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Care Pathways in US Healthcare Settings: Current Successes and Limitations, and Future Challenges
Anita Chawla, PhD; Kimberly Westrich, MA; Susanna Matter, MBA, MA; Anna Kaltenboeck, MA; and Robert Dubois, MD, PhD
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Care Pathways in US Healthcare Settings: Current Successes and Limitations, and Future Challenges

Anita Chawla, PhD; Kimberly Westrich, MA; Susanna Matter, MBA, MA; Anna Kaltenboeck, MA; and Robert Dubois, MD, PhD
Care pathways influence quality of care and outcomes. Despite positive trends in development and implementation, further efforts in process transparency and evaluation are required.
Health plans are typically responsible for monitoring care pathways, according to 58% (11 of 19) of all respondents (payers, providers, and vendors) who answered questions in this section, while 47% (9 of 19) and 37% (7 of 19) reported that providers and care pathway vendors, respectively, play a role. In response to follow-up questions, half (50%; 8 of 16 respondents [including payers, providers, and vendors] who answered “yes” to the initial question) indicated that compliance is measured for any patients entering a practice rather than patients selected for on-pathway treatment, implying that true pathway adherence may be underestimated, since the entire practice patient population would serve as the denominator in a compliance measure, but only patients who are eligible for and treated on the pathway are counted in the numerator. Two respondents of 16 (13%) reported measuring compliance only among patients with specific diseases or conditions, or using varying measurements. Some interviewees noted specifically that outliers or deviation from pathways that resulted in significant variation from target adherence rates, most often quoted as 75% to 80%, would trigger follow-up investigation. None of the respondents indicated that medically appropriate deviation from pathway recommendations was precluded.

Interviewees reported limited knowledge of the impact of care pathways on patient outcomes or quality of care, and whether the impact might be sustainable. Among respondents familiar with care pathways research, several voiced doubts about the meaningfulness of patient outcome studies, citing a lack of proven results and concerns about limitations of available data. Data availability, level of detail collected, and analytic methods were identified repeatedly as challenges in conducting robust analyses of performance.

Transparency and Disclosure

Although most respondents indicated that some aspects of the care pathway development process may be documented, access to this information remains limited to internal stakeholders with direct involvement. Transparency surrounding implementation was perceived as similarly limited––in part because the proprietary nature of many pathways limits public disclosure. Most healthcare providers who responded to the survey (80%; 4 of 5), all of whom use care pathways, indicated that patients are not informed or directly educated about the use of care pathways; voluntary opt-out by patients was reportedly in the form of declining treatment, not through a formal mechanism. Several respondents noted that patients may have trouble understanding the care pathways or have a negative response if the concept is not sufficiently explained.

Barriers to Pathway Uptake

Among all survey respondents, 85% (22 of 26) indicated that physician pushback is the largest barrier to the expansion of care pathways (Figure 4). Insufficient tracking systems and administrative burdens rank high for most respondents. Additional barriers are failure to demonstrate results or cost savings.

DISCUSSION
Generally, care pathways appear to provide a good mechanism for integrating evidence-based medicine with real-world clinical practice, with the goal of using high-quality evidence for pathway development and affording physicians flexibility in implementation. Our research indicates that development efforts have prioritized high-quality clinical studies and guidelines as sources for determining clinical management and treatment choices. In this context, data on treatment efficacy and safety are prioritized over cost when determining the best treatment options. Cost considerations, however, remain a major focus in guiding pathway development, particularly in selection of therapeutic areas, and they are dominant in the absence of clear differentiation among alternative treatment options. Nonetheless, physicians wield substantial influence on care pathway development and implementation, reflecting the emphasis on clinical considerations. Furthermore, developers appear to recognize the need to provide flexibility in treatment decision making to account for differences in patient characteristics or needs, and heterogeneity of treatment effect.

However, several concerns associated with current care practices remain. Variation in development and implementation methodology persists, given the lack of standardization or policy on best practices. Wide variation in approaches to pathway development and evidence requirements, particularly when high-quality data are not available, impedes the practice of medicine based on the best available evidence. This finding is consistent with increasingly high-profile criticism of attempts to reduce variation in care,52 requiring the establishment of industry best practices across all therapeutic areas and treatment modalities, in order to ensure that evidence quality is characterized using appropriate criteria and evaluation is systematic. Recommendations for care pathways in oncology,51 and the IOM initiative on standards for clinical practice guidelines, may serve as valuable starting points.19,53 After the IOM standards were disseminated, evaluation studies were conducted, and they provided valuable insights into the extent to which activities associated with evidence evaluation and guideline development adhered to the best practices that had been codified.

Because evaluation methodology and metrics for assessing care pathways have not been standardized, the true impacts of pathways on patient outcomes, on quality of care, on medical care resource use, or on cost of treatment are not yet fully known. To date, most published analyses have focused on frequently used treatments, healthcare resource utilization, and costs. They have covered relatively limited time frames, and few have provided insight on the impact of care pathways on quality of care. Several respondents in our research voiced doubts about the ability to collect and analyze data beyond compliance and resource use, largely due to challenges associated with integrating data from different sources, which are typically administrative claims and electronic medical records.

