Measuring and Improving the Safety of Test Result Follow-Up

February 22, 2024 updated by: VA Office of Research and Development

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Michael E. DeBakey VA Medical Center, Houston, TX
    • Vermont
      • White River Junction, Vermont, United States, 05009-0001
        • White River Junction VA Medical Center, White River Junction, VT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SAFER TRACKS Intervention
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.
Behavioral: SAFER TRACKS Intervention
SAFER Change Package delivered using a Virtual Breakthrough Series [VBTS] Collaborative supplemented with automated surveillance data on test results.
No Intervention: Non-intervention period
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trigger Outcome
Time Frame: 32 months

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.
32 months
External Peer Review Program (EPRP) Outcome
Time Frame: 32 months
Percentage of patients notified of actionable test results within seven days via EPRP
32 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Collaborators

Baylor College of Medicine
Michael E. DeBakey VA Medical Center
Birmingham Veterans Affairs Health Care System

Investigators

  • Principal Investigator: Hardeep Singh, MD MPH, Michael E. DeBakey VA Medical Center, Houston, TX

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2018

Primary Completion (Actual)

April 1, 2022

Study Completion (Actual)

September 30, 2023

Study Registration Dates

First Submitted

November 14, 2019

First Submitted That Met QC Criteria

November 14, 2019

First Posted (Actual)

November 18, 2019

Study Record Updates

Last Update Posted (Actual)

August 6, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 17-127
  • H-45450 (Other Identifier: Baylor College of Medicine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plans to share individual site data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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