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in response to major implementation challenges: (a) the availability of EHR system-wide PDC calculations that superseded our ability to limit PDC adherence information solely to intervention clinics; (b) the unforeseen closure of pharmacies committed to conducting the pharmacist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.

The Impact of Stimulant Medications on Blood Pressure and Body Mass Index in Children with Attention Deficit Hyperactivity Disorder.

OBJECTIVE: To describe changes in blood pressure (BP) and body mass index (BMI) associated with stimulant medication fills in children. METHODS: Observational, retrospective matched cohort study of children 6-17.9 years initiating stimulant medication between 7/1/2010-6/30/2017 matched 1:3 by age, race, ethnicity, and sex to children with no stimulant use during this period. All BPs and BMIs recorded during ambulatory visits were identified. Generalized linear models were used to estimate differences in change in systolic BP (SBP), diastolic BP (DBP), and BMI over time. RESULTS: The 686 children with stimulant prescription fills and 2048 matched controls did not differ by baseline SBP or BMI. The matched control group (30.5% female, mean age 11.2 ± 3.4 years 79.7% white) was more likely to be publicly insured (35% vs. 21%, P < .01). After adjusting for baseline values, over a mean follow-up of 144 days change in SBP or DBP did not differ significantly between patients with stimulant medication fills and matched controls. Stimulant use was associated with a 4.7 percentile decrease in BMI percentile compared to matched controls (95% CI: 3.69, 5.71; P < .01). CONCLUSIONS: In a pediatric primary care cohort, stimulant prescription fills were associated with marked decreases in BMI but no significant changes in BP over time.

Adapting a clinical decision support system to improve identification of pediatric hypertension in a rural health system: Design of a pragmatic trial.

BACKGROUND: Identifying hypertension (HTN) early is crucial in preventing and lowering the long-term risk of heart disease, yet HTN in children often goes undiagnosed. An electronic health record linked, web-based clinical decision support (CDS) called PedsBP can help address this care gap and has been previously shown to increase recognition of HTN by primary care clinicians. OBJECTIVES: To adapt the PedsBP tool for use in a mostly rural health system and then to evaluate the effectiveness of PedsBP for repeat of hypertensive level blood pressure (BP) measurements and HTN recognition among youth 6-17 years of age in primary care settings, comparing low-intensity and high-intensity implementation approaches. METHODS AND DESIGN: PedsBP was evaluated through a pragmatic, clinic-randomized trial. The tool was piloted in 2 primary care clinics and modified prior to the full trial. Forty community-based, primary care clinics (or clusters of clinics) were randomly allocated in a 1:1:1 ratio to usual care, low-intensity implementation (CDS only), or high-intensity implementation (CDS plus in-person training, monthly use reports, and ongoing communication between study staff and clinics). Accrual of eligible patients started on August 1, 2022 and will continue for 18 months. Primary outcomes include repeating hypertensive level BP measurements at office visits and clinical recognition of HTN. Secondary outcomes include lifestyle counseling, dietician referral, and BP at follow-up. CONCLUSION: This report focuses on the design and feasibility of adapting and implementing PedsBP in a rural primary care setting. The trial and analysis are ongoing with main results expected in mid-2024.

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.

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.

Primary care clinicians' opinions before and after implementation of cancer screening and prevention clinical decision support in a clinic cluster-randomized control trial: a survey research study.

