	Lung Cancer Breast Cancer Colon Cancer Bladder Cancer Hepatocellular ...	SAFER TRACKS In...	18 Years - 65 Years	VA Office of Research and Development

Spots Global Cancer Trial Database for delayed diagnosis