A Quality Improvement Initiative on Documentation of Guideline-Directed Medical Therapy Implementation Among Primary Prevention CRT-D Implant

Abstract

The treatment for heart failure with reduced ejection fraction has advanced significantly in recent years. The 2022 American Heart Association/American College of Cardiology/Heart Failure Society of America Guideline for the Management of Heart Failure recommends 4 pillars of medication in its guideline-directed medical therapy (GDMT): sodium-glucose cotransporter-2 inhibitors, beta-blockers, mineralocorticoid receptor antagonists, and angiotensin-converting enzyme inhibitors or angiotensin receptor-neprilysin inhibitors. The implementation of GDMT at maximally tolerated doses has been proven effective in multiple trials. Rates of quadruple GDMT adoption among patients with cardiac resynchronization therapy with defibrillator (CRT-D) remain suboptimal in the published literature. We explored challenges to documentation on GDMT use among patients with CRT-D and identified different approaches to overcome them. This article highlights our observations and findings.

Visual Summary

Visual Summary.

Enhancing GDMT Documentation: Current Efforts and Future Plans

Steps initially implemented, continued as ongoing measures, and potential future initiatives. CRT-D = cardiac resynchronization therapy with defibrillator; EMR = electronic medical record; EP = electrophysiologist; GDMT = guideline-directed medical therapy; HF = heart function.

The National Cardiovascular Data Registry (NCDR) launched the Electrophysiology Device Implant (EPDI) registry in April 2021; this gave sites the opportunity to include data for cardiac resynchronization therapy with defibrillator (CRT-D) devices for the first time. An early finding in our outcome reports showed that in many patients with CRT-D implants, guideline-directed medical therapy (GDMT) was not implemented according to established guideline recommendations (2022 American Heart Association [AHA]/American College of Cardiology [ACC]/Heart Failure Society of America [HFSA] Guideline for the Management of Heart Failure).¹

Take-Home Message

• •Appropriate GDMT documentation and implementation is challenging and requires an end-to-end view of the patient's journey and the provider's decision-making and documentation.

The GDMT, which involves the initiation and titration of 4 drug classes, is recommended for patients with heart failure with reduced ejection fraction (HFrEF) owing to its proven benefits in reducing mortality and rehospitalization rates.¹ Based on the 20220AHA/ACC/HFSA guidelines, CRT-D is recommended in patients with symptomatic heart failure, left ventricular ejection fraction of ≤35%, and QRS duration ≥150 ms despite treatment with GDMT for at least 3 months (Figure 1).¹

Figure 1.

2022 AHA/ACC/HFSA GDMT Recommendations for Patients With HFrEF

ACEI = angiotensin-converting enzyme inhibitor; ARB = angiotensin (II) receptor blocker; ARNI = angiotensin receptor neprilysin inhibitor; CRT-D = cardiac resynchronization therapy with defibrillator; GDMT = guideline-directed medical therapy; HFrEF = heart failure with reduced ejection fraction; MRA = mineralocorticoid receptor antagonist; SGLT2i = sodium-glucose cotransporter-2 inhibitor.

Project Rationale

We conducted this quality improvement (QI) initiative at the Peter Munk Cardiac Centre in Toronto, Canada, between the first quarter (Q1) and fourth quarter (Q4) of 2023. The purpose was to understand the reasons why patients with HFrEF were not on documented maximally tolerated GDMT for 3 months before primary prevention CRT-D implant. The project sought to address and rectify these gaps to improve patient outcomes. Our goal was to improve GDMT documentation and implementation as much as possible, tracking progress using registry data and implementing steps as reasonable. To monitor the improvement, we used registry data points without additional data collection.

Project Design

Pre–QI intervention cohort: We conducted a retrospective review from April 2021 to December 2022, including all adults with HFrEF with either ischemic or nonischemic cardiomyopathy who received a CRT-D implant for primary prevention at initial implantation. We analyzed records where the GDMT status for heart failure medications was not mentioned in the chart. This included cases where GDMT was not at the target dose for 3 months and instances where GDMT was implemented but lacked documentation regarding its status, leading to a “not documented” designation. Our objective was to identify potential reasons for nondocumentation.

