The role of patient-reported outcomes in a patient-centered care model for managing chronic liver diseases

INTRODUCTION The Institute of Medicine has put forth 6 essential aims for a high-quality health care system for the 21st century: safe, effective, timely, efficient, equitable, and patient-centered.1 Innovations in health care delivery can achieve these aims for the care of individuals with chronic liver disease (CLD). In this review, we aim to describe patient-centered care (PCC) and the key role of patient-reported outcomes (PROs) to optimize PCC for CLD. PCC is a model of care in which patients’ values and preferences inform decision‐making and care is responsive to individual patient needs. Within PCC, the IOM has endorsed a framework of 6 domains that should be measured and tracked to ensure PCC (Figure 1).2–18 These include care that is respectful to the patient’s values, preferences, and expressed needs; coordinated and integrated; provides information, communication, and education; ensures physical comfort; provides emotional support; and involves family and friends. Importantly, the quality of PCC in these domains needs to be assessed directly from patients in the form of PROs. (PROs are any report of the status of a patient’s health condition that comes directly from the patient.) Examples of common PROs are health-related quality of life, behaviors, treatment preferences, functional recovery, and health care experience, all of which are collected using standardized measures (ie, questionnaires).19FIGURE 1: Examples of patient-reported outcomes that can measure the quality of patient-centered care.Patients with CLD are often underdiagnosed and undermanaged for symptoms and psychosocial issues, commonly due to inadequate methods to illicit these directly from patients. These symptoms often lead to emergency room visits and unplanned admissions. This creates a missed opportunity for health care providers and systems. Integration of PROs within routine CLD care is in its infancy. There are limited studies describing the clinical application of PROs to provide PCC within routine clinical care for patients with CLD. PRO integration is a complex bundled intervention that requires provider training and an understanding of the clinical role of PROs coupled with workflow and system changes. Our discussion below is informed by the implementation of PROs within other fields, such as oncology, which has demonstrated the feasibility and effectiveness of these bundled interventions in improving health care quality and overall survival. ROLE OF PATIENT-REPORTED OUTCOMES IN PATIENT-CENTERED CARE PROs have a critical role in improving patient-centered care systems, and there have been increasing efforts to bring PROs into routine practices. The goals of integrating PROs within PCC models include optimizing individual care, improving population health, informing value-based care, and guiding PCC research. Routinely using PROs empowers patients to actively participate in their health care, facilitates early detection and monitoring of patient symptoms, and enables clinicians to better understand and act on individual needs.20 The Quality Adjusted Life Years gained by patients receiving novel treatments can be calculated based on PRO data.21 PROs can be collected before the clinical visit, and results can be displayed to patients and providers within electronic medical records.22 However, implementing such practices is challenging and complex, involving support from multiple stakeholders (such as system leaders, administrators, health informatics, and end users). As with any chronic disease, patient-centered care models are ideal for serving the needs of patients with CLD, which, however, remain understudied.19 CLINICAL APPLICATION OF PROS WITHIN LIVER DISEASES In chronic diseases such as chronic obstructive pulmonary disease and cancer, PROs have been used for screening, monitoring, and triggering early care management for adverse events and acute episodes. The enhanced oncology care model requires PRO collection, which enables care navigators to provide proactive PCC for the patients and is linked with financial incentives for the health care providers. However, limited knowledge and evidence exist for the clinical integration of PROs in hepatology practices. Table 1 outlines some examples where PROs can have a clinical role for patients with CLD. There is extensive literature on the poor health-related quality of life in individuals with chronic liver disease.23,24 Lower PRO scores, independent of MELD scores, are reported to be linked with higher 30-day mortality for patients with alcohol-associated CLD. One point increase in PRO scores predicted a 4% reduction in mortality for patients with CLD.25 Building on this foundation, recent studies have expanded on the types of PROs and their potential role in informing and guiding patient care. Studies have shown that patient-reported functional status can improve the prediction of hospital readmission.26 In patients undergoing local regional therapy for HCC, symptoms were common after treatment and most patients favored systematic monitoring of symptoms electronically