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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.

Objectives: Care pathways are used widely in US healthcare settings and are expected to have greater influence on quality of care and patient outcomes in the future. We conducted qualitative research to evaluate the state of care pathways and their impact in the United States.

Study Design: Targeted literature review followed by an online survey and in-person interviews.

Methods: The PubMed and Cochrane databases were searched for publications on care pathways (January 1, 2005, to July 21, 2014) to inform the subsequent surveys and interviews with payers, providers, and pathway vendors regarding care pathway design, development, and management. A targeted hand search was completed in May 2015 to supplement the earlier review.

Results: Twenty-nine publications, posters, or abstracts on specific care pathways were identified; the online survey and follow-up interviews included 26 and 18 respondents, respectively. Positive trends in current care pathways development and implementation include prioritization of high-quality evidence, enhancing the role of providers in development and implementation, and flexibility for providers to tailor treatment decisions to patients’ needs. Nevertheless, there are some limitations in methodology for development and implementation, in criteria for evaluation, and in the degree of transparency surrounding these activities.

Conclusions: Our research confirms that high-quality evidence of efficacy and safety are expected to be central to future pathway development, and that physicians play a major role in development and implementation. To achieve the goals of improving quality of care while managing costs, further efforts are required regarding systematic development and evaluation, consistent implementation and compliance metrics, and transparency in implementation outcomes and financial motivators.

Am J Manag Care. 2016;22(1):53-62
Take-Away Points
Care pathways are developed to manage patient care, improve quality, reduce variation, and increase efficient use of healthcare. They provide a mechanism for integrating evidence-based medicine into clinical practice. However, formal best practices to guide development, implementation, evaluation, and monitoring are needed. 
  • Often, pathways are implemented to manage drug utilization, particularly specialty drugs.
  • Trends in development and implementation have not been investigated systematically. 
  • Pathways will have more influence in the future, particularly with bundled or episode-based payments.
  • Research findings support implementation of standards and increased transparency in all dimensions of pathway development, implementation, and evaluation.
Care pathways, sometimes referred to as clinical pathways or integrated care pathways, are used widely in US healthcare settings. The concept goes as far back as 1985, with roots in efforts to codify or formalize patterns of care that were initiated at the New England Medical Center in Boston, Massachusetts.1 Although without a uniformly accepted definition, care pathways are typically characterized as a method for managing patient care based on clinical practice guidelines, with the main goals of improving quality of care, reducing variation in clinical practice, and increasing the efficient use of healthcare resources.1-4 Care pathways are generally expected to reduce the overall costs of treatment related to the condition for which a pathway is developed.2,3,5,6 A Cochrane systematic review of published studies that compared clinical pathways—both stand-alone and as part of a multifaceted intervention—with usual care found a reduction in in-hospital complications and improved documentation in 20 studies that compared stand-alone clinical pathways with usual care.7

Care pathways vary in content, implementation, and place of service. In some healthcare systems, reduction in resource use can be achieved effectively by integrating patient management across different treatment settings. In these situations, such as in the United Kingdom healthcare system, pathways may place greater emphasis on clinical flow than management of prescription drugs. In the United States, where care is often fragmented even within integrated systems, pathways tend to focus on resource use that can be controlled by choice of pharmacologic treatment. Many consider US care pathways an option for managing utilization of pharmaceuticals, particularly specialty drugs. Payers and provider networks have shown considerable interest in oncology care pathways, in large part because of wide variation in utilization and costs of oncology drugs, which continue to receive considerable attention.6,8-15 Care pathways have been noted as an approach for managing utilization of specialty drugs, and their use in other therapeutic areas is likely to grow16; for example, a care pathway has been developed in rheumatoid arthritis.17

Care pathways are intended to be a pragmatic translation of clinical guidelines and evidence, with specific direction for delivering care that may extend over the course of disease or continuum of care. Consequently, they have enormous potential to impact quality of care and patient outcomes. Best practices for developing clinical practice guidelines include a formal, structured process with systematic literature review, critical appraisal, multidisciplinary consultation, and grading of recommendation by evidence levels.18,19 In the United States, the Institute of Medicine (IOM) developed 8 standards for developing clinical practice guidelines,18,19 which address transparency, conflict of interest, development group composition, systematic review methodology, criteria for evaluating evidence quality, articulation of recommendations, external review, and updating. Care pathways, however, do not yet have published formal development standards.

Care pathways are expected to have more influence on quality of care and patient outcomes in the future. With movement from fee-for-service to bundled payments in commercial health plans and with the Oncology Care Model being launched by CMS in 2016,20 care pathways are expected to play a major role.21,22 Moreover, expansion into nononcologic therapeutic areas suggests that their impact will be even broader. Current use of care pathways, and their impact on costs, patient outcomes, and quality of care in US healthcare settings, has not been characterized fully. Furthermore, because only relatively mature pathway programs have data for such assessments, trends in care pathway development and implementation across therapeutic areas and treatment settings have not been investigated systematically.

