Use of Sequential Hot-Deck Imputation for Missing Health Care Systems Data for Population Health Research.

Electronic medical record (EMR) data present many opportunities for population health research. The use of EMR data for population risk models can be impeded by the high proportion of missingness in key patient variables. Common approaches like complete case analysis and multiple imputation may not be appropriate for some population health initiatives that require a single, complete analytic data set. In this study, we demonstrate a sequential hot-deck imputation (HDI) procedure to address missingness in a set of cardiometabolic measures in an EMR data set. We assessed the performance of sequential HDI within the individual variables and a commonly used composite risk score. A data set of cardiometabolic measures based on EMR data from 2 large urban hospitals was used to create a benchmark data set with simulated missingness. Sequential HDI was applied, and the resulting data were used to calculate atherosclerotic cardiovascular disease risk scores. The performance of the imputation approach was assessed using a set of metrics to evaluate the distribution and validity of the imputed data. Of the 567,841 patients, 65% had at least 1 missing cardiometabolic measure. Sequential HDI resulted in the distribution of variables and risk scores that reflected those in the simulated data while retaining correlation. When stratified by age and sex, risk scores were plausible and captured patterns expected in the general population. The use of sequential HDI was shown to be a suitable approach to multivariate missingness in EMR data. Sequential HDI could benefit population health research by providing a straightforward, computationally nonintensive approach to missing EMR data that results in a single analytic data set.

The Impact of Text Messaging to Promote Patient Reported Outcome Measures (PROMs) Completion in Orthopedic Practice: Findings From a Randomized Controlled Study.

It is difficult to achieve high response rates to Patient Reported Outcome Measures (PROMs) surveys collected as part of clinical care. However, they are operationally and clinically important. To understand the impact of text message reminders on response rates to PROMs collected via email as part of routine care for hip or knee replacement surgery, initial nonresponders were randomized to receive a text reminder or not at 7 and 12 days, if needed. At day 7, the overall survey response rate was 63%. Model-derived estimates for survey return after this point were 51.1% (95% confidence interval [CI], 48.0%-54.2%) in the text arm compared to 34.5% (95% CI, 31.6%-37.6%) in the no text arm. The effect of text messages on response rates did not vary by subpopulations considered nor were there differences in rates of key outcomes between the 2 groups, suggesting that it did not impact any underlying response bias. Given the relative low cost of text messages, they can be an efficient means to increase response rates.

Protocol of a patient randomized clinical trial to improve medication adherence in primary care.

BACKGROUND: Enhanced awareness of poor medication adherence could improve patient care. This article describes the original and adapted protocols of a randomized trial to improve medication adherence for cardiometabolic conditions. METHODS: The original protocol entailed a cluster randomized trial of 28 primary care clinics allocated to either (i) medication adherence enhanced chronic disease care clinical decision support (eCDC-CDS) integrated within the electronic health record (EHR) or (ii) usual care (non-enhanced CDC-CDS). Enhancements comprised (a) electronic interfaces printed for patients and clinicians at primary care encounters that encouraged discussion about specific medication adherence issues that were identified, and (b) pharmacist phone outreach. Study subjects were individuals who at an index visit were aged 18-74 years and not at evidence-based care goals for hypertension (HTN), diabetes mellitus (DM), or lipid management, along with low medication adherence (proportion of days covered [PDC] <80%) for a corresponding medication. The primary study outcomes were improved medication adherence and clinical outcomes (BP and A1C) at 12 months. Protocol adaptation became imperative in response to major implementation challenges: (a) the availability of EHR system-wide PDC calculations that superseded our ability to limit PDC adherence information solely to intervention clinics; (b) the unforeseen closure of pharmacies committed to conducting the pharmacist outreach; and (c) disruptions and clinic closures due to the Covid-19 pandemic. CONCLUSION: This manuscript details the protocol of a study to assess whether enhanced awareness of medication adherence issues in primary care settings could improve patient outcomes. The need for protocol adaptation arose in response to multiple implementation challenges.

Care coordination in primary care: mapping the territory.

