Quality improvement and practice-based research in sleep medicine using structured clinical documentation in the electronic medical record.

BACKGROUND: We developed and implemented a structured clinical documentation support (SCDS) toolkit within the electronic medical record, to optimize patient care, facilitate documentation, and capture data at office visits in a sleep medicine/neurology clinic for patient care and research collaboration internally and with other centers. METHODS: To build our SCDS toolkit, physicians met frequently to develop content, define the cohort, select outcome measures, and delineate factors known to modify disease progression. We assigned tasks to the care team and mapped data elements to the progress note. Programmer analysts built and tested the SCDS toolkit, which included several score tests. Auto scored and interpreted tests included the Generalized Anxiety Disorder 7-item, Center for Epidemiological Studies Depression Scale, Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, Insomnia Severity Index, and the International Restless Legs Syndrome Study Group Rating Scale. The SCDS toolkits also provided clinical decision support (untreated anxiety or depression) and prompted enrollment of patients in a DNA biobank. RESULTS: The structured clinical documentation toolkit captures hundreds of fields of discrete data at each office visit. This data can be displayed in tables or graphical form. Best practice advisories within the toolkit alert physicians when a quality improvement opportunity exists. As of May 1, 2019, we have used the toolkit to evaluate 18,105 sleep patients at initial visit. We are also collecting longitudinal data on patients who return for annual visits using the standardized toolkits. We provide a description of our development process and screenshots of our toolkits. CONCLUSIONS: The electronic medical record can be structured to standardize Sleep Medicine office visits, capture data, and support multicenter quality improvement and practice-based research initiatives for sleep patients at the point of care.

Optimizing the electronic medical record to improve patient care and conduct quality improvement initiatives in a concussion specialty clinic.

Objective: To use the electronic medical record (EMR) to optimize patient care, facilitate documentation, and support quality improvement and practice-based research in a concussion (mild traumatic brain injury; mTBI) clinic.Methods: We built a customized structured clinical documentation support (SCDS) toolkit for patients in a concussion specialty clinic. The toolkit collected hundreds of fields of discrete, standardized data. Autoscored and interpreted score tests include the Generalized Anxiety Disorder 7-item scale, Center for Epidemiology Studies Depression scale, Insomnia Severity Index, and Glasgow Coma Scale. Additionally, quantitative score measures are related to immediate memory, concentration, and delayed recall. All of this data collection occurred in a standard appointment length.Results: To date, we evaluated 619 patients at an initial office visit after an mTBI. We provided a description of our toolkit development process, and a summary of the data electronically captured using the toolkit.Conclusions: The electronic medical record can be used to effectively structure and standardize care in a concussion clinic. The toolkit supports the delivery of care consistent with Best Practices, provides opportunities for point of care decision support, and writes comprehensive progress notes that can be communicated to other providers.

Poorer outcomes of all low birth weight groups at age 10: Missouri statewide case-control study.

BACKGROUND: In 1989-1991, a population-based cohort of every Missouri birth weighing < 1500 g was identified over a 16-month period. Infants born moderately low birth weight (MLBW, 1500-2499 g) and normal birth weight (NBW, ≥ 2500 g), were matched to < 1500 g infants by delivery date, race, maternal age, and residence. AIMS: To compare outcomes of extremely low birth weight (ELBW, < 1000 g), very low birth weight (VLBW, 1000-1499 g), and MLBW, to NBW infants at age 10. STUDY DESIGN: A population-based cohort and matched case-control study OUTCOME MEASURES: A Child Health and Development Questionnaire developed for this study collected social, medical, educational and special services history. The Conners' Parent Rating Scale-Revised was also completed by parents/caregivers. RESULTS: As birth weight declined, the prevalence of adverse outcomes increased. Children in all LBW groups were more likely than NBW children to have problems in speech and language, vision, fine and gross motor tasks, illnesses, attention, school performance, and increased requirements for therapy and accommodation. Repetition of a grade was three times higher for MLBW children and over three times higher for the other LBW groups. CONCLUSION: In this statewide population-based study, controlling for child's sex, mother's age, race, residence, education, marital status, Medicaid assistance, and smoking or alcohol use during pregnancy, failed to eliminate the strong effect of decreasing birth weight. Problems were most frequent in ELBW, however, VLBW and MLBW also had many significantly greater problems than NBW children. All LBW groups of children experienced greater adverse health and developmental outcomes resulting in significant habilitation and educational challenges.

Building of EMR Tools to Support Quality and Research in a Memory Disorders Clinic.

