Considerations Before Selecting a Stepped-Wedge Cluster Randomized Trial Design for a Practice Improvement Study.

PURPOSE: Despite the growing popularity of stepped-wedge cluster randomized trials (SW-CRTs) for practice-based research, the design's advantages and challenges are not well documented. The objective of this study was to identify the advantages and challenges of the SW-CRT design for large-scale intervention implementations in primary care settings. METHODS: The EvidenceNOW: Advancing Heart Health initiative, funded by the Agency for Healthcare Research and Quality, included a large collection of SW-CRTs. We conducted qualitative interviews with 17 key informants from EvidenceNOW grantees to identify the advantages and challenges of using SW-CRT design. RESULTS: All interviewees reported that SW-CRT can be an effective study design for large-scale intervention implementations. Advantages included (1) incentivized recruitment, (2) staggered resource allocation, and (3) statistical power. Challenges included (1) time-sensitive recruitment, (2) retention, (3) randomization requirements and practice preferences, (4) achieving treatment schedule fidelity, (5) intensive data collection, (6) the Hawthorne effect, and (7) temporal trends. CONCLUSIONS: The challenges experienced by EvidenceNOW grantees suggest that certain favorable real-world conditions constitute a context that increases the odds of a successful SW-CRT. An existing infrastructure can support the recruitment of many practices. Strong retention plans are needed to continue to engage sites waiting to start the intervention. Finally, study outcomes should be ones already captured in routine practice; otherwise, funders and investigators should assess the feasibility and cost of data collection.VISUAL ABSTRACT.

Readiness and Implementation of Quality Improvement Strategies Among Small- and Medium-Sized Primary Care Practices: an Observational Study.

BACKGROUND: Little is known about what determines strategy implementation around quality improvement (QI) in small- and medium-sized practices. Key questions are whether QI strategies are associated with practice readiness and practice characteristics. OBJECTIVE: Grounded in organizational readiness theory, we examined how readiness and practice characteristics affect QI strategy implementation. The study was a component of a larger practice-level intervention, Heart of Virginia Healthcare, which sought to transform primary care while improving cardiovascular care. DESIGN: This observational study analyzed practice correlates of QI strategy implementation in primary care at 3 and 12 months. Data were derived from surveys completed by clinicians and staff and from assessments by practice coaches. PARTICIPANTS: A total of 175 small- and medium-sized primary care practices were included. MAIN MEASURES: Outcome was QI strategy implementation in three domains: (1) aspirin, blood pressure, cholesterol, and smoking cessation (ABCS); (2) care coordination; and (3) organizational-level improvement. Coaches assessed implementation at 3 and 12 months. Readiness was measured by baseline member surveys, 1831 responses from 175 practices, a response rate of 73%. Practice survey assessed practice characteristics, a response rate of 93%. We used multivariate regression. KEY RESULTS: QI strategy implementation increased from 3 to 12 months: the mean for ABCS from 1.20 to 1.59, care coordination from 2.15 to 2.75, organizational improvement from 1.37 to 1.78 (95% CI). There was no statistically significant association between readiness and QI strategy implementation across domains. Independent practice implementation was statistically significantly higher than hospital-owned practices at 3 months for ABCS (95% CI, P = 0.01) and care coordination (95% CI, P = 0.03), and at 12 months for care coordination (95% CI, P = 0.04). CONCLUSION: QI strategy implementation varies by practice ownership. Independent practices focus on patient care-related activities. FQHCs may need additional time to adopt and implement QI activities. Practice readiness may require more structural and organizational changes before starting a QI effort.

Practice facilitation to promote evidence-based screening and management of unhealthy alcohol use in primary care: a practice-level randomized controlled trial.

