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Measuring and Improving the Safety of Test Result Follow-Up

Measuring and Improving the Safety of Test Result Follow-Up

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04166240
Enrollment
46
Registered
2019-11-18
Start date
2018-10-01
Completion date
2023-09-30
Last updated
2024-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder Cancer, Breast Cancer, Colon Cancer, Hepatocellular Cancer, Lung Cancer

Keywords

Diagnostic Errors, Quality Improvement, Patient Safety, Delayed Diagnosis

Brief summary

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 Veteran's Health Administration (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.

Detailed description

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 Institutional Review Board (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.

Interventions

BEHAVIORALSAFER TRACKS Intervention

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

Sponsors

Michael E. DeBakey VA Medical Center
CollaboratorFED
Baylor College of Medicine
CollaboratorOTHER
Birmingham VA Health Care System
CollaboratorFED
VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Medical records identified via CDW which fall under the EPRP measures (Fecal Occult Blood Test FOBT)/Fecal Immunohistochemical Test (FIT), Hepatitis C Virus (HCV), Mammogram, alpha feto protein (AFP), dual energy x-ray absorptiometry (DEXA) Scan, Pap/ human papillomavirus (HPV), Chest X-ray, and Chest CT) * Medical records containing clinical findings suspicious for breast cancer, lung cancer, bladder cancer, hepatocellular carcinoma, and colorectal cancer (CRC)

Exclusion criteria

* Medical records that don't contain any tests, procedures, or appointments that need to be followed up on

Design outcomes

Primary

MeasureTime frameDescription
Trigger Outcome32 monthsPercentage of missed test results determined by electronic indicators. The percentage of test results with timely follow up was calculated for each participating site, out of all abnormal tests at that site. Reporting measure type: Percentage of tests with timely follow-up across all sites.
External Peer Review Program (EPRP) Outcome32 monthsPercentage of patients notified of actionable test results within seven days via EPRP

Countries

United States

Participant flow

Recruitment details

Records from VA's Data warehouse (Fecal Occult Blood Test, Hep C Virus, Mammogram, alpha feto protein, dual energy x-ray absorptiometry, human papillomavirus, Chest X-ray, and Chest CT) Medical records suspicious for breast, lung, bladder, hepatocellular, and colorectal cancer. All data collected at the site level; number enrolled reflects number of sites enrolled Michael E. DeBakey VA Medical Center, Houston, Texas White River Junction VA Medical Center, White River Junction, Vermont

Pre-assignment details

Exclusion criteria: Medical records that don't contain any tests, procedures, or appointments that need to be followed up on.

Participants by arm

ArmCount
Sequence 1
7 months of pre intervention, 6 months of action phase, 13 months of continuous improvement
4
Sequence 1
7 months of pre intervention, 6 months of action phase, 13 months of continuous improvement
4
Sequence 2
14 months of pre intervention, 6 months of action phase, 6 months of continuous improvement
4
Sequence 2
14 months of pre intervention, 6 months of action phase, 6 months of continuous improvement
4
Sequence 3
20 months of pre intervention, 6 months of action phase
3
Sequence 3
20 months of pre intervention, 6 months of action phase
3
Total22

Baseline characteristics

CharacteristicSequence 1Sequence 2Sequence 3Total
Age, Customized
Not Reported
0 Sites0 Sites0 Sites0 Sites
Percentage of abnormal test results with timely follow-up action
Baseline percentage for Fecal Occult Blood Test follow up
77.1 percentage72.1 percentage80.4 percentage75.9 percentage
Percentage of abnormal test results with timely follow-up action
Baseline percentage for lung follow up
65.1 percentage73.3 percentage77.4 percentage72.1 percentage
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States : Midwest
0 participants2 participants0 participants2 participants
Region of Enrollment
United States : Northeast
2 participants0 participants2 participants4 participants
Region of Enrollment
United States : South
1 participants1 participants1 participants3 participants
Region of Enrollment
United States : West
1 participants1 participants0 participants2 participants
Sex/Gender, Customized
Not Reported
0 Sites0 Sites0 Sites0 Sites

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 40 / 40 / 3
other
Total, other adverse events
0 / 40 / 40 / 3
serious
Total, serious adverse events
0 / 40 / 40 / 3

Outcome results

Primary

External Peer Review Program (EPRP) Outcome

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

Time frame: 32 months

Population: Data could not be reported because EPRP measures are aggregated quarterly. Our previous understanding was that these data was granular enough for the needed breakdown of data by month. On final analysis, however, the action phases did not align with EPRP quarters, so EPRP rates could not be assigned correctly to action phase vs other phases.

Primary

Trigger Outcome

Percentage of missed test results determined by electronic indicators. The percentage of test results with timely follow up was calculated for each participating site, out of all abnormal tests at that site. Reporting measure type: Percentage of tests with timely follow-up across all sites.

Time frame: 32 months

ArmMeasureGroupValue (NUMBER)
Sequence 1Trigger Outcomepercent abnormal chest imaging tests with follow up67.0 percentage of abnormal tests w/ followup
Sequence 1Trigger Outcomepercent abnormal Fecal Occult Blood tests with follow up78.1 percentage of abnormal tests w/ followup
Sequence 2Trigger Outcomepercent abnormal Fecal Occult Blood tests with follow up67.7 percentage of abnormal tests w/ followup
Sequence 2Trigger Outcomepercent abnormal chest imaging tests with follow up65.9 percentage of abnormal tests w/ followup
Sequence 3Trigger Outcomepercent abnormal chest imaging tests with follow up78.6 percentage of abnormal tests w/ followup
Sequence 3Trigger Outcomepercent abnormal Fecal Occult Blood tests with follow up78.2 percentage of abnormal tests w/ followup

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026