The electronic medical record (EMR) presents an opportunity to standardize patient data collection based on quality guidelines and conduct practice-based research. We describe the development of a customized EMR "toolkit" that standardizes patient data collection with hundreds of discrete fields that supports Best Practices for treating patients with memory disorders. The toolkit also supports practice-based research. We describe the design and successful implementation of a customized EMR toolkit to support Best Practices in the care of patients with memory disorders. We discuss applications, including quality improvement projects and current research initiatives, using the toolkit. This toolkit is being shared with other departments of Neurology as part of the Neurology Practice-Based Research Network. Data collection is ongoing, including longitudinal follow-up. This toolkit will generate data that will allow for descriptive and hypothesis driven research as well-quality improvement among patients seen in a memory clinic.

Design and Implementation of Structured Clinical Documentation Support Tools for Treating Stroke Patients.

BACKGROUND AND PURPOSE: Standardized electronic medical record tools provide an opportunity to efficiently provide care that conforms to Best Practices and supports quality improvement and practice-based research initiatives. METHODS: We describe the development of a customized structured clinical documentation "toolkit" that standardizes patient data collection to conform to Best Practices for treating patients with stroke. The toolkit collects patients' demographic information, relevant score test measures, and captures information on disability, treatment, and outcomes. RESULTS: We describe here our creation and implementation of the toolkits and provide example screenshots. As of August 1, 2018, we have evaluated 2332 patients at an initial visit for a possible stroke. We provide basic descriptive data gathered from the use of the toolkits, demonstrating their utility in collecting patient data in a manner that supports both quality clinical care and research initiatives. CONCLUSIONS: We have developed an EMR toolkit to support Best Practices in the care of patients with stroke. We discuss quality improvement projects and current research initiatives using the toolkit. This toolkit is being shared with other Departments of Neurology as part of the Neurology Practice-Based Research Network.

Successful utilization of the EMR in a multiple sclerosis clinic to support quality improvement and research initiatives at the point of care.

BACKGROUND: Many physicians enter data into the electronic medical record (EMR) as unstructured free text and not as discrete data, making it challenging to use for quality improvement or research initiatives. OBJECTIVES: The objective of this research paper was to develop and implement a structured clinical documentation support (SCDS) toolkit within the EMR to facilitate quality initiatives and practice-based research in a multiple sclerosis (MS) practice. METHODS: We built customized EMR toolkits to capture standardized data at office visits. Content was determined through physician consensus on necessary elements to support best practices in treating patients with demyelinating disorders. We also developed CDS tools and best practice advisories within the toolkits to alert physicians when a quality improvement opportunity exists, including enrollment into our DNA biobanking study at the point of care. RESULTS: We have used the toolkit to evaluate 541 MS patients in our clinic and begun collecting longitudinal data on patients who return for annual visits. We provide a description and example screenshots of our toolkits, and a brief description of our cohort to date. CONCLUSIONS: The EMR can be effectively structured to standardize MS clinic office visits, capture data, and support quality improvement and practice-based research initiatives at the point of care.

Design and implementation of pragmatic clinical trials using the electronic medical record and an adaptive design.

OBJECTIVES: To demonstrate the feasibility of pragmatic clinical trials comparing the effectiveness of treatments using the electronic medical record (EMR) and an adaptive assignment design. METHODS: We have designed and are implementing pragmatic trials at the point-of-care using custom-designed structured clinical documentation support and clinical decision support tools within our physician's typical EMR workflow. We are applying a subgroup based adaptive design (SUBA) that enriches treatment assignments based on baseline characteristics and prior outcomes. SUBA uses information from a randomization phase (phase 1, equal randomization, 120 patients), to adaptively assign treatments to the remaining participants (at least 300 additional patients total) based on a Bayesian hierarchical model. Enrollment in phase 1 is underway in our neurology clinical practices for 2 separate trials using this method, for migraine and mild cognitive impairment (MCI). RESULTS: We are successfully collecting structured data, in the context of the providers' clinical workflow, necessary to conduct our trials. We are currently enrolling patients in 2 point-of-care trials of non-inferior treatments. As of March 1, 2018, we have enrolled 36% of eligible patients into our migraine study and 63% of eligible patients into our MCI study. Enrollment is ongoing and validation of outcomes has begun. DISCUSSION: This proof of concept article demonstrates the feasibility of conducting pragmatic trials using the EMR and an adaptive design. CONCLUSION: The demonstration of successful pragmatic clinical trials based on a customized EMR and adaptive design is an important next step in achieving personalized medicine and provides a framework for future studies of comparative effectiveness.