BACKGROUND: Unhealthy alcohol use is the third leading cause of preventable death in the United States. Evidence demonstrates that screening for unhealthy alcohol use and providing persons engaged in risky drinking with brief behavioral and counseling interventions improves health outcomes, collectively termed screening and brief interventions. Medication assisted therapy (MAT) is another effective method for treatment of moderate or severe alcohol use disorder. Yet, primary care clinicians are not regularly screening for or treating unhealthy alcohol use. METHODS AND ANALYSIS: We are initiating a clinic-level randomized controlled trial aimed to evaluate how primary care clinicians can impact unhealthy alcohol use through screening, counseling, and MAT. One hundred and 25 primary care practices in the Virginia Ambulatory Care Outcomes Research Network (ACORN) will be engaged; each will receive practice facilitation to promote screening, counseling, and MAT either at the beginning of the trial or at a 6-month control period start date. For each practice, the intervention includes provision of a practice facilitator, learning collaboratives with three practice champions, and clinic-wide information sessions. Clinics will be enrolled for 6-12 months. After completion of the intervention, we will conduct a mixed methods analysis to identify changes in screening rates, increase in provision of brief counseling and interventions as well as MAT, and the reduction of alcohol intake for patients after practices receive practice facilitation. DISCUSSION: This study offers a systematic process for dissemination and implementation of the evidence-based practice of screening, counseling, and treatment for unhealthy alcohol use. Practices will be asked to implement a process for screening, counseling, and treatment based on their practice characteristics, patient population, and workflow. We propose practice facilitation as a robust and feasible intervention to assist in making changes within the practice. We believe that the process can be replicated and used in a broad range of clinical settings; we anticipate this will be supported by our evaluation of this approach. TRIAL REGISTRATION: ClinicalTrials.gov, ClinicalTrials.gov Identifier: NCT04248023, Registered 5 February 2020.

Effect of Practice Ownership on Work Environment, Learning Culture, Psychological Safety, and Burnout.

PURPOSE: Physicians have joined larger groups and hospital systems in the face of multiple environmental challenges. We examine whether there are differences across practice ownership in self-reported work environment, a practice culture of learning, psychological safety, and burnout. METHODS: Using cross-sectional data from staff surveys of small and medium-size practices that participated in EvidenceNOW in Virginia, we tested for differences in work environment, culture of learning, psychological safety, and burnout by practice type. We conducted weighted multivariate linear regression of outcomes on ownership, controlling for practice size, specialty mix, payer mix, and whether the practice was located in a medically underserved area. We further analyzed clinician and staff responses separately. RESULTS: Participating were 104 hospital-owned and 61 independent practices and 24 federally qualified health centers (FQHCs). We analyzed 2,005 responses from practice clinicians and staff, a response rate of 49%. Working in a hospital-owned practice was associated with favorable ratings of work environment, psychological safety, and burnout compared with independent practices. When we examined separately the responses of clinicians vs staff, however, the association appears to be largely driven by staff. CONCLUSIONS: Hospital ownership was associated with positive perceptions of practice work environment and lower burnout for staff relative to independent ownership, whereas clinicians in FQHCs perceive a more negative, less joyful work environment and burnout. Our findings are suggestive that clinician and nonclinician staff perceive practice adaptive reserve differently, which may have implications for creating the energy for ongoing quality improvement work.

The EvidenceNOW Practice Support Initiative: The Heart of Virginia Healthcare.

PURPOSE: HHS' Million Hearts campaign focused the delivery system on ABCS clinical quality measures (appropriate Aspirin use, Blood pressure control, Cholesterol control, and Smoking cessation counseling). AHRQ's Evidence Now project funded 7 collaboratives to test different ways to improve performance and outcomes on ABCS within small primary care practices. The Heart of Virginia Health care (HVH) collaborative designed 1 of the approaches in Evidence Now. METHODS: Two hundred sixty-four eligible practices were recruited to participate and randomized to 3 cohorts in a stepped wedge design, and 173, employing 16 different EHRs, remained for the duration of the initiative. The practice support curriculum was delivered by trained practice coaches to enhance overall practice function and improve performance on the ABCS metrics. The intervention consisted of a kickoff meeting, 3 months of intensive support, 9 months of ongoing support, and access to online learning materials and expert faculty. The mean practice contact time with coaches was 428 minutes, but the standard deviation was 426 minutes. RESULTS: Overall, the short HVH intervention had a small but statistically significant positive average effects on appropriate use of aspirin and other antithrombotics, small negative effects on blood pressure control, except for those practices which did not attend the kickoff, and small negative effects on smoking cessation counseling. CONCLUSIONS: The intervention phase was truncated due to difficulty in recruiting a sufficient number of practices. This undoubtedly contributed to the lack of substantial improvements in the ABCS. Other likely contributing factors were our inability to provide real time feedback on metrics and the frequency with which major practice disruptions occurred. Future efforts to improve primary care practice function should allow adequate time for both practice recruitment and external support.

