Measuring and Improving the Safety of Test Result Follow-Up

INTRODUCTION

  • Org Study ID: IIR 17-127
  • Secondary ID: H-45450
  • NTC ID: NCT04166240
  • Sponsor: VA Office of Research and Development

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 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 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.


  • Overall Status
    Recruiting
  • Start Date
    October 1, 2018
  • Phase
    N/A
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Trigger Outcome

Primary Outcome 1 - Timeframe: 6 months

Primary Outcome 2 - Measure: EPRP Outcome

Primary Outcome 2 - Timeframe: 6 months

CONDITION

  • Lung Cancer
  • Breast Cancer
  • Colon Cancer
  • Bladder Cancer
  • Hepatocellular Cancer

ELIGIBILITY


Inclusion Criteria:

- Medical records identified via CDW which fall under the EPRP measures (FOBT/FIT, HCV,
Mammogram, AFP, DEXA Scan, Pap/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

Gender: All

Minimum Age: 65 Years

Maximum Age: 18 Years

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Hardeep Singh, MD MPH

Role: Principal Investigator

Affiliation: Michael E. DeBakey VA Medical Center, Houston, TX

Overall Contact

Name: Hardeep Singh, MD MPH

Phone: (713) 794-8515

Email: hardeep.singh@va.gov

LOCATION

Facility Status Contact
Facility: Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas 77030
United States
Status: Recruiting Contact:
Hardeep Singh, MD MPH
713-794-8515
hardeep.singh@va.gov