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Background: The clinical research enterprise is not producing the evidence decision makers arguably need in a timely and cost effective manner; research currently involves the use of labor-intensive parallel systems that are separate from clinical care. The emergence of pragmatic clinical trials (PCTs) poses a possible solution: these large-scale trials are embedded within routine clinical care and often involve cluster randomization of hospitals, clinics, primary care providers, etc. Interventions can be implemented by health system personnel through usual communication channels and quality improvement infrastructure, and data collected as part of routine clinical care. However, experience with these trials is nascent and best practices regarding design operational, analytic, and reporting methodologies are undeveloped., Methods: To strengthen the national capacity to implement cost-effective, large-scale PCTs, the Common Fund of the National Institutes of Health created the Health Care Systems Research Collaboratory (Collaboratory) to support the design, execution, and dissemination of a series of demonstration projects using a pragmatic research design., Results: In this article, we will describe the Collaboratory, highlight some of the challenges encountered and solutions developed thus far, and discuss remaining barriers and opportunities for large-scale evidence generation using PCTs., Conclusion: A planning phase is critical, and even with careful planning, new challenges arise during execution; comparisons between arms can be complicated by unanticipated changes. Early and ongoing engagement with both health care system leaders and front-line clinicians is critical for success. There is also marked uncertainty when applying existing ethical and regulatory frameworks to PCTS, and using existing electronic health records for data capture adds complexity.

Pragmatic clinical trials (PCTs) are research investigations embedded in health care settings designed to increase the efficiency of research and its relevance to clinical practice. The Health Care Systems Research Collaboratory, initiated by the National Institutes of Health Common Fund in 2010, is a pioneering cooperative aimed at identifying and overcoming operational challenges to pragmatic research. Drawing from our experience, we present 4 broad categories of informatics-related challenges: (1) using clinical data for research, (2) integrating data from heterogeneous systems, (3) using electronic health records to support intervention delivery or health system change, and (4) assessing and improving data capture to define study populations and outcomes. These challenges impact the validity, reliability, and integrity of PCTs. Achieving the full potential of PCTs and a learning health system will require meaningful partnerships between health system leadership and operations, and federally driven standards and policies to ensure that future electronic health record systems have the flexibility to support research., (© The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.)

Background: While electronic health records (EHRs) play a key role in increasing colorectal cancer (CRC) screening by identifying individuals who are overdue, important shortfalls remain., Objectives: As part of the Strategies and Opportunities to STOP Colon Cancer (STOP CRC) study, we assessed the accuracy of EHR codes in identifying patients eligible for CRC screening., Methods: We selected a stratified random sample of 800 study participants from 26 participating clinics, in the Pacific Northwest region of the USA. We compared data obtained through codes in the EHR to conduct a manual chart audit. A trained chart abstractor completed the abstraction of eligible and ineligible patients., Results: Of 520 individuals in need of CRC screening, identified via the EHR, 459 were confirmed through chart review (positive predictive value = 88%). Of 280 individuals flagged as up-to-date in their screening per EHR data, 269 were confirmed through chart review (negative predictive value = 96%). Among the 61 patients incorrectly classified as eligible, 83.6% of disagreements were due to evidence of a prior colonoscopy or referral that was not captured in recognizable fields in the EHR., Conclusions: Our findings highlight importance of better capture of past screening events in the EHR. While the need for better population-based data is not unique to CRC screening, it provides an important example of the use of population-based data not only for tracking care, but also for delivering interventions., (© The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: Multivariable cardiovascular disease (CVD) risk calculators, such as the Framingham risk equations, can be used to identify populations most likely to benefit from treatments to decrease risk., Purpose: To determine the proportion of adults within an electronic health record (EHR) for whom Framingham CVD risk scores could be calculated using cholesterol (lab-based) and/or BMI (BMI-based) formulae., Methods: EHR data were used to identify patients aged 30-74 years with no CVD and at least 2 years continuous enrollment before April 1, 2010, and relevant data from the preceding 5-year time frame. Analyses were conducted between 2010 and 2011 to determine the proportion of patients with a lab- or BMI-based risk score, the data missing, and the concordance between scores., Results: Of 122,270 eligible patients, 59.7% (n=73,023) had sufficient data to calculate the lab-based risk score and 84.1% (102,795) the BMI-based risk score. Risk categories were concordant in 78.2% of patients. When risk categories differed, BMI-based risk was almost always in a higher category, with 20.3% having a higher and 1.4% a lower BMI- than lab-based risk score. Concordance between lab- and BMI-based risk was greatest among those at lower estimated risk, including people who were younger, female, without diabetes, not obese, and those not on blood pressure- or lipid-lowering medications., Conclusions: EHR data can be used to classify CVD risk for most adults aged 30-74 years. In the population for the current study, CVD risk scores based on BMI could be used to identify those at low risk for CVD and potentially reduce unnecessary laboratory cholesterol testing., Trial Registration: This study is registered at clinicaltrials.gov NCT01077388., (Copyright © 2012 American Journal of Preventive Medicine. All rights reserved.)

