Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Lung Neoplasms

Prostatic Neoplasms

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.

The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a "View Alert" window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.

Contact Intervention

Hardeep Singh, MD MPH

Diagnostic delays in ambulatory care are often due to breakdowns of related care processes. Electronic systems can improve follow-up and reduce delays by detecting missed appointments or incomplete procedures so that patients are called back to conduct timely investigations when appropriate. To achieve high standards of patient safety in cancer diagnosis, the investigators not only need to use information technology appropriately but also improve the processes, policies, and procedures of monitoring, communication, and coordination of care.

Given the importance of cancer-related diagnostic delays in ambulatory care, the investigators need effective methods to detect them, understand their causes, and intervene to reduce them. Manual techniques to detect these delays, such as spontaneous reporting and random chart reviews, have limited effectiveness. Our proposed study focuses on testing methods to proactively identify delays using certain "triggers" as they occur and intervene in a timely manner.

The goal of this proposal is to demonstrate and test methods by which large health care systems can efficiently identify cancer patients who are more likely to experience diagnostic delays and pre-emptively rectify these delays. This study will build upon tools developed in our recent work (Aim1, prior IRB Protocol Number: H-23801) and test their effectiveness to identify patients at risk of experiencing delays in cancer diagnosis followed by an intervention that the investigators hypothesize will reduce these delays.

This is Aim 2 (for which the investigators are seeking approval) is the final Aim of this proposal. Aim 1 was approved under Protocol Number: H-23801.

In Aim 2 the investigators will determine the effectiveness of an IT-based intervention (consisting of data mining using triggers tested in Aim 1 followed by targeted electronic communication and surveillance techniques) to facilitate cancer diagnosis as compared with usual care (no use of trigger or electronic communication and surveillance). Hypothesis 1: The time from first appearance of a diagnostic clue to follow-up action (e.g. colonoscopy performance after a positive FOBT) will be significantly less in the intervention arm than in usual care. Hypothesis 2: The percentage of patients receiving timely follow-up care will be significantly more in the intervention arm than in usual care. To improve the generalizability of our findings to multiple ambulatory care environments, the investigators will conduct our research in two settings: an urban Veterans Affairs facility in Houston, Texas and a large primary care network in central Texas. These settings include internal medicine and family medicine, academic and nonacademic practices, and significant racial, gender, ethnic, age, urban/rural, and socioeconomic diversity. Our study addresses coordination and timeliness of care, both of which are priorities to achieve high quality care.

Hypothesis 3: Overall, the trigger will achieve a positive predictive value (PPV) of at least 50% in identifying delays in care. PPV is defined as the number of charts correctly identified with a delay in diagnostic evaluation, divided by the total number of charts identified by the trigger, and was deemed to be the approximately level necessary to avoid substantial contribution to provider alert fatigue.

Effectiveness of Electronic Health Record-Based Interventions for Improving Follow-Up in Primary Care

Differences between the intervention and control groups (based on a Cox Proportional Hazards Survival Analysis) in median time to documented follow-up of a red flag (e.g., colonoscopy performance after positive FOBT) or of a deliberate decision by the treating provider not to take follow-up action. When less than 50% of patients in either group received diagnostic evaluation (ie, medians were not reached), the point at which 40% received diagnostic evaluation was compared instead.

The percentage of patients receiving timely follow-up care, as defined by action taken by provider within appropriate pre-defined time intervals for each diagnostic clue, in both intervention and control groups.

This is a descriptive sub-analysis looking only at cases with no follow-up at the end of the follow-up period. Specifically, out of the cases that never got follow-up, this represents the percent of that subsample that had no justification in the medical record for the lack of follow-up. This is based on manual chart reviews.

Subsequent diagnosis of nonmalignant neoplasia, cancer, or death, and treatments required as a result of new cancer diagnoses after a pre-specified interval.

Positive Predictive Values of each of the triggers in identifying patients with a true delay in diagnostic evaluation. Calculated as: percentage of patients identified as trigger positive that actually had a delay.

Scott and White Hospital & Clinic

Baylor College of Medicine

Principal Investigator

The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.

Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.

Usual Care Control

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Number of Comorbidities

Dr. Hardeep Singh

Time to Follow-up of Colorectal Trigger

Time to Follow-up of Prostate Trigger

Time to Follow-up of Lung Trigger

Differences in Time to Documented Follow-up of a Red Flag Suggestive of Cancer

Percentage of Patients Receiving Timely Follow-up of a Red Flag Suggestive of Cancer

Percentage of Cases With no Documented Justification for no Follow-up

Number of Participants Diagnosed With Cancer After Delay in Diagnostic Evaluation

Trigger Positive Predictive Value

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Carcinoma, Hepatocellular

Urinary Bladder Neoplasms

Liver Neoplasms

Carcinoma

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effectiveness of Electronic Health Record-Based Interventions for Improving Follow-Up in Primary Care	NCT01346839	Colon Cancer Lung Cancer Prostate Cancer	Contact Interve...	18 Years - 65 Years	Baylor College of Medicine
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
Effectiveness of Electronic Health Record-Based Interventions for Improving Follow-Up in Primary Care	NCT01346839	Colon Cancer Lung Cancer Prostate Cancer	Contact Interve...	18 Years - 65 Years	Baylor College of Medicine
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

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