OBJECTIVE: To document the current approaches to care coordination among different types of care systems in Minnesota. STUDY DESIGN: Observational survey of leaders of most of the care systems in Minnesota that have implemented care coordination. METHODS: Survey questions about organizational structure, size, and approach to care coordination were sent to the leaders of 42 care systems with a total of 327 primary care clinics. RESULTS: Surveys were completed by leaders at every care system participating in this study (100% response rate); 16 small care systems (each with 1-2 clinics) had a total of 26 primary care clinics, 15 medium care systems (3-9 clinics) had 57 clinics, and 11 large care systems (> 9 clinics) had 244 clinics. The large care systems had larger clinics (clinicians per clinic, 8.6 in large vs 4.3 in small and 5.2 in medium; P = .03) and more clinicians per care coordinator (5.7 vs 3.3 and 4.0; P = .04). They also more frequently included a social worker in their care coordination team: 82% vs 25% of small and 40% of medium care systems (P = .01). However, the services provided and complexity tools used were similar. Nearly all reported addressing both medical and social needs for their complex patients with multiple chronic conditions. CONCLUSIONS: Although there are large differences in resources and capabilities between large and small care systems, they were not associated with much difference in the approach taken to care coordination. This map of the care coordination territory in Minnesota has the potential to be valuable to researchers and care system leaders for understanding current implementation trends and directing further evaluations.

Periodontal treatment and subsequent clinical outcomes and medical care costs: A retrospective cohort study.

INTRODUCTION: Periodontitis is a common oral disease associated with coronary artery disease (CAD), cerebrovascular disease (CBVD) and type 2 diabetes (T2D). We studied if periodontitis treatment improves clinical outcomes and reduces medical care costs in patients with CAD, CBVD or T2D. METHODS: We used clinic records and claims data from a health care system to identify patients with periodontitis and CAD, CBVD or T2D, and to assess periodontal treatments, hospitalizations, medical costs (total, inpatient, outpatient, pharmacy), glycated hemoglobin, cardiovascular events, and death following concurrent disease diagnoses. We compared clinical outcomes according to receipt of periodontal treatment and/or maintenance care in the follow-up period, and care costs according to treatment status within one year following concurrent disease diagnoses, while adjusting for covariates. The data were analyzed in 2019-21. RESULTS: We identified 9,503 individuals, 4,057 of whom were in the CAD cohort; 3,247 in the CBVD cohort; and 4,879 in the T2D cohort. Patients who were selected and elected to receive treatment and maintenance care were less likely to be hospitalized than untreated individuals (CAD: OR = 0.71 (95% CI: 0.55, 0.92); CBVD: OR = 0.73 (0.56, 0.94); T2D: OR = 0.80 (0.64, 0.99)). Selection to treatment and/or maintenance care was not significantly associated with cardiovascular events, mortality, or glycated hemoglobin change. Total care costs did not differ significantly between treated and untreated groups over 4 years. Treated patients experienced lower inpatient costs but higher pharmacy costs. CONCLUSIONS: Patients with periodontitis and CAD, CBVD or T2D who were selected and elected to undergo periodontal treatment or maintenance care had lower rates of hospitalizations, but did not differ significantly from untreated individuals in terms of clinical outcomes or total medical care costs.

The Impact of COVID-19 on Patients Receiving Care Coordination in Primary Care: A Qualitative Study.

INTRODUCTION: Care coordination addresses the needs of patients with complex chronic illness and psychosocial issues, coordinating their care and social needs. It is not known how such patients receiving these services managed during the COVID-19 pandemic. The objective of this study was to learn how the health, health care, social needs, and finances of patients receiving care coordination were affected by the disruptions caused by the COVID-19 pandemic. METHOD: We conducted semistructured interviews with 19 patients receiving care coordination in primary care across a statewide sample about how the COVID-19 pandemic affected their life in general, including their overall health, social connections, finances and employment, and mental health. A content analysis approach was applied in the data analysis. RESULTS: We identified 4 primary themes in patient interviews including: (1) patients reported few to no impacts on their physical health status or health care services; (2) patients felt disconnected from family, friends, and community in ways that affected their mental health and wellbeing; (3) there were little to no pandemic related impacts for those on fixed incomes or government supports; and (4) care coordinators provided a significant and reliable source of help, support, and comfort. CONCLUSIONS: Care coordination provided a supporting framework for the health and the health care needs of these patients, helping them navigate resources and maintain their physical health during the pandemic. Care coordinators were seen as providing needed communication, connection, and support that was especially needed during a time of social isolation and disconnection.

Design of a pragmatic clinical trial to improve screening and treatment for opioid use disorder in primary care.