Electronic medical records (EMRs) allow for real-time access to blood pressure (BP) information on a population basis and improve identification and treatment of individuals with hypertension. Despite the potential uses of the data available from EMRs, relatively little research has examined the reliability of this data. To address this gap, the authors examined the reliability of BP taken at primary care visits and recorded in an EMR with those taken at a research study visit at which standard protocols were used to measure BP among all adults as well as by sex and age. Systolic BP (SBP) averaged 3.7 (17.3) points and diastolic BP (DBP) was 2.8 (10.6) points lower in the EMR than in the study visit across age and sex groups, with all differences statistically significant. For this cohort of patients with a diagnosis of hypertension, there was moderate correlation between BP measurements taken in clinic and at research. However, BP control for individuals, as defined by an SBP <140 mm Hg and DBP 90 mm Hg, differed by almost 25%. Known variability of BP and clinic procedures for measuring and recording BP may account for these differences., (© 2011 Wiley Periodicals, Inc.)

BackgroundLong-term adherence to colorectal cancer (CRC) screening is particularly important for fecal testing. Some U.S. studies report that only 25% of individuals repeat fecal testing annually. The purpose of this qualitative study was to identify barriers and facilitators reported by patients with suboptimal screening adherence to refine interventions for starting ongoing adherence to CRC screening. We also explored whether participants, particularly never screeners, would be willing to do a CRC screening blood test.MethodsForty-one patients who previously enrolled in the Systems of Support to Increase CRC Screening (SOS) trial were interviewed 4-5 years later. Participants were purposively selected to include men and women with diverse race/ethnicities who had either been inconsistent screeners or had never screened during the first three years of SOS despite receiving at least two rounds of mailed fecal tests. Two interviewers conducted 30-min telephone interviews using a semi-structured interview guide. An iterative thematic analysis approach was used.ResultsThemes related to screening barriers were more pervasive among never screeners including: (1) Avoidance (inattention, procrastination) (2) Concerns about handling stool; (3) Health concerns; (4) Fear of a cancer diagnosis or positive test results. Themes related to screening facilitators were more often mentioned by participants who screened at least once including: (1) Use of a simpler 1-sample fecal test; (2) Convenience of mailings and doing the test at home; (3) Salience of prevention, especially as one got older; and (4) Influence of recommendations from providers, family and friends. Participants had diverse preferences for the number (3 on average) and types (phone, mail, text) of screening reminders. Some participants did not prefer e-mail links to the patient shared electronic health record because of difficulties remembering their password. It was acceptable for a nurse or medical assistant not from their clinic to call them as long as that person was knowledgeable about their records and could communicate with their physician. Participants, especially never screeners, were generally very enthusiastic about the potential option of a CRC screening blood test.ConclusionFuture CRC screening programs should be designed to minimize these barriers and maximize facilitators to improve long-term screening adherence.Trial registrationPrimary Funding Agency: The National Cancer Institute of the National Institutes of Health (R01CA121125). Registered at clinicaltrials.gov NCT00697047 .