as part of their care experience.27 Recent studies have also shown that the psychosocial burden of patients undergoing liver transplant is currently not systematically measured and, therefore, underaddressed.28 PROs can also guide PCC by identifying models of care acceptable to patients. To this end, several studies have shown the acceptability of telemedicine for outpatient hepatology care.29–31 TABLE 1 - Clinical application of PROs within liver diseases Role of PROs Purpose Examples Screening Identify undiagnosed problems such as depression, distress, alcohol, and substance use PHQ-9Distress thermometerAUDITDAST-10 Symptom monitoring Track symptoms such as pain or fatigue over time, cognitive function ESAS, FACIT-F, PROMIS instruments Self-monitoring and management Track weight over time to help manage ascites (using weighing scales that can send data to EMRs), knowledge assessment, medication adherence, lifestyle monitoring (mobile health applications to monitor diet and physical activity) Web-based appsBAASIS (Basel Assessment of Adherence to Immunosuppressive Medications Scale) Health-related social needs assessment Assessing financial stress, food insecurity, nutrition conditions, housing, etc using standardized PROs, caregiver burden CMS ScreenerZarit Burden Interview Satisfaction with health care Acceptability of novel models of health care such as telemedicine FAMCARE-P Abbreviations: AUDIT, Alcohol Use Disorders Identification Test; BAASIS, Basel Assessment of Adherence to Immunosuppressive Medication Scale; CMS, centers for medicare and medicaid services; DAST-10, Drug Abuse Screening Test; ESAS, Edmonton Symptom Assessment System; EMR, electronic medical recor; FACIT-F, Functional Assessment of Chronic Illness Therapy – Fatigue Scale; PHQ-9, Patient Health Questionnaire; PRO, patient-reported outcomes; PROMIS, Patient-Reported Outcome Measurement Information System. PROs are categorized into generic and disease-specific instruments. Generic instruments such as Patient-Reported Outcome Measurement Information System Profile 29 (PROMIS-29) (assessing 7 health domains—physical function, fatigue, social function, depression, anxiety, pain interference and social function, and pain intensity), Edmonton Symptom Assessment System (assessing symptom burden), Patient Health Questionnaire-9 (assessing depression) can be used clinically. PROMIS-29 is a disease-agnostic PRO measurement that can be completed quickly, scored immediately, available in a variety of languages, and can be completed within medical records, making it very useful for direct clinical application. Optimizing care management plans based on these scores can add value-based approaches to CLD care delivery and allow comparisons with other advanced illnesses. Liver disease–specific PROs such as the Chronic Liver Disease Questionnaire (CLDQ), Functional Assessment of Cancer Therapy-Hepatobiliary Scale (FACT-Hep), and Liver Disease Quality of Life (LDQOL) have mostly been used for research purposes (as secondary outcomes in clinical trials) but likely could be tested for clinical utility. The critical features of PROs, which are helpful to consider, include low measurement errors (so the clinicians have a precise assessment of patients’ suffering), availability of reference values and thresholds to quantify the problem into mild, moderate, and severe, and responsiveness to change over time. Other aspects to assess before deciding which PRO to use are respondent burden, cost/licensing, and availability of platforms to conduct these in different languages (to avoid creating health disparities). Notably, electronic PROs allow the patient to report their symptoms in real time outside of their clinic visits and facilitate direct data collection within electronic health records, enabling longitudinal assessment of symptoms.32 The clinical use of PROs has been associated with better health outcomes, inducing improved quality of life, decreased emergency care, and prolonged overall survival in oncology.33 Despite these demonstrated benefits, PROs are rarely used within routine CLD care. This may be due to several limitations reported in the literature from diverse disease conditions and practices, which likely apply to Hepatology as well (Table 2). Most common barriers include difficulty in integrating PROs within clinical workflows, technical aspects of electronic health records and other web-based platforms/apps, protocols to address the issues identified through PROs, understanding of PROs among the providers, clinical staff, and patients, and above all limited reimbursement linked with PRO collection (eg, reimbursement for Patient Health Questionnaire-9–based depression screening). TABLE 2 - Barriers and facilitators to the use of PROs in patient-centered care Locus Barriers Facilitators Health system Cost and lack of understanding of purpose, limited technical staff availability, legal/regulatory concerns on critical PROs. Co-designing the systems with direct input from health system leaders and administrators. Providers Limited understanding of PROs and uncertainty on how to integrate PROs into clinical discussions, disruption in their