BACKGROUND: Opioid-related deaths continue to rise in the U.S. A shared decision-making (SDM) system to help primary care clinicians (PCCs) identify and treat patients with opioid use disorder (OUD) could help address this crisis. METHODS: In this cluster-randomized trial, primary care clinics in three healthcare systems were randomized to receive or not receive access to an OUD-SDM system. The OUD-SDM system alerts PCCs and patients to elevated risk of OUD and supports OUD screening and treatment. It includes guidance on OUD screening and diagnosis, treatment selection, starting and maintaining patients on buprenorphine for waivered clinicians, and screening for common comorbid conditions. The primary study outcome is, of patients at high risk for OUD, the percentage receiving an OUD diagnosis within 30 days of index visit. Additional outcomes are, of patients at high risk for or with a diagnosis of OUD, (a) the percentage receiving a naloxone prescription, or (b) the percentage receiving a medication for OUD (MOUD) prescription or referral to specialty care within 30 days of an index visit, and (c) total days covered by a MOUD prescription within 90 days of an index visit. RESULTS: The intervention started in April 2021 and continues through December 2023. PCCs and patients in 90 clinics are included; study results are expected in 2024. CONCLUSION: This protocol paper describes the design of a multi-site trial to help PCCs recognize and treat OUD. If effective, this OUD-SDM intervention could improve screening of at-risk patients and rates of OUD treatment for people with OUD.

Bolstering the Business Case for Adoption of Shared Decision-Making Systems in Primary Care: Randomized Controlled Trial.

BACKGROUND: Limited budgets may often constrain the ability of health care delivery systems to adopt shared decision-making (SDM) systems designed to improve clinical encounters with patients and quality of care. OBJECTIVE: This study aimed to assess the impact of an SDM system shown to improve diabetes and cardiovascular patient outcomes on factors affecting revenue generation in primary care clinics. METHODS: As part of a large multisite clinic randomized controlled trial (RCT), we explored the differences in 1 care system between clinics randomized to use an SDM intervention (n=8) versus control clinics (n=9) regarding the (1) likelihood of diagnostic coding for cardiometabolic conditions using the 10th Revision of the International Classification of Diseases (ICD-10) and (2) current procedural terminology (CPT) billing codes. RESULTS: At all 24,138 encounters with care gaps targeted by the SDM system, the proportion assigned high-complexity CPT codes for level of service 5 was significantly higher at the intervention clinics (6.1%) compared to that in the control clinics (2.9%), with P<.001 and adjusted odds ratio (OR) 1.64 (95% CI 1.02-2.61). This was consistently observed across the following specific care gaps: diabetes with glycated hemoglobin A1c (HbA1c)>8% (n=8463), 7.2% vs 3.4%, P<.001, and adjusted OR 1.93 (95% CI 1.01-3.67); blood pressure above goal (n=8515), 6.5% vs 3.7%, P<.001, and adjusted OR 1.42 (95% CI 0.72-2.79); suboptimal statin management (n=17,765), 5.8% vs 3%, P<.001, and adjusted OR 1.41 (95% CI 0.76-2.61); tobacco dependency (n=7449), 7.5% vs. 3.4%, P<.001, and adjusted OR 2.14 (95% CI 1.31-3.51); BMI >30 kg/m2 (n=19,838), 6.2% vs 2.9%, P<.001, and adjusted OR 1.45 (95% CI 0.75-2.8). Compared to control clinics, intervention clinics assigned ICD-10 diagnosis codes more often for observed cardiometabolic conditions with care gaps, although the difference did not reach statistical significance. CONCLUSIONS: In this randomized study, use of a clinically effective SDM system at encounters with care gaps significantly increased the proportion of encounters assigned high-complexity (level 5) CPT codes, and it was associated with a nonsignificant increase in assigning ICD-10 codes for observed cardiometabolic conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT02451670; https://clinicaltrials.gov/ct2/show/NCT02451670.

Aspirin Use to Prevent Cardiovascular Disease and Colorectal Cancer: Updated Modeling Study for the US Preventive Services Task Force.

