Association of State Certificate of Need Regulation With Procedural Volume, Market Share, and Outcomes Among Medicare Beneficiaries.

Importance: Certificate of need laws provide state-level regulation of health system expenditure. These laws are intended to limit spending and control hospital expansion in order to prevent excess capacity and improve quality of care. Several states have recently introduced legislation to modify or repeal these regulations, as encouraged by executive order 13813, issued in October 2017 by the Trump administration. Objective: To evaluate the difference in markers of hospital activity and quality by state certificate of need status. These markers include hospital procedural volume, hospital market share, county-level procedures per 10 000 persons, and patient-level postoperative outcomes. Design, Setting, and Participants: A cross-sectional study involving Medicare beneficiaries aged 65 years or older who underwent 1 of the following 10 procedures from January 1, 2016, through November 30, 2018: total knee or hip arthroplasty, coronary artery bypass grafting, colectomy, ventral hernia repair, lower extremity vascular bypass, lung resection, pancreatic resection, cystectomy, or esophagectomy. Exposures: State certificate of need regulation status as determined by data from the National Conference of State Legislatures. Main Outcomes and Measures: Outcomes of interest included hospital procedural volume; hospital market share (range, 0-1; reflecting 0%-100% of market share); county-level procedures per 10 000 persons; and patient-level postoperative 30-day mortality, surgical site infection, and readmission. Results: A total of 1 545 952 patients (58.0% women; median age 72 years; interquartile range, 68-77 years) at 3631 hospitals underwent 1 of the 10 operations. Of these patients, 468 236 (30.3%) underwent procedures in the 15 states without certificate of need regulations and 1 077 716 (69.7%) in the 35 states with certificate of need regulations. The total number of procedures ranged between 729 855 total knee arthroplasties (47.21%) and 4558 esophagectomies (0.29%). When comparing states without vs with certificate of need regulations, there were no significant differences in overall hospital procedural volume (median hospital procedure volume, 241 vs 272 operations per hospital for 3 years; absolute difference, 31; 95% CI, -27.64 to 89.64; P = .30). There were no statistically significant differences between states without vs with certificate of need regulations for median hospital market share (median, 28% vs 52%; absolute difference, 24%; 95% CI, -5% to 55%; P = .11); procedure rates per 10 000 Medicare-eligible population (median, 239.23 vs 205.41 operations per Medicare-eligible population in 3 years; absolute difference, 33.82; 95% CI, -84.08 to 16.43; P = .19); or 30-day mortality (1.17% vs 1.33%, odds ratio [OR], 1.04; 95% CI, 0.93 to 1.16; P = .52), surgical site infection (1.24% vs 1.25%; OR, 0.93; 95% CI, 0.83 to 1.04; P = .21), or readmission rate (9.69% vs 8.40%; OR, 0.80; 95% CI, 0.57 to 1.12; P = .19). Conclusions and Relevance: Among Medicare beneficiaries who underwent a range of surgical procedures from 2016 through 2018, there were no significant differences in markers of hospital volume or quality between states without vs with certificate of need laws. Policy makers should consider reevaluating whether the current approach to certificate of need regulation is achieving the intended objectives and whether those objectives should be updated.

A Framework for Tracking Former Patients in the Electronic Health Record Using an Educational Registry.

One challenge of contemporary medical education is that shorter lengths of stay and time-limited clerkships often interrupt a student's relationship with a patient before a diagnosis is made or treatment is completed, limiting the learning experience. Medical students sometimes use electronic health records (EHRs) to overcome these limitations. EHRs provide access to patients' future medical records, enabling students to track former patients across care venues to audit their diagnostic impressions and observe outcomes. While this activity has potential to improve clinical training, there is a risk of unintended harm to patients through loss of privacy. Students need guidance on how to perform this activity appropriately. This article describes an ethical framework for tracking using an "educational registry," a list of former patients housed within the EHR that one follows longitudinally for educational purposes. Guiding principles include obtaining permission from patients, having legitimate educational intent, and restricting review of records to those essential for training. This framework could serve as a foundation for institutions seeking to develop a policy on tracking former patients, and may facilitate research on the use of EHRs to improve medical education, such as reducing diagnostic error and promoting self-directed learning.

Physician report cards and implementing standards of practice are both significantly associated with improved screening colonoscopy quality.

