Evaluating the Implementation of Patient-Reported Outcomes in Heart Failure Clinic: A Qualitative Assessment.

BACKGROUND: Patient-reported outcomes (PROs) may improve care for patients with heart failure. The Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) is a patient survey that captures symptom frequency, symptom burden, physical limitations, social limitations, and quality of life. Despite the utility of PROs and the KCCQ-12, the implementation and routine use of these measures can be difficult. We conducted an evaluation of clinician perceptions of the KCCQ-12 to identify barriers and facilitators to implementation into clinical practice. METHODS: We conducted interviews with cardiologists from 4 institutions across the United States and Canada (n=16) and observed clinic visits at 1 institution in Northern California (n=5). Qualitative analysis was conducted in 2 rounds: (1) rapid analysis constructed around major themes related to the aims of the study and (2) content analysis with codes derived from the rapid analysis and implementation science. RESULTS: Most heart failure physicians and advanced practice clinicians reported that the KCCQ-12 was acceptable, appropriate, and useful in clinical care. Clinician engagement efforts, trialability, and the straightforward design of the KCCQ-12 facilitated its use in clinical care. Further opportunities identified to facilitate implementation include more streamlined integration into the electronic health record and comprehensive staff education on PROs. Participants highlighted that the KCCQ-12 was useful in clinic visits to improve the consistency of patient history taking, focus patient-clinician conversations, collect a more accurate account of patient quality of life, track trends in patient well-being over time, and refine clinical decision-making. CONCLUSIONS: In this qualitative study, clinicians reported that the KCCQ-12 enhanced several aspects of heart failure patient care. Use of the KCCQ-12 was facilitated by a robust clinician engagement campaign and the design of the KCCQ-12 itself. Future implementation of PROs in heart failure clinic should focus on streamlining electronic health record integration and providing additional staff education on the value of PROs. REGISTRATION: URL: https://clinicaltrials.gov; Unique identifier: NCT04164004.

Professional Behavior and Value Erosion: A Qualitative Study of Physicians and the Electronic Health Record.

GOAL: Occurrences of physician burnout have reached epidemic numbers, and the electronic health record (EHR) is a commonly cited cause of the distress. To enhance current understanding of the relationship between burnout and the EHR, we explored the connections between physicians' distress and the EHR. METHODS: In this qualitative study, physicians and graduate medical trainees from two healthcare organizations in California were interviewed about EHR-related distressing events and the impact on their emotions and actions. We analyzed physician responses to identify themes regarding the negative impact of the EHR on physician experience and actions. EHR "distressing events" were categorized using the Accreditation Council for Graduate Medical Education (ACGME) Physician Professional Competencies. PRINCIPAL FINDINGS: Every participating physician reported EHR-related distress affecting professional activities. Five main themes emerged from our analysis: system blocks to patient care; poor implementation, design, and functionality of the EHR; billing priorities conflicting with ideal workflow and best-practice care; lack of efficiency; and poor teamwork function. When mapped to the ACGME competencies, physician distress frequently stemmed from situations where physicians prioritized systems-based practice above other desired professional actions and behaviors. Physicians also reported a climate of silence in which physicians would not share problems due to fear of retribution or lack of confidence that the problems would be addressed. PRACTICAL APPLICATIONS: Physicians and administrators need to address the hierarchy of values that prioritizes system requirements such as those required by the EHR above physicians' other desired professional actions and behaviors. Balancing the importance of competing competencies may help to address rising burnout. We also recommend that administrators consider qualitative anonymous interviews as an effective method to uncover and understand physician distress in light of physicians' reported climate of silence.

Relationship of socio-demographics, comorbidities, symptoms and healthcare access with early COVID-19 presentation and disease severity.

BACKGROUND: COVID-19 studies are primarily from the inpatient setting, skewing towards severe disease. Race and comorbidities predict hospitalization, however, ambulatory presentation of milder COVID-19 disease and characteristics associated with progression to severe disease is not well-understood. METHODS: We conducted a retrospective chart review including all COVID-19 positive cases from Stanford Health Care (SHC) in March 2020 to assess demographics, comorbidities and symptoms in relationship to: 1) their access point of testing (outpatient, inpatient, and emergency room (ER)) and 2) development of severe disease. RESULTS: Two hundred fifty-seven patients tested positive: 127 (49%), 96 (37%), and 34 (13%) at outpatient, ER and inpatient, respectively. Overall, 61% were age < 55; age > 75 was rarer in outpatient setting (11%) than ER (14%) or inpatient (24%). Most patients presented with cough (86%), fever/chills (76%), or fatigue (63%). 65% of inpatients reported shortness of breath compared to 30-32% of outpatients and ER patients. Ethnic/minority patients had a significantly higher risk of developing severe disease (Asian OR = 4.8 [1.6-14.2], Hispanic OR = 3.6 [1.1-11.9]). Medicare-insured patients were marginally more likely (OR = 4.0 [0.9-17.8]). Other factors associated with developing severe disease included kidney disease (OR = 6.1 [1.0-38.1]), cardiovascular disease (OR = 4.7 [1.0-22.1], shortness of breath (OR = 5.4 [2.3-12.6]) and GI symptoms (OR = 3.3 [1.4-7.7]; hypertension without concomitant CVD or kidney disease was marginally significant (OR = 2.3 [0.8-6.5]). CONCLUSIONS: Early widespread symptomatic testing for COVID-19 in Silicon Valley included many less severely ill patients. Thorough manual review of symptomatology reconfirms the heterogeneity of COVID-19 symptoms, and challenges in using clinical characteristics to predict decline. We re-demonstrate that socio-demographics are consistently associated with severity.

