Streamlining and Reimagining Prior Authorization Under Value-Based Contracts: A Call to Action From the Value in Healthcare Initiative's Prior Authorization Learning Collaborative.

Utilization management strategies, including prior authorization, are commonly used to facilitate safe and guideline-adherent provision of new, individualized, and potentially costly cardiovascular therapies. However, as currently deployed, these approaches encumber multiple stakeholders. Patients are discouraged by barriers to appropriate access; clinicians are frustrated by the time, money, and resources required for prior authorizations, the frequent rejections, and the perception of being excluded from the decision-making process; and payers are weary of the intensive effort to design and administer increasingly complex prior authorization systems to balance value and appropriate use of these treatments. These issues highlight an opportunity to collectively reimagine utilization management as a transparent and collaborative system. This would benefit the entire healthcare ecosystem, especially in light of the shift to value-based payment. This article describes the efforts and vision of the multistakeholder Prior Authorization Learning Collaborative of the Value in Healthcare Initiative, a partnership between the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University. We outline how healthcare organizations can take greater utilization management responsibility under value-based contracting, especially under different state policies and local contexts. Even with reduced payer-mandated prior authorization in these arrangements, payers and healthcare organizations will have a continued shared need for utilization management. We present options for streamlining these programs, such as gold carding and electronic and automated prior authorization processes. Throughout the article, we weave in examples from cardiovascular care when possible. Although reimagining prior authorization requires collective action by all stakeholders, it may significantly reduce administrative burden for clinicians and payers while improving outcomes for patients.

Improving Cardiovascular Drug and Device Development and Evidence Through Patient-Centered Research and Clinical Trials: A Call to Action From the Value in Healthcare Initiative's Partnering With Regulators Learning Collaborative.

The pipeline of new cardiovascular drugs is relatively limited compared with many other clinical areas. Challenges causing lagging drug innovation include the duration and expense of cardiovascular clinical trials needed for regulatory evaluation and approvals, which generally must demonstrate noninferiority to existing standards of care and measure longer-term outcomes. By comparison, there has been substantial progress in cardiovascular device innovation. There has also been progress in cardiovascular trial participation equity in recent years, especially among women, due in part to important efforts by Food and Drug Administration, National Institutes of Health, American Heart Association, and others. Yet women and especially racial and ethnic minority populations remain underrepresented in cardiovascular trials, indicating much work ahead to continue recent success. Given these challenges and opportunities, the multistakeholder Partnering with Regulators Learning Collaborative of the Value in Healthcare Initiative, a collaboration of the American Heart Association and the Robert J. Margolis, MD, Center for Health Policy at Duke University, identified how to improve the evidence generation process for cardiovascular drugs and devices. Drawing on a series of meetings, literature reviews, and analyses of regulatory options, the Collaborative makes recommendations across four identified areas for improvement. First, we offer strategies to enhance patient engagement in trial design, convenient participation, and meaningful end points and outcomes to improve patient recruitment and retention (major expenses in clinical trials). Second, new digital technologies expand the potential for real-world evidence to streamline data collection and reduce cost and time of trials. However, technical challenges must be overcome to routinely leverage real-world data, including standardizing data, managing data quality, understanding data comparability, and ensuring real-world evidence does not worsen inequities. Third, as trials are driven by evidence needs of regulators and payers, we recommend ways to improve their collaboration in trial design to streamline and standardize efficient and innovative trials, reducing costs and delays. Finally, we discuss creative ways to expand the minuscule proportion of sites involved in cardiovascular evidence generation and medical product development. These actions, paired with continued policy research into better ways to pay for and equitably develop therapies, will help reduce the cost and complexity of drug and device research, development, and trials.

Overcoming the Challenges of Unstructured Data in Multisite, Electronic Medical Record-based Abstraction.