BACKGROUND: Electronic health record (EHR)-linked clinical decision support (CDS) may impact primary care clinicians' (PCCs') clinical care opinions. As part of a clinic cluster-randomized control trial (RCT) testing a cancer prevention and screening CDS system with patient and PCC printouts (with or without shared decision-making tools [SDMT]) for patients due for breast, cervical, colorectal, and lung cancer screening and/or human papillomavirus (HPV) vaccination compared to usual care (UC), we surveyed PCCs at study clinics pre- and post-CDS implementation. Our primary aim was to learn if PCCs' opinions changed over time within study arms. Secondary aims including examining whether PCCs' opinions in study arms differed both pre- and post-implementation, and gauging PCCs' opinions on the CDS in the two intervention arms. METHODS: This study was conducted within a healthcare system serving an upper Midwestern population. We administered pre-implementation (11/2/2017-1/24/2018) and post-implementation (2/2/2020-4/9/2020) cross-sectional electronic surveys to PCCs practicing within a RCT arm: UC; CDS; or CDS + SDMT. Bivariate analyses compared responses between study arms at both time periods and longitudinally within study arms. RESULTS: Pre-implementation (53%, n = 166) and post-implementation (57%, n = 172) response rates were similar. No significant differences in PCC responses were seen between study arms on cancer prevention and screening questions pre-implementation, with few significant differences found between study arms post-implementation. However, significantly fewer intervention arm clinic PCCs reported being very comfortable with discussing breast cancer screening options with patients compared to UC post-implementation, as well as compared to the same intervention arms pre-implementation. Other significant differences were noted within arms longitudinally. For intervention arms, these differences related to CDS areas like EHR alerts, risk calculators, and ordering screening. Most intervention arm PCCs noted the CDS provided overdue screening alerts to which they were unaware. Few PCCs reported using the CDS, but most would recommend it to colleagues, expressed high CDS satisfaction rates, and thought patients liked the CDS's information and utility. CONCLUSIONS: While appreciated by PCCs with high satisfaction rates, the CDS may lower PCCs' confidence regarding discussing patients' breast cancer screening options and may be used irregularly. Future research will evaluate the impact of the CDS on cancer prevention and screening rates. TRIAL REGISTRATION: clinicaltrials.gov , NCT02986230, December 6, 2016.

Patient Perceptions of Using Clinical Decision Support for Cancer Screening and Prevention: "I wouldn't have thought about getting screened without it."

PURPOSE: We sought to gain an understanding of cancer prevention and screening perspectives among patients exposed to a clinical decision support (CDS) tool because they were due or overdue for certain cancer screenings or prevention. METHODS: Semi-structured qualitative interviews were conducted with 37 adult patients due or overdue for cancer prevention services in 10 primary care clinics within the same health system. Data were thematically segmented and coded using qualitative content analysis. RESULTS: We identified three themes: 1) The CDS tool had more strengths than weaknesses, with areas for improvement; 2) Many facilitators and barriers to cancer prevention and screening exist; and 3) Discussions and decision-making varied by type of cancer prevention and screening. Almost all participants made positive comments regarding the CDS. Some participants learned new information, reporting the CDS helped them make a decision they otherwise would not have made. Participants who used the tool with their provider had higher self-reported rates of deciding to be screened than those who did not. CONCLUSIONS: Learning about patients' perceptions of a CDS tool may increase understanding of how patient-tailored CDS impacts cancer screening and prevention rates. Participants found a personalized CDS tool for cancer screening and prevention in primary care useful and a welcome addition to their visit. However, many providers were not using the tool with eligible patients.

Pragmatic clinic randomized trial to improve chronic kidney disease care: Design and adaptation due to COVID disruptions.

BACKGROUND: We describe a clinic-randomized trial to improve chronic kidney disease (CKD) care through a CKD-clinical decision support (CKD-CDS) intervention in primary care clinics and the challenges we encountered due to COVID-19 care disruption. METHODS/DESIGN: Primary care clinics (N = 32) were randomized to usual care (UC) or to CKD-CDS. Between April 17, 2019 and March 14, 2020, more than 7000 patients had accrued for analysis by meeting study-eligibility criteria at an index office visit: age 18-75, laboratory criteria for stage 3 or 4 CKD (eGFR 15-59 mL/min/1.73 m2), and one or more opportunities algorithmically identified to improve CKD care such as blood pressure (BP) or glucose control, angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) use, discontinuance of a nonsteroidal anti-inflammatory drug (NSAID), or nephrology referral. At CKD-CDS clinics, CDS provided individualized treatment suggestions that were printed for patients and clinicians at the start of office encounters and were viewable within the electronic health record. By initial design, the impact of the CKD-CDS intervention on care gaps was to be assessed 12 months after the index date, but COVID-19 caused major disruptions to care delivery during the intervention period. In response to disruptions, the intervention was temporarily suspended while we expanded CDS use for telehealth encounters and programmed new criteria for displaying the CKD-CDS to intervention patients due to clinic closures and scheduling changes. DISCUSSION: We describe a NIH-funded pragmatic trial of web-based EHR-integrated CKD-CDS and modifications necessary mid-study to complete the study as intended in the face of COVID-19 pandemic challenges.