Adapting rapid assessment procedures for implementation research using a team-based approach to analysis: a case example of patient quality and safety interventions in the ICU.

BACKGROUND: Innovations to improve quality and safety in healthcare are increasingly complex, targeting multiple disciplines and organizational levels, and often requiring significant behavior change by those delivering care. Learning health systems must tackle the crucial task of understanding the implementation and effectiveness of complex interventions, but may be hampered in their efforts by limitations in study design imposed by business-cycle timelines and implementation into fast-paced clinical environments. Rapid assessment procedures are a pragmatic option for producing timely, contextually rich evaluative information about complex interventions implemented into dynamic clinical settings. METHODS: We describe our adaptation of rapid assessment procedures and introduce a rapid team-based analysis process using an example of an evaluation of an intensive care unit (ICU) redesign initiative aimed at improving patient safety in four academic medical centers across the USA. Steps in our approach included (1) iteratively working with stakeholders to develop evaluation questions; (2) integration of implementation science frameworks into field guides and analytic tools; (3) selecting and training a multidisciplinary site visit team; (4) preparation and trust building for 2-day site visits; (5) engaging sites in a participatory approach to data collection; (6) rapid team analysis and triangulation of data sources and methods using a priori charts derived from implementation frameworks; and (7) validation of findings with sites. RESULTS: We used the rapid assessment approach at each of the four ICU sites to evaluate the implementation of the sites' innovations. Though the ICU projects all included three common components, they were individually developed to suit the local context and had mixed implementation outcomes. We generated in-depth case summaries describing the overall implementation process for each site; implementation barriers and facilitators for all four sites are presented. One of the site case summaries is presented as an example of findings generated using the method. CONCLUSIONS: A rapid team-based approach to qualitative analysis using charts and team discussion using validation techniques, such as member-checking, can be included as part of rapid assessment procedures. Our work demonstrates the value of including rapid assessment procedures for implementation research when time and resources are limited.

Primary Care 2.0: Design of a Transformational Team-Based Practice Model to Meet the Quadruple Aim.

A new transformational model of primary care is needed to address patient care complexity and provider burnout. An 18-month design effort (2015-2016) included the following: (1) Needs Finding, (2) Integrated Facility Design, (3) Design Process Assessment, and (4) Development of Evaluation. Initial outcome metrics were assessed. The design team successfully applied Integrated Facility Design to primary care transformation design; qualitative survey results suggest that design consensus was facilitated by team-building activities. Initial implementation of Quadruple Aim-related outcome metrics showed positive trends. Redesign processes may benefit from emphasis on team building to facilitate consensus and increased patient involvement to incorporate patient voices successfully.

Development of a tailored survey to evaluate a patient-centered initiative.

OBJECTIVES: Patient-centered care initiatives have proliferated, but assessing their effectiveness requires measures tailored to their likely effects. In this article, we describe the development and pilot testing of patient surveys used to assess change in patients' cancer care experiences over time in response to a patient-centered care initiative. STUDY DESIGN: Prospective case series. METHODS: Domains of patient-centered care were informed by the goals of the initiative and a review of existing tools. Items were selected and modified from 6 domains of validated or semivalidated instruments. Items were piloted with patients with cancer in waiting room settings to further assess the relevance and clarity of items, whether important concepts were missing, and acceptability regarding place and timing of the surveys and to estimate baseline top box scores (percentage of patients scoring an item the highest quality level) to minimize likely ceiling effects. The instrument was then administered to a consecutive sample of Stanford Cancer Center patients. Baseline item responses, Cronbach's alpha, and response bias were estimated. RESULTS: Items were modified based on patient feedback, top box scores, and reassessment of the domains. Over 6 months, 11,273 patients were surveyed, with a 49.7% response rate. Baseline top box scores ranged from 41.7% to 75.0% for any given item. Reliability and internal consistency were high for all domains (Cronbach's alpha ≥0.80) except for the access domain. CONCLUSIONS: We developed reliable instruments to evaluate the essential elements of a patient-centered care initiative at an academic medical center, which minimized patient burden and maximized the response rate.

