Design of Behavioral Economic Applications to Geriatrics Leveraging Electronic Health Records (BEAGLE): A pragmatic cluster randomized controlled trial.

BACKGROUND: Overtesting and treatment of older patients is common and may lead to harms. The Choosing Wisely campaign has provided recommendations to reduce overtesting and overtreatment of older adults. Behavioral economics-informed interventions embedded within the electronic health record (EHR) have been shown to reduce overuse in several areas. Our objective is to conduct a parallel arm, pragmatic cluster-randomized trial to evaluate the effectiveness of behavioral-economics-informed clinical decision support (CDS) interventions previously piloted in primary care clinics and designed to reduce overtesting and overtreatment in older adults. METHODS/DESIGN: This trial has two parallel arms: clinician education alone vs. clinician education plus behavioral-economics-informed CDS. There are three co-primary outcomes for this trial: (1) prostate-specific antigen (PSA) screening in older men, (2) urine testing for non-specific reasons in older women, and (3) overtreatment of diabetes in older adults. All eligible primary care clinics from a large regional health system were randomized using a modified constrained randomization process and their attributed clinicians were included. Clinicians were recruited to complete a survey and educational module. We randomized 60 primary care clinics with 374 primary care clinicians and achieved adequate balance between the study arms for prespecified constrained variables. Baseline annual overuse rates for the three co-primary outcomes were 25%, 23%, and 17% for the PSA, urine, and diabetes measures, respectively. DISCUSSION: This trial is evaluating behavioral-economics-informed EHR-embedded interventions to reduce overuse of specific tests and treatments for older adults. The study will evaluate the effectiveness and safety of these interventions.

Rationale and design of the regimen education and messaging in diabetes (REMinD) trial.

BACKGROUND: Individuals with type 2 diabetes manage complex multi-drug regimens, but nearly half of all patients do not consistently take the dose prescribed for them, and therefore may not receive the full potential therapeutic benefit. Both patient and health system factors contribute to achieving and maintaining medication adherence. To determine if patients with type 2 diabetes who are concurrently managing other chronic conditions could improve their adherence, we devised and are testing a multifaceted, primary care-based strategy to provide health literacy-appropriate and language concordant regimen information, guidance and reminders. OBJECTIVE: We are testing the effectiveness of an electronic health record (EHR) based strategy and short message service (SMS) text reminders to help patients with type 2 diabetes adhere to their medications. METHODS: We are conducting a 3-arm, multi-site trial to test and compare the effectiveness of the EHR, and EHR + SMS text reminder strategies compared to usual care on medication adherence. Our goal is to enroll a total of 900 English or Spanish-speaking patients with type 2 diabetes and hemoglobin A1C value ≥7.5%. Enrolled participants will complete interviews at baseline and 3 and 6 months following their baseline interview. CONCLUSIONS: Our trial is evaluating practical, clinic-based, scalable, evidence-based solutions for patients with type 2 diabetes managing complex medication regimens. Our findings will evaluate strategies that can be implemented broadly in primary care practices, and programmed as defaults within EHRs to support appropriate medication adherence to allow the widespread implementation of those strategies.

Effect of Electronic Health Record-Based Medication Support and Nurse-Led Medication Therapy Management on Hypertension and Medication Self-management: A Randomized Clinical Trial.

