Leslie Lenert

The Utah Remote Monitoring Project: Improving Health Care One Patient at a Time

BACKGROUND The expanding role of technology to augment diabetes care and management highlights the need for clinicians to learn about these new tools. As these tools continue to evolve and enhance improved outcomes, it is imperative that clinicians consider the role of telemonitoring, or remote monitoring, in patient care. This article describes a successful telemonitoring project in Utah. SUBJECTS AND METHODS This was a nonrandomized prospective observational preintervention-postintervention study, using a convenience sample. Patients with uncontrolled diabetes and/or hypertension from four rural and two urban primary care clinics and one urban stroke center participated in a telemonitoring program. The primary clinical outcome measures were changes in hemoglobin A1C (A1C) and blood pressure. Other outcomes included fasting lipids, weight, patient engagement, diabetes knowledge, hypertension knowledge, medication adherence, and patient perceptions of the usefulness of the telemonitoring program. RESULTS Mean A1C decreased from 9.73% at baseline to 7.81% at the end of the program (P<0.0001). Systolic blood pressure also declined significantly, from 130.7 mm Hg at baseline to 122.9 mm Hg at the end (P=0.0001). Low-density lipoprotein content decreased significantly, from 103.9 mg/dL at baseline to 93.7 mg/dL at the end (P=0.0263). Other clinical parameters improved nonsignificantly. Knowledge of diabetes and hypertension increased significantly (P<0.001 for both). Patient engagement and medication adherence also improved, but not significantly. Per questionnaires at study end, patients felt the telemonitoring program was useful. CONCLUSIONS Telemonitoring improved clinical outcomes and may be a useful tool to help enhance disease management and care of patients with diabetes and/or hypertension.

A model to support shared decision making in electronic health records systems.

Shared decision making (SDM) is an approach to medical care based on collaboration between provider and patient, with both sharing in medical decisions. When patients’ values and preferences are incorporated in decision making, care is more appropriate, ethically sound, and often lower in cost. However, SDM is difficult to implement in routine practice because of the time required for SDM methods, the lack of integration of SDM approaches into electronic health record (EHR) systems, and absence of explanatory mechanisms for providers on the results of patients’ use of decision aids. This article discusses potential solutions, including the concept of a “personalize button” for EHRs. Leveraging a 4-phase clinical model for SDM, this article describes how computer decision support (CDS) technologies integrated into EHRs can help ensure that health care is delivered in a way that is respectful of those preferences. The architecture described herein, called CDS for SDM, is built on recognized standards that are currently integrated into certification requirements for EHRs as part of meaningful use regulations. While additional work is needed on modeling of preferences and on techniques for rapid communication models of preferences to clinicians, unless EHRs are redesigned to support SDM around and during clinical encounters, they are likely to continue to be an unintended barrier to SDM. With appropriate development, EHRs could be a powerful tool to promote SDM by reminding providers of situations for SDM and monitoring ongoing care to ensure treatments are consistent with patients’ preferences.

Pharmacist-provided diabetes management and education via a telemonitoring program.

OBJECTIVE To assess clinical outcomes (glycosylated hemoglobin [A1C], blood pressure, and lipids) and other measurements (disease state knowledge, adherence, and self-efficacy) associated with the use of approved telemonitoring devices to expand and improve chronic disease management of patients with diabetes, with or without hypertension. SETTING Four community health centers (CHCs) in Utah. PRACTICE DESCRIPTION Federally qualified safety net clinics that provide medical care to underserved patients. PRACTICE INNOVATION Pharmacist-led diabetes management using telemonitoring was compared with a group of patients receiving usual care (without telemonitoring). INTERVENTIONS Daily blood glucose (BG) and blood pressure (BP) values were reviewed and the pharmacist provided phone follow-up to assess and manage out-of-range BG and BP values. EVALUATION Changes in A1C, BP, and low-density lipoprotein (LDL) at approximately 6 months were compared between the telemonitoring group and the usual care group. Patient activation, diabetes/hypertension knowledge, and medication adherence were measured in the telemonitoring group. RESULTS Of 150 patients, 75 received pharmacist-provided diabetes management and education via telemonitoring, and 75 received usual medical care. Change in A1C was significantly greater in the telemonitoring group compared with the usual care group (2.07% decrease vs. 0.66% decrease; P <0.001). Although BP and LDL levels also declined, differences between the two groups were not statistically significant. Patient activation measure, diabetes/hypertension knowledge, and medication adherence with antihypertensives (but not diabetes medications) improved in the telemonitoring group. CONCLUSION Pharmacist-provided diabetes management via telemonitoring resulted in a significant improvement in A1C in federally qualified CHCs in Utah compared with usual medical care. Telemonitoring may be considered a model for providing clinical pharmacy services to patients with diabetes.