BACKGROUND: Unstructured data encountered during retrospective electronic medical record (EMR) abstraction has routinely been identified as challenging to reliably abstract, as these data are often recorded as free text, without limitations to format or structure. There is increased interest in reliably abstracting this type of data given its prominent role in care coordination and communication, yet limited methodological guidance exists. OBJECTIVES: As standard abstraction approaches resulted in substandard data reliability for unstructured data elements collected as part of a multisite, retrospective EMR study of hospital discharge communication quality, our goal was to develop, apply and examine the utility of a phase-based approach to reliably abstract unstructured data. This approach is examined using the specific example of discharge communication for warfarin management. RESEARCH DESIGN: We adopted a "fit-for-use" framework to guide the development and evaluation of abstraction methods using a 4-step, phase-based approach including (1) team building; (2) identification of challenges; (3) adaptation of abstraction methods; and (4) systematic data quality monitoring. MEASURES: Unstructured data elements were the focus of this study, including elements communicating steps in warfarin management (eg, warfarin initiation) and medical follow-up (eg, timeframe for follow-up). RESULTS: After implementation of the phase-based approach, interrater reliability for all unstructured data elements demonstrated κ's of ≥0.89-an average increase of +0.25 for each unstructured data element. CONCLUSIONS: As compared with standard abstraction methodologies, this phase-based approach was more time intensive, but did markedly increase abstraction reliability for unstructured data elements within multisite EMR documentation.

Omission of Physical Therapy Recommendations for High-Risk Patients Transitioning From the Hospital to Subacute Care Facilities.

OBJECTIVES: To assess the quality and explore the potential impact of the communication of physical therapy (PT) recommendations in hospital discharge summaries/orders for high-risk subacute care populations, specifically targeting recommendations for (1) maintenance of patient safety, (2) assistance required for mobility, and (3) use of assistive devices. DESIGN: Medical record abstraction of retrospective cohort comparing discharge recommendations made by inpatient PT to orders included in written hospital discharge summaries/orders, the primary form of hospital-to-subacute care communication. Data were linked to Medicare outcomes from corresponding years for all Medicare beneficiaries in the cohort. SETTING: Academic hospital. PARTICIPANTS: All hospitalized patients (N=613 overall) 18 years and older with primary diagnoses of stroke or hip fracture, with an inpatient PT consultation and discharged to subacute care during the years 2006 to 2008; 366 of these were Medicare beneficiaries. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Combined rehospitalization, emergency department visit, and/or death within 30 days of discharge. RESULTS: Omission of recommendations for maintaining patient safety occurred in 54% (316/584) of patients; for assistance required for mobility, in approximately 100% (535/537); and for use of assistive devices, in 77% (409/532). As compared with those without patient safety restriction/precaution omissions, Medicare beneficiaries with such omissions demonstrated a trend toward more negative 30-day outcomes (26% vs 18%, P=.10). Similar, albeit nonsignificant, outcome trends were observed in the other omission categories. CONCLUSIONS: PT recommendations made during a hospital stay in high-risk patients are routinely omitted from hospital discharge communications to subacute care facilities. Interventions to reliably improve this communication are needed.

Building capacity for the conduct of nursing research at a Veterans Administration hospital.

Evidence is the bedrock of nursing practice, and nursing research is the key source for this evidence. In this article, we draw distinctions between the use and the conduct of nursing research and provide a perspective for how the conduct of nursing research in a Veterans Administration hospital can build an organization's capacity for nursing research.

Preparing tomorrow's nursing home nurses: the wisconsin long term care clinical scholars program.

Preparing future nurses to care for the growing population of older adults has become a national priority. The demand for long term care services is expected to double between 2000 and 2040, yet the field remains stigmatized as an undesirable place for highly skilled nurses to work. Recent efforts to increase student preparation in geriatrics have been shown to improve student attitudes toward working with older adults and increase knowledge, but long term care settings remain unattractive to students. This article reports on the development, implementation, and evaluation of The Wisconsin Long Term Care Clinical Scholars Program, a nursing home internship for baccalaureate nursing students. The program couples a paid nursing home work experience with an evidence-based long term care nursing curriculum. The program increased student preparation and interest in working both with older adults and in nursing homes, while increasing the capacity of nursing homes to provide a positive student experience.

Linking cognition and frailty in middle and old age: metabolic syndrome matters.

