Objective

To examine the effect of Lean primary care redesigns on patient satisfaction with care and timeliness of care received.

Data/setting

We used patient surveys and time-stamped electronic health record (EHR) data in a large ambulatory care system.

Design

Lean-based changes to clinical spaces and care team workflows were implemented in one pilot site and then scaled to all primary care departments across the system. Redesigns included standardizing equipment and patient education materials in examination rooms, streamlining call management functions, co-locating physician and medical assistant dyads in a shared workspace, and creating new care team workflows. We used a non-randomized stepped-wedge study design and segmented regression with interrupted time series analysis to examine Lean impacts on patient outcomes.

Data collection

We analyzed patient satisfaction ratings and wait times as documented by the EHR. These longitudinal data were collected for 317 physician-led teams in 46 primary care departments from January 2011 to December 2016.

Principal findings

After implementation of Lean redesigns, patients reported a 44.8 percent increase in satisfaction with the adequacy of time spent with care providers during office visits (P < .05). They also reported 71.6 percent higher satisfaction with their care provider's ability to listen to their concerns, and a 55.4 percent increase in perceived staff helpfulness at the visit (P < .01). Based on monthly EHR data, the amount of time elapsed between a patient request for a routine appointment and the scheduled visit day decreased from baseline by an average 2 percent per month (P < .01). On the day of the visit, patient wait times to be seen also decreased gradually by an average 1.2 percent per month (P < .05).

Conclusions

Patient experiences of care after Lean implementations have not been widely studied in primary care settings. We found that Lean redesign yielded improvements that may strengthen clinical operations while enhancing value for patients.

Purpose

To assess the impact of Lean primary care redesigns on the amount of time that physicians spent working each day.

Methods

This observational study was based on 92 million time-stamped Epic® EHR access logs captured among 317 primary care physicians in a large ambulatory care delivery system. Seventeen clinic facilities housing 46 primary care departments were included for study. We conducted interrupted time series analysis to monitor changes in physician work patterns over 6 years. Key measures included total daily work time; time spent on "desktop medicine" outside the exam room; time spent with patients during office visits; time still working after clinic, i.e., after seeing the last patient each day; and remote work time.

Results

The amount of time that physicians spent on desktop EHR activities throughout the day, including after clinic hours, decreased by 10.9% (95% CI: -22.2, -2.03) and 8.3% (95% CI: -13.8, -2.12), respectively, during the first year of Lean implementation. Total daily work hours among physicians, which included both desktop activity and time in office visits, decreased by 20% (95% CI: -29.2, -9.60) by the third year of Lean implementation.

Conclusions

These findings suggest that Lean redesign may be associated with time savings for primary care physicians. However, since this was an observational analysis, further study is warranted (e.g., randomized trial) -to determine the impact of Lean interventions on physician work experiences.

Background

Many primary care practices have adopted Lean techniques to reduce the amount of time spent completing routine tasks. Few studies have evaluated both immediate and sustained impacts of Lean to improve this aspect of primary care work efficiency.

Objective

To examine 3-year impacts of Lean implementation on the amount of time taken for physicians to complete common clinical tasks.

Design

Non-randomized stepped wedge with segmented regression and interrupted time series analysis (January 2011-December 2016).

Participants

A total of 317 physician-led teams in 46 primary care departments in a large ambulatory care delivery system.

Intervention

Lean redesign was initiated in one pilot site followed by system-wide spread across all primary care departments. Redesigns included standardization of exam room equipment and supplies, streamlining of call management processes, care team co-location, and team management of the electronic inbox.

Measures

Time-stamped EHR tracking of physicians' completion time for 4 common tasks: (1) office visit documentation and closure of patient charts; (2) telephone call resolution; (3) prescription refill renewal; and (4) response to electronic patient messages.

Results

After Lean implementation, we found decreases in the amount of time to complete: office visit documentation (- 29.2% [95% CI: - 44.2, - 10.1]), telephone resolution (- 22.2% [95% CI: - 38.1, - 2.27]), and renewal of prescription refills (- 2.96% per month [95% CI: - 4.21, - 1.78]). These decreases were sustained over several years. Response time to electronic patient messages did not change significantly.

Conclusions

Lean redesigns led to improvements in timely completion of 3 out of 4 common clinical tasks. Our findings support the use of Lean techniques to engage teams in routine aspects of patient care. More research is warranted to understand the mechanisms by which Lean promotes quality improvement and effectiveness of care team workflows.

The objective of this paper is to provide an overview of economic evaluation of personalized medicine, focusing particularly on the use of cost-effectiveness analysis and other methods of valuation. We draw on insights from the literature and our work at the University of California, San Francisco Center for Translational and Policy Research on Personalized Medicine (TRANSPERS). We begin with a discussion of why personalized medicine is of interest and challenges to adoption, whether personalized medicine is different enough to require different evaluation approaches, and what is known about the economics of personalized medicine. We then discuss insights from TRANSPERS research and six areas for future research: Develop and Apply Multiple Methods of Assessing Value Identify Key Factors in Determining the Value of Personalized Medicine Use Real World Perspectives in Economic Analyses Consider Patient Heterogeneity and Diverse Populations in Economic Analyses Prepare for Upcoming Challenges of Assessing Value of Emerging Technologies Incorporate Behavioral Economics into Value Assessments.

