Abstract: Modern clinical practice places restrictions on the amount of information communicated in a typical office visit, impeding patient concerns from being adequately addressed. A point-of-care case management system to identify patient-reported quality-of-life (QOL) concerns and to translate them into actionable clinical pathways was created in order to address this gap. A patient-reported outcomes quality-of-life (PROQOL) tool that was originally created for diabetes was adapted to better fit the needs of hematology-oncology patients. Potential concerns of patients were identified, using a literature review and focus groups, and were categorized. Corresponding resources were collected and incorporated into a clinical pathway. A quality improvement study was then undertaken with 20 patients to assess the feasibility of incorporating the system into clinical visits. Participating patients were administered a Linear Analogue Scale Assessment QOL survey as well as a “was it worth it” survey to assess their satisfaction with the PROQOL system. Initial findings indicate that this system has the potential to improve patient well-being without increasing provider burden.
With 1,658,370 new cases of cancer diagnosed in 2015 in the United States, and a projected 18 million cancer survivors by 2020,1 the impact of sequelae of cancer and of its treatment will become an increasingly large part of hematology-oncology practice. Patients with cancer receive complex medical care, involving surgery, radiation, chemotherapy, and/or targeted agents, which may result in physical, emotional, financial, and spiritual consequences. It behooves the medical community to actively engage patients with cancer to effectively assess their needs in order to provide better care and improve their quality of life (QOL).
The significance of assessing patients’ needs beyond tumor response was initially demonstrated by the Institute of Medicine’s 2007 report, Cancer Care for the Whole Patient: Meeting Psychosocial Health Needs.2 This has further been defined by The National Comprehensive Cancer Network guidelines for assessing distress in all cancer patients.3 The importance of health-related QOL assessment in patients with cancer is also highlighted by its use by the US Food and Drug Administration as a clinical endpoint for the approval of new therapies. These publications and regulations highlight the importance of assessing patients’ psychosocial health in addition to their physical needs and diagnoses. Moreover, there have been multiple publications on the prognostic value of QOL for survival of patients.4,5 Collectively, this represents a strong recommendation for the incorporation of the patient perspective into routine medical care.
The question of how the patient’s perspective can be elicited efficiently has yet to be answered. There are a plethora of questionnaires and assessment tools aimed at obtaining and summarizing patient needs and opinions,6 but the complexity and length of these tools can limit real-time data collection and interpretation in routine clinical practice.7,8
This challenge, as well as preliminary findings from our previous work, led us down a more practical path of distilling and identifying the patient perspective regarding their single most important concern at a given time.9 If a patient’s single biggest concern could be identified for every clinical visit, the focus of the encounter would shift to the most vital issue as perceived by the patient without influence by clinicians or caregivers. Issues that might otherwise not be raised could be addressed. More importantly, the patient and clinician would benefit from knowing that each visit has dealt specifically with at least the most important issue for the patient, in addition to routine care.
This approach recognizes the reality that modern clinical practice places restrictions on the amount of information and processing that can be done in a typical office visit.10 Clinicians and patients are both challenged to communicate efficiently and obtain essential case management resources.10 On average, clinicians in modern oncology practices have between 1 and 3 minutes of “extra” time to discuss additional concerns with the patient.11,12 The remainder of the visit is taken up with prescribed clinical and administrative processes.13
It is clear that, for the busy practitioner, the challenge lies not only with identifying the variety of QOL issues that the patient might be experiencing but also with managing them once identified, as many of these issues are outside their realm of expertise. For example, concerns over costs of many aspects of cancer care are certainly an issue for patients, but clinicians do not have specific knowledge of social services available to aid with these issues. Furthermore, studies have shown that health care providers are not adept at identifying patient QOL symptoms or functioning challenges, and, even when they do, they often underestimate the impairment.14,15 To date, there are few studies that collect patient-reported outcomes (PROs) to inform the health care team in real time in order to individualize their therapy. Those studies that have been reported use lengthy instruments or assessments from a single time point.16,17
In 2009, the Office of the National Coordinator for Health Information Technology (www.healthit.gov) funded a Beacon Community Cooperative Agreement Program. The goal of this program is to translate investments in health information technology (IT) into measurable improvements in cost, quality, and population health. It also aims to develop innovative approaches to care delivery to accelerate evidence generation for new approaches.