Improving Care With a Portfolio of Physician-Led Cancer Quality Measures at an Academic Center.

PURPOSE: Development and implementation of robust reporting processes to systematically provide quality data to care teams in a timely manner is challenging. National cancer quality measures are useful, but the manual data collection required is resource intensive, and reporting is delayed. We designed a largely automated measurement system with our multidisciplinary cancer care programs (CCPs) to identify, measure, and improve quality metrics that were meaningful to the care teams and their patients. METHODS: Each CCP physician leader collaborated with the cancer quality team to identify metrics, abiding by established guiding principles. Financial incentive was provided to the CCPs if performance at the end of the study period met predetermined targets. Reports were developed and provided to the CCP physician leaders on a monthly or quarterly basis, for dissemination to their CCP teams. RESULTS: A total of 15 distinct quality measures were collected in depth for the first time at this cancer center. Metrics spanned the patient care continuum, from diagnosis through end of life or survivorship care. All metrics improved over the study period, met their targets, and earned a financial incentive for their CCP. CONCLUSION: Our quality program had three essential elements that led to its success: (1) engaging physicians in choosing the quality measures and prespecifying goals, (2) using automated extraction methods for rapid and timely feedback on improvement and progress toward achieving goals, and (3) offering a financial team-based incentive if prespecified goals were met.

Validation of colorectal cancer surgery data from administrative data sources.

BACKGROUND: Surgery is the primary treatment for colorectal cancer for both curative and palliative intent. Availability of high quality surgery data is essential for assessing many aspects of the quality of colorectal cancer care. The objective of this study was to determine the quality of different administrative data sources in identifying surgery for colorectal cancer with respect to completeness and accuracy. METHODS: All residents in Alberta, Canada who were diagnosed with invasive colorectal cancer in years 2000-2005 were identified from the Alberta Cancer Registry and included in the study. Surgery data for these patients were obtained from the Cancer Registry (which collects the date of surgery for which the primary tumor was removed) and compared to surgery data obtained from two different administrative data sources: Physician Billing and Hospital Inpatient data. Sensitivity, specificity, positive predictive value, negative predictive value and observed agreement were calculated compared to the Cancer Registry data. RESULTS: The Physician Billing data alone or combined with Hospital Inpatient data demonstrated equally high sensitivity (97% for both) and observed agreement with the Cancer Registry data (93% for both) for identifying surgeries. The Hospital Inpatient data, however, had the highest specificity (80%). The positive predictive value varied by disease stage and across data sources for stage IV (99% for stages I-III and 83-89% for stage IV), the specificity is better for colon cancer surgeries (72-85%) than for rectal cancer surgeries (60-73%); validation measures did not vary over time. CONCLUSION: Physician Billing data identify the colorectal cancer surgery more completely than Hospital Inpatient data although both sources have a high level of completeness.

Evaluation of serum protein profiling by surface-enhanced laser desorption/ionization time-of-flight mass spectrometry for the detection of prostate cancer: I. Assessment of platform reproducibility.

BACKGROUND: Protein expression profiling for differences indicative of early cancer has promise for improving diagnostics. This report describes the first stage of a National Cancer Institute/Early Detection Research Network-sponsored multiinstitutional evaluation and validation of this approach for detection of prostate cancer. METHODS: Two sequential experimental phases were conducted to establish interlaboratory calibration and standardization of the surface-enhanced laser desorption (SELDI) instrumental and assay platform output. We first established whether the output from multiple calibrated Protein Biosystem II SELDI-ionization time-of-flight mass spectrometry (TOF-MS) instruments demonstrated acceptable interlaboratory reproducibility. This was determined by measuring mass accuracy, resolution, signal-to-noise ratio, and normalized intensity of three m/z "peaks" present in a standard pooled serum sample. We next evaluated the ability of the calibrated and standardized instrumentation to accurately differentiate between selected cases of prostate cancer and control by use of an algorithm developed from data derived from a single site 2 years earlier. RESULTS: When the described standard operating procedures were established at all laboratory sites, the across-laboratory measurements revealed a CV for mass accuracy of 0.1%, signal-to-noise ratio of approximately 40%, and normalized intensity of 15-36% for the three pooled serum peaks. This was comparable to the intralaboratory measurements of the same peaks. The instrument systems were then challenged with sera from a selected group of 14 cases and 14 controls. The classification agreement between each site and the established decision algorithm were examined by use of both raw peak intensity boosting and ranked peak intensity boosting. All six sites achieved perfect blinded classification for all samples when boosted alignment of raw intensities was used. Four of six sites achieved perfect blinded classification with ranked intensities, with one site passing the criteria of 26 of 28 correct and one site failing with 19 of 28 correct. CONCLUSIONS: These results demonstrate that "between-laboratory" reproducibility of SELDI-TOF-MS serum profiling approaches that of "within-laboratory" reproducibility as determined by measuring discrete m/z peaks over time and across laboratories.