Importance: Complex medication regimens pose self-management challenges, particularly among populations with low levels of health literacy. Objective: To test medication management tools delivered through a commercial electronic health record (EHR) with and without a nurse-led education intervention. Design, Setting, and Participants: This 3-group cluster randomized clinical trial was performed in community health centers in Chicago, Illinois. Participants included 794 patients with hypertension who self-reported using 3 or more medications concurrently (for any purpose). Data were collected from April 30, 2012, through February 29, 2016, and analyzed by intention to treat. Interventions: Clinics were randomly assigned to to groups: electronic health record-based medication management tools (medication review sheets at visit check-in, lay medication information sheets printed after visits; EHR-alone group), EHR-based tools plus nurse-led medication management support (EHR plus education group), or usual care. Main Outcomes and Measures: Outcomes at 12 months included systolic blood pressure (primary outcome), medication reconciliation, knowledge of drug indications, understanding of medication instructions and dosing, and self-reported medication adherence. Medication outcomes were assessed for all hypertension prescriptions, all prescriptions to treat chronic disease, and all medications. Results: Among the 794 participants (68.6% women; mean [SD] age, 52.7 [9.6] years), systolic blood pressure at 12 months was greater in the EHR-alone group compared with the usual care group by 3.6 mm Hg (95% CI, 0.3 to 6.9 mm Hg). Systolic blood pressure in the EHR plus education group was not significantly lower compared with the usual care group (difference, -2.0 mm Hg; 95% CI, -5.2 to 1.3 mm Hg) but was lower compared with the EHR-alone group (-5.6 mm Hg; 95% CI, -8.8 to -2.4 mm Hg). At 12 months, hypertension medication reconciliation was improved in the EHR-alone group (adjusted odds ratio [OR], 1.8; 95% CI, 1.1 to 2.9) and the EHR plus education group (adjusted odds ratio [OR], 2.0; 95% CI, 1.3 to 3.3) compared with usual care. Understanding of medication instructions and dosing was greater in the EHR plus education group than the usual care group for hypertension medications (OR, 2.3; 95% CI, 1.1 to 4.8) and all medications combined (OR, 1.7; 95% CI, 1.0 to 2.8). Compared with usual care, the EHR tools alone and EHR plus education interventions did not improve hypertension medication adherence (OR, 0.9; 95% CI, 0.6-1.4 for both) or knowledge of chronic drug indications (OR for EHR tools alone, 1.0 [95% CI, 0.6 to 1.5] and OR for EHR plus education, 1.1 [95% CI, 0.7-1.7]). Conclusions and Relevance: The study found that EHR tools in isolation improved medication reconciliation but worsened blood pressure. Combining these tools with nurse-led support suggested improved understanding of medication instructions and dosing but did not lower blood pressure compared with usual care. Trial Registration: ClinicalTrials.gov identifier: NCT01578577.

Effects of a Patient-Provider, Collaborative, Medication-Planning Tool: A Randomized, Controlled Trial.

Among patients with various levels of health literacy, the effects of collaborative, patient-provider, medication-planning tools on outcomes relevant to self-management are uncertain. Objective. Among adult patients with type II diabetes mellitus, we tested the effectiveness of a medication-planning tool (Medtable™) implemented via an electronic medical record to improve patients' medication knowledge, adherence, and glycemic control compared to usual care. Design. A multicenter, randomized controlled trial in outpatient primary care clinics. 674 patients received either the Medtable tool or usual care and were followed up for up to 12 months. Results. Patients who received Medtable had greater knowledge about indications for medications in their regimens and were more satisfied with the information about their medications. Patients' knowledge of drug indication improved with Medtable regardless of their literacy status. However, Medtable did not improve patients' demonstrated medication use, regimen adherence, or glycemic control (HbA1c). Conclusion. The Medtable tool supported provider/patient collaboration related to medication use, as reflected in patient satisfaction with communication, but had limited impact on patient medication knowledge, adherence, and HbA1c outcomes. This trial is registered with ClinicalTrials.gov NCT01296633.

Implementation of EHR-based strategies to improve outpatient CAD care.