The impact of personalized clinical decision support on primary care patients' views of cancer prevention and screening: a cross-sectional survey.

BACKGROUND: Few studies have assessed the impact of clinical decision support (CDS), with or without shared decision-making tools (SDMTs), on patients' perceptions of cancer screening or prevention in primary care settings. This cross-sectional survey was conducted to understand primary care patient's perceptions on cancer screening or prevention. METHODS: We mailed surveys (10/2018-1/2019) to 749 patients aged 18 to 75 years within 15 days after an index clinical encounter at 36 primary care clinics participating in a clinic-randomized control trial of a CDS system for cancer prevention. All patients were overdue for cancer screening or human papillomavirus vaccination. The survey compared respondents' answers by study arm: usual care; CDS; or CDS + SDMT. RESULTS: Of 387 respondents (52% response rate), 73% reported having enough time to discuss cancer prevention options with their primary care provider (PCP), 64% reported their PCP explained the benefits of the cancer screening choice very well, and 32% of obese patients reported discussing weight management, with two-thirds reporting selecting a weight management intervention. Usual care respondents were significantly more likely to decide on colorectal cancer screening than CDS respondents (p < 0.01), and on tobacco cessation than CDS + SDMT respondents (p = 0.02) and both CDS and CDS + SDMT respondents (p < 0.001). CONCLUSIONS: Most patients reported discussing cancer prevention needs with PCPs, with few significant differences between the three study arms in patient-reported cancer prevention care. Upcoming research will assess differences in screening and vaccination rates between study arms during the post-intervention follow-up period. TRIAL REGISTRATION: clinicaltrials.gov , NCT02986230 , December 6, 2016.

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.

Pre-implementation adaptation of primary care cancer prevention clinical decision support in a predominantly rural healthcare system.

BACKGROUND: Cancer is a leading cause of death in the United States. Primary care providers (PCPs) juggle patient cancer prevention and screening along with managing acute and chronic health problems. However, clinical decision support (CDS) may assist PCPs in addressing patients' cancer prevention and screening needs during short clinic visits. In this paper, we describe pre-implementation study design and cancer screening and prevention CDS changes made to maximize utilization and better fit a healthcare system's goals and culture. We employed the Consolidated Framework for Implementation Research (CFIR), useful for evaluating the implementation of CDS interventions in primary care settings, in understanding barriers and facilitators that led to those changes. METHODS: In a three-arm, pragmatic, 36 clinic cluster-randomized control trial, we integrated cancer screening and prevention CDS and shared decision-making tools (SDMT) into an existing electronic medical record-linked cardiovascular risk management CDS system. The integrated CDS is currently being tested within a predominately rural upper Midwestern healthcare system. Prior to CDS implementation, we catalogued pre-implementation changes made from 2016 to 2018 based on: pre-implementation site engagement; key informant interviews with healthcare system rooming staff, providers, and leadership; and pilot testing. We identified influential barriers, facilitators, and changes made in response through qualitative content analysis of meeting minutes and supportive documents. We then coded pre-implementation changes made and associated barriers and facilitators using the CFIR. RESULTS: Based on our findings from system-wide pre-implementation engagement, pilot testing, and key informant interviews, we made changes to accommodate the needs of the healthcare system based on barriers and facilitators that fell within the Intervention Characteristics, Inner Setting, and Outer Setting CFIR domains. Changes included replacing the expansion of medical assistant roles in one intervention arm with targeted SDMT, as well as altering cancer prevention CDS and study design elements. CONCLUSIONS: Pre-implementation changes to CDS may help meet healthcare systems' evolving needs and optimize the intervention by being responsive to real-world implementation barriers and facilitators. Frameworks like the CFIR are useful tools for identifying areas where pre-implementation barriers and facilitators may result in design changes, both to research studies and CDS systems. TRIAL REGISTRATION: NCT02986230.