Effects of electronic health record use on the exam room communication skills of resident physicians: a randomized within-subjects study

Background The effects of electronic health records (EHRs) on doctor–patient communication are unclear. Objective To evaluate the effects of EHR use compared with paper chart use, on novice physicians’ communication skills. Design Within-subjects randomized controlled trial using observed structured clinical examination methods to assess the impact of use of an EHR on communication. Setting A large academic internal medicine training program. Population First-year internal medicine residents. Intervention Residents interviewed, diagnosed, and initiated treatment of simulated patients using a paper chart or an EHR on a laptop computer. Video recordings of interviews were rated by three trained observers using the Four Habits scale. Results Thirty-two residents completed the study and had data available for review (61.5% of those enrolled in the residency program). In most skill areas in the Four Habits model, residents performed at least as well using the EHR and were statistically better in six of 23 skills areas (p<0.05). The overall average communication score was better when using an EHR: mean difference 0.254 (95% CI 0.05 to 0.45), p = 0.012, Cohens d of 0.47 (a moderate effect). Residents scoring poorly (>3 average score) with paper methods (n = 8) had clinically important improvement when using the EHR. Limitations This study was conducted in first-year residents in a training environment using simulated patients at a single institution. Conclusions Use of an EHR on a laptop computer appears to improve the ability of first-year residents to communicate with patients relative to using a paper chart.

A Comprehensive View of Frequent Emergency Department Users Based on Data from a Regional HIE.

Objectives A small but significant number of patients make frequent emergency department (ED) visits to multiple EDs within a region. We have a unique health information exchange (HIE) that includes every ED encounter in all hospital systems in our region. Using our HIE we were able to characterize all frequent ED users in our region, regardless of hospital visited or payer class. The objective of our study was to use data from an HIE to characterize patients in a region who are frequent ED users (FEDUs). Methods We constructed a database from a cohort of adult patients (18 years old or older) with information in a regional HIE for a 1-year period beginning in April 2012. Patients were defined as FEDUs (those who made four or more visits during the study period) and non-FEDUs (those who made fewer than four ED visits during the study period). Predictor variables included age, race, sex, payer class, county of residence, and International Classification of Diseases, Ninth Revision codes. Bivariate (&khgr;2) and multivariate (logistic regression) analyses were performed to determine associations between predictor variables and the outcome of being a FEDU. Results The database contained 127,672 patients, 12,293 (9.6%) of whom were FEDUs. Logistic regression showed the following patient characteristics to be significantly associated with the outcome of being a FEDU: age 35 to 44 years; African American race; Medicaid, Medicare, and dual-pay payer class; and International Classification of Diseases, Ninth Revision codes 630 to 679 (complications of pregnancy, childbirth, and puerperium), 780 to 799 (ill-defined conditions), 280 to 289 (diseases of the blood), 290–319 (mental disorders), 680 to 709 (diseases of the skin and subcutaneous tissue), 710 to 739 (musculoskeletal and connective tissue disease), 460 to 519 (respiratory disease), and 520 to 579 (digestive disease). No significant differences were noted between men and women. Conclusions Data from an HIE can be used to describe all of the patients within a region who are FEDUs, regardless of the hospital system they visited. This information can be used to focus care coordination efforts and link appropriate patients to a medical home. Future studies can be designed to learn the reasons why patients become FEDUs, and interventions can be developed to address deficiencies in health care that result in frequent ED visits.

Teleconsent: A Novel Approach to Obtain Informed Consent for Research.

Lack of recruitment of qualified research participants continues to be a significant bottleneck in clinical trials, often resulting in costly time extensions, underpowered results, and in some cases early termination. Some of the reasons for suboptimal recruitment include laborious consent processes and access to participants at remote locations. While new electronic consents technologies (eConsent) help overcome challenges related to readability and consent management, they do not adequately address challenges related to remote access. To address this, we have developed an innovative solution called “teleconsent”, which embeds the informed consent process into a telemedicine session. Teleconsent allows a researcher to remotely video conference with a prospective research participant, display and interactively guide participants in real-time through a consent form. When finished, the researcher and participant can electronically sign the consent form and print or download the signed document for archiving. This process can eliminate challenges related to travel and management of personnel at remote sites. Teleconsent has been successfully implemented in several clinical trials. Teleconsent can improve research recruitment by reducing the barriers related to informed consent, while preserving human interaction.

A population-based approach for implementing change from opt-out to opt-in research permissions