clinical timings, Providing training to familiarize with PRO systems, scoring, and potential clinical actions. Workflows Limited time available between subsequent patients and limited privacy in waiting areas to use the wait time for PRO collection. Consulting with clinical teams to find the best way to reduce time burden and embedding resources to help address identified concerns (making it useful to clinicians). Patients Access to electronic systems, limited understanding of the need for PROs, health literacy and ownership of their care planning, additional time to complete PROs, dissatisfaction with care if PRO collected but not acted on Motivated to have their voice incorporated into clinical care; increasing ability to use devices for PRO collection Technology integration Inadequate communication between different systems often creates the need to start from scratch in each system. Of note, Epic has many inbuilt PROs that can now be accessed by health systems. Availability of electronically scored measures Abbreviation: PRO, patient-reported outcomes. Table 3 shows selected studies in which PROs are used as a part of the clinical intervention within populations with CLD. The PAL-LIVER trial (Palliative Care for End-Stage Liver Disease) comparing models of palliative care delivery utilizes PROs as a part of the toolkit for hepatologists to tailor primary palliative care. Specifically, symptom burden, depression, and distress are assessed at baseline and study follow-up visits, and the scores are shared with providers to inform the clinical consultation.35 A behavioral health intervention utilized PROs such as Alcohol Use Disorders Identification Test, Drug Abuse Screening Test, and Patient Health Questionnaire-9 to tailor intervention using the Screening Brief Intervention and Referral to Treatment model.34 The Screening Brief Intervention and Referral to Treatment model has demonstrated effectiveness in primary care and other settings to improve care for patients with substance use disorders and can very well inform care for the population with alcohol-associated CLD.37 TABLE 3 - Examples of studies using PROs as a part of patient-centered care interventions within liver diseases Author, Year PRO used as an intervention Inclusion criteria and sample size Primary outcome Intervention/findings Verma et al, 201822 PROMIS-29 Outpatients with cirrhosis (n = 75) Acceptability and clinical value of PRO assessment; CLDQ Completion of PROMIS-29 before visit. Results presented to the clinician before the visit.91% of patients and 88% of providers found PROs useful; treatment changes in 26% of clinical interactions Verma et al, 201934 AUDIT, DAST-10, PHQ-9 Outpatients with CLD presenting to hepatology (n = 303) 1) Changes in CLDQ scores2) Changes in AUDIT, DAST-10, and PHQ-9 scores Completion of PROs before visit. Patients screening positive for alcohol use disorder, substance use disorder, or depression received intervention.CLDQ scores improved with greater improvement in those with depression who received intervention. Verma et al, 201935 ESAS, distress thermometer, PHQ-9 Decompensated cirrhosis within 6 months of enrollment; Multifocal HCCSample size = 944 Change in FACT-HepSecondary: Change in symptoms, depression, distress, and caregiver burden “PAL-LIVER” compares models of palliative care for ESLD (PC delivered by trained hepatologists vs. PC-trained providers). Care tailored to PROs reported at the time of enrollment.This study is still recruiting, Cirrhosis medical home Study, Orman et al, 202326 SF-36, GAD-7, PHQ-9, and PSE Test Hospitalized patients with cirrhosis with ascites or HE with poor HRQOL were discharged home Feasibility of enrollmentSecondary: Change in QOL, readmissions, mortality Standard of care after discharge vs. completion of PROs and needs assessment by the nurse after discharge to create a multidisciplinary plan of care, which was then implemented using a medical home model of care.Study feasibility was established with trends toward improved HRQOL for those in the intervention group. PRIMER Study, Serper et al, 202336 PG-SGA, step counter Undergoing evaluation or awaiting a liver transplant, MELD ≤ 25 at risk for frailty or malnutrition Feasibility of enrollmentSecondary: Daily study step count at the end of study, frailty measures, and body composition Personalized nutrition and exercise recommendations for a home-based physical activity program supported by financial incentives for meeting walking goals and participating in weekly telephone check-ins, and text messages with medication remindersStudy feasibility established with 997 more daily steps at the end of the study in the intervention group. Abbreviations: AUDIT, Alcohol Use Disorders Identification Test; CLDQ, Chronic Liver Disease Questionnaire; DAST-10, Drug Abuse Screening Test; ESAS, Edmonton Symptom Assessment System; FACT-Hep, Functional Assessment of Cancer Therapy-Hepatobiliary Scale; PG-SGA, Patient-Generated Subjective Global Assessment; PHQ-9, Patient Health Questionnaire; PROMIS, Patient-Reported Outcome Measurement Information System; SF-36, Short-form-36. PROCESSES INVOLVED IN THE CLINICAL INTEGRATION OF PROS (A BUNDLED INTERVENTION) It needs to be clear that a mere collection of PROs is not enough. The PRO collection needs to be preceded by provider education on the role of PROs and what is expected of them to address issues identified by the PROs. Completion and reporting of PROs need to be linked with navigation programs (based on evidence-based interventions) to improve symptom management and reduce health care utilization.38 In addition, frontline staff and medical assistants need to be made familiar with the role of PROs and methods to get these completed before the consultation visits. Health information technology expertise is required to allow a seamless collection of PROs either through medical records or other web-based platforms. Furthermore, the patients need to be familiarized with the role of PROs in their care and assured that their responses will be reviewed by the clinical team and used to tailor their management plans. This step will highly promote the response rates. Once the PROs are completed, results should autopopulate within medical records, or paper copies given to the patients and providers. It is of utmost importance that providers utilize and refer to their PRO responses during the consultation. Once the visit is complete, it is important to evaluate if there was any change in the clinical care plan as a result of PRO integration. Direct capture of this impact in addition to estimated time spent during the consultation can help sustain the use of PROs. Several platforms that allow ePRO collection exist, but the ones that can be integrated into medical records are the most useful clinically, given the limited time within clinics to login to outside servers. Most recently, text messaging has been used to collect PROs as well. There is a need to compare these implementation approaches and strategies to identify which method may work best in a given setting and population. To summarize, 3 key steps to include PROs within clinical CLD care are as follows: (1) provider training and selecting the PRO that meets the goal of the practice, patients, and providers; (2) selecting the mode of assessment, timing, and associated workflow adaptations, which are sustainable; and (3) methods by which the results will be made available during the clinical consultation.39 FUTURE DIRECTIONS Given the evolving focus of health care systems to a patient-centered care approach and the key role of PROs within a patient-centered care, it is obvious that the field of hepatology needs to accelerate research in this area. Innovations in programs focused on PRO integration within routine CLD care are needed to advance this field. These could focus on using modern measurement methods, that is, computerized adaptive testing within electronic health records; collecting PROs before the clinical consultations so the reports can be made available to both patients and providers during the consultation; and additional reimbursements from payers to enhance the use of PROs. The American Association for the Study of Liver Diseases is leading efforts to improve the field forward, such as harmonizing which PROs are most clinically applicable, and future efforts must optimize how to respond to PRO scores to further inform the hepatologists interested in using them in routine practice. Including PROs within clinical care could offer several benefits. These include making the patients feel heard, complementing traditional clinical data on disease severity, and measuring direct treatment effects over time. There is a need for large-scale multisite trials using robust, pragmatic designs such as cluster randomized controlled trials or stepped wedge designs to test and implement methods of PRO integration within routine CLD care. In addition, capacity building and infrastructure support initiatives are required for this paradigm shift. A special emphasis on provider education on the role of PROs and ways to interpret them and utilize them to tailor clinical decision-making can serve as the backbone for large-scale implementation and sustainability efforts. To guide these efforts, several good quality guidelines on PRO integration are available, which can help launch the field of PRO integration within CLD care. Most recently, the Patient-Reported Outcomes Tools: Engaging Users and Stakeholders consortium has developed a practice guide information from these available This guide the and management of PRO systems. The key steps are to the clinical goal of PRO collection, the setting where PRO collection will health care or between clinical available resources for the clinical and data and the of completion by patients coupled with by the providers. potential future research within CLD care include the (1) PRO and PCC domains are clinically and what change in scores is clinically (2) is the time to (3) Within hepatology practices, what are the clinical best practices to act the PRO PRO measurement impact patient and provider experience, and with the In the hepatology field is still in its of using PROs to guide clinical care, many to improve the quality of PCC for patients with CLD.

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