Are Clinical Pathways Addressing Glasses Half Full, Half Empty or Simply Too Big?

J Clin Pathways. 2021;7(9):22-23. doi:10.25270/jcp.2021.11.1

Clinical pathways are meant to improve both clinical and financial outcomes, but are they doing so by addressing treatment gaps or system failures? Typically, clinical pathways are developed in response to new therapies coming to market and a need for stakeholders to use these treatments correctly in the patient journey.

Beyond Treatment Needs

While it may seem like there is a constant stream of new treatments coming to market, there are still many incidents where for many the glass looks disappointedly half empty (Figure 1). The many diseases without effective treatments include disorders of infectious, noninfectious, genetic, metabolic, neoplastic, or autoimmune nature that do not currently have a cure. Incurable diseases include rare diseases that are genetic in nature in ≥80% of cases.

A retrospective study by the National Institutes of Health found that only about 10% of rare diseases have a therapy approved by the US Food and Drug Administration for their treatment. The study, “The IDeaS initiative: pilot study to assess the impact of rare diseases on patients and healthcare systems,” was published in the Orphanet Journal of Rare Diseases.¹ Tisdale and colleagues’ main goals were to estimate the prevalence for these diseases in four different health care system (HCS) databases, including the Eversana HCS and the National Center for Advancing Translational Sciences database, and to identify the average direct cost estimate per disease.

These researchers suggested that machine-learning strategies applied to HCS databases and medical records using sentinel disease and patient characteristics may hold promise for faster and more accurate diagnosis for many patients with rare diseases and should be explored to help address the high unmet medical needs of this patient population. 

While we await treatments for these conditions, even in areas where treatments are available (such as hepatitis), their effective use is limited. This loudly calls out the need for clinical practice guidelines to be fully used to improve outcomes through system improvements. Clinical practice guidelines are positioned to play a critical role here especially for those rare diseases without effective treatments.

Making System Changes

While clinical practice guidelines are most often meant as a means to introduce a new treatment to assure its appropriate use, there are many situations where new treatments are not available but care can be improved through practice improvements. This is especially true given the fact that it is frequently cited that it takes an average of 17 years for research evidence to reach clinical practice. Several studies estimated a time lag of 17 years measuring different points of the process.^2-7 Such convergence around an “average” time lag of 17 years illustrates the many complexities within clinical practices that require systematic changes that can be promoted through a more holistic use of clinical practice guidelines. This highlights the fact that clinical practice guidelines are needed to promote new medications and to assure the consistent use of best practices.

Ways to Improve Outcomes

Clinical pathways can improve both clinical and financial outcomes through several avenues. It starts with patient engagement. While clinical pathways often are thought of as tools for providers and in some cases payers, they are being used increasingly by patients. As patients look to improve their own disease state knowledge, especially in rare conditions where a well-informed patient may have greater knowledge than their own physician, patient education is critical in assuring the delivery of appropriate care. A well-informed patient can assist in the direction of their own care, and clinical pathways provide an excellent vehicle for this engagement to occur.

Providers need not only the knowledge but aligned incentives to assure adherence to clinical pathway best practices. These incentives are being guided by Integrated Delivery Systems as well as CMS. These organizations benefit from the information within clinical practice guidelines that illustrate desired outcomes. These desired outcomes can be used by stakeholders to align incentives for providers being more adherent to clinical guidelines.

Finally, clinical guidelines must be built into practice flow through such means as incorporation into the electronic health record. Embedded guidelines can assist providers from diagnosis to treatment recommendations such that providers are much more likely to avoid the decades it takes for clinical best practices to be incorporated into clinical practice. Through these uses of clinical practice guidelines even when not introducing the proper use of a new therapy, clinical and financial outcomes can be improved through simply getting the delivery of care to follow best practices thus making sure the glass is in fact the correct size especially in the face of a lack of water.

References

1. Tisdale A, Cutillo CM, Nathan R, et al. The IDeaS initiative: pilot study to assess the impact of rare diseases on patients and healthcare systems. Orphanet J Rare Dis. 2021;16(1):429. doi:10.1186/s13023-021-02061-3

2. Westfall JM, Mold J, Fagnan L. Practice-based research--”Blue Highways” on the NIH roadmap. JAMA. 2007;297(4):403-406. doi:10.1001/jama.297.4.403

3. Trochim W. Translation won’t happen without dissemination and implementation: some measurement and evaluation issues. Presented at: 3rd Annual Conference on the Science of Dissemination and Implementation; March 16, 2010; Bethesda, MD 

4. Green LW, Ottoson JM, García C, Hiatt RA. Diffusion theory and knowledge dissemination, utilization, and integration in public health. Annu Rev Public Health. 2009;30:151-174. doi:10.1146/annurev.publhealth.031308.100049

5. Balas EA, Boren SA. Managing clinical knowledge for health care improvement. Yearb Med Inform. 2000;(1):65-70.

6. Grant J, Green L, Mason B. Basic research and health: a reassessment of the scientific basis for the support of biomedical science. Res Eval. 2003:12(3):217-224. doi:10.3152/147154403781776618

7. Wratschko K. Empirical Setting: The pharmaceutical industry. In: Wratschko K. Strategic Orientation and Alliance Portfolio Configuration. Gabler; 2009:87-96. 

Author Information

Author: Richard G. Stefanacci, DO, MGH, MBA, AGSF, CMD

Affiliation: EVERSANA™, Berkeley Heights, NJ

Disclosures: Dr Stefanacci is the chief medical director for the managed markets agency of EVERSANA™.