Background: The US Preventive Services Task Force recommends measuring blood pressure (BP) outside of clinic/office settings. While various options are available, including home devices, BP kiosks, and 24-h ambulatory BP monitoring (ABPM), understanding patient acceptability and adherence is a critical factor for implementation. Objective: To compare the acceptability and adherence of clinic, home, kiosk, and ABPM measurement. Design: Comparative diagnostic accuracy study which randomized adults to one of three BP measurement arms: clinic, home, and kiosk. ABPM was conducted on all participants. Participants: Adults (18–85 years) receiving care at 12 Kaiser Permanente Washington primary care clinics (Washington State, USA) with a high BP (≥ 138 mmHg systolic or ≥ 88 mmHg diastolic) in the electronic health record with no hypertension diagnosis and on no hypertensive medications and with high BP at a research screening visit. Measures: Patient acceptability was measured using a validated survey which was used to calculate an overall acceptability score (range 1–7) at baseline, after completing their assigned BP measurement intervention, and after completing ABPM. Adherence was defined based on the pre-specified number of BP measurements completed. Key Results: Five hundred ten participants were randomized (mean age 59 years), with mean BP of 150/88. Overall acceptability score was highest (i.e. most acceptable) for Home BP (mean 6.2, SD 0.7) and lowest (least acceptable) for ABPM (mean 5.0, SD 1.0); scores were intermediate for Clinic (5.5, SD 1.1) and Kiosk (5.4, SD 1.0). Adherence was higher for Home (154/170, 90.6%) and Clinic (150/172, 87.2%) than for Kiosk (114/168, 67.9%)). The majority of participants (467/510, 91.6%) were adherent to ABPM. Conclusions: Participants found home BP measurement most acceptable followed by clinic, BP kiosks, and ABPM. Our findings, coupled with recent evidence regarding the accuracy of home BP measurement, further support the routine use of home-based BP measurement in primary care practice in the US. Trial registration: ClinicalTrials.gov NCT03130257 https://clinicaltrials.gov/ct2/show/NCT03130257 [ABSTRACT FROM AUTHOR]

Purpose: To estimate the positive predictive value (PPV) of International Classification of Diseases, Tenth Revision, Clinical Modification (ICD‐10‐CM) diagnosis codes for identifying HF subtypes. Methods: We validated ICD‐10‐CM HF diagnosis codes among Kaiser Permanente Washington enrollees who were ≥18 years of age and had an ICD‐10‐CM HF diagnosis code during 2017–2018 and a procedure code for an echocardiogram in the 12 months before through 6 months after the HF code. Left ventricular ejection fraction (LVEF) ascertained from medical chart review was used as the gold standard for classifying patients as having reduced ejection fraction (rEF), mid‐range ejection fraction (mEF), or preserved ejection fraction (pEF). Results: Among 6194 eligible patients, we randomly sampled 1000 for medical chart review. A total of 974 patients had LVEF information in their chart. The ICD‐10‐CM HF code group with the highest PPV for rEF was I50.20‐I50.23, "Systolic (congestive) heart failure," PPV = 41.4% (95% CI, 34.5–48.7%); and the highest PPV for mEF or rEF was also I50.20‐I50.23, PPV = 70.2% (95% CI, 63.1–76.4%). The highest PPV for pEF was the I50.30‐I50.33 group, "Diastolic (congestive) heart failure," PPV = 92.0% (95% CI, 88.1–94.7%); and the highest PPV for mEF or pEF was also I50.30‐I50.33, PPV = 97.7% (95% CI, 95.1–99.0%). Conclusions: If the accuracy measure of greatest interest is PPV, our results suggest that ICD‐10‐CM HF codes alone may not be adequate for identifying patients with rEF but may be adequate for identifying patients with pEF. HF coding practices may vary across settings, which may impact generalizability of our findings. [ABSTRACT FROM AUTHOR]

In this study, we conducted telephone interviews with patients in community clinics who had abnormal fecal immunochemical test (FIT) results to identify follow-up colonoscopy challenges. The FIT is an effective colorectal cancer screening method, but its value is contingent on follow-up diagnostic colonoscopy. Methods: We explored barriers at 3 timepoints: (1) abnormal FIT-result communication, (2) scheduling/completion of colonoscopy, and (3) receipt of results. We sought to understand variation in experience by both Spanish and English language patients. Results: We interviewed 32 patients (16 English; 16 Spanish), 66% of whom were women. There were 13 early completers (≤ 2 months after FIT result), 14 later completers (> 2 months after FIT result), and 5 non-completers of the colonoscopy. The greatest challenge was fear of the procedure, expressed more often by Spanish language (SL) participants and later completers. SL participants also cited cost and lack of clear communication about the need for a colonoscopy. English language (EL) participants experienced lack of reliable transportation. Conclusions: Barriers to timely colonoscopy completion following an abnormal FIT can occur at different transitions in care and vary by patient characteristics. Our findings may inform the design of programs to improve colonoscopy completion in safety net clinics. [ABSTRACT FROM AUTHOR]