Use of an Electronic Medical Record to Track Adherence to the Mediterranean Diet in a US Neurology Clinical Practice.

OBJECTIVE: We describe our experience with routinely capturing and analyzing Mediterranean diet data via structured clinical documentation support tools built into the electronic medical record and describe adherence to the Mediterranean diet in patients at risk for either stroke or dementia in a US neurology clinical practice. PATIENTS AND METHODS: The Mediterranean diet is associated with a reduced risk of stroke and dementia. The Department of Neurology at NorthShore University HealthSystem routinely evaluates patients at initial and annual outpatient visits using structured clinical documentation support (SCDS) tools built into the electronic medical record (EMR). For patient evaluations in our Vascular Neurology and Brain Health subspecialty clinics, SCDS tools in the EMR include the validated 14-item questionnaire for Mediterranean diet adherence (PREvención con DIeta MEDiterránea [PREDIMED]) that autoscores, auto-interprets, writes to the progress note, and electronically captures data. Our study population includes patients seen at these clinics from July 1, 2015, through November 29, 2017. RESULTS: At their initial office visit, 25.5% (95/373) of Brain Health patients scored 10 or more points ("strongly adherent") on the PREDIMED (median, 8; range, 0-14) whereas 6.7% (55/829) of Vascular Neurology patients achieved a score of 10 or more points (median, 6; range, 0-12). By contrast, 34.7% (2586/7447) of individuals in the original PREDIMED cohort were strongly adherent to the Mediterranean diet. CONCLUSION: PREDIMED scores can be electronically captured to tailor nutrition interventions by assessing baseline adherence at the time of their initial neurology clinic visit. Patients in our Midwestern US clinics were weakly adherent to the Mediterranean diet. This suggests a major opportunity for nutrition intervention and education in US neurology clinical practices, toward preserving and improving brain health.

Structured Clinical Documentation to Improve Quality and Support Practice-Based Research in Headache.

OBJECTIVE: To use the electronic medical record (EMR) to optimize patient care, facilitate documentation, and support quality improvement and practice-based research, in a headache specialty clinic. BACKGROUND: Many physicians enter data into the EMR as unstructured free text and not as discrete data. This makes it challenging to use data for quality improvement or research initiatives. METHODS: We describe the process of building a customized structured clinical documentation support toolkit, specific for patients seen in a headache specialty clinic. The content was developed through frequent physician meetings to reach consensus on elements that define clinical Best Practices. Tasks were assigned to the care team and data mapped to the progress note. RESULTS: The toolkit collects hundreds of fields of discrete, standardized data. Auto scored and interpreted score tests include the Generalized Anxiety Disorder 7-item, Center for Epidemiology Studies Depression Scale, Migraine Disability Assessment questionnaire, Insomnia Sleep Index, and Migraine-Specific Quality of Life. We have developed Best Practice Advisories (BPA) and other clinical documentation support tools that alert physicians, when appropriate. As of April 1, 2018, we have used the toolkits at 4346 initial patient visits. We provide screenshots of our toolkits, details of data fields collected, and diagnoses of patients at the initial visit. CONCLUSIONS: The EMR can be used to effectively structure and standardize headache clinic visits for quality improvement and practice-based research. We are sharing our proprietary toolkit with other clinics as part of the Neurology Practice-Based Research Network. These tools are also facilitating clinical research enrollment and a pragmatic trial of comparative effectiveness at the point-of-care among migraine patients.

Correcting vitamin D insufficiency improves insulin sensitivity in obese adolescents: a randomized controlled trial.