Clinical Decision Support for Recognizing and Managing Hypertensive Blood Pressure in Youth: No Significant Impact on Medical Costs.

OBJECTIVE: To evaluate economic costs from the health system perspective of an electronic health record-based clinical decision support (CDS) tool, TeenBP, designed to assist in the recognition and management of hypertension in youth. METHODS: Twenty primary care clinics within an integrated health system were randomized to the TeenBP CDS or usual care (UC), with patient enrollment from 4/15/14 to 4/14/16. The 12-month change in standardized medical care costs for insured patients aged 10 to 17 years without prior hypertension were calculated for each study arm. The primary analysis compared patients with ≥1 visit with blood pressure (BP) ≥95th percentile (isolated hypertensive BP), and secondary analyses compared patients with ≥3 visits within one year with BP ≥95th percentile (incident hypertension). Generalized estimating equation models estimated the difference-in-differences in costs between groups over time. RESULTS: Among 925 insured patients with an isolated hypertensive BP, the pre-to-post change in overall costs averaged $22 more for TeenBP CDS versus UC patients over 12 months, but this difference was not statistically significant (P = .723). Among 159 insured patients with incident hypertension, the pre-to-post change in overall costs over 12 months was higher by $227 per person on average for TeenBP CDS versus UC patients, but this difference also was not statistically significant (P = .313). CONCLUSIONS: The TeenBP CDS intervention was previously found to significantly improve identification and management of hypertensive BP in youth, and in this study, we find that this tool did not significantly increase care costs in its first 12 months of clinical use.

Barriers and facilitators to implementing cancer prevention clinical decision support in primary care: a qualitative study.

BACKGROUND: In the United States, primary care providers (PCPs) routinely balance acute, chronic, and preventive patient care delivery, including cancer prevention and screening, in time-limited visits. Clinical decision support (CDS) may help PCPs prioritize cancer prevention and screening with other patient needs. In a three-arm, pragmatic, clinic-randomized control trial, we are studying cancer prevention CDS in a large, upper Midwestern healthcare system. The web-based, electronic health record (EHR)-linked CDS integrates evidence-based primary and secondary cancer prevention and screening recommendations into an existing cardiovascular risk management CDS system. Our objective with this study was to identify adoption barriers and facilitators before implementation in primary care. METHODS: We conducted semi-structured interviews guided by the Consolidated Framework for Implementation Research (CFIR) with 28 key informants employed by the healthcare organization in either leadership roles or the direct provision of clinical care. Transcribed interviews were analyzed using qualitative content analysis. RESULTS: EHR, CDS workflow, CDS users (providers and patients), training, and organizational barriers and facilitators were identified related to Intervention Characteristics, Outer Setting, Inner Setting, and Characteristics of Individuals CFIR domains. CONCLUSION: Identifying and addressing key informant-identified barriers and facilitators before implementing cancer prevention CDS in primary care may support a successful implementation and sustained use. The CFIR is a useful framework for understanding pre-implementation barriers and facilitators. Based on our findings, the research team developed and instituted specialized training, pilot testing, implementation plans, and post-implementation efforts to maximize identified facilitators and address barriers. TRIAL REGISTRATION: clinicaltrials.gov , NCT02986230 , December 6, 2016.

Development of a Clinical Decision Support System for Pediatric Abdominal Pain in Emergency Department Settings Across Two Health Systems Within the HCSRN.