Importance: The US Preventive Services Task Force (USPSTF) is updating its 2016 recommendation on the use of aspirin for the primary prevention of cardiovascular disease (CVD) and colorectal cancer (CRC). Objective: To provide updated model-based estimates of the net balance in benefits and harms from routine use of low-dose aspirin for primary prevention. Design, Setting, and Participants: Microsimulation modeling was used to estimate long-term benefits and harms for hypothetical US cohorts of men and women aged 40 to 79 years with up to 20% 10-year risk for an atherosclerotic CVD event and without prior history of CVD or elevated bleeding risks. Exposures: Low-dose (≤100 mg/d) aspirin for lifetime use, unless contraindicated by a bleeding event, and with stopping ages in 5-year intervals from age 65 to 85 years. Main Outcomes and Measures: Primary outcomes were lifetime net benefits measured in quality-adjusted life-years (QALYs) and life-years. Benefits included reduced nonfatal myocardial infarction and ischemic stroke. Harms included increased nonfatal major gastrointestinal bleeding and intracranial hemorrhage. Reduced CRC incidence was considered in sensitivity analysis. Results: Estimated lifetime net QALYs were positive for both men and women at 5% or greater 10-year CVD risk when starting between ages 40 and 59 years and at 10% or greater 10-year CVD risk when starting between ages 60 and 69 years. These estimates ranged from 2.3 (95% CI, -2.7 to 7.4) to 66.2 (95% CI, 58.2 to 74.1) QALYs per 1000 persons. Lifetime net life-years were positive for men at 5% or greater and women at 10% or greater 10-year CVD risk starting aspirin at ages 40 to 49 years and for men at 7.5% or greater and women at 15% or greater 10-year CVD risk at ages 50 to 59 years. These estimates ranged from 0.4 (95% CI, -6.1 to 6.9) to 52.4 (95% CI, 43.9 to 60.9) life-years per 1000 persons. Lifetime net life-years were negative in most cases for persons starting aspirin between ages 60 and 79 years, as were lifetime net QALYs for persons aged 70 to 79 years. Stopping aspirin between ages 65 and 85 years generally showed little advantage compared with lifetime use. Sensitivity analyses showed lifetime net benefits may be higher if aspirin reduced CRC incidence or CVD mortality and lower if aspirin increased fatal major gastrointestinal bleeding or reduced quality of life with routine use. Conclusions and Relevance: This microsimulation study suggested that several population groups may benefit from taking aspirin for the primary prevention of CVD, primarily in persons starting at younger ages with higher 10-year CVD risk.

Human Papillomavirus vaccination clinical decision support for young adults in an upper midwestern healthcare system: a clinic cluster-randomized control trial.

INTRODUCTION: Human papillomavirus (HPV) vaccination rates are low in young adults. Clinical decision support (CDS) in primary care may increase HPV vaccination. We tested the treatment effect of algorithm-driven, web-based, and electronic health record-linked CDS with or without shared decision-making tools (SDMT) on HPV vaccination rates compared to usual care (UC). METHODS: In a clinic cluster-randomized control trial conducted in a healthcare system serving a largely rural population, we randomized 34 primary care clinic clusters (with three clinics sharing clinicians randomized together) to: CDS; CDS+SDMT; UC. The sample included young adults aged 18-26 due for HPV vaccination with a study index visit from 08/01/2018-03/15/2019 in a study clinic. Generalized linear mixed models tested differences in HPV vaccination status 12 months after index visits by study arm. RESULTS: Among 10,253 patients, 6,876 (65.2%) were due for HPV vaccination, and 5,054 met study eligibility criteria. In adjusted analyses, the HPV vaccination series was completed by 12 months in 2.3% (95% CI: 1.6%-3.2%) of CDS, 1.6% (95% CI: 1.1%-2.3%) of CDS+SDMT, and 2.2% (95% CI: 1.6%-3.0%) of UC patients, and at least one HPV vaccine was received by 12 months in 13.1% (95% CI: 10.6%-16.1%) of CDS, 9.2% (95% CI: 7.3%-11.6%) of CDS+SDMT, and 11.2% (95% CI: 9.1%-13.7%) of UC patients. Differences were not significant between arms. Females, those with prior HPV vaccinations, and those seen at urban clinics had significantly higher odds of HPV vaccination in adjusted models. DISCUSSION: CDS may require optimization for young adults to significantly impact HPV vaccination. TRIAL REGISTRATION: clinicaltrials.gov NCT02986230, 12/6/2016.

Clinical Decision Support with or without Shared Decision Making to Improve Preventive Cancer Care: A Cluster-Randomized Trial.