BACKGROUND: Obese adolescents are at a greater risk of vitamin D deficiency because vitamin D is thought to be sequestered by excess adipose tissue. Poor vitamin D status has been associated with a higher prevalence of the metabolic syndrome, type 2 diabetes, or both in adults and adolescents. OBJECTIVE: The objective was to determine in obese adolescents the efficacy and safety of 4000 IU vitamin D3/d and whether subsequent increased circulating concentrations of 25-hydroxyvitamin D [25(OH)D] are associated with improved markers of insulin sensitivity and resistance and reduced inflammation. DESIGN: Obese adolescent patients [n = 35; mean ± SD age: 14.1 ± 2.8 y; BMI (in kg/m(2)): 39.8 ± 6.1; 25(OH)D: 19.6 ± 7.1 ng/mL] were recruited from the University of Missouri Adolescent Diabetes and Obesity Clinic and were randomly assigned to receive either vitamin D3 (4000 IU/d) or placebo as part of their standard care. Anthropometric measurements, inflammatory markers (IL-6, TNF-α, C-reactive protein), adipokines (leptin, adiponectin), fasting glucose, fasting insulin, and HOMA-IR values were measured at baseline and at 2 follow-up visits (3 and 6 mo). RESULTS: After 6 mo, there were no significant differences in BMI, serum inflammatory markers, or plasma glucose concentrations between groups. Participants supplemented with vitamin D3 had increases in serum 25(OH)D concentrations (19.5 compared with 2.8 ng/mL for placebo; P < 0.001), fasting insulin (-6.5 compared with +1.2 µU/mL for placebo; P = 0.026), HOMA-IR (-1.363 compared with +0.27 for placebo; P = 0.033), and leptin-to-adiponectin ratio (-1.41 compared with +0.10 for placebo; P = 0.045). Inflammatory markers remained unchanged. CONCLUSION: The correction of poor vitamin D status through dietary supplementation may be an effective addition to the standard treatment of obesity and its associated insulin resistance. This trial was registered at clinicaltrials.gov as NCT00994396.

Percent true calcium absorption, mineral metabolism, and bone mass in children with arthritis: effect of supplementation with vitamin D3 and calcium.

OBJECTIVE: To assess whether percent true calcium absorption (alpha) is normal and whether supplementation with placebo, vitamin D3 (2,000 IU/day), calcium (1,000 mg/day), or vitamin D3 plus calcium improves alpha, mineral metabolism, or bone mass accrual in children with arthritis. METHODS: Eighteen children received all 4 treatments, each for 6 months, in 4 different, randomly assigned orders. Changes in levels of 25-hydroxyvitamin D (25[OH]D), 1,25-dihydroxyvitamin D (1,25[OH]2D), parathyroid hormone, bone turnover markers, and minerals and in bone mineral content were measured. Calcium absorption was determined with a dual stable isotope method using 48Ca administered intravenously and 46Ca administered orally, and measuring 48Ca, 46Ca, and 42Ca in a 24-hour urine specimen by high-resolution inductively coupled plasma mass spectroscopy. Wilcoxon's signed rank test was used both to identify significant change over the treatment period with a given regimen and to compare change with an experimental treatment versus change with placebo. RESULTS: Percent true calcium absorption was in the lower-normal range and did not differ by treatment (mean+/-SD 28.3+/-20.2% with placebo, 26.1+/-12.1% with calcium, 19.2+/-11.7% with vitamin D3, and 27.1+/-16.5% with vitamin D3 plus calcium). With vitamin D3 and vitamin D3 plus calcium treatment, 25(OH)D levels were increased and 1,25(OH)2D levels were maintained. Serum calcium levels were increased only with vitamin D3 and vitamin D3 plus calcium treatment. Levels of bone turnover markers and increases in bone mineral content did not differ by treatment. CONCLUSION: The findings of this study indicate that percent true calcium absorption is low-normal in children with arthritis. Vitamin D3 at 2,000 IU/day increases serum 25(OH)D and calcium levels but does not improve bone mass accretion. Calcium at 1,000 mg/day also failed to improve bone mass.

Percent true calcium absorption, mineral metabolism, and bone mineralization in children with cystic fibrosis: effect of supplementation with vitamin D and calcium.

OBJECTIVE: To assess whether percent true calcium absorption (alpha) is normal in children with cystic fibrosis (CF) and to assess whether supplementation with 2,000 IU vitamin D(3), 1 g calcium, or both will alter alpha, mineral metabolism, and/or bone mass in children with CF. STUDY DESIGN: Fifteen children ages 7-13 were randomly assigned to one of four different orders to receive all four 6-month treatments including placebos. Change in 25-hydroxyvitamin D (25-OHD), 1,25-dihydroxyvitamin D (1,25(OH)(2)D), PTH, bone turnover markers, and minerals after 6 months, and bone mineral content (Hologic 1000W) after 9 months was measured. alpha was measured by a dual stable isotope method using (48)Ca intravenously and (46)Ca orally and measuring (48)Ca, (46)Ca, and (42)Ca in a 24-hr urine using High Resolution Inductively Coupled Mass Spectroscopy (HR-ICP-MS). Analysis used Wilcoxon Sign Ranks. RESULTS: alpha was in the normal range and did not differ by treatment (P 35 +/- 10%, Ca 38 +/- 23%, D 36 +/- 11%, D + Ca 46 +/- 21%). One gram calcium did not increase serum or urine calcium. Two thousand IU D(3) did not increase 25-OHD or change 1,25(OH)(2)D. Serum and urine minerals, markers of bone turnover and bone mineral gains did not differ by treatment. CONCLUSIONS: alpha is normal in children with CF. One gram calcium and/or 2,000 IU D(3) does not change alpha or increase 25-OHD, serum calcium, or mineralization. Longer trials of a significantly higher dose of vitamin D(3) shown to increase serum 25-OHD are needed to assess effects on mineral metabolism and bone mass accrual. However, study of therapeutic options other than calcium and vitamin D should be encouraged.

