Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Bladder Cancer
  • Breast Cancer
  • Colon Cancer
  • Hepatocellular Cancer
  • Lung Cancer
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 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

Participation Requirements

Age
Between 18 years and 65 years
Gender
Both males and females

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 ...

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.

Tracking Information

NCT #
NCT04166240
Collaborators
  • Michael Debakey Veterans Affairs Medical Center
  • Baylor College of Medicine
  • Birmingham Veterans Affairs Health Care System
Investigators
Principal Investigator: Hardeep Singh, MD MPH Michael E. DeBakey VA Medical Center, Houston, TX