Post–QI intervention cohort (Q1-Q4 2023): We conducted a prospective review to assess progress. We evaluated GDMT documentation and compared the data between these 2 groups.

Ethical approval was waived by the Research Ethics Board at the University Health Network for participation in the EPDI registry, for which this project falls under. Under the Personal Health Information Protection Act of Ontario, we are unable make data available from this review.

Limitations

No additional data points were collected outside the EPDI registry form. The data collection form captured 4 GDMT designations: 1) maximally tolerated dose for 3 months; 2) inability to complete; 3) not documented; and 4) not attempted.

The specific reasons of not having optimum GDMT were not collected. Also, the database did not collect data on drug dosing, so we were unable to assess whether a given patient was receiving the target dose or maximal tolerated at suboptimal dose.

Project Description

The review of the registry data in the preintervention group appeared as inconsistent guideline adherence. Initially, improper charting and data entry errors were suspected as the main issue. However, the review process subsequently identified several potential causes for the lag in GDMT documentation.

The causes identified were lack of consulting provider awareness regarding the implications of inadequate documentation, workflow issues, and the absence of a structured GDMT protocol across various disciplines Additionally, some providers were focused on device-related issues and showed reluctance toward optimizing GDMT, viewing it as outside their scope of practice and a possible delay to CRT-D benefit. Several studies also support this school of thought.²

For patients from remote locations, waiting for GDMT titration was sometimes seen as a barrier to accessing CRT-D benefits. Other common issues included patient adherence, lack of drug insurance coverage, excessive out-of-pocket expenses, having other comorbidities, frailty, limited family support, and logistical convenience—for instance, when a patient was scheduled for a generator change or lead revision for a pacemaker/implantable cardioverter-defibrillator, where upgrading to CRT-D had potential benefits for heart failure management. Furthermore, some patients had contraindications for certain medications but lacked proper documentation of these contraindications. NCDR coders are not authorized to interpret these values without consulting the responsible providers. This leads to a gap in data interpretation (Figure 2).

Figure 2.

Common Challenges in GDMT Implementation

CHB = complete heart block; CRT-D = cardiac resynchronization therapy with defibrillator; GDMT = guideline-directed medical therapy; HF = heart failure; ICD = implantable cardioverter-defibrillator; Mx = management; Pt. = patient; PGR = pulse generator replacement; PPM = permanent pacemaker.

Intervention: Changes Made to Improve GDMT Implementation

The following changes were made after retrospective chart review:

• 1.Data reconciliation meetings: Quarterly data reconciliation meetings were arranged to address gaps in GDMT documentation. These meetings also facilitated effective communication and ensured the clinical lead was informed of outstanding scenarios.
• 2.Enhanced training of coders: Educational meetings were arranged with electrophysiologists and heart function specialists to understand each team's workflows, the context behind limited documentation, and the consideration process for CRT-D implant to broaden coders' understanding.
• 3.Having the statement on GDMT status: The providers were encouraged to incorporate a statement regarding optimization status, whether in up-titration, optimized in maximum, or suboptimal doses. In the electronic medical record (EMR), we created smart phrases and statements to use in clinic notes more efficiently.
• 4.Identify gaps to find solutions: We met with physicians in the heart function clinic to review charts to understand if there was a way to track optimization status when any statement regarding optimization was missing. It was concluded that without a statement or comment, it was not always obvious, even to another provider.
• 5.Increase in communication and awareness: We encouraged a workflow to ensure the trial of GDMT medications before accepting referred patients.

Project Outcome

We used NCDR-EPDI registry data, which requires manual chart review. The study compared the preintervention group (n = 88) and postintervention group (n = 88) of a total of 176 patients with CRT-D implants for primary prevention (Table 1).

Table 1.