OBJECTIVES: Adenoma-detection rates (ADRs) are associated with decreased interval colorectal cancer (CRC) rates and CRC mortality; quality improvement strategies focus on improving physician ADRs. The objective of this study was to examine the sequential effect of physician report cards and implementing institutional standards of practice (SOP) on ADRs. METHODS: Colonoscopy metrics were prospectively evaluated at a single academic medical center over a 23-month period (November 2012 to October 2014). ADRs were evaluated over three time periods-Period 1: Before initial report card distribution or SOP (November 2012 to March 2013); Period 2: After individualized report card distribution detailing physician and institutional ADRs (April 2013 to March 2014); Period 3: After second report card and SOP implementation (April 2014 to October 2014). The SOP required physicians to have a minimum 5-min withdrawal time in normal colonoscopies (WT) and an ADR minimum of 20%; those who did not meet benchmarks would require further training or endoscopy block time alterations. Only endoscopists averaging >15 colonoscopies/month were included in this analysis. RESULTS: Twenty endoscopists met the inclusion criteria, performing 12,894 screening colonoscopies over the 23-month period. Following report card distribution, physician ADRs increased by 3% (P<0.001). SOP implementation resulted in a further significant increase in mean physician ADR of 8% (P<0.0001). Overall, mean ADR increased by 11% from Period 1 to Period 3 (P<0.0001). All physicians met the minimum 20% ADR benchmark during Period 3. Although ADRs significantly correlated with WT overall (r=0.45; 95% CI 0.01, 0.75; P=0.04), mean WT did not significantly increase from Period 1 to Period 3. CONCLUSIONS: Our data suggest that distributing colonoscopy quality report cards resulted in a significant ADR improvement. Further, we report evidence that implementing SOP significantly improved ADRs beyond report card distribution and resulted in all endoscopists meeting minimum benchmarks. This suggests that report cards and SOPs may have an additive effect in improving colonoscopy quality, and their implementation in endoscopy labs should be encouraged.

Hospital Characteristics Associated With Penalties in the Centers for Medicare & Medicaid Services Hospital-Acquired Condition Reduction Program.

IMPORTANCE: In fiscal year (FY) 2015, the Centers for Medicare & Medicaid Services (CMS) instituted the Hospital-Acquired Condition (HAC) Reduction Program, which reduces payments to the lowest-performing hospitals. However, it is uncertain whether this program accurately measures quality and fairly penalizes hospitals. OBJECTIVE: To examine the characteristics of hospitals penalized by the HAC Reduction Program and to evaluate the association of a summary score of hospital characteristics related to quality with penalization in the HAC program. DESIGN, SETTING, AND PARTICIPANTS: Data for hospitals participating in the FY2015 HAC Reduction Program were obtained from CMS' Hospital Compare and merged with the 2014 American Hospital Association Annual Survey and FY2015 Medicare Impact File. Logistic regression models were developed to examine the association between hospital characteristics and HAC program penalization. An 8-point hospital quality summary score was created using hospital characteristics related to volume, accreditations, and offering of advanced care services. The relationship between the hospital quality summary score and HAC program penalization was examined. Publicly reported process-of-care and outcome measures were examined from 4 clinical areas (surgery, acute myocardial infarction, heart failure, pneumonia), and their association with the hospital quality summary score was evaluated. EXPOSURES: Penalization in the HAC Reduction Program. MAIN OUTCOMES AND MEASURES: Hospital characteristics associated with penalization. RESULTS: Of the 3284 hospitals participating in the HAC program, 721 (22.0%) were penalized. Hospitals were more likely to be penalized if they were accredited by the Joint Commission (24.0% accredited, 14.4% not accredited; odds ratio [OR], 1.33; 95% CI, 1.04-1.70); they were major teaching hospitals (42.3%; OR, 1.58; 95% CI, 1.09-2.29) or very major teaching hospitals (62.2%; OR, 2.61; 95% CI, 1.55-4.39; vs nonteaching hospitals, 17.0%); they cared for more complex patient populations based on case mix index (quartile 4 vs quartile 1: 32.8% vs 12.1%; OR, 1.98; 95% CI, 1.44-2.71); or they were safety-net hospitals vs non-safety-net hospitals (28.3% vs 19.9%; OR, 1.36; 95% CI, 1.11-1.68). Hospitals with higher hospital quality summary scores had significantly better performance on 9 of 10 publicly reported process and outcomes measures compared with hospitals that had lower quality scores (all P ≤ .01 for trend). However, hospitals with the highest quality score of 8 were penalized significantly more frequently than hospitals with the lowest quality score of 0 (67.3% [37/55] vs 12.6% [53/422]; P < .001 for trend). CONCLUSIONS AND RELEVANCE: Among hospitals participating in the HAC Reduction Program, hospitals that were penalized more frequently had more quality accreditations, offered advanced services, were major teaching institutions, and had better performance on other process and outcome measures. These paradoxical findings suggest that the approach for assessing hospital penalties in the HAC Reduction Program merits reconsideration to ensure it is achieving the intended goals.