Emergence of Gun Violence as a Patient Priority.

PURPOSE: Gun violence is a growing public health epidemic that disproportionately affects underserved and minority communities. Our study sought to document patient experiences of community gun violence as a theme that emerged in the context of interviews exploring community-level factors influencing patients' engagement in primary care within the context of a larger study on cardiovascular health. METHODS: We completed semistructured qualitative interviews of individuals with uncontrolled hypertension recruited from primary care practices serving underserved communities in metro Richmond, Virginia that were participating in a larger study on improving cardiovascular health. RESULTS: Of 19 individuals interviewed, 11 discussed without prompting the negative effects of gun violence in their community. Themes that emerged included both the acute and chronic traumatic experience, the physiologic and cognitive effects of gun violence and the negative effects on ability to manage heart health. CONCLUSIONS: The effects of gun violence on not only cardiovascular health but also all aspects of health emerged unprompted in qualitative interviews about community level factors influencing management of cardiovascular health. Given the widespread negative effects of experiencing gun violence on health, family physicians could play an important role in identifying and managing the effects of gun violence. Future studies on how primary care clinicians can address gun violence in the caring for their patients comprehensively are needed.

Designing a patient-centered personal health record to promote preventive care.

BACKGROUND: Evidence-based preventive services offer profound health benefits, yet Americans receive only half of indicated care. A variety of government and specialty society policy initiatives are promoting the adoption of information technologies to engage patients in their care, such as personal health records, but current systems may not utilize the technology's full potential. METHODS: Using a previously described model to make information technology more patient-centered, we developed an interactive preventive health record (IPHR) designed to more deeply engage patients in preventive care and health promotion. We recruited 14 primary care practices to promote the IPHR to all adult patients and sought practice and patient input in designing the IPHR to ensure its usability, salience, and generalizability. The input involved patient usability tests, practice workflow observations, learning collaboratives, and patient feedback. Use of the IPHR was measured using practice appointment and IPHR databases. RESULTS: The IPHR that emerged from this process generates tailored patient recommendations based on guidelines from the U.S. Preventive Services Task Force and other organizations. It extracts clinical data from the practices' electronic medical record and obtains health risk assessment information from patients. Clinical content is translated and explained in lay language. Recommendations review the benefits and uncertainties of services and possible actions for patients and clinicians. Embedded in recommendations are self management tools, risk calculators, decision aids, and community resources--selected to match patient's clinical circumstances. Within six months, practices had encouraged 14.4% of patients to use the IPHR (ranging from 1.5% to 28.3% across the 14 practices). Practices successfully incorporated the IPHR into workflow, using it to prepare patients for visits, augment health behavior counseling, explain test results, automatically issue patient reminders for overdue services, prompt clinicians about needed services, and formulate personalized prevention plans. CONCLUSIONS: The IPHR demonstrates that a patient-centered personal health record that interfaces with the electronic medical record can give patients a high level of individualized guidance and be successfully adopted by busy primary care practices. Further study and refinement are necessary to make information systems even more patient-centered and to demonstrate their impact on care. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT00589173.

Engagement of Small to Medium-Sized Primary Care Practices in Quality Improvement Efforts.

BACKGROUND: Engaging primary care practices in quality improvement (QI) efforts has been challenging. Literature provides little guidance on the engagement of small to medium-sized practices in QI. This study examined the association between practice readiness and practice characteristics and engagement during a targeted QI effort. METHODS: The study analyzed cross-sectional data collected by the Heart of Virginia Health care, a cardiovascular disease QI intervention study with 195 practices. Data sources include 1) coach-assessed practice engagement in 7 domains (outcome), 2) surveys of readiness completed by 2529 clinicians and staff, a response rate of 86%, and 3) surveys of practice characteristics completed by a physician leader or practice manager. We used descriptive statistics and ordered logit regression for the analysis. RESULTS: Associations between readiness and engagement were statistically significant for clinician engagement (odds ratio [OR] = 5,74; 95% CI, 1.79-18.42; P = .003) and leadership engagement (OR = 3.19; 95% CI, 1.10-9.24; P = .032). Adjusting for covariates, being a hospital-owned practice was associated with a lower level of clinician engagement (OR = 0.35; 95% CI, 0.16-0.76; P = .009) relative to independent practices. DISCUSSION: Our study highlights the importance of clinician and leadership engagement as drivers of practice readiness to change in a QI effort. Lack of clinician engagement in hospital-owned practices could be driven by other factors such as burnout that need to be explored in future studies. CONCLUSIONS: Clinicians and leadership involvement in QI efforts is critical. The findings suggest that QI plans should involve clinicians and leaders early in the process to foster commitment, establish practice readiness, and sustain improvement efforts.