BACKGROUND: Appendicitis is a common surgical emergency in children, yet diagnosis can be challenging. An electronic health record (EHR) based, clinical decision support (CDS) system called Appy CDS was designed to help guide management of pediatric patients with acute abdominal pain within the Health Care Systems Research Network (HCSRN). OBJECTIVES: To describe the development and implementation of a clinical decision support tool (Appy CDS) built independently but synergistically at two large HCSRN affiliated health systems using well-established platforms, and to assess the tool's Triage component, aiming to identify pediatric patients at increased risk for appendicitis. RESULTS: Despite differences by site in design and implementation, such as the use of alerts, incorporating gestalt, and other workflow variations across sites, using simple screening questions and automated exclusions, both systems were able to identify a population with similar appendicitis rates (11.8 percent and 10.6 percent), where use of the full Appy CDS would be indicated. DISCUSSION: These 2 HCSRN sites designed Appy CDS to capture a population at risk for appendicitis and deliver CDS to that population while remaining locally relevant and adhering to organizational preferences. Despite different approaches to point-of-care CDS, the sites have identified similar cohorts with nearly identical background rates of appendicitis. NEXT STEPS: The full Appy CDS tool, providing personalized risk assessment and tailored recommendations, is undergoing evaluation as part of a pragmatic cluster randomized trial aiming to reduce reliance on advanced diagnostic imaging. The novel approaches to CDS we present could serve as the basis for future ED interventions.

Impact of updated pediatric hypertension guidelines on progression from elevated blood pressure to hypertension in a community-based primary care population.

In 2017, definitions for pediatric hypertension were updated. A threshold of 130/80 mm Hg was introduced for stage 1 hypertension in adolescents, and children with obesity were removed from the reference population, lowering the 95th percentile, compared to the 2004 Fourth Report. The impact of these changes on care for youth with elevated blood pressure has not been well described. The objective of this study was to compare the 2017 and 2004 criteria for hypertension, evaluating how they impact estimates of risks for elevated blood pressure to progress to hypertension. Data came from youth 10-17 years of age with ≥2 elevated blood pressure measurements (≥90th percentile or ≥120/80 mm Hg) between 04/15/2014 and 04/14/2016 and three additional measurements over two subsequent years. Blood pressures were recorded in primary care practices within a large health system, as part of routine care. Rates of incident hypertension following persistent elevated blood pressure based on the 2017 guidelines vs the 2004 Fourth Report were compared. We found, among 2025 youth with persistent elevated blood pressure, 46% were female and mean age was 14.6 years. Over 2 years of follow-up, progression to hypertension occurred in 5.9% using the 2017 guidelines vs 1.1% using 2004 Fourth Report definitions. Using the 2017 criteria, progression was most common in older youth and those with obesity. In conclusion, for most youth, elevated blood pressure does not progress to hypertension within 2 years. However, progression from elevated blood pressure to hypertension was more than 5-fold greater when applying the 2017 guidelines compared to the older 2004 Fourth Report criteria.

Understanding primary care providers' perceptions of cancer prevention and screening in a predominantly rural healthcare system in the upper Midwest.

BACKGROUND: Cancer is the leading cause of death in the United States, with the burden expected to rise in the coming decades, increasing the need for effective cancer prevention and screening options. The United States Preventive Services Task Force has suggested that a shared decision-making process be used when clinicians and patients discuss cancer screening. The electronic medical record (EMR) often provides only reminders or alerts to primary care providers (PCPs) when screenings are due, a strategy with limited efficacy. METHODS: We administered a cross-sectional electronic survey to PCPs (n = 165, 53% response rate) at 36 Essentia Health primary care clinics participating in a large, National Cancer Institute-funded study on a cancer prevention clinical decision support (CDS) tool. The survey assessed PCP demographics, perceptions of the EMR's ability to help assess and manage patients' cancer risk, and experience and comfort level discussing cancer screening and prevention with patients. RESULTS: In these predominantly rural clinics, only 49% of PCPs thought the EMR was well integrated to help assess and manage cancer risk. Both advanced care practitioners and physicians agreed that cancer screening and informed discussion of cancer risks are important; however, only 53% reported their patients gave cancer screening a high priority relative to other health issues. CONCLUSIONS: The impact of EMR-linked CDS delivered to both patients and PCPs may improve cancer screening, but only if it is easy to use and saves PCPs time.