The goal of this study was to explore diagnostic colonoscopy completion in adults with abnormal screening fecal immunochemical test (FIT) results. This was a secondary analysis of the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (Stop CRC) study, a cluster-randomized pragmatic trial to increase uptake of CRC screening in federally qualified community health clinics. Diagnostic colonoscopy completion and reasons for non-completion were ascertained through a manual review of electronic health records, and completion was compared across a wide range of individual patient health and sociodemographic characteristics. Among 2,018 adults with an abnormal FIT result, 1066 (52.8%) completed a follow-up colonoscopy within 12 months. Completion was generally similar across a wide range of participant subpopulations; however, completion was higher for participants who were younger, Hispanic, Spanish-speaking, and had zero or one of the Charlson medical comorbidities, compared to their counterparts. Neighborhood-level predictors were not associated with diagnostic colonoscopy completion. Thus, completion of a diagnostic colonoscopy was relatively low in a large sample of community health clinic adults who had an abnormal screening FIT result. While completion was generally similar across a wide range of characteristics, younger, healthier, Hispanic participants tended to have a higher likelihood of completion. [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer (CRC) screening rates remain suboptimal, particularly in low-income and underserved populations. Mailed fecal immunochemical testing (FIT) may overcome common barriers to screening; however, the effect of mailed FIT kits may differ across important subpopulations. The goal of the current study was to examine sociodemographic and health-related factors that moderate the effect of an intervention of automated direct mail of FIT kits at health clinics serving low-income populations.Methods: This study is a secondary analysis of the Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC) study, a cluster-randomized pragmatic trial to increase uptake of CRC screening in patients seen at federally qualified health centers. The intervention involved tools embedded in the electronic medical records to enable participating clinics to mail FIT kits and related materials to eligible participants. We examined the rate of FIT completion by potential moderating characteristics using electronic health record data supplemented by the American Community Survey and the Centers for Medicare & Medicaid Services Geographic Variation datasets, linked via geocoding to patients' addresses. All patients aged 50-75 seen in participating health clinics who were eligible for CRC screening were included.Results: Although not always statistically significant, we saw a consistent pattern of increased FIT return rates among intervention participants compared to control participants across all subgroups studied, with incidence rate ratios (IRRs) generally ranging from 1.25 to 1.50. FIT completion in the intervention group ranged from 15 and 20% across subpopulations, typically three to six percentage points higher than the control group participants. The only moderator with a statistically significant interaction was race: persons of Asian descent showed a twofold response to the intervention (adjusted incidence rate ratio [aIRR] = 2.06, 95% confidence interval 1.41 to 3.00).Conclusions: Response to a mailed FIT intervention was generally consistent across a wide range of individual and neighborhood-level patient characteristics, including typically underserved patients and those in low-resource communities.Trial Registration: ClinicalTrials.gov, NCT01742065. Registered on 5 December 2012. [ABSTRACT FROM AUTHOR]

Objective: Variations in processes for different clinics and health systems can dramatically change the way preventive interventions are implemented. We present a method for documenting these variations using workflow diagrams and demonstrate how understanding workflow aided an electronic health record (EHR) embedded colorectal cancer screening intervention. Materials and Methods: We mapped variation in processes for ordering and documenting fecal testing, current colonoscopy, prior colonoscopies, and pathology results. This work was part of a multi-site cluster-randomized pragmatic trial to test a mailed approach to offering fecal testing at 26 safety net clinics (in eight organizations) in Oregon and Northern California. We created clinic-specific workflow diagrams and then distilled them into consolidated diagrams that captured the variations. Results: Clinics had varied practices for storing and using information about colorectal cancer screening. Developing workflow diagrams of key processes enabled clinics to find optimal ways to send fecal test kits to patients due for screening. The workflows informed the rollout of new EHR tools and identified best practices for data capture. Discussion: Diagramming workflows can have great utility when implementing and refining EHR tools for clinical practice, especially when doing so across multiple clinical sites. The process of developing the workflows uncovered successful practice recommendations and revealed limitations and potential effects of a research intervention. Conclusion: Our method of documenting clinical process variation might inform other EHR-powered, multi-site research and can improve data feedback from EHR systems to clinical caregivers. [ABSTRACT FROM AUTHOR]