OBJECTIVES: This study examined whether metabolic syndrome (MetS) would moderate the association of cognition with frailty in middle and old age. METHODS: A cross-sectional design was used. Six hundred and ninety participants (age ≥ 50 years) from an on-going national survey were included in the study. Confirmatory factor analysis was applied to determine latent variables of executive function (EF), episodic memory (EM), and MetS based on relevant measurements. Frailty was defined using a modified form of Fried's criteria. RESULTS: Applying structural equation modeling, having MetS significantly increased the likelihood of being frail. Better performance on EM tasks, but not EF, was significantly associated with lower likelihood of MetS. Worse performance on EF, but not EM, significantly increased the likelihood of being frail. There was a significant interacting effect between MetS and EF, but not EM, on frailty. Further contrast analysis indicated that having MetS strengthened the negative association between EF and frailty. CONCLUSION: Metabolic syndrome moderates the relationship between EF and frailty. A prospecitve study is needed to validate such relationships before developing interventions targeting the prevention or treatment of EF and frailty in individuals with MetS.

Evaluation of objective and perceived mental fatigability in older adults with vascular risk.

OBJECTIVES: Mental fatigability refers to the failure to sustain participation in tasks requiring mental effort. Older adults with vascular risk are at particular risk for experiencing mental fatigability. The present study (1) tested a new way of measuring objective mental fatigability by examining its association with perceived mental fatigability; and (2) identified associated psychological, physiological, and situational predictors. METHODS: A cross-sectional study was conducted with 49 community-dwelling participants aged 75+ years with vascular risk. A 20-minute fatigability-manipulation task was used to induce mental fatigability and develop objective and perceived mental fatigability measures. Objective fatigability was calculated by the change of reaction time over the course of the task. Perceived fatigability was calculated by the change of fatigue self-reported before and after the task. A set of potential psychological, physiological, and situational predictors were measured. RESULTS: There was a significant increase in reaction time and self-reported fatigue to the fatigability manipulation task, indicating occurrence of objective and perceived mental fatigability. Reaction time and self-reported fatigue were moderately, but significantly correlated. Higher levels of executive control and having a history of more frequently engaging in mental activities were associated with lower objective mental fatigability. None of the examined factors were associated with perceived mental fatigability. CONCLUSION: Objective and perceived mental fatigability were sensitive to our fatigability-manipulation task. While these two measures were correlated, they were not associated with the same factors. These findings need to be validated in studies with a more heterogeneous sample and a greater variety of fatigability-manipulation tasks.

Fatigability disrupts cognitive processes' regulation of inflammatory reactivity in old age.

OBJECTIVE: High fatigability, a dysfunctional adaption to fatigue, may lead to difficulties performing otherwise regularly encountered cognitive activities and may be related to pro-inflammatory reactivity. The purpose of the study was to investigate the effect of fatigability on cognitive processes and inflammatory response after an acute cognitive stress task in older adults. METHODS: In an observational stress reactivity study conducted in a light- and temperature-controlled laboratory, we measured IL-6, self-reported acute fatigue, and frontally oriented cognitive processes in 55 community-dwelling individuals aged 75 years or older as part of a demanding set of cognitive tasks intended to induce stress. RESULTS: Subjects were classified into groups of low and high fatigability based on cluster analysis of their self-report acute fatigue before and after the cognitive tasks. The two clusters were comparable on levels of baseline IL-6 and cognitive processes; however, the high fatigability cluster had significantly higher levels of IL-6 response than the low fatigability cluster. After controlling for multiple covariates, fatigability moderated the relationship between speed of processing and IL-6 reactivity. Further exploratory analyses indicated significant adverse associations between speed of processing and attention and IL-6 reactivity in the group with low but not high fatigability. CONCLUSION: Although observational, these data are consistent with the notion that pro-inflammatory states in older adults might be reduced by improvements in cognitive processes. Because fatigability was associated with increased acute inflammatory response and disrupted the normal stress regulation provided by the cognitive processes, future randomized studies might examine whether fatigability alleviation reduces IL-6.

The consequences of poor communication during transitions from hospital to skilled nursing facility: a qualitative study.