Medicare in the 21 st Century: Understanding the Program to Promote Improvements.

Medicare is the largest single purchaser of health care in the United States and currently helps to pay medical expenses for approximately one-fifth of the US population. The impetus for Medicare to move away from fee-for-service and toward value-based care payments reflects the need to incentivize and improve healthcare quality while containing increasing costs. This primer provides a detailed overview of several interrelated topics for an improved understanding of the Medicare program for orthopaedic surgeons, other clinicians, healthcare administrators, policymakers, and business leaders. An improved understanding may stimulate additional ideas for successful program advancements.

Building a Cohort of Transgender and Nonbinary Patients from the Electronic Medical Record.

Purpose: Sexual orientation, gender identity, and sex recorded at birth (SOGI) have been routinely excluded from demographic data collection tools, including in electronic medical record (EMR) systems. We assessed the ability of adding structured SOGI data capture to improve identification of transgender and nonbinary (TGNB) patients compared to using only International Classification of Diseases (ICD) codes and text mining and comment on the ethics of these cohort formation methods. Methods: We conducted a retrospective chart review to classify patient gender at a single institution using ICD-10 codes, structured SOGI data, and text mining for patients presenting for care between March 2019 and February 2021. We report each method's overall and segmental positive predictive value (PPV). Results: We queried 1,530,154 EMRs from our institution. Overall, 154,712 contained relevant ICD-10 diagnosis codes, SOGI data fields, or text mining terms; 2964 were manually reviewed. This multipronged approach identified a final 1685 TGNB patient cohort. The initial PPV was 56.8%, with ICD-10 codes, SOGI data, and text mining having PPV of 99.2%, 47.9%, and 62.2%, respectively. Conclusion: This is one of the first studies to use a combination of structured data capture with keyword terms and ICD codes to identify TGNB patients. Our approach revealed that although structured SOGI documentation was <10% in our health system, 1343/1685 (79.7%) of TGNB patients were identified using this method. We recommend that health systems promote patient EMR documentation of SOGI to improve health and wellness among TGNB populations, while centering patient privacy.

Implementing a Patient-Reported Outcome Dashboard in Oncology Telemedicine Encounters: Clinician and Patient Adoption and Acceptability.

PURPOSE: Telemedicine provides numerous benefits to patients, yet effective communication and symptom assessment remain a concern. The recent uptake of telemedicine provided an opportunity to use a newly developed dashboard with patient-reported outcome (PRO) information to enhance communication and shared decision making (SDM) during telemedicine appointments. The objective of this study was to identify barriers to using the dashboard during telemedicine, develop implementation strategies to address barriers, and pilot test use of this dashboard during telemedicine appointments in two practice settings to evaluate acceptability, adoption, fidelity, and effectiveness. METHODS: Patients and clinicians were interviewed to identify determinants to dashboard use in telemedicine. Implementation strategies were designed and refined through iterative feedback from stakeholders. A pilot study of dashboard use was conducted from March to September 2022. Acceptability, adoption, and fidelity were evaluated using mixed methods. SDM was evaluated using the collaboRATE measure. RESULTS: One hundred two patient encounters were evaluated. Most patients (62; 60%) had completed some PRO data at the time of their telemedicine encounter. Most (82; 80%) encounters had clinician confirmation that PRO data had been reviewed; however, collaborative review of the dashboard was documented in only 27%. Degree of SDM was high (mean collaboRATE score 3.40; SD, 0.11 [95% CI, 3.17 to 3.63] out of a maximum score of 4). Implementation strategies focused on patient engagement, education, and remote PRO completion. Clinician-facing strategies included education, practice facilitation, and small tests of change. CONCLUSION: This study demonstrated that implementation of a PRO-based dashboard into telemedicine appointments was feasible and had acceptable adoption and acceptability by patients and clinicians when several strategies were used to engage end users. Strategies targeting both patients and clinicians are needed to support routine and effective PRO integration in telemedicine.

Development of an electronic health record-integrated patient-reported outcome-based shared decision-making dashboard in oncology.