Changing hospital newborn nursery practice: results from a statewide "Back to Sleep" nurses training program.

OBJECTIVE: In response to findings from a statewide survey of hospital nurses, the authors designed, conducted, and evaluated a "Back to Sleep" nursing curriculum and training program in Missouri hospitals using two distinct training formats. This article evaluates the initial and follow-up outcomes for training participants and assesses the impact of training format on participant outcomes. METHODS: Participants selected training format by hospital site. In each training format, participants responded to a pre and post test questionnaire measuring knowledge, beliefs, and current infant care behaviors as well as satisfaction with the training. Three months after completion of all statewide trainings, the authors also conducted a follow-up survey. RESULTS: Nurses who participated in the training reported statistically significant improvements in knowledge and "Back to Sleep" adherent beliefs. Over 98% of participants (N=515) intended to place infants in back-only sleep positions following the training. Knowledge, attitudes, and practice intentions were significantly improved across both training formats. Additionally, follow-up survey respondents statewide (N=295) reported lasting improvements, including 63% of nurses reportedly using supine-only sleep position for infants after the first 24 h of life, compared to 28% in the original statewide survey. CONCLUSIONS: Further research is needed to determine the long-term impact of this intervention and assess its applicability beyond this initial implementation. Ultimately, the findings from the evaluation of this pilot intervention and nursing-specific "Back to Sleep" curriculum demonstrate that it has a promising effect on risk-reduction adherence in hospital settings where parent observations of safe sleep behavior first occur.

Serum Markers of Inflammation and Endothelial Function are Elevated by Hormonal Contraceptive Use but not by Exercise-Associated Menstrual Disorders in Physically Active Young Women.

The purpose of the study was to determine the effects of exercise-associated menstrual disorders and hormonal contraceptives (HC) on systemic inflammatory markers and endothelial function in female athletes. Thirty-nine active women (≥5 h of aerobic exercise per wk), aged 18-33 y, participated in this cross-sectional study comparing women with menstrual disorders (MD, n = 10; 0-9 cycles·y(-1)), eumenorrheic women (E, n = 13; 10-13 cycles·y(-1)), and HC users (HC, n = 16; 12 cycles·y(-1)). Fasting serum samples were collected during the early follicular phase (d2-5) for the menstruating women. Tumor necrosis factor-α (TNFα), interleukin-6 (IL-6), C-reactive protein (CRP), soluble vascular adhesion molecule-1 (sVCAM-1), total cholesterol (TC), high- and low density lipoprotein-cholesterol (HDL-C, LDL-C), triglycerides (TG), reproductive hormones, and cortisol were measured in serum. Estradiol, progesterone, and cortisol were not statistically different between MD and E groups; cortisol was significantly greater in the HC versus E group (p = 0.002). TC (p = 0.005), LDL-C (p = 0.03), and CRP (p = 0.05) were increased in the HC versus MD and E groups. TNF-α was significantly higher in the HC (p=0.001) compared with the E group. There were no significant group differences in the concentrations of sVCAM-1 or IL-6. TNF-α and cortisol were positively correlated (r=0.31, p = 0. 058), as were sVCAM-1 and estradiol (r = 0.41, p = 0.010). In conclusion, HC use, but not exercise- associated menstrual disorders, is associated with increased TNFα and LDL-C. Key PointsSerum lipids and markers of inflammation were not altered by exercise-associated oligomenorrhea or amenorrhea.Hormonal contraceptive users had elevated total and LDL cholesterol compared with regularly menstruating non-HC users.C-reactive protein and tumor necrosis factor-α, but not soluble vascular adhesion molecule-1, were increased in hormonal contraceptive users.The long-term effect of these changes on cardiovascular disease is unknown.