In November of 2010, the Southeast Minnesota Beacon Community launched the Patient-Reported Outcome Quality of Life (PROQOL) project to help capture electronic PRO data in a patient population. The goal was to develop a system that would function both as a self-reported electronic questionnaire that could assess symptoms/QOL over time and provide physicians and nurses with information regarding symptoms and/or psychosocial problems that need to be addressed.
The original system was developed by a multi-disciplinary team that reviewed QOL instruments in the literature and found more than 300 potential items to include. Subsequently, focus groups of physicians and patients were held to determine the importance of the various items. Prevalent themes were identified, and several categories emerged as the most relevant topics: personal relationships, monitoring health, emotional health, money, health behaviors, medicine, receiving health care, work, physical health, and “something else,” a category used to encompass all other concerns.
The system was initially tested in diabetes clinics.7 Patients were asked, “Which of the following categories, if any, represents your single biggest concern right now?” Once a category was selected, a list of possible concerns appeared, and patients were recommended to select all that applied. Depending on the major category and subset of questions chosen, they were then provided with a list of resources.
We sought to address the array of additional issues cancer patients have in a way that allows us to aid providers in delivering optimal care and to measure improvement. We chose to adapt the original Beacon instrument as a medical hematology-oncology PROQOL system because of its user-friendly nature, ability to provide recommendations, and validated QOL metrics that are measurable over time. The Beacon system was modified to better address the needs for assessing the challenging symptoms and psychosocial problems of complex cancer patients. The feasibility and practicality of this case management system was tested prior to launching a larger randomized trial to test the tool’s efficacy, refine the tool, and eventually integrate it into clinical practice.
DEVELOPMENT OF THE PROQOL TOOL FOR CANCER
Because the concerns included in the original PROQOL were directed towards patients with diabetes, the challenge was to ascertain what issues were important specifically for patients with cancer as well as to find the appropriate resources to aid in addressing their concerns. We originally met with a group of oncologists and hematologists to identify common concerns that arise among patients and their providers. The concerns were then grouped into categories that spanned physical health, appearance, emotional health, financial concerns, treatment and diagnosis issues, and end-of-life care.
Once the categories were determined, corresponding resources were identified. The actionable resources provided were developed from a thorough literature review, followed by discussions with a multidisciplinary group to gain insight on how experts may address various possible topics. First, we contacted the Cancer Center Education Group and American Cancer Society patient navigators at Mayo Clinic. They provided a wealth of information, including pamphlets, reputable websites, support groups, and foundations that were available locally and nationwide. Additional reliable, up-to-date online resources were sought out and collated. As the list was being finalized, a multidisciplinary group comprised of chaplains, social workers, chemotherapy nurses, clinical assistants, nurse practitioners, physician assistants, patient advocates, and physicians were asked to review and edit as needed. Through their input, the resources specific to cancer patients were collected and organized.
INCORPORATING THE PROQOL INTO A CLINICAL PATHWAY
Once the PROQOL system was developed, we created a workflow in order to incorporate it into practice. As soon as a patient arrives, they are provided the PROQOL survey prior to the appointment by clinical desk staff or a nurse. The patient can use that to identify their biggest concern, detail the aspects of the concern, and provide some general information about their well-being and distress levels. The program then provides a summary document detailing the concern and providing a list of suggested actions to be taken by all stakeholders to address the concern. For example, the document may include suggested consultations, prescriptions, and a review of medications for the provider as well as education material, support groups, and online resources for the patient. The report of actionable resources is given to both the patient and clinical team upon completion. Finally, the material provided to patients is scanned into the electronic medical record for future reference by all involved. There is also a graphical representation of the QOL domains selected by the patient that is given to patients and providers to review, allowing them to track their progress (Figure 1).