Background: The national mandate for health systems to transition from ICD-9-CM to ICD-10-CM in October 2015 has an impact on research activities. Clinical phenotypes defined by ICD-9-CM codes need to be converted to ICD-10-CM, which has nearly four times more codes and a very different structure than ICD-9-CM. Methods: We used the Centers for Medicare & Medicaid Services (CMS) General Equivalent Maps (GEMs) to translate, using four different methods, condition-specific ICD-9-CM code sets used for pragmatic trials (n=32) into ICD-10-CM. We calculated the recall, precision, and F score of each method. We also used the ICD-9-CM and ICD-10-CM value sets defined for electronic quality measure as an additional evaluation of the mapping methods. Results: The forward-backward mapping (FBM) method had higher precision, recall and F score metrics than simple forward mapping (SFM). The more aggressive secondary (SM) and tertiary mapping (TM) methods resulted in higher recall but lower precision. For clinical phenotype definition, FBM was the best (F=0.67), but was close to SM (F=0.62) and TM (F=0.60), judging on the F scores alone. The overall difference between the four methods was statistically significant (one-way ANOVA, F=5.749, p=0.001). However, pairwise comparisons between FBM, SM, and TM did not reach statistical significance. A similar trend was found for the quality measure value sets. Discussion: The optimal method for using the GEMs depends on the relative importance of recall versus precision for a given use case. It appears that for clinically distinct and homogenous conditions, the recall of FBM is sufficient. The performance of all mapping methods was lower for heterogeneous conditions. Since code sets used for phenotype definition and quality measurement can be very similar, there is a possibility of cross-fertilization between the two activities. Conclusion: Different mapping approaches yield different collections of ICD-10-CM codes. All methods require some level of human validation. [ABSTRACT FROM AUTHOR]

Context: Pragmatic trials lack the relatively tight quality control of traditional efficacy studies and hence may pose added analytic challenges owing to the practical realities faced in carrying them out. Case Description: STOP CRC is a cluster randomized trial testing the effectiveness of automated, electronic medical record (EMR)-driven strategies to raise colorectal cancer (CRC) screening rates in safety net clinics. Screen-eligible participants were accrued during year 1 and followed for 12 months (measurement window) to assess completion of a fecal screening test. Control clinics implemented the intervention in year 2. Implementation Challenges/Analytic Issues: Due to limitations on how we could build the intervention tools, the overlap of the year 1 measurement windows with year 2 intervention rollout posed a potential for contamination of the primary outcome for control participants. In addition, a variety of factors led to a lack of synchronization of the measurement windows with actual intervention delivery. In both cases, the net impact of these factors would be to diminish the estimated impact of the intervention. Proposed Solutions: We dealt with the overlap issue by delaying the start of intervention rollout to control clinics in year 2 by 6 months and by truncating the measurement windows for intervention and control participants at this point. In addition we formulated three sensitivity analyses to help address the issue of asynchronization. Conclusion: This case study might help other investigators facing similar challenges think about such issues and the pros and cons of various strategies for dealing with them. [ABSTRACT FROM AUTHOR]

Background: Pharmacist- or nurse-led team care decreases patient blood pressure (BP) and cardiovascular disease (CVD) risk. Purpose: To evaluate whether a Web-based dietitian-led (WD) team care intervention was feasible and resulted in decreased BP, CVD risk, and weight compared to usual care (UC). Methods: Electronic health record (EHR) data identified patients aged 30−69 years with BMI >26, elevated BP, and 10%−25% 10-year Framingham CVD risk who were registered patient website users. Patients with uncontrolled BP at screening were randomized to UC or WD, which included a home BP monitor, scale, and dietitian team care. WD participants had a single in-person dietitian visit to obtain baseline information and create a plan to reduce CVD risk. Planned follow-up occurred via secure messaging to report BP, weight, and fruit and vegetable intake and receive ongoing feedback. If needed, dietitians encouraged patients and their physicians to intensify antihypertensive and lipid-lowering medications. Primary outcomes were change in systolic BP and weight loss ≥4 kg at 6 months. Feasibility outcomes included intervention utilization and satisfaction. Results: Between 2010 and 2011, a total of 90 of 101 participants completed 6-month follow-ups. The WD group had higher rates of secure messaging utilization and patient satisfaction. The WD group lost significantly more weight than the UC group (adjusted net difference=−3.2 kg, 95% CI=−5.0, −1.5, p<0.001) and was more likely to lose ≥4 kg (adjusted relative risk [RRadj]=2.96, 95% CI=1.16, 7.53). BP control and CVD risk reduction were greater in WD than UC, but differences were not statistically significant. Conclusions: WD intervention was feasible and resulted in decreased weight, BP, and CVD risk. A larger trial is justified. Trial Registration Number: Trial Registration Number: NCT01077388. [Copyright &y& Elsevier]