Objectives: Patient-reported outcomes (PROs) describe a patient's unique experiences with disease or treatment, yet effective use of this information during clinical encounters remains challenging. This project sought to build a PRO based dashboard within the electronic health record (EHR), prioritizing interpretability and utility of PROs for clinical decision-making. Materials and Methods: Codesign principles were used to define the goal, features, and visualization of the data elements on the dashboard. Codesign sessions occurred between February 2019 and May 2020 and involved a diverse group of stakeholders. Pilot evaluation of dashboard usability was performed with patients and clinicians not involved in the codesign process through qualitative interviews and the Systems Usability Scale. Results: The dashboard was placed into a single tab in the EHR and included select PROM scores, clinical data elements, and goals of care questions. Real-time data analytics and enhanced visualization of data was necessary for the dashboard to provide meaningful feedback to clinicians and patients for decision-making during clinic visits. During soft launch, the dashboard demonstrated "good" usability in patients and clinicians at 3 and 6 months (mean total SUS score >70). Discussion: The current dashboard had good usability and made PRO scores more clinically understandable to patients and clinicians. This paper highlights the development, necessary data elements, and workflow considerations to implement this dashboard at an academic cancer center. Conclusion: As the use of PROs in clinical care is increasing, patient- and clinician-centered tools are needed to ensure that this information is used in meaningful ways.

Seamless Integration of Computer-Adaptive Patient Reported Outcomes into an Electronic Health Record.

BACKGROUND: Patient-reported outcome (PRO) measures have become an essential component of quality measurement, quality improvement, and capturing the voice of the patient in clinical care. In 2004, the National Institutes of Health endorsed the importance of PROs by initiating the Patient-Reported Outcomes Measurement Information System (PROMIS), which leverages computer-adaptive tests (CATs) to reduce patient burden while maintaining measurement precision. Historically, PROMIS CATs have been used in a large number of research studies outside the electronic health record (EHR), but growing demand for clinical use of PROs requires creative information technology solutions for integration into the EHR. OBJECTIVES: This paper describes the introduction of PROMIS CATs into the Epic Systems EHR at a large academic medical center using a tight integration; we describe the process of creating a secure, automatic connection between the application programming interface (API) which scores and selects CAT items and Epic. METHODS: The overarching strategy was to make CATs appear indistinguishable from conventional measures to clinical users, patients, and the EHR software itself. We implemented CATs in Epic without compromising patient data security by creating custom middleware software within the organization's existing middleware framework. This software communicated between the Assessment Center API for item selection and scoring and Epic for item presentation and results. The middleware software seamlessly administered CATs alongside fixed-length, conventional PROs while maintaining the display characteristics and functions of other Epic measures, including automatic display of PROMIS scores in the patient's chart. Pilot implementation revealed differing workflows for clinicians using the software. RESULTS: The middleware software was adopted in 27 clinics across the hospital system. In the first 2 years of hospital-wide implementation, 793 providers collected 70,446 PROs from patients using this system. CONCLUSION: This project demonstrated the importance of regular communication across interdisciplinary teams in the design and development of clinical software. It also demonstrated that implementation relies on buy-in from clinical partners as they integrate new tools into their existing clinical workflow.

Implementation of a Co-Design Strategy to Develop a Dashboard to Support Shared Decision Making in Advanced Cancer and Chronic Kidney Disease.

Background: Shared decision making (SDM) is the process by which patients and clinicians exchange information and preferences to come to joint healthcare decisions. Clinical dashboards can support SDM by collecting, distilling, and presenting critical information, such as patient-reported outcomes (PROs), to be shared at points of care and in between appointments. We describe the implementation strategies and outcomes of a multistakeholder collaborative process known as "co-design" to develop a PRO-informed clinical dashboard to support SDM for patients with advanced cancer or chronic kidney disease (CKD). Methods: Across 14 sessions, two multidisciplinary teams comprising patients, care partners, clinicians, and other stakeholders iteratively co-designed an SDM dashboard for either advanced cancer (N = 25) or CKD (N = 24). Eligible patients, care partners, and frontline clinicians were identified by six physician champions. The co-design process included four key steps: (1) define "the problem", (2) establish context of use, (3) build a consensus on design, and (4) define and test specifications. We also evaluated our success in implementing the co-design strategy using measures of fidelity, acceptability, adoption, feasibility, and effectiveness which were collected throughout the process. Results: Mean (M) scores across implementation measures of the co-design process were high, including observer-rated fidelity and adoption of co-design practices (M = 19.1 on a 7-21 scale, N = 36 ratings across 9 sessions), as well as acceptability based on the perceived degree of SDM that occurred during the co-design process (M = 10.4 on a 0 to 12 adapted collaboRATE scale). Capturing the feasibility and adoption of convening multistakeholder co-design teams, min-max normalized scores (ranging from 0 to 1) of stakeholder representation demonstrated that, on average, 95% of stakeholder types were represented for cancer sessions (M = 0.95) and 85% for CKD sessions (M = 0.85). The co-design process was rated as either "fully" or "partially" effective by 100% of respondents, in creating a dashboard that met its intended objective. Conclusions: A co-design process was successfully implemented to develop SDM clinical dashboards for advanced cancer and CKD care. We discuss key strategies and learnings from this process that may aid others in the development and uptake of patient-centered healthcare innovations.