BACKGROUND: Innovative interventions are needed to address gaps in preventive cancer care, especially in rural areas. This study evaluated the impact of clinical decision support (CDS) with and without shared decision making (SDM) on cancer-screening completion. METHODS: In this 3-arm, parallel-group, cluster-randomized trial conducted at a predominantly rural medical group, 34 primary care clinics were randomized to clinical decision support (CDS), CDS plus shared decision making (CDS+SDM), or usual care (UC). The CDS applied web-based clinical algorithms identifying patients overdue for United States Preventive Services Task Force-recommended preventive cancer care and presented evidence-based recommendations to patients and providers on printouts and on the electronic health record interface. Patients in the CDS+SDM clinic also received shared decision-making tools (SDMTs). The primary outcome was a composite indicator of the proportion of patients overdue for breast, cervical, or colorectal cancer screening at index who were up to date on these 1 y later. RESULTS: From August 1, 2018, to March 15, 2019, 69,405 patients aged 21 to 74 y had visits at study clinics and 25,198 were overdue for 1 or more cancer screening tests at an index visit. At 12-mo follow-up, 9,543 of these (37.9%) were up to date on the composite endpoint. The adjusted, model-derived percentage of patients up to date was 36.5% (95% confidence interval [CI]: 34.0-39.1) in the UC group, 38.1% (95% CI: 35.5-40.9) in the CDS group, and 34.4% (95% CI: 31.8-37.2) in the CDS+SDM group. For all comparisons, the screening rates were higher than UC in the CDS group and lower than UC in the CDS+SDM group, although these differences did not reach statistical significance. CONCLUSION: The CDS did not significantly increase cancer-screening rates. Exploratory analyses suggest a deeper understanding of how SDM and CDS interact to affect cancer prevention decisions is needed. Trial registration: ClinicalTrials.gov ID: NCT02986230, December 6, 2016.

Implementing a prediabetes clinical decision support system in a large primary care system: Design, methods, and pre-implementation results.

BACKGROUND: Early detection of prediabetes and management of cardiovascular (CV) risk factors to prevent CV disease is essential, but clinicians are often slow to address this risk. Clinical decision support (CDS) systems, with appropriate implementation, can potentially improve prediabetes identification and treatment. METHODS/DESIGN: 34 Midwestern primary care clinics were randomized to receive or not receive access to a prediabetes (PreD) CDS tool. Between October 2016 and December 2019, primary care clinicians (PCPs) received Pre-D CDS alerts during visits with adult patients identified with prediabetes and who met minimal inclusion criteria and had at least one CV risk factor not at goal. The PCP Pre-D CDS included a summary of six modifiable CV risk factors and patient-specific treatment recommendations. Study outcomes included total modifiable CV risk, six modifiable CV risk factors, use of CV medications, and referrals. The Consolidated Framework for Implementation Research was used to examine CDS implementation processes. DISCUSSION: This cluster-randomized pragmatic trial allowed PCPs the opportunity to improve CV risk in a timely manner for patients with prediabetes. Effectiveness will be assessed using an intent-to-treat analysis. Implementation processes and outcomes will be assessed through interviews, surveys, and electronic health record data harvested by the CDS tool itself. Pre-implementation interviews and activities identified key strategies to incorporate as part of the Pre-D CDS implementation process to ensure acceptability and high use rates. Analyses are ongoing and trial results are expected in mid-2021.

Is Shared Decision-making Associated with Better Patient-reported Outcomes? A Longitudinal Study of Patients Undergoing Total Joint Arthroplasty.