A "Behind-the-Scenes" Look at Interprofessional Care Coordination: How Person-Centered Care in Safety-Net Health System Complex Care Clinics Produce Better Outcomes.

INTRODUCTION: While the effectiveness of team-based care and wrap-around services for high utilizers is clear, how complex care clinics deliver effective, person-centered care to these vulnerable populations is not well understood. This paper describes how interactions among interprofessional team members enabled individualized, rapid responses to the complex needs of vulnerable patients at the Virginia Commonwealth University Health System's Complex Care Clinic. METHODS: Researchers attended twenty weekly care coordination meetings, audio-recorded the proceedings, and wrote brief observational field notes. Researchers also qualitatively interviewed ten clinic team members. Emergent coding based on grounded theory and a consensus process were used to identify and describe key themes. RESULTS: Analysis resulted in three themes that evidence the structures, processes, and interactions which contributed to the ability to provide person-centred care: team-based communication strategies, interprofessional problem-solving, and personalized patient engagement efforts. CONCLUSION: Our study suggests that in care coordination meetings team members were able to strategize, brainstorm, and reflect on how to better care for patients. Specifically, flexible team leadership opened an inter-disciplinary communicative space to foster conversations, which revealed connections between the physical, and socio-emotional components of patients' lives and hidden factors undermining progress, while proactive strategies prevented patient's rapid deterioration and unnecessary use of inappropriate health services.

Medicare Access and CHIP Reauthorization Act in Small to Medium-Sized Primary Care Practices.

BACKGROUND: Despite major efforts to transition to a new physician payment system under the Medicare Access and CHIP Reauthorization Act (MACRA), little is known about how well practices are prepared. This study aimed to understand how small and medium-sized primary care practices in the Heart of Virginia Healthcare (https://www.vahealthinnovation.org/hvh/) perceive their quality incentives under MACRA. METHODS: This study analyzed data from 16 focus-groups (70 participants), which yielded a range of physician, advanced practice clinician, office manager, and staff perspectives. Focus-groups were audio-recorded and transcribed, then imported into NVivo for coding and analysis of themes. A multidisciplinary research team reviewed the transcripts to maximize coding insights and to improve validity. RESULTS: The main findings from the focus-groups are: 1) MACRA awareness is relatively higher in independent practices, 2) steps taken toward MACRA differ by practice ownership, and 3) practices have mixed perceptions about the expected impact of MACRA. Two additional themes emerged from data: 1) practices that joined accountable care organizations are taking proactive approaches to MACRA, and 2) independent practices face ongoing challenges. CONCLUSIONS: This study highlights a dilemma in which independent practices are proactively attempting to prepare for MACRA's requirements, yet they continue to have major challenges. Practices are under extreme pressure to comply with reimbursement regulations, which may force some practices joining a health system or merging with another practice or completely closing the practices. Policy makers should assess the unintended consequences of payment reform policies on independent practices and provide support in transitioning to a new payment system.

Enhanced care planning and clinical-community linkages versus usual care to address basic needs of patients with multiple chronic conditions: a clinician-level randomized controlled trial.