OBJECTIVES: To examine how skilled nursing facility (SNF) nurses transition the care of individuals admitted from hospitals, the barriers they experience, and the outcomes associated with variation in the quality of transitions. DESIGN: Qualitative study using grounded dimensional analysis, focus groups, and in-depth interviews. SETTING: Five Wisconsin SNFs. PARTICIPANTS: Twenty-seven registered nurses. MEASUREMENTS: Semistructured questions guided the focus group and individual interviews. RESULTS: SNF nurses rely heavily on written hospital discharge communication to transition individuals into the SNF effectively. Nurses cited multiple inadequacies of hospital discharge information, including regular problems with medication orders (including the lack of opioid prescriptions for pain), little psychosocial or functional history, and inaccurate information regarding current health status. These communication inadequacies necessitated repeated telephone clarifications, created care delays (including delays in pain control), increased SNF staff stress, frustrated individuals and family members, contributed directly to negative SNF facility image, and increased risk of rehospitalization. SNF nurses identified a specific list of information and components that they need to facilitate a safe, high-quality transition. CONCLUSION: Nurses note multiple deficiencies in hospital-to-SNF transitions, with poor quality discharge communication being identified as the major barrier to safe and effective transitions. This information should be used to refine and support the dissemination of evidence-based interventions that support transitions of care, including the Interventions to Reduce Acute Care Transfers program.

Pilot randomized controlled trial of a patient-controlled cognitive-behavioral intervention for the pain, fatigue, and sleep disturbance symptom cluster in cancer.

CONTEXT: Pain, fatigue, and sleep disturbance commonly co-occur in patients receiving treatment for advanced cancer. OBJECTIVES: A pilot randomized controlled trial was conducted to assess initial efficacy of a patient-controlled cognitive-behavioral (CB) intervention for the pain, fatigue, and sleep disturbance symptom cluster. METHODS: Eighty-six patients with advanced lung, prostate, colorectal, or gynecologic cancers receiving treatment at a comprehensive cancer center were stratified by recruitment clinics (chemotherapy and radiation therapy) and randomized to intervention or control groups. Forty-three patients were assigned to receive training in and use of up to 12 relaxation, imagery, or distraction exercises delivered via an MP3 player for two weeks during cancer treatment. Forty-three patients were assigned to a waitlist control condition for the same two week period. Outcomes included symptom cluster severity and overall symptom interference with daily life measured at baseline (Time 1) and two weeks later (Time 2). RESULTS: Eight participants dropped out; 78 completed the study and were analyzed (36 intervention and 42 control subjects). Participants used the CB strategies an average of 13.65 times (SD=6.98). Controlling for baseline symptom cluster severity and other relevant covariates, it was found that the symptom cluster severity at Time 2 was lower in the intervention group (M(Adj)=2.99, SE=0.29) than in the waitlist group (M(Adj)=3.87, SE=0.36), F(1, 65)=3.57, P=0.032. Symptom interference with daily life did not differ between groups. No significant adverse events were noted with the CB intervention. CONCLUSION: Findings suggest that the CB intervention may be an efficacious approach to treating the pain, fatigue, and sleep disturbance symptom cluster. Future research is planned to confirm efficacy and test mediators and moderators of intervention effects.

Symptom clusters and quality of life in older adult breast cancer survivors.

PURPOSE/OBJECTIVES: To identify symptom clusters in older adult breast cancer survivors (ages 65-97 years) and examine whether symptom clusters are related to demographic, health, and quality-of-life variables. DESIGN: Factor analysis to identify possible symptom clusters. The resulting clusters then were correlated with quality-of-life measures. SETTING: Phone interviews between the participants and a trained research nurse. SAMPLE: 192 breast cancer survivors (X age = 70). METHODS: This was a secondary data analysis of the baseline measures of demographics, health history, symptom bother, and physical, mental, and existential dimensions of quality of life. Exploratory and confirmatory factor analyses were conducted as well as multiple indicator multiple cause modeling and partial correlation analyses to assess the relationships among clusters and demographic, health history, and quality-of-life measures. MAIN RESEARCH VARIABLES: Self-reported symptom bother, demographics such as age and education level, health history, and quality of life. FINDINGS: Seven clinically distinct symptom clusters tapping 36 different symptoms in older adult breast cancer survivors were found. These symptom clusters were significantly related to multiple dimensions of quality of life. CONCLUSIONS: Older adult breast cancer survivors experience multiple concurrent symptoms that appear to cluster. Identifying symptom clusters helps to elucidate possible intersymptom relationships which may lead to the design of more effective symptom management interventions for older adult breast cancer survivors. IMPLICATIONS FOR NURSING: Older adult breast cancer survivors should be assessed for a wide variety of symptoms if clinicians hope to identify and understand intersymptom relationships. Such assessment would enable more comprehensive symptom management.