Shared decision-making and disease management in advanced cancer and chronic kidney disease using patient-reported outcome dashboards.

OBJECTIVES: To assess the use of a co-designed patient-reported outcome (PRO) clinical dashboard and estimate its impact on shared decision-making (SDM) and symptomatology in adults with advanced cancer or chronic kidney disease (CKD). MATERIALS AND METHODS: We developed a clinical PRO dashboard within the Northwestern Medicine Patient-Reported Outcomes system, enhanced through co-design involving 20 diverse constituents. Using a single-group, pretest-posttest design, we evaluated the dashboard's use among patients with advanced cancer or CKD between June 2020 and January 2022. Eligible patients had a visit with a participating clinician, completed at least two dashboard-eligible visits, and consented to follow-up surveys. PROs were collected 72 h prior to visits, including measures for chronic condition management self-efficacy, health-related quality of life (PROMIS measures), and SDM (collaboRATE). Responses were integrated into the EHR dashboard and accessible to clinicians and patients. RESULTS: We recruited 157 participants: 66 with advanced cancer and 91 with CKD. There were significant improvements in SDM from baseline, as assessed by collaboRATE scores. The proportion of participants reporting the highest level of SDM on every collaboRATE item increased by 15 percentage points from baseline to 3 months, and 17 points between baseline and 6-month follow-up. Additionally, there was a clinically meaningful decrease in anxiety levels over study period (T-score baseline: 53; 3-month: 52; 6-month: 50; P < .001), with a standardized response mean (SRM) of -0.38 at 6 months. DISCUSSION: PRO clinical dashboards, developed and shared with patients, may enhance SDM and reduce anxiety among patients with advanced cancer and CKD.

The Imperfect Science of Publicly Reported Hospital Rating Systems: Lessons From Credit Rating Agencies.

The number of publicly available hospital quality rating systems has substantially increased over the past 2 decades. These rating systems are meant to provide patients, clinicians, and payers with relevant information to select and pay differentially for better quality of care. However, there is evidence of inconsistency, unreliability, and bias in current hospital quality rating systems. Financial ratings are similarly intended to enable investors to identify stronger companies (as investment targets), and these rating systems could provide insight into strategies to improve hospital quality ratings. We evaluate the credit rating methodologies of Standard & Poor's, Moody's, and Fitch Group and propose principles to improve hospital quality rating systems through better standardized measures and the use of external audits of source data. Emulating key features of credit rating systems may advance the delivery of meaningful hospital quality ratings.

Enhancement and Implementation of a Health Information Technology Module to Improve the Discrete Capture of Cancer Staging in a Diverse Regional Health System.

PURPOSE: Cancer staging is the foundation for all cancer management decisions. For real-time use, stage must be embedded in the electronic health record as a discrete data element. The objectives of this quality improvement (QI) initiative were to (1) identify barriers to utilization of an existing discrete cancer staging module, (2) identify health information technology (HIT) solutions to support discrete capture of cancer staging data, and (3) increase capture across the oncology enterprise in our diverse health system. METHODS: Six sigma QI methodologies were used to define barriers and solutions to improve discrete cancer staging. Design thinking principles informed solution development to test prototypes. Two multidisciplinary teams of disease-specific clinicians within GI and genitourinary conducted phased testing pilots to determine health system solutions. Solutions were expanded to all oncology specialties across our health system. RESULTS: Baseline average discrete staging capture across our health system was 31%. Poor workflow efficiency, limited accountability, and technical design gaps were key barriers to timely, complete staging. Implementation of more than 25 design enhancements to a HIT solution and passive user alerts led to a postimplementation capture rate of 58% across 55 outpatient clinics involving more than 400 clinicians. CONCLUSION: We identified key barriers to discrete data capture and designed solutions through iterative use of QI methodologies and disease-specific pilots. After implementation, discrete capture of cancer staging nearly doubled across our diverse health system. This approach is scalable and transferable to other initiatives to develop and implement clinically relevant HIT solutions across a diverse health system.