BACKGROUND: Many patients with poorly controlled multiple chronic conditions (MCC) also have unhealthy behaviors, mental health challenges, and unmet social needs. Medical management of MCC may have limited benefit if patients are struggling to address their basic life needs. Health systems and communities increasingly recognize the need to address these issues and are experimenting with and investing in new models for connecting patients with needed services. Yet primary care clinicians, whose regular contact with patients makes them more familiar with patients' needs, are often not included in these systems. METHODS: We are starting a clinician-level cluster-randomized controlled trial to evaluate how primary care clinicians can participate in these community and hospital solutions and whether doing so is effective in controlling MCC. Sixty clinicians in the Virginia Ambulatory Care Outcomes Research Network will be matched by age and sex and randomized to usual care (control condition) or enhanced care planning with clinical-community linkage support (intervention). From the electronic health record we will identify all patients with MCC, including cardiovascular disease or risks, diabetes, obesity, or depression. A baseline assessment will be mailed to up to 50 randomly selected patients for each clinician (3000 total). Ten respondents per clinician (600 patients total) with uncontrolled MCC will be randomly selected for study inclusion, with oversampling of minorities. The intervention includes two components. First, we will use an enhanced care planning tool, My Own Health Report (MOHR), to screen patients for health behavior, mental health, and social needs. Patients will be supported by a patient navigator, who will help patients prioritize needs, create care plans, and write a personal narrative to guide the care team. Patients will update care plans every 1 to 2 weeks. Second, we will create community-clinical linkage to help address patients' needs. The linkage will include community resource registries, personnel to span settings (patient navigators and a community health worker), and care team coordination across team members through MOHR. DISCUSSION: This study will help inform efforts by primary care clinicians to help address unhealthy behaviors, mental health needs, and social risks as a strategy to better control MCC. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03885401. Registered on 19 September 2019.

Elements of the patient-centered medical home in family practices in Virginia.

PURPOSE: The patient-centered medical home (PCMH) is a widely accepted theory of a practice model to improve quality of care, patient satisfaction, and access to primary care services. This study explores existing elements of the PCMH and characteristics of family practices in Virginia. METHOD: We developed and administered a survey questionnaire to capture information on practice characteristics and PCMH elements. We randomly sampled 700 family medicine offices in Virginia from a population of practices derived from the Virginia Board of Medicine Practitioner Information Database. We used a mixed-mode survey, allowing practices in the sample to respond by mail or Internet or at a regional family medicine conference. RESULTS: The survey resulted in a response rate of 56%, with 342 office locations participating in the study. Most practices reported continuity-of-care processes (87%) and clinical guidelines (77%). Fewer reported use of patient surveys (48%), electronic medical record for internal coordination (38%), community linkages for care (31%), and clinical performance measurement (28%). A small number reported patient registries for multiple diseases (19%). Very few practices exhibited all elements outlined in the PCMH model (1%). Practice size (number of physicians) is significantly related to PCMH model alignment. CONCLUSIONS: Most family practices in Virginia exhibit some elements of the PCMH model. Full implementation of the PCMH model is low. Baseline information on practice characteristics, prevalence of PCMH, and challenges of small practices should be considered in guiding efforts, evaluating progress, and developing policies for care model reform.

A Plan for Useful and Timely Family Medicine and Primary Care Research.

BACKGROUND AND OBJECTIVES: Our nation's health care system is changing. Nowhere is this more evident than in primary care, where fundamental improvements are necessary if we are to achieve the Triple Aim. Such improvements are possible if we can put useful and timely information into the hands of stakeholders to enable practical decision-making. To do this, family medicine and primary care researchers need to (1) build on our substantial current research foundation, (2) increase the relevance and pace of our research, (3) reconceive the research workforce to engage new partners, (4) disseminate findings more rapidly into the hands of those who can take action, and (5) build a "question-ready" research infrastructure to make this possible. Family medicine researchers face exciting opportunities: technical capacity to generate and manage large amounts of data; clinic- and system-level networks for testing innovations; digital health technologies for real-time and asynchronous monitoring and management of risk factors and chronic diseases; the know-how to make fast, local improvements in our systems of care; partnerships beyond those traditionally engaged in research that can multiply our capacity to generate new knowledge; and new methods for creating generalizable knowledge from the study of local efforts. This is a historic time for family medicine research. Now is the time to build on our past work, accelerate the pace, and capitalize on emerging opportunities that open an incredibly bright future.

Making the case for a qualitative study of medical errors in primary care.

In the interest of publicizing examples of funded qualitative health research, the authors share a proposal to the Agency for Healthcare Research and Quality in Washington, D.C., in which they sought to elicit patient stories of preventable problems in their primary health care that were associated with psychological or physical harms. These stories would allow for the construction of a tentative typology of errors and harms as experienced by patients and the contrasting of this with errors and harms reported by primary care physicians in the United States and other countries. The authors make explicit the anticipated concerns of reviewers more accustomed to quantitative research proposals and the arguments and strategies employed to address them.

Facilitators and barriers to implementing antimicrobial stewardship strategies: Results from a qualitative study.

