HEART Pathway Accelerated Diagnostic Protocol Implementation: Prospective Pre-Post Interrupted Time Series Design and Methods

Background Most patients presenting to US Emergency Departments (ED) with chest pain are hospitalized for comprehensive testing. These evaluations cost the US health system >$10 billion annually, but have a diagnostic yield for acute coronary syndrome (ACS) of <10%. The history/ECG/age/risk factors/troponin (HEART) Pathway is an accelerated diagnostic protocol (ADP), designed to improve care for patients with acute chest pain by identifying patients for early ED discharge. Prior efficacy studies demonstrate that the HEART Pathway safely reduces cardiac testing, while maintaining an acceptably low adverse event rate. Objective The purpose of this study is to determine the effectiveness of HEART Pathway ADP implementation within a health system. Methods This controlled before-after study will accrue adult patients with acute chest pain, but without ST-segment elevation myocardial infarction on electrocardiogram for two years and is expected to include approximately 10,000 patients. Outcomes measures include hospitalization rate, objective cardiac testing rates (stress testing and angiography), length of stay, and rates of recurrent cardiac care for participants. Results In pilot data, the HEART Pathway decreased hospitalizations by 21%, decreased hospital length (median of 12 hour reduction), without increasing adverse events or recurrent care. At the writing of this paper, data has been collected on >5000 patient encounters. The HEART Pathway has been fully integrated into health system electronic medical records, providing real-time decision support to our providers. Conclusions We hypothesize that the HEART Pathway will safely reduce healthcare utilization. This study could provide a model for delivering high-value care to the 8-10 million US ED patients with acute chest pain each year. ClinicalTrial Clinicaltrials.gov NCT02056964; https://clinicaltrials.gov/ct2/show/NCT02056964 (Archived by WebCite at http://www.webcitation.org/6ccajsgyu)

As noted in the RFP, fund distribution is contingent upon a signed contract with the AAMC and documentation of current IRB approval of the project. We will send the contract to you under separate cover. I will also contact you to arrange a discussion to this end, and to organize a meeting around the AAMC evaluation of the project.
Our scientific peer review committee faced a difficult task in selecting two proposals from among the many interesting proposals submitted. Their enthusiasm for your proposal is captured in the review committee comments which are attached below. We look forward to working with you in the years ahead to shepherd this outstanding project to completion.

Qualifications of the leadership and investigative team
Dr. Simon A. Mahler is well qualified to head this program. He is an established scientist in the area of cardiac assessment in the ED and has published several articles. He has research support from AHA and NIH on cardiac assessment. Dr. C. Miller, the coinvestigator is also the director of clinical research / ED. Thus, the team is well experienced with a track record and departmental success.

Rigor of study design and analytic plan
The weak prepost design is well justified and need for it documented. This is a carefully designed implementation study and the analytic plan is appropriate and straightforward. Power estimates are satisfactory. Will look at primary outcomes in 30 days for cardiac events, secondary outcomes analysis of utilization of cardiac testing, LOS, ED visits. Hospitalizations will be reviewed for both inpatient and ovservational status. Strong evidence base for intervention. Some of death data not specified (at home, out of area).

Likelihood that approach will be innovative and outcomes will have impact
This is not a highly innovative approach, the Heart Pathway has been around for some time. What is significant is the incredible institutional support to train/educate and support this program. The impact at Wake Forest will be significant and long lasting if the outcomes data supports the program. The project could be a model for organizational commitment to solving an important clinical problem that controls cost and provides acceptable safe care. The ideas behind it are solid and the premise that we should not be overtesting lowrisk patents is compelling.

Inclusion of education and training elements
The program is driven by well informed team members. There is heightened awareness of this Heart Pathway implementation by training all team members, residents, nurses, physicians, etc.

Commitment and engagement of health system partner
Dr. Mahler has strong support of Wake Forest/Baptist Medical Center as evidenced by the lettes from the CEO/COO/Dean/CIO. With various third party insurers, i.e., Medcost, BlueCross BlueShield.
It appears that the team is well integrated with the health system and has already obtained the appropriate buyin. It should be verified before funding that the IRB will, indeed, waive informed consent for this sturdy, because it is research and not just quality improvement.

Additional review comments
The program will be most successful where there are well run Emergency Departments that are supported by an observation program where the assignments can be completed. The impact score is limited because the expectation of < 1% missed diagnoses. Suggest DSMB. Low miss rate for HEART vs. usual care.