BACKGROUND: Although shared decision-making (SDM) has knowledge and satisfaction benefits for patients and is promising, we lack data demonstrating that SDM is associated with better patient-reported functional outcomes. Such data would support the integration and prioritization of SDM into all aspects of orthopaedic care. QUESTIONS/PURPOSES: (1) Is a measure of SDM before total joint arthroplasty associated with better patient-reported outcome measures (PROMs) 1 year postoperatively? (2) What is the relationship between the measure of SDM and two measures of patient experience (patient rating of the provider and patient likelihood of recommending the provider) at 1 year postoperatively? METHODS: In this observational longitudinal survey-based study, patients receiving an initial THA or TKA from a large, multispecialty medical group in the Midwestern United States were surveyed after they were scheduled for surgery and again at 12 months after their procedure. The three-item collaboRATE measure of SDM was added to existing patient surveys of PROMs. However, the surgeons and their department had no organized approach to SDM during this time. The surveys also included the Oxford knee or hip score and two validated measures of patient experience (patient rating of the provider and whether a patient would recommend the provider). Of the 2779 eligible primary joint arthroplasties that occurred from April 23, 2018 to May 1, 2019, 48% (1334 procedures; 859 TKAs and 485 THAs) of the patients responded to both the preoperative and 12-month postoperative surveys. Most of the patients who were included in the analytic sample were white (93%; 1255 of 1344), with only 3% (37) using Medicaid benefits at the time of surgery. Differences between responders and nonresponders were present and explored in an analysis. Patient responses were analyzed in regression models to estimate the association between preoperative collaboRATE scores and the Oxford knee or hip scores, and patient experience measures 12 months postoperatively. RESULTS: There was a moderate, positive association between preoperative collaboRATE scores and the Oxford scores at 12 months, after adjustment for potential confounders such as patient age and preoperative functional score (ß = 0.58; 95% CI 0.14-1.02; p = 0.01). Similarly, patients with preoperative collaboRATE scores had marginally higher patient experience scores at 12 months postoperatively (ß = 0.14; 95% CI 0.05-0.24; p = 0.003) and were more likely to recommend their surgeon (OR 1.43; 95% CI 1.11-1.84; p = 0.005). The patient experience measures were also modestly correlated with collaboRATE scores in cross-sectional associations, both preoperatively and at 12 months postoperatively (0.29 ≤ r ≤ 0.54; p < 0.01). CONCLUSION: The association between preoperative collaboRATE scores and Oxford hip or knee scores suggests that SDM could be one tool to encourage better outcomes. Although previous studies have shown that SDM can improve patient experience, the lack of a strong correlation in our study suggests that PROMs and experience measures are separate domains, at least partly. Improving preoperative SDM between the surgeon and patient might help improve surgical outcomes for patients undergoing TKA and THA. LEVEL OF EVIDENCE: Level II, therapeutic study.

Personalized outcomes for hip and knee replacement: the patients point of view.

BACKGROUND: Patient reported outcome measures (PROMs) are increasingly being incorporated into clinical and surgical care for assessing outcomes. This study examined outcomes important to patients in their decision to have hip or knee replacement surgery, their perspectives on PROMs and shared decision-making, and factors they considered important for postoperative care. METHODS: A cross-sectional study employing survey methods with a stratified random sample of adult orthopedic patients who were scheduled for or recently had hip or knee replacement surgery. RESULTS: In a representative sample of 226 respondents, patients identified personalized outcomes important to them that they wanted from their surgery including the ability to walk without pain/discomfort, pain relief, and returning to an active lifestyle. They preferred a personalized outcome (54%) that they identified, compared to a PROM score, for tracking progress in their care and thought it important that their surgeon know their personal outcomes (63%). Patients also wanted to engage in shared decision-making (79%) about their post-surgical care and identified personal factors important to their aftercare, such as living alone and caring for pets. CONCLUSIONS: Patients identified unique personalized outcomes they desired from their care and that they wanted their orthopedic surgeons to know about. Asking patients to identify their personalized outcomes could add value for both patients and surgeons in clinical care, facilitating more robust patient involvement in shared decision-making.

Effect of Clinical Decision Support on Diagnostic Imaging for Pediatric Appendicitis: A Cluster Randomized Trial.

Importance: Appendicitis is the most common pediatric surgical emergency. Efforts to improve efficiency and quality of care have increased reliance on computed tomography (CT) and ultrasonography (US) in children with suspected appendicitis. Objective: To evaluate the effectiveness of an electronic health record-linked clinical decision support intervention, AppyCDS, on diagnostic imaging, health care costs, and safety outcomes for patients with suspected appendicitis. Design, Setting, and Participants: In this parallel, cluster randomized trial, 17 community-based general emergency departments (EDs) in California, Minnesota, and Wisconsin were randomized to the AppyCDS intervention group or usual care (UC) group. Patients were aged 5 to 20 years, presenting for an ED visit with right-sided or diffuse abdominal pain lasting 5 days or less. We excluded pregnant patients, those with a prior appendectomy, those with selected comorbidities, and those with traumatic injuries. The trial was conducted from October 2016 to July 2019. Interventions: AppyCDS prompted data entry at the point of care to estimate appendicitis risk using the pediatric appendicitis risk calculator (pARC). Based on pARC estimates, AppyCDS recommended next steps in care. Main Outcomes and Measures: Primary outcomes were CT, US, or any imaging (CT or US) during the index ED visit. Safety outcomes were perforations, negative appendectomies, and missed appendicitis. Costs were a secondary outcome. Ratio of ratios (RORs) for primary and safety outcomes and differences by group in cost were used to evaluate effectiveness of the clinical decision support tool. Results: We enrolled 3161 patients at intervention EDs and 2779 patients at UC EDs. The mean age of patients was 11.9 (4.6) years and 2614 (44.0%) were boys or young men. RORs for CT (0.94; 95% CI, 0.75-1.19), US (0.98; 95% CI, 0.84-1.14), and any imaging (0.96; 95% CI, 0.86-1.07) did not differ by study group. In an exploratory analysis conducted in 1 health system, AppyCDS was associated with a reduction in any imaging (ROR, 0.82; 95% CI, 0.73- 0.93) for patients with pARC score of 15% or less and a reduction in CT (ROR, 0.58; 95% CI, 0.45-0.74) for patients with a pARC score of 16% to 50%. Perforations, negative appendectomies, and cases of missed appendicitis by study phase did not differ significantly by study group. Costs did not differ overall by study group. Conclusions and Relevance: In this study, AppyCDS was not associated with overall reductions in diagnostic imaging; exploratory analysis revealed more appropriate use of imaging in patients with a low pARC score. Trial Registration: ClinicalTrials.gov Identifier: NCT02633735.