BACKGROUND: Many hospitals have implemented antimicrobial stewardship programs (ASPs) and have included in their programs strategies such as prior authorization and audit and feedback. However there are few data concerning the facilitators and barriers that ASPs face when implementing their strategies. We conducted a qualitative study to discern factors that lead to successful uptake of ASP strategies. METHODS: Semistructured telephone interviews were conducted from June-July 2013 with 15 ASP member pharmacists and 6 physicians representing 21 unique academic medical centers. RESULTS: Successful implementation of ASP strategies was found to be related to communication style, types of relationships formed between the ASP and non-ASP personnel, and conflict management. Success was also influenced by the availability of resources in the form of adequate personnel, health information technology personnel and infrastructure, and the ability to generate and analyze ASP-specific data. Types of effective strategies commonly cited included audit and feedback; prior authorization, especially with an educative component; and use of real-time alert technology and guidelines. CONCLUSIONS: Several factors may influence ASP success in the implementation of their strategies. ASP members may use these findings to improve upon the success of their programs.

Team-based care: a critical element of primary care practice transformation.

The purpose of this study was to gain an in-depth understanding of how primary care practices in the United States are transforming their practice to deliver patient-centered care. The study used qualitative research methods to conduct case studies of small primary care practices in the state of Virginia. The research team collected data from practices using in-depth interviews, structured telephone questionnaires, observation, and document review. Team-based care stood out as the most critical method used to successfully transform practices to provide patient-centered care. This article presents 3 team-based care models that were utilized by the practices in this study.

Why do some primary care practices engage in practice improvement efforts whereas others do not?

OBJECTIVE: To understand what motivates primary care practices to engage in practice improvement, identify external and internal facilitators and barriers, and refine a conceptual framework. DATA SOURCES: In-depth interviews and structured telephone surveys with clinicians and practice staff (n = 51), observations, and document reviews. STUDY DESIGN: Comparative case study of primary care practices (n = 8) to examine aspects of the practice and environment that influence engagement in improvement activities. DATA COLLECTION METHODS: Three on-site visits, telephone interviews, and two surveys. PRINCIPAL FINDINGS: Pressures from multiple sources create conflicting forces on primary care practices' improvement efforts. Pressures include incentives and requirements, organizational relationships, and access to resources. Culture, leadership priorities, values set by the physician(s), and other factors influence whether primary care practices engage in improvement efforts. CONCLUSIONS: Most primary care practices are caught in a cross fire between two groups of pressures: a set of forces that push practices to remain with the status quo, the "15-minute per patient" approach, and another set of forces that press for major transformations. Our study illuminates the elements involved in the decision to stay with the status quo or to engage in practice improvement efforts needed for transformation.

How patients want to engage with their personal health record: a qualitative study.

OBJECTIVE: To assess factors related to use and non-use of a sophisticated interactive preventive health record (IPHR) designed to promote uptake of 18 recommended clinical preventive services; little is known about how patients want to use or be engaged by such advanced information tools. DESIGN: Descriptive and interpretive qualitative analysis of transcripts and field notes from focus groups of the IPHR users and of patients who were invited but did not use the IPHR (non-users). Grounded theory techniques were then applied via an editing approach for key emergent themes. SETTING: Primary care patients in eight practices of the Virginia Ambulatory Care Outcomes Research Network (ACORN). PARTICIPANTS: Three focus groups involved a total of 14 IPHR users and two groups of non-users totalled 14 participants. OUTCOMES/RESULTS: For themes identified (relevance, trust and functionality) participants indicated that endorsement and use of the IPHR by their personal clinician was vital. In particular, participants' comments linked the IPHR use to: (1) integrating the IPHR into current care, (2) promoting effective patient-clinician encounters and communication and (3) their confidence in the accuracy, security and privacy of the information. CONCLUSIONS: In addition to patients' stated desires for advanced functionality and information accuracy and privacy, successful adoption of the IPHRs by primary care patients depends on such technology's relevance, and on its promotion via integration with primary care practices' processes and the patient-clinician relationship. Accordingly, models of technological success and adoption, when applied to primary care, may need to include the patient-clinician relationship and practice workflow. These findings are important for healthcare providers, the information technology industry and policymakers who share an interest in encouraging patients to use personal health records. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT00589173.