Background: Screening decreases colorectal cancer (CRC) incidence and mortality, yet almost half of age-eligible patients are not screened at recommended intervals. Objective: To determine whether interventions using electronic health records (EHRs), automated mailings, and stepped increases in support improve CRC screening adherence over 2 years. Design: 4-group, parallel-design, randomized, controlled comparative effectiveness trial with concealed allocation and blinded outcome assessments. Setting: 21 primary care medical centers. Patients: 4675 adults aged 50 to 73 years not current for CRC screening. Intervention: Usual care, EHR-linked mailings ("automated"), automated plus telephone assistance ("assisted"), or automated and assisted plus nurse navigation to testing completion or refusal ("navigated"). Interventions were repeated in year 2. Measurements: The proportion of participants current for screening in both years, defined as colonoscopy or sigmoidoscopy (year 1) or fecal occult blood testing (FOBT) in year 1 and FOBT, colonoscopy, or sigmoidoscopy (year 2). Results: Compared with those in the usual care group, participants in the intervention groups were more likely to be current for CRC screening for both years with significant increases by intensity (usual care, 26.3% [95% CI, 23.4% to 29.2%]; automated, 50.8% [CI, 47.3% to 54.4%]; assisted, 57.5% [CI, 54.5% to 60.6%]; and navigated, 64.7% [CI, 62.5% to 67.0%]; P < 0.001 for all pairwise comparisons). Increases in screening were primarily due to increased uptake of FOBT being completed in both years (usual care, 3.9% [CI, 2.8% to 5.1%]; automated, 27.5% [CI, 24.9% to 30.0%]; assisted, 30.5% [CI, 27.9% to 33.2%]; and navigated, 35.8% [CI, 33.1% to 38.6%]). Limitation: Participants were required to provide verbal consent and were more likely to be white and to participate in other types of cancer screening, limiting generalizability. Conclusion: Compared with usual care, a centralized, EHR-linked, mailed CRC screening program led to twice as many persons being current for screening over 2 years. Assisted and navigated interventions led to smaller but significant stepped increases compared with the automated intervention only. The rapid growth of EHRs provides opportunities for spreading this model broadly. Primary Funding Source: National Cancer Institute, National Institutes of Health. [ABSTRACT FROM AUTHOR]

Background: Patient-shared electronic health records provide opportunities for care outside of office visits. However, those who might benefit may be unable to or choose not to use these resources, while others might not need them. Objective: Electronic Communications and Home Blood Pressure Monitoring (e-BP) was a randomized trial that demonstrated that Web-based pharmacist care led to improved blood pressure (BP) control. During recruitment we attempted to contact all patients with hypertension from 10 clinics to determine whether they were eligible and willing to participate. We wanted to know whether particular subgroups, particularly those from vulnerable populations, were less willing to participate or unable to because they lacked computer access. Methods: From 2005 to 2006, we sent invitation letters to and attempted to recruit 9298 patients with hypertension. Eligibility to participate in the trial included access to a computer and the Internet, an email address, and uncontrolled BP (BP = 140/90 mmHg). Generalized linear models within a modified Poisson regression framework were used to estimate the relative risk (RR) of ineligibility due to lack of computer access and of having uncontrolled BP. Results: We were able to contact 95.1% (8840/9298) of patients. Those refusing participation (3032/8840, 34.3%) were significantly more likely (P < .05) to be female, be nonwhite, have lower levels of education, and have Medicaid insurance. Among patients who answered survey questions, 22.8% (1673/7354) did not have computer access. Older age, minority race, and lower levels of education were risk factors for lack of computer access, with education as the strongest predictor (RR 2.63, 95% CI 2.30-3.01 for those with a high school degree compared to a college education). Among hypertensive patients with computer access who were willing to participate, African American race (RR 1.22, 95% CI 1.06-1.40), male sex (RR 1.28, 95% CI 1.18-1.38), and obesity (RR 1.53, 95% CI 1.31-1.79) were risk factors for uncontrolled BP. Conclusion: Older age, lower socioeconomic status, and lower levels of education were associated with decreased access to and willingness to participate in a Web-based intervention to improve hypertension control. Failure to ameliorate this may worsen health care disparities. [ABSTRACT FROM AUTHOR]