OBJECTIVES: To evaluate the effects of a multifaceted quality improvement intervention during 2 time periods on 4 coronary artery disease [CAD] measures in 4 primary care practices. During the first phase, electronic reminders prompted physicians to order indicated medications or record contraindications and refusals (exceptions). In the second phase, physicians also received reports about their performance (including lists of patients not satisfying these measures), and financial incentives were announced. STUDY DESIGN: Time series analysis. METHODS: Adult CAD patients seen within the preceding 18 months were included. The primary outcome was the performance on each measure (proportion of eligible patients satisfying each measure after removing those with exceptions). Secondary outcomes were the proportion with the medication on their medication list, and the proportion with exceptions. RESULTS: Median performance at baseline was 78.8% for antiplatelet treatment, 85.1% for statin treatment, 77.0% for beta-blocker after myocardial infarction (MI), and 67.1% for angiotensinconverting enzyme inhibitor or angiotensin receptor blocker after MI. Performance improved slightly for 3 measures during the first phase and improved more substantially for all 4 measures during the second phase. For 3 of 4 measures, however, documentation of exceptions increased but not medication prescribing. Most exceptions were judged to be appropriate by peer review. CONCLUSIONS: Physicians responded more to the combination of feedback and financial incentives than they had to electronic reminders alone. High performance was only achieved for 1 of 4 measures and recording of exceptions rather than increases in medication prescribing accounted for most of the observed improvements.

An EMR-based tool to support collaborative planning for medication use among adults with diabetes: design of a multi-site randomized control trial.

Patients with type II diabetes often struggle with self-care, including adhering to complex medication regimens and managing their blood glucose levels. Medication nonadherence in this population reflects many factors, including a gap between the demands of taking medication and the limited literacy and cognitive resources that many patients bring to this task. This gap is exacerbated by a lack of health system support, such as inadequate patient-provider collaboration. The goal of our project is to improve self-management of medications and related health outcomes by providing system support. The Medtable™ is an Electronic Medical Record (EMR)-integrated tool designed to support patient-provider collaboration needed for medication management. It helps providers and patients work together to create effective medication schedules that are easy to implement. We describe the development and initial evaluation of the tool, as well as the process of integrating it with an EMR system in general internal medicine clinics. A planned evaluation study will investigate whether an intervention centered on the Medtable™ improves medication knowledge, adherence, and health outcomes relative to a usual care control condition among type II diabetic patients struggling to manage multiple medications.

Effects of standardized outreach for patients refusing preventive services: a quasiexperimental quality improvement study.

OBJECTIVE: To determine the effect of standardized outreach on the receipt of preventive services for patients whose physicians record that the patient refused the service. STUDY DESIGN: Prospective observational study of a quality improvement intervention using a nonrandomly assigned comparator group. METHODS: Patients from a large internal medicine practice with recorded refusals to preventive services were included. A nonclinician care manager mailed plain-language educational brochures, attempted telephone contact, and provided logistical assistance. The primary patient outcome was the time from refusal to first receipt of a refused service (colorectal cancer screening, breast cancer screening [mammography], cervical cancer screening, osteoporosis screening [bone density testing], or pneumococcal vaccination). We compared the time to completion of refused sevices during the period when outreach was performed (February 8, 2008, to November 25, 2008 [outreach cohort]), and during a subsequent period when refusals were recorded but no outreach was performed (November 26, 2008, to December 1, 2009 [nonintervention cohort]), using Cox proportional hazards regression models adjusted for patient characteristics. We recorded the time spent performing outreach. RESULTS: In total, 407 patients refused 520 preventive services in the outreach cohort, and 378 patients refused 510 services in the nonintervention cohort. After 6 months of follow-up, 6.1% of the outreach cohort and 4.8% of the nonintervention cohort had received a refused service (adjusted hazard ratio, 1.3; 95% confidence interval, 0.7-2.5). The care manager spent 214 hours performing the outreach. CONCLUSIONS: Standardized educational outreach was not a promising strategy for improving preventive services use among patients who have refused services recommended by their physician. The amount of time required to perform the outreach was substantial.

The marginal value of pre-visit paper reminders when added to a multifaceted electronic health record based quality improvement system.