Design and rationale of an intervention to improve cancer prevention using clinical decision support and shared decision making: A clinic-randomized trial.

BACKGROUND: Despite decades of research the gap in primary and secondary cancer prevention services in the U. S. remains unacceptably wide. Innovative interventions are needed to address this persistent challenge. Electronic health records linked with Web-based clinical decision support may close this gap, especially if delivered to both patients and their providers. OBJECTIVES: The Cancer Prevention Wizard (CPW) study is an implementation, clinic-randomized trial designed to achieve these aims: 1) assess impact of the Cancer Prevention Wizard-Clinical Decision Support (CPW-CDS) alone and CPW-CDS plus Shared Decision Making Tools (CPW + SDMTs) compared to usual care (UC) on tobacco cessation counseling and drugs, HPV vaccinations, and screening tests for breast, cervical, colorectal, or lung cancer; 2) assess cost of the CPW-CDS intervention; and 3) describe critical facilitators and barriers for CPW-CDS implementation, use, and clinical impact using a mixed-methods approach supported by the CFIR and RE-AIM frameworks. METHODS: 34 predominantly rural, primary care clinics were randomized to CPW-CDS, CPW + SMDTs, or UC. Between August 2018 and October 2020, primary care providers and their patients who met inclusion criteria in intervention clinics were exposed to the CPW-CDS with or without SDMTs. Study outcomes at 12 months post index visit include patients up to date on screening tests and HPV vaccinations, overall healthcare costs, and diagnostic codes and billing levels for cancer prevention services. CONCLUSIONS: We will test in rural primary care settings whether CPW-CDS with or without SDMTs can improve delivery of primary and secondary cancer prevention services. The trial and analyses are ongoing with results expected in 2021.

Cardiovascular Events and Costs With Home Blood Pressure Telemonitoring and Pharmacist Management for Uncontrolled Hypertension.

Uncontrolled hypertension is a leading contributor to cardiovascular disease. A cluster-randomized trial in 16 primary care clinics showed that 12 months of home blood pressure telemonitoring and pharmacist management lowered blood pressure more than usual care (UC) for 24 months. We report cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, hospitalized heart failure, coronary revascularization, and cardiovascular death) and costs over 5 years of follow-up. In the telemonitoring intervention (TI group, n=228), there were 15 cardiovascular events (5 myocardial infarction, 4 stroke, 5 heart failure, 1 cardiovascular death) among 10 patients. In UC group (n=222), there were 26 events (11 myocardial infarction, 12 stroke, 3 heart failure) among 19 patients. The cardiovascular composite end point incidence was 4.4% in the TI group versus 8.6% in the UC group (odds ratio, 0.49 [95% CI, 0.21-1.13], P=0.09). Including 2 coronary revascularizations in the TI group and 10 in the UC group, the secondary cardiovascular composite end point incidence was 5.3% in the TI group versus 10.4% in the UC group (odds ratio, 0.48 [95% CI, 0.22-1.08], P=0.08). Microsimulation modeling showed the difference in events far exceeded predictions based on observed blood pressure. Intervention costs (in 2017 US dollars) were $1511 per patient. Over 5 years, estimated event costs were $758 000 in the TI group and $1 538 000 in the UC group for a return on investment of 126% and a net cost savings of about $1900 per patient. Telemonitoring with pharmacist management lowered blood pressure and may have reduced costs by avoiding cardiovascular events over 5 years. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT00781365.