Due to recently proposed changes in the Common Rule regarding the collection of research preferences, there is an increased need for efficient methods to document opt-in research preferences at a population level. Previously, our institution developed an opt-out paper-based workflow that could not be utilized for research in a scalable fashion. This project was designed to demonstrate the feasibility of implementing an electronic health record (EHR)-based active opt-in research preferences program. The first phase of implementation required creating and disseminating a patient questionnaire through the EHR portal to populate discreet fields within the EHR indicating patients’ preferences for future research study contact (contact) and their willingness to allow anonymised use of excess tissue and fluid specimens (biobank). In the second phase, the questionnaire was presented within a clinic nurse intake workflow in an obstetrical clinic. These permissions were tabulated in registries for use by investigators for feasibility studies and recruitment. The registry was also used for research patient contact management using a new EHR encounter type to differentiate research from clinical encounters. The research permissions questionnaire was sent to 59,670 patients via the EHR portal. Within four months, 21,814 responses (75% willing to participate in biobanking, and 72% willing to be contacted for future research) were received. Each response was recorded within a patient portal encounter to enable longitudinal analysis of responses. We obtained a significantly lower positive response from the 264 females who completed the questionnaire in the obstetrical clinic (55% volunteers for biobank and 52% for contact). We demonstrate that it is possible to establish a research permissions registry using the EHR portal and clinic-based workflows. This patient-centric, population-based, opt-in approach documents preferences in the EHR, allowing linkage of these preferences to health record information.

IRB reliance

Multi-site Institutional Review Board (IRB) review of clinical research projects is an important but complex and time-consuming activity that is hampered by disparate non-interoperable computer systems for management of IRB applications. This paper describes our work toward harmonizing the workflow and data model of IRB applications through the development of a software-as-a-service shared-IRB platform for five institutions in South Carolina. Several commonalities and differences were recognized across institutions and a core data model that included the data elements necessary for IRB applications across all institutions was identified. We extended and modified the system to support collaborative reviews of IRB proposals within routine workflows of participating IRBs. Overall about 80% of IRB application content was harmonized across all institutions, establishing the foundation for a streamlined cooperative review and reliance. Since going live in 2011, 49 applications that underwent cooperative reviews over a three year period were approved, with the majority involving 2 out of 5 institutions. We believe this effort will inform future work on a common IRB data model that will allow interoperability through a federated approach for sharing IRB reviews and decisions with the goal of promoting reliance across institutions in the translational research community at large.

The association between method of solicitation and patient permissions for use of surplus tissues and contact for future research

Abstract Objective Obtaining patient permissions for research contact and for surplus tissue use as part of routine clinical practice can improve research participation. This study aims to investigate the difference in patient permissions for use of surplus tissues, and for direct contact for research, using 2 different methods of solicitation. Methods An opt-in, population-based approach for gathering research permissions was implemented in 2 methods. The first method, applied a 2-item patient questionnaire delivered through the electronic health record patient portal. The questionnaire composed of 2 questions (1) whether de-identified surplus specimens may be used for research and (2) whether patients could be contacted about research. In the second method, the same questionnaire was physically presented in clinic within the clinical workflow. We used 1 to 1 propensity score matching and multivariate logistic regression to estimate the odds of obtaining permission and the difference between the 2 methods of solicitation. Results The propensity score model matched 8044 observations (4114 submissions in each group). Among the in-clinic submission group, 70.13% provided permission for surplus tissue compared with 66.65% in the patient portal submission group (odds ratio [OR] = 1.20; 95% confidence interval [CI] 1.09–1.32; P < 0.001). Permission for future research contact was similar among in-clinic (65.07%) and patient portal submission (66.65%) groups (OR = 0.94; 95% CI 0.85–1.03; P = 0.175). These trends were consistent among European Americans and African American patients. However, among patients of other race, higher permission for both future contact (OR = 0.58; 95% CI 0.39–0.86; P < 0.007) and surplus tissue use (OR = 0.65; 95% CI 0.43–0.97; P = 0.036) was observed among patient portal submission. Discussion Our findings suggest that in-clinic solicitation of patient permissions may provide the same opportunity to patients who do not use patient portals and may be associated with higher permission rate for surplus tissue. However, this was primary true for European American and African Americans patients. Patients of other race minorities might respond better to online approaches. Conclusion Adopting a patient-centric approach that combines in-clinic and portal-based administration may be feasible and promising. Further research is required in this area.

Research participation preferences as expressed through a patient portal: implications of demographic characteristics

Abstract Objective As patient portals are increasingly used for research recruitment, it is important to examine the demographic makeup of research registries that are populated via portals and the factors that influence participation in these registries. Methods We examined the response to a routine research preference questionnaire among patients who were enrolled in a patient portal at an academic health center and characterized the sub-population that responded and was tracked in a research preferences registry. We examined the factors that influence choices in two research preferences: future contact for research opportunities and biobanking of de-identified specimens. Results Out of 79 834 patients to whom the questionnaire was sent, 32% responded. Of those 74% agreed to future contact and 77% to the biobank preference. We found significantly lower odds of agreement in both preferences in minority populations, especially in the population >65 years of age when stratified by race. Individuals with higher comorbidity indexes had significantly higher odds for agreement. Discussion The disparities in volunteerism as expressed by agreement to future contact and willingness to participate in biobanking are exacerbated by lower levels of enrollment in the patient portal by minorities, especially in the oldest age group. Future work should examine other socioeconomic factors and the differences across age groups, sicker individuals, and payer categories. Conclusion Although patient portals can be more efficient for recruitment, researchers have to be cognizant of, and proactively address, potential biases when recruiting participants from these registries.