The most serious concern about the state of care pathway development and aspects of implementation is lack of transparency. Interviewees substantiated recent public calls for transparency, and they echoed concerns about the absence of development standards and inconsistent application of methodologies in care pathway development.50,51 Some payers have disclosed treatment options, compliance measures, and reimbursement associated with their care pathways12,13,22,25; however, information about development and implementation has been relatively limited. In 2012, the National Comprehensive Cancer Network convened a policy summit to discuss use and implementation of care pathways, and in 2014 the American Society of Clinical Oncology’s Payment Reform Workgroup included high-level guiding principles for developing and using oncology care pathways as part of its recommendations for payment reform.11,54 To our knowledge, however, no other medical professional associations have yet made similar recommendations. Similar concerns about disclosure of research and evaluation methods in other areas of healthcare have resulted in heightened scrutiny and public attention. Calls for greater transparency and documentation emerged after inconsistencies between stated and actual practice were identified in a review of the 6 major US drug compendia, which use similar methods and are subject to the same evidence limitations as care pathway developers.53

Lack of transparency may also foster greater potential for conflict of interest. Our research found that selection of therapeutic areas is driven primarily by financial considerations rather than quality of care, and the selection process is not typically discussed outside an organization. Provider feedback confirmed that use of care pathways remains mostly undisclosed to patients, as previously noted in recent publications exploring this issue.50,51 Incentive structures, which tie payment to care pathway compliance directly, may discourage deviation from on-pathway treatment options.

This research was conducted using a sample of respondents with varying backgrounds and experience with care pathways, limiting the ability to cross-validate responses. There was little variability in respondents’ knowledge and opinion; survey/interview responses were generally consistent across respondents and differed by experience and background in expected ways. Nevertheless, our findings should be interpreted as directional—particularly those findings related to new developments and trends in care pathway development, implementation, and evaluation, which are evolving.

CONCLUSIONS
As care pathway use expands in the US healthcare system, we expect high-quality evidence of efficacy and safety will be central to future pathway development, and physicians will play a major role in its development and implementation. In light of our findings, there are several options for improving current practices. First, a unanimously supported initiative is needed to create best practices that guide pathway development, implementation, and evaluation and monitoring. Best practices must require disclosure of methods used to develop a care pathway and evaluate evidence used in the process; they must also be clearly documented. These objectives may best be accomplished with an effort similar to development of standards for clinical practice guidelines, spearheaded by the IOM. Any such effort should ensure that concerns about intellectual property are addressed; certification programs or review boards may offer solutions. Second, given the potential for care pathways to affect patient outcomes and quality of care directly, within a specific pathway and broadly, consistent methods for collection and analysis of data are needed to support critical evaluation of care pathway performance against the goals of improving quality of care and efficient allocation of resources. Data collection should include measures of compliance with pathways, resource use, and patient outcomes, including functional status and quality of life. Other programs, particularly those that address quality of care, may offer existing approaches and measures to leverage.

As with clinical practice guidelines, best practices or standards can provide a natural framework for evaluating care pathway performance. Third, transparency in all elements of pathway development, implementation, and evaluation should be adopted and endorsed. Specifically, the development approach, and underlying evidence, as well as the roles, responsibilities, and potential conflicts of interest in the development efforts should be clear. Finally, patients should have access to disclosures, including whether treatment plans follow a care pathway, whether the clinical practice in which care is being delivered is subject to pathway-related incentives, and information about development and impact of pathways, should they wish to review it.

Acknowledgments

The authors acknowledge and thank Robert Navarro, PharmD, from Navarro Pharma, and Robert M. Kaminsky, MBA, from MedSpan Research, for their assistance with the primary research; and Sarah Mantels for her assistance with the literature review and editorial assistance with the manuscript.

Author Affiliations: Analysis Group, Menlo Park, CA (AC), New York, NY (AK), Boston, MA (SM); National Pharmaceutical Council (KW, RD), Washington, DC.

Source of Funding: Funding for this research was provided by National Pharmaceutical Council.

Author Disclosures: Dr Dubois and Ms Westrich report employment by National Pharmaceutical Council, an industry-funded health policy research group that is not involved in lobbying or advocacy. Dr Chawla, Ms Matter, and Ms Kaltenboeck report employment by Analysis Group, Inc, which received grants from National Pharmaceutical Council for this research.

Authorship Information: Concept and design (AC, KW, AK,SM, RD); acquisition of data (AC, SM, AK); analysis and interpretation of data (AC, KW, SM, AK, RD); drafting of the manuscript (AC, KW, SM, AK, RD); critical revision of the manuscript for important intellectual content (AC, KW, AK, RD); obtaining funding (AC, AK); administrative, technical, or logistic support (AK); and supervision (AC, SM, AK).

Address correspondence to: Anita Chawla, PhD, Analysis Group, 1010 El Camino Real, Ste 310, Menlo Park, CA 94025-4355. E-mail: anita.chawla@analysisgroup.com.
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