Characteristics and Price Increases Among Sole-Source, Off-Patent Drugs in the United States, 2008 to 2018.

Importance: Some sole-source, off-patent drugs in the United States have undergone substantial price hikes in recent years. Despite increased attention by lawmakers, there are limited data to guide policy. Objectives: To describe key attributes of sole-source, off-patent, off-exclusivity drugs; to characterize the prevalence of price increases; and to identify attributes associated with price increases. Design, Setting, and Participants: In this cross-sectional study, 300 sole-source, off-patent, off-exclusivity drug products met inclusion criteria and were selected for analysis from January 1, 2008, to December 31, 2018. Attributes were identified from multiple sources, and yearly wholesale acquisition cost prices were determined from First Databank. Main Outcomes and Measures: The association of drug attributes with the following 2 price change thresholds was measured after adjusting for inflation: 25% or more price increase in a calendar year (wholesale acquisition cost) and 50% or more price increase in a calendar year. The rate of annual price increase over time was also measured. Results: Of the 300 drug products and 2242 observations analyzed, the overall inflation-adjusted mean increase in drug prices was 8.8% (95% CI, 7.8%-9.8%) per year. Ninety-five drugs (31.7%) increased by 25% or more during any calendar year, and 66 drugs (22.0%) increased by 50% or more during any calendar year. An initial price of less than $2 per unit (adjusted odds ratio [aOR], 2.36; 95% CI, 1.69-3.29), antineoplastic and immunomodulatory class (aOR, 2.72; 95% CI, 1.31-5.65), dermatologic class (aOR, 2.95; 95% CI, 1.80-4.84), oral route (aOR, 2.01; 95% CI, 1.45-2.79), and US Food and Drug Administration (FDA) approval before 1990 (aOR, 1.52; 95% CI, 1.14-2.03) were attributes of drugs that were more likely to be associated with a 25% or more price increase in a calendar year after adjusting for by initial price. Similarly, an initial price of less than $2 per unit (aOR, 2.68; 95% CI, 1.76-4.09), antineoplastic and immunomodulatory class (aOR, 3.07; 95% CI, 1.54-6.12), oral route of administration (aOR, 1.70; 95% CI, 1.11-2.60), and FDA approval before 1990 (aOR, 2.02; 95% CI, 1.40-2.94) were attributes of drugs that were more likely to be associated with a 50% or more price increase in a calendar year after adjusting for by initial price. Price increases of 25% or more were most common in 2014, and price increases of 50% or more were most common in 2013. Conclusions and Relevance: Price increases among sole-source, off-patent drugs are common, and policy interest in this practice is warranted. These findings should inform state drug pricing legislation.

Health and Budgetary Impact of Achieving 10-Year U.S. Sodium Reduction Targets.

INTRODUCTION: This study estimates the health, economic, and budgetary impact resulting from graduated sodium reductions in the commercially produced food supply of the U.S., which are consistent with draft U.S. Food and Drug Administration voluntary guidance and correspond to Healthy People 2020 objectives and the 2015-2020 Dietary Guidelines for Americans. METHODS: Reduction in mean U.S. dietary sodium consumption to 2,300 mg/day was implemented in a microsimulation model designed to evaluate prospective cardiovascular disease-related policies in the U.S. POPULATION: The analysis was conducted in 2018-2020, and the microsimulation model was constructed using various data sources from 1948 to 2018. Modeled outcomes over 10 years included prevalence of systolic blood pressure ≥140 mmHg; incident myocardial infarction, stroke, cardiovascular disease events, and cardiovascular disease-related mortality; averted medical costs by payer in 2017 U.S. dollars; and productivity. RESULTS: Reducing sodium consumption is expected to reduce the number of people with systolic blood pressure ≥140 mmHg by about 22% and prevent approximately 895.2 thousand cardiovascular disease events (including 218.9 thousand myocardial infarctions and 284.5 thousand strokes) and 252.5 thousand cardiovascular disease-related deaths over 10 years in the U.S. Savings from averted disease costs are expected to total almost $37 billion-most of which would be attributed to Medicare ($18.4 billion) and private insurers ($13.4 billion)-and increased productivity from reduced disease burden and premature mortality would account for another $18.2 billion in gains. CONCLUSIONS: Systemic sodium reductions in the U.S. food supply can be expected to produce substantial health and economic benefits over a 10-year period, particularly for Medicare and private insurers.