We conducted qualitative research to evaluate the current state of care pathways and their impact in the United States. First, we conducted a targeted review of published literature on care pathways, including publications in peer-reviewed journals and the gray literature. Second, we supplemented this review with primary research using online surveys and semi-structured interviews with individuals having detailed knowledge of care pathway development and implementation. Our evaluation assessed stated objectives of care pathways, processes for development, supporting evidence, application, trends in development and use across therapeutic areas, and evidence of effects on outcomes. Together, this research provides information on the ways in which care pathways are currently succeeding and where they have limitations, as well as the challenges and opportunities for enhancing their future impact.

Targeted Literature Review

We searched the PubMed and Cochrane Reviews databases and selected conferences’ websites with keywords, combining “care pathway,” “clinical pathway,” “treatment pathway,” “critical pathway,” “evidence-based,” “cost,” and “comparative effectiveness.” We conducted targeted searches of trade journals and the websites of professional organizations, pathway vendors, payers, and large provider groups to supplement our database search for publications. Publications, posters, or abstracts were selected for further evaluation if they were published in English, dated between January 1, 2005, and July 21, 2014, and if they specifically described development, implementation, or evaluation of care pathways in US healthcare settings. Our selection criteria required that a care pathway have stated objectives defining the goals and key elements of care, including at least one of the following goals: improving patient outcomes, improving quality of care, reducing treatment variation, or reducing healthcare resource utilization.3

Guidance for prescribing decisions and other aspects of patient care (including processes and timeframes) was required to be based on specific disease states in defined patient populations. Additionally, a care pathway had to translate available evidence to local clinical practice,1 or use evidence-based medicine or clinical guidelines to develop treatment recommendations.3,4 The care pathway had to include a monitoring and evaluation mechanism.2-4 Finally, we focused our investigation on care pathways that included criteria for the use of pharmacologic therapies. A targeted hand search was completed in May 2015 to supplement the earlier review with more recent information.

Primary Research

Subjects. Between August and November 2014, we conducted online surveys with 26 participants, based on a target of 20 to 30 respondents, followed by semi-structured interviews with 15 of those participants and an additional 3 opinion leaders, given a target of 50% follow-up interviews. This research did not include human subjects, according to the federal definition of human subject research,23 and thus was exempt from institutional review board review.

Respondents were selected to represent a mix of health plans with commercial, Medicare (Part D, Advantage), and/or Medicaid lines of business; pharmacy benefit management organizations; healthcare providers; and commercial care pathway vendors. To capture perspectives from most US healthcare provider organizations, provider respondents were selected from small and large group practices, accountable care organizations (ACOs), and integrated health delivery systems (IDSs). All respondents were screened for involvement in the development, implementation, use, or evaluation of care pathways used to guide pharmaceutical or medical treatment decisions. The online survey and semi-structured interviews were administered only to respondents who indicated familiarity with care pathways and had at least some knowledge relevant to the sections covered by the survey. Participants were offered honoraria for survey and interview participation.

Online survey. The survey instrument consisted of 8 sections: an introduction, de-identified participant information, participant experience with care pathways, care pathway development, implementation and use, evaluation, key stakeholder agreements and relationships, and perceptions about the future of care pathways. Respondents were asked to provide answers to questions only if they indicated having at least some knowledge of the information covered in a given section (a rating of at least “3” on a 5-point scale); those who reported experience with non-oncology care pathways were instructed to respond to questions from this perspective. The total number of questions answered per respondent depended on their role and experience, to a maximum of 86 possible questions. Descriptive analyses were conducted in Excel; due to small sample sizes, statistical testing was not conducted.

Interviews. Trained interviewers administered an hour-long semi-structured discussion guide with open-ended questions. Interviews were designed to supplement information obtained from the online survey with additional detail on selected issues. Interviews were digitally recorded, transcribed, and de-identified. Data abstraction and extraction of interview responses were conducted in parallel by 2 reviewers (SM and AK), with adjudication in rare instances of discordance.

Phase I: Literature Review

We identified 616 unique citations from our search of electronic databases, gray literature, and websites of care pathway vendors, payers, and major oncology provider networks. Full text review of publications was conducted for 73 citations; of these, 11 were full-length published articles, and 18 were conference abstracts and posters describing findings for studies of specific care pathways. This review was supplemented by unpublished information identified on the websites of care pathway vendors, payers, and oncology provider networks. Our goal was to identify key themes and gaps in information to inform the design of the online survey and interviews.

In our review of the literature on care pathways, we observed variation in the characterization of care pathways. Evaluations of care pathways were more frequently focused on resource use and cost, and some concerns about transparency were expressed. The extent to which care pathway development, implementation, and evaluation were documented varied, and descriptions were not standardized, although some studies described these activities in detail.10,13,24-29 Furthermore, roles and responsibilities of key stakeholder groups in these activities were documented in some cases,12,25 but were not always clear. Evidence documenting the impact of care pathways on quality of care, patient outcomes, and healthcare resource use is beginning to emerge; a few studies have been published, and others have been presented in conference abstracts or posters. Some studies documented pathway adherence or compliance,12,25,28,30-36 or patient outcomes.31,33,37-39 Most studies we identified assessed the ability of care pathways to control resource use or costs.25,28,31,33,34,38-49 In addition to concerns about transparency in methodology associated with pathway development, concerns about lack of patient awareness of use of pathways, and implications for clinical decision making in delivery of their care, have also been noted.50,51

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