A FOCUS GROUP TO PROVIDE FEEDBACK ON THE PROQOL CLINICAL PATHWAY
Focus groups were hosted to demonstrate the system and gain feedback from the vested parties, including clinical staff caring for hematology and medical oncology patients as well as cancer patients seen in these divisions. Overall, 23 providers and 5 patients participated in three, one-time focus groups. Each session involved a brief demonstration of the PROQOL system (Figure 2) followed by completion of a “was it worth it” (WIWI) survey. A WIWI asks overall was the process worth it to do, would you do it again, and would you recommend this to others.18 Each session was recorded and later transcribed for data collection and assessment of themes.
The patient participants provided valuable input regarding the PROQOL system. For example, originally there was not an “other” category; however, through the patient focus groups, we discovered that patients requested a category for “something else” if they did not have a particular issue or had a more specific issue to discuss with their health care team.
In addition, there was concern about the specific wording in the “end-of-life care” category. Staff members at the focus groups felt that this would not be well received and advocated for euphemisms. The patients unanimously stated that they appreciated the directness of the category, and the wording for “advanced care planning” and “end-of-life care” category was well received. In fact, the patients felt it could possibly facilitate the initiation of discussions of difficult topics. The participants reported that the PROQOL categories covered their pertinent issues and included topics that they would not necessarily bring up independently. Further, the patients expressed interest in having the ability to choose multiple categories to address per clinical visit instead of being limited to one concern per visit.
The provider focus group was primarily intended to inform planning for the logistics of implementing the PROQOL system. The multidisciplinary group of participants included physicians, nurse practitioners, physician assistants, nurses, and clinical assistants. This group recommended that the PROQOL system be available after patients’ first consultation to ensure that they had gained some understanding of the diagnosis, treatment plan, and trajectory of their care. In addition, some revisions to the questions and resources were made, such as the addition of key physical issues and the addition of lifestyle behaviors (tobacco, alcohol, and exercise) and stress to the emotional health category.
The providers also recommended additional resources that are helpful in their practice, including the Livestrong program, which offers free YMCA exercise program to cancer patients nationally, and mindfulness classes for stress management.
Providers expressed concern about the increasingly busy clinic schedules, time constraints, and how this system would aid in their time with their patients. They wanted to have the system provide resources that were easy to deliver and quick to access. The idea of having more than one issue addressed per visit was not well received. The health providers thought it was improbable for both the staff and patient to complete two issue assessments per visit in addition to reviewing labs, imaging, treatments, and possible toxicities. These suggestions in turn resulted in restricting the number of issues to one per visit, and resource lists were refined, simplified, and bulleted for convenience of use.
PROQOL QUALITY IMPROVEMENT PROJECT
After the focus groups took place, additional edits and revisions were made to the clinical resource list, and the clinical pathways were refined. Next, we wanted to assess the feasibility and benefit of using this system in this patient population. A clear priority was to establish if this system could be incorporated into a clinical visit quickly and efficiently. A quality improvement (QI) project, rather than a research pilot, was performed because we were looking to improve an internal process that would benefit patients and determine if any logistical issues arose prior to larger randomized testing and clinical implication.
To complete this QI project, the system was provided in a practice to patients with hematological cancers and solid tumor malignancies. Patients were approached on their clinic visits and invited to participate in the pilot, and oral consent was obtained. No Institutional Review Board approval was required because this was a QI project.
Twenty patients were identified who were willing to utilize this process as part of their clinical visit. The 20 cancer patients who participated in the pilot study had a median age of 62 years (range 33-78), and 65% of the patients were female. There was a mixture of patients receiving active treatment as well as surveillance. The baseline characteristics are shown in Table 1. Among the 20 patients surveyed, 3 have subsequently died since the writing of this publication.
The PROQOL system was used to identify patient’s main concerns prior to the visit and to review the resources triggered by the patient’s responses during the visit. The clinical issue was discussed, and a list of actionable options was printed and provided to the patient. The category selected and the list of resources provided were uploaded to the electronic medical record. All the categories of the PROQOL system were selected by at least one of the participating patients. The cancer diagnosis and treatment category was selected most commonly, with 6 selections (30%; Table 1). The next most popular categories included personal relationships, emotional health, and something else, which had 3 selections each. On average, the completion of the PROQOL system took 4.0 minutes, and reviewing the resources did not add more than a few minutes to the clinical visit.