Records Lacking GDMT Documentation: Comparison Between Preintervention and Postintervention Cohorts

	Preintervention	Postintervention
Time period	2021 RQ3 2022 RQ4	2023 RQ4
Total number of cases	88	88
Cases lacking GDMT documentation	47 (53.41%)	1 (1.13%)

GDMT = guideline-directed medical therapy; RQ3 = 3 quarters data in 2021 (9 months); RQ4 = 4 quarters data in 2022 (12 months).

In the preintervention group, 53% of patients had no documented GDMT status. In many of these cases, patients were on a beta-blocker and a renin-angiotensin-aldosterone system inhibitor, but the provider's comments on GDMT status were missing. According to NCDR definitions, those records lacked optimal GDMT documentation. Also, patients without all 4 pillars of GDMT (mineralocorticoid receptor antagonists and sodium-glucose cotransporter-2 inhibitors, beta-blockers and renin-angiotensin-aldosterone system inhibitors) were considered as lacking optimal documented status unless there was a contraindication mentioned in the note.

In the postintervention group, only 1% of records lacked GDMT documentation (Figure 3).

Figure 3.

GDMT Documentation Trend After Intervention

GDMT = guideline-directed medical therapy.

Impact

This QI initiative brought value across different levels, benefiting patients, payers, providers, and society as a whole.

• •Patients: Patients benefitted from maximal GDMT. Additionally, deferring an invasive procedure until all noninvasive measures have been attempted may reduce the requirement for CRT-D and exposure to device-related complications.
• •Providers: Higher patient satisfaction and better care efficiencies.
• •Payers: Better use of public resources.
• •Society: Improved trust toward publicly funded health care.

Discussion

We identified a gap in GDMT documentation in patients undergoing CRT-D implant. This documentation gap also encompassed a gap in implementation to some extent. Although a single approach cannot effectively resolve this matter for everyone, the strategies we have outlined offer a reliable framework for us to improve the documentation.

The strategies that contributed to this outcome include increased awareness among providers across different teams within our institution, having reconciliation meetings, a slight shift in workflow by prioritizing the GDMT trial from the community cardiologist before implant, the addition of smart phrases and statements in our EMR, better training of data coordinators, and improved charting.

Taking the data into account, we found 52% improvement in documentation in 3 months, with another 3 months of gray period when the situation was being assessed and strategies were being implemented. An important question is, How much of the GDMT documentation change is attributable to improved use of GDMT versus solely being due to improved documentation? Additionally, can we sustain this improvement and expect a cultural shift? Have we truly accomplished improvement, or was this merely a reflection of a concentrated effort in a target group? If it is the latter, how can we ensure that all patients benefit from the optimal GDMT? This includes heart failure patients receiving CRT-D who are under the care of electrophysiologists, as well as patients managed by heart function specialists, general internal medicine practitioners, and community cardiologists.

Future Directions

Although we have limited influence on patient-related barriers, we can do much more at the provider or infrastructure level. By addressing these, we can ensure more patients benefit from optimal medication.

Some proposed solutions include:

• 1.Increasing awareness and facilitating ongoing discussions on this topic.
• 2.Reducing provider hesitancy (eg, fear of complications) in managing patients with multiple comorbidities and side effects by implementing easy-to-use, structured protocols.³
• 3.Introducing user-friendly tools, such as EMR prompts, to provide guidance in navigating complex clinical scenarios and side effects.
• 4.Engaging leaders who can set organizational priorities.
• 5.Adopting an institutional preference for rapid sequencing (∼6 weeks) of GDMT rather than a longer up-titration approach.
• 6.Involving all members, including pharmacists, nurse practitioners, and physician assistants, as applicable.

Conclusions

Evaluation of data and outcome metrics is essential for improvement in any area. Through this QI process, we have observed a measurable increase in documentation of GDMT, as well as documentation of reasons when GDMT was not employed. Ongoing efforts are essential to ensure optimal dose implementation and documentation for all patients after heart failure.

Funding Support and Author Disclosures

This work was made possible through the generosity of Peter and Melanie Munk Charitable foundation, the Rogers's foundation, and donors of UHN foundation. The authors have reported that they have no relationships relevant to the contents of this paper to disclose.