Implementation of high sensitivity troponin in a veterans health system: lessons learned

Background

The North Florida/South Georgia Health System is a network of 2 medical centers and 11 outpatient clinics spanning 50 counties and 40,000 square miles, providing care for 130,000 Veterans with over 12,000 hospital admissions annually. Our health system elected to transition from the Elecsys Troponin T (Roche Diagnostics US, Indianapolis IN) to the Elecsys Troponin T-hs assay (Roche Diagnostics US, Indianapolis IN). Discussion of implementation will be focused on the primary medical center, Malcom Randall VAMC (MRVAMC), which is located in Gainesville, FL and accounts for the substantial majority of inpatient care in our health system. MRVAMC is academically affiliated with the University of Florida College of Medicine (UFCOM). The academic hospital affiliated with the UFCOM implemented a hsTn assay approximately one year prior to MRVAMC. Many, but not all, academic departments and graduate medical education programs share resources between the University and medical center; cardiology and internal medicine trainees rotate through MRVAMC, emergency medicine does not.

When a patient with suspected ACS is seen in our facility, the first point of medical contact is with the Emergency Department (ED). Initial evaluation includes history taking, physical examination, electrocardiogram, and measurement of cardiac biomarkers. If the patient is felt to be having or be at high risk for ACS after the initial evaluation, they will be admitted to the hospital medicine service. Admission is often under an observation status and the patient may be placed on a non-teaching teaching or teaching (with internal medicine residents) service. Cardiologists serve as consultants and do not have an independent admission service. Cardiology fellows are often the first contact with a patient if a consult is requested. A cardiology attending is directly available to anyone in the health system 24 h a day via an on-call cellular telephone. Our coronary catheterization laboratory is also available 24 h a day and is one of the highest volume centers for diagnostic and interventional cardiovascular procedures in the VA network.

Six months in advance

At our facility, the change to hsTn was driven primarily by the cardiology and laboratory services. In addition to these groups, the physician champions also recognized the importance of a multidisciplinary approach and made plans to involve a multitude of groups in the implementation [Figure 1]. Our initial planning meetings started approximately 6 months prior to the date we intended to go live with our hsTn assay and a general timeline for the implementation was drafted [Figure 2]. Important tasks included establishing goals for implementation, correlation between the standard and hsTn assays, discussion of cutpoints, and deciding on a “go-live” date. The planning team specifically wanted to focus on implementation on four goals: maximizing sensitivity of the assay, minimizing confusion for clinicians, make adoption as easy as possible for the end users, and to encourage clinicians to use uniform terminology while referring to troponin results.

Figure 1. Multidisciplinary approach to the care for patients with suspected acute coronary syndromes (ACS)

Figure 2. Timeline of activities prior to hsTn adoption

Laboratory staff took samples from 38 patients who were evaluated with the standard troponin and analyzed them using the hsTn assay [Supplementary Table 1]. Clinical data for the patients were reviewed by cardiology physicians for agreement between the assays. The manufacturer recommended 99^th percentile (99%ile) [> 14 nanograms per liter (ng/L) for women; > 22 ng/L for men] was used for this exercise and no evidence was observed to justify considering an alternative. While the MRVAMC, like many Veteran-oriented care facilities, care for significantly more men than women, we elected to adopt gender specific 99%ile thresholds recommended by the manufacturer. Our team, in consultation with hospital medicine, agreed to avoid adoption of the hsTn assay during winter months when volume of influenza cases was anticipated to be highest. We also agreed that when the new assay went live, we would not simultaneously report the standard and hsTn assays to minimize potential confusion if one assay was abnormal and the other was note. Initially, the “go-live” date was scheduled for April 15, 2020; due to the coronavirus pandemic, this was ultimately delayed to June 15, 2020.

Our cardiology service had a detailed discussion regarding the degree of change in hsTn (or “delta”) to be considered significant, that would represent a potentially acute cardiac process. Two primary options were considered: using a whole number as recommended by the manufacturer or using a percentage change as recommended in the Universal Definition for Myocardial Infarction^[3]. At present, all VA health care facilities use the Computerized Patient Record System (CPRS) for electronic medical recordkeeping. Within the laboratory reporting section of the software, there is no functionality to automatically calculate and report changes on serial assays. As such, using or encouraging a percentage change in hsTn would require end users to manually calculate if the values changed by a certain threshold between samples (20% change if initial value is below the 99%ile, 50% change if the initial value is above the 99%ile)^[3]. We acknowledged the difficulty this would pose for individual physicians and elected to report in CPRS that a change of 5 ng/L may indicate a significant change that would warrant further action. Under each patient’s laboratory values, CPRS is capable of displaying a text box with further guidance. The cardiology team drafted text to help explain the importance of serial testing and how to interpret serial values into 1 of 3 categories, all values under the 99%ile (no cardiac process), values that are above the 99%ile but not dynamic (chronic myocardial injury), or values above the 99%ile with dynamic change (acute injury/infarction) [Table 1]. The decision to recommend serial testing at 0, 1, and 3 h was the consensus of our clinicians based on professional society documents and published literature on similar protocols^[2,3]. Our team did not elect to use an absolute cutoff to indicate potential ACS. This decision was made, in part, on the experience at UFCOM where a threshold of 100 ng/L was identified as a “possible myocardial infarction” and led to a number of panicked consults from physicians. Once all these decisions were made, the cardiology team began working on educational materials to inform the facility staff.

One month in advance

At this stage, the implementation team reached out to clinical services most likely to be affected by the new hsTn assay: emergency medicine, hospital medicine, critical care and the internal medicine residency. Staff communicated, primarily through email, to identify clinical pathways that would be affected and how to plan for the hsTn change. This broader coalition also identified hospital units and clinical groups that should receive targeted, in-person training on the new assay. E-mail communication and staff meetings were used at this stage to inform front-line clinicians about the hsTn change. Notice of the change was sent to the local members of Congress, in anticipation of any possible concerns from citizens.

Educational materials were finalized with at least a month to go before implementation. The materials started with background on the assay and how sensitivity was improved over the standard assay. This required a brief explanation of concepts such as the limit of detection, limit of quantification, and the 99%ile. Next discussed was the change in units that would result in whole number reporting. Standard terminology of type 1 myocardial infarction, type 2 myocardial infarction, acute myocardial injury, and chronic myocardial injury were reviewed. Learners were specifically encouraged to avoid non-standard terms such as “troponinemia” and “troponin leak”. Data on prevalence, sensitivity, specificity, and positive/negative predictive values were discussed with a request that clinicians DO NOT order hsTn in the outpatient setting or for inpatients without a high pretest suspicion of an ACS.

Multiple slide presentations were created including a detailed review (approximately 30 min), a brief summary (10 min), and a summary specifically for the nursing staff. A single page summary was also created for staff to print and make available in their work areas. Each were uploaded to a shared intranet website so staff could review independently. Versions were created with and without recorded audio of the content. A specialized doctor conducted training sessions with hospital medicine, cardiology, the emergency department, the medical and surgical intensive care units, and one of the general inpatient units where most patients with cardiac diagnoses are grouped geographically.

One week in advance

The general medical staff (physicians, nurses, and technologists) were informed of hsTn via email from the Chief of Staff’s office and in the facility’s weekly all-staff newsletter. This notice included an 8-point summary of what the new hsTn assay would mean, the link to more information on the intranet, and an invitation to attend 1 of 4 open educational sessions, hosted by a specialized doctor [Table 2].