All participants completed a validated standardized Linear Analogue Scale Assessment (LASA) with 8 questions, scored on a Likert scale from 0 (as bad as it can be) to 10 (as good as it can be), to assess multiple QOL domains including Physical, Functional, Social, and Emotional (Figure 3).19 The LASA was selected as the QOL assessment because it is routinely used in hematology-oncology clinical practice at Mayo Clinic and its simplicity and ease to administer and score. The overall QOL mean (range) was 7.2 (1-10) with a pain severity rating of 2.4 (0-8). When patients were asked if they felt overwhelmed by the demands of living with cancer, the average score was 2.4. All of the LASA items and patient results are shown in Table 2.
After the discussion was completed, each patient was offered the opportunity to complete a WIWI form for additional feedback. Nineteen of the twenty participants completed the WIWI survey, and 100% of the patients who took the survey thought it was worth it and would recommend this tool to others.
DISCUSSION
Health care providers rely on a variety of clinical parameters such as lab values, imaging, and history to design care plans for their patients, but some information about the patient’s health is best gathered through patient self-report. Recent quality- and performance-related standards, such as those put forth by the Patient-Centered Outcomes Research Institute and the Institute for Healthcare Improvement, have given routine collection of PROs new emphasis in health care delivery research.
The development and adaptation of this case management system for hematology and oncology required a multidisciplinary team including psychometricians, clinicians, statisticians, and IT specialists for its successful creation. The opportunity to use PRO data in the clinic is important for clinicians to individualize care in real time. Hosting the patient and provider focus groups was fundamental to gain a deeper understanding of the needs of this population and the potential issues to workflow and logistics. Collecting and collating the actionable resources will be different for individual practices depending on the local resources available, but many of the resources compiled are national and available online. Although a one-size-fits-all process is not possible, these steps of brainstorming, collecting, and organizing resources could guide in the development of a similar case management system in other hematology-oncology practices. A key aspect of this system is that it identifies key stakeholders that can address each suggested action, thus alleviating demands on the clinical team and engaging more expert and appropriate resources to deal with the specific concerns of the patient.
This PROQOL system was well received by the pilot group of patients. The feasibility QI testing illustrated that all eight of the PROQOL categories were useful and relevant for this patient population. The data also demonstrated that the survey could be completed by a diverse population of patients in a short period of time. Although the LASA results indicated that an average participant had a greater QOL and a low pain severity, it still indicated that even this population, which overall was doing well, had questions, comments, and concerns that affected their QOL. All of the patients also indicated that they would like to use the system at future appointments and would recommend it to others. The patients in the pilot also made many useful recommendations to improve the tool for future use, including adding a section or category on survivorship issues.
The case management system developed indicated that the PROQOL system was adaptable from diabetes content to oncology and hematology clinical practice variables. The system performed well in a small number of clinical visits and has the potential to substantially improve patient well-being and clinical outcomes as well as reduce the burden on clinicians and distribute the case management activities to the most appropriate providers.
CONCLUSION
This study has been the basis for a prospective, randomized, single-center protocol that has been written for patients with dysproteinemias, and gynecologic and head and neck cancers. The primary aims will be to evaluate whether this system improves the average QOL over 12 months, places an increased burden on providers, aids our understanding of the natural history of QOL issues, has a positive impact on physician-patient relationships, and can feasibly be incorporated into the workflow of a busy clinical department. This last aim will require meeting with providers and clinical staff to discover the issues related to workflow, perception of values, and challenges overall. The importance of finding the logistical issues early and getting feedback from patients on the usefulness will be key to the successful incorporation of the PROQOL system in our clinical practice. This system provides a platform to individualize treatments to improve QOL and allocate resources appropriately whilst not increasing clinician burden.
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