Measuring and Improving the Safety of Test Result Follow-Up

Sponsor

VA Office of Research and Development (U.S. Fed)

Overall Status

Active, not recruiting

CT.gov ID

NCT04166240

Collaborator

Michael E. DeBakey VA Medical Center (U.S. Fed), Baylor College of Medicine (Other), Birmingham Veterans Affairs Health Care System (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

5.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer Breast Cancer Colon Cancer Bladder Cancer Hepatocellular Cancer	Behavioral: SAFER TRACKS Intervention	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

11 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

None (Open Label)

Masking Description:

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

Primary Purpose:

Health Services Research

Official Title:

Measuring and Improving the Safety of Test Result Follow-Up

Actual Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Trigger Outcome [6 months]
Number of missed test results determined by electronic indicators
EPRP Outcome [6 months]
Percentage of patients notified of actionable test results within seven days via EPRP

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Michael E. DeBakey VA Medical Center, Houston, TX	Houston	Texas	United States	77030
2	White River Junction VA Medical Center, White River Junction, VT	White River Junction	Vermont	United States	05009-0001