OBJECTIVE: We have reported that implementation of an electronic health record (EHR) based quality improvement system that included point-of-care electronic reminders accelerated improvement in performance for multiple measures of chronic disease care and preventive care during a 1-year period. This study examined whether providing pre-visit paper quality reminders could further improve performance, especially for physicians whose performance had not improved much during the first year. DESIGN: Time-series analysis at a large internal medicine practice using a commercial EHR. All patients eligible for each measure were included (range approximately 100-7500). MEASUREMENTS: The proportion of eligible patients in the practice who satisfied each of 15 quality measures after removing those with exceptions from the denominator. To analyze changes in performance for individual physicians, two composite measures were used: prescribing seven essential medications and completion of five preventive services. RESULTS: During the year after implementing pre-encounter reminders, performance continued to improve for eight measures, remained stable for four, and declined for three. Physicians with the worst performance at the start of the pre-encounter reminders showed little absolute improvement over the next year, and most remained below the median performance for physicians in the practice. CONCLUSIONS: Paper pre-encounter reminders did not appear to improve performance beyond electronic point-of-care reminders in the EHR alone. Lagging performance is likely not due to providers' EHR workflow alone, and trying to step backwards and use paper reminders in addition to point-of-care reminders in the EHR may not be an effective strategy for engaging slow adopters.

Changes in performance after implementation of a multifaceted electronic-health-record-based quality improvement system.

BACKGROUND: Electronic health record (EHR) systems have the potential to revolutionize quality improvement (QI) methods by enhancing quality measurement and integrating multiple proven QI strategies. OBJECTIVES: To implement and evaluate a multifaceted QI intervention using EHR tools to improve quality measurement (including capture of contraindications and patient refusals), make point-of-care reminders more accurate, and provide more valid and responsive clinician feedback (including lists of patients not receiving essential medications) for 16 chronic disease and preventive service measures. DESIGN: Time series analysis at a large internal medicine practice using a commercial EHR. SUBJECTS: All adult patients eligible for each measure (range approximately 100-7500). MEASURES: The proportion of eligible patients who satisfied each measure after removing those with exceptions from the denominator. RESULTS: During the year before the intervention, performance improved significantly for 8 measures. During the year after the intervention, performance improved significantly for 14 measures. For 9 measures, the primary outcome improved more rapidly during the intervention year than during the previous year (P < 0.001 for 8 measures, P = 0.02 for 1). Four other measures improved at rates that were not significantly different from the previous year. Improvements resulted from increases in patients receiving the service, documentation of exceptions, or a combination of both. For 5 drug-prescribing measures, more than half of physicians achieved 100% performance. CONCLUSIONS: Implementation of a multifaceted QI intervention using EHR tools to improve quality measurement and the accuracy and timeliness of clinician feedback improved performance and/or accelerated the rate of improvement for multiple measures simultaneously.

Frequency of inappropriate medical exceptions to quality measures.

BACKGROUND: Quality improvement programs that allow physicians to document medical reasons for deviating from guidelines preserve clinicians' judgment while enabling them to strive for high performance. However, physician misconceptions or gaming potentially limit programs. OBJECTIVE: To implement computerized decision support with mechanisms to document medical exceptions to quality measures and to perform peer review of exceptions and provide feedback when appropriate. DESIGN: Observational study. SETTING: Large internal medicine practice. PARTICIPANTS: Patients eligible for 1 or more quality measures. MEASUREMENTS: A peer-review panel judged medical exceptions to 16 chronic disease and prevention quality measures as appropriate, inappropriate, or of uncertain appropriateness. Medical records were reviewed after feedback was given to determine whether care changed. RESULTS: Physicians recorded 650 standardized medical exceptions during 7 months. The reporting tool was used without any medical reason 36 times (5.5%). Of the remaining 614 exceptions, 93.6% were medically appropriate, 3.1% were inappropriate, and 3.3% were of uncertain appropriateness. Frequencies of inappropriate exceptions were 7 (6.9%) for coronary heart disease, 0 (0%) for heart failure, 10 (10.8%) for diabetes, and 2 (0.6%) for preventive services. After physicians received direct feedback about inappropriate exceptions, 8 of 19 (42%) changed management. The peer-review process took less than 5 minutes per case, but for each change in clinical care, 65 reviews were required. LIMITATION: The findings could differ at other sites or if financial incentives were in place. CONCLUSION: Physician-recorded medical exceptions were correct most of the time. Peer review of medical exceptions can identify myths and misconceptions, but the process needs to be more efficient to be sustainable. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.