Mailing HPV self-sampling kits to overdue individuals increases cervical cancer screening adherence; offering self-sampling to previously adherent individuals has not been evaluated in the U.S. Given heterogeneity of the U.S. health system and population, data are needed to optimize how HPV self-sampling is offered to individuals who are overdue, due after successful past screening, or have an unknown screening history. STEP is a pragmatic randomized controlled trial set within a U.S. integrated healthcare delivery system, designed to compare different outreach approaches for offering HPV self-sampling in populations defined by prior screening behavior (previously-adherent, overdue, or unknown screening history). Over 14 months, eligible individuals were identified through electronic medical record (EMR) data and randomized to Usual Care (UC), Education (UC + educational materials about cervical cancer screening), Direct-Mail (UC + Education + a mailed self-sampling kit) or Opt-In (UC + Education + option to request a kit), depending on screening history. The primary objective is to compare screening completion by outreach approach and screening history. Secondary objectives include evaluating incremental cost-effectiveness of outreach approaches, and identifying patient preference for, and satisfaction with, HPV self-screening, and barriers to abnormal results follow-up (measured through interviews and focus groups). The trial was designed to generate data that U.S. health systems can use to inform primary HPV screening implementation strategies that incorporate HPV self-sampling options to improve screening access, adherence, and patient satisfaction. The objective of this report is to describe the rationale and design of this pragmatic trial. [ABSTRACT FROM AUTHOR]

Introduction Recent colorectal cancer screening studies focus on optimizing adherence. This study evaluated the cost effectiveness of interventions using electronic health records (EHRs); automated mailings; and stepped support increases to improve 2-year colorectal cancer screening adherence. Methods Analyses were based on a parallel-design, randomized trial in which three stepped interventions (EHR-linked mailings [“automated”]; automated plus telephone assistance [“assisted”]; or automated and assisted plus nurse navigation to testing completion or refusal [navigated”]) were compared to usual care. Data were from August 2008 to November 2011, with analyses performed during 2012–2013. Implementation resources were micro-costed; research and registry development costs were excluded. Incremental cost-effectiveness ratios (ICERs) were based on number of participants current for screening per guidelines over 2 years. Bootstrapping examined robustness of results. Results Intervention delivery cost per participant current for screening ranged from $21 (automated) to $27 (navigated). Inclusion of induced testing costs (e.g., screening colonoscopy) lowered expenditures for automated (ICER=–$159) and assisted (ICER=–$36) relative to usual care over 2 years. Savings arose from increased fecal occult blood testing, substituting for more expensive colonoscopies in usual care. Results were broadly consistent across demographic subgroups. More intensive interventions were consistently likely to be cost effective relative to less intensive interventions, with willingness to pay values of $600–$1,200 for an additional person current for screening yielding ≥80% probability of cost effectiveness. Conclusions Two-year cost effectiveness of a stepped approach to colorectal cancer screening promotion based on EHR data is indicated, but longer-term cost effectiveness requires further study. [ABSTRACT FROM AUTHOR]

Uncontrolled hypertension is the largest single contributor to all-cause and cardiovascular mortality in the U.S. population. Nurse- and pharmacist-led team-based care and telehealth care interventions have been shown to result in large and lasting improvements in blood pressure (BP); however, it is unclear how successfully these can be implemented at scale in real-world settings. It is also uncertain how telehealth interventions impact patient experience compared to traditional clinic-based care. To compare the effects of two evidence-based blood pressure care strategies in the primary care setting: (1) best-practice clinic-based care and (2) telehealth care with home BP telemonitoring and management by a clinical pharmacist. To evaluate implementation using mixed-methods supported by the RE-AIM framework and Consolidated Framework for Implementation Research. The design is a cluster-randomized comparative effectiveness pragmatic trial in 21 primary care clinics (9 clinic-based care, 12 telehealth care). Adult patients (age 18–85) with hypertension are enrolled via automated electronic health record (EHR) tools during primary care encounters if BP is elevated to ≥150/95 mmHg at two consecutive visits. The primary outcome is change in systolic BP over 12 months as extracted from the EHR. Secondary outcomes are change in key patient-reported outcomes over 6 months as measured by surveys. Qualitative data are collected at various time points to investigate implementation barriers and help explain intervention effects. This pragmatic trial aims to inform health systems about the benefits, strengths, and limitations of implementing home BP telemonitoring with pharmacist management for uncontrolled hypertension in real-world primary care settings. [ABSTRACT FROM AUTHOR]