The objective of this paper is to provide an overview of economic evaluation of personalized medicine, focusing particularly on the use of cost-effectiveness analysis and other methods of valuation. We draw on insights from the literature and our work at the University of California, San Francisco Center for Translational and Policy Research on Personalized Medicine (TRANSPERS). We begin with a discussion of why personalized medicine is of interest and challenges to adoption, whether personalized medicine is different enough to require different evaluation approaches, and what is known about the economics of personalized medicine. We then discuss insights from TRANSPERS research and six areas for future research:

Although modest improvements in colorectal cancer (CRC) screening utilization have occurred, rates remain low among Latinos. It is unclear whether acculturation plays a role in the utilization of CRC screening. This study aimed to examine the relationships between acculturation and CRC screening among older Mexican, Puerto-Rican and Cuban adults. Cross-sectional observational study. Latinos 50 years and older, never diagnosed with CRC, and who were surveyed in the 2000, 2003 and 2005 National Health Interview Survey (NHIS). We measured acculturation with US nativity and language of interview, and examined three different CRC screening outcomes: fecal occult blood test (FOBT) in the past year, up-to-date endoscopy and any up-to-date CRC screening. Logistic regression models were adjusted for predisposing, enabling and health-care need factors consistent with the behavioral model of health-care utilization. In adjusted analyses, US nativity was positively associated with up-to-date endoscopy among Mexicans (OR: 1.5; 95% CI: 1.1, 2.2), but negatively associated with FOBT in the past year among Puerto Ricans (OR: 0.3; 95% CI: 0.2, 0.7). In contrast to this latter finding among Puerto Ricans, English language interview was positively associated with FOBT in the past year (OR: 2.5; 95% CI: 1.1, 5.4). Results underscore the importance of stratification by national origin in studies of acculturation and cancer screening and of targeting less acculturated adults to promote CRC screening. Clinicians, however, should consider the complexity of acculturation and treat US nativity and language preference as independent dimensions among their Latino patients.

Aims

Trastuzumab, one of the best known examples of personalized medicine, requires regular cardiac monitoring because it can cause heart failure. We aimed to assess the utilization of cardiac monitoring in women with nonmetastatic breast cancer receiving trastuzumab-based chemotherapy in routine clinical practice.

Patients & methods

The medical records of women continuously enrolled in a large national health insurance plan who were diagnosed with nonmetastatic breast cancer and treated with trastuzumab from 2006 to 2008 were reviewed (n = 109). The primary outcome variables were the use and type of cardiac monitoring testing before and during trastuzumab therapy. An exploratory multivariable logistic regression analysis was performed to identify predictors for receiving cardiac monitoring both at baseline and during trastuzumab treatment.

Results

Monitoring both before and during therapy was less common (62%), although 74% had cardiac monitoring before therapy and 80% had at least one test during therapy. Radionuclide ventriculogram was utilized more often than echocardiography (48 vs 42%). Only the use of anthracycline (odds ratio: 2.39; 95% CI: 1.01-5.71) was significantly associated with use of a cardiac monitoring both at baseline and during trastuzumab treatment.

Conclusion

The use of cardiac monitoring testing was variable and opportunities to improve quality and reduce cost are evident. These results have clinical implications for other personalized medicine interventions requiring regular laboratory monitoring.

Purpose

There is uncertainty about when personalized medicine tests provide economic value. We assessed evidence on the economic value of personalized medicine tests and gaps in the evidence base.

Methods

We created a unique evidence base by linking data on published cost-utility analyses from the Tufts Cost-Effectiveness Analysis Registry with data measuring test characteristics and reflecting where value analyses may be most needed: (i) tests currently available or in advanced development, (ii) tests for drugs with Food and Drug Administration labels with genetic information, (iii) tests with demonstrated or likely clinical utility, (iv) tests for conditions with high mortality, and (v) tests for conditions with high expenditures.

Results

We identified 59 cost-utility analyses studies that examined personalized medicine tests (1998-2011). A majority (72%) of the cost/quality-adjusted life year ratios indicate that testing provides better health although at higher cost, with almost half of the ratios falling below $50,000 per quality-adjusted life year gained. One-fifth of the results indicate that tests may save money.

Conclusion

Many personalized medicine tests have been found to be relatively cost-effective, although fewer have been found to be cost saving, and many available or emerging medicine tests have not been evaluated. More evidence on value will be needed to inform decision making and assessment of genomic priorities.

Objectives

To examine the temporal trajectory of insurance coverage for next-generation tumor sequencing (sequencing) by private US payers, describe the characteristics of coverage adopters and nonadopters, and explore adoption trends relative to the Centers for Medicare and Medicaid Services' National Coverage Determination (CMS NCD) for sequencing.

Methods

We identified payers with positive coverage (adopters) or negative coverage (nonadopters) of sequencing on or before April 1, 2019, and abstracted their characteristics including size, membership in the BlueCross BlueShield Association, and whether they used a third-party policy. Using descriptive statistics, payer characteristics were compared between adopters and nonadopters and between pre-NCD and post-NCD adopters. An adoption timeline was constructed.

Results

Sixty-nine payers had a sequencing policy. Positive coverage started November 30, 2015, with 1 payer and increased to 33 (48%) as of April 1, 2019. Adopters were less likely to be BlueCross BlueShield members (P < .05) and more likely to use a third-party policy (P < .001). Fifty-eight percent of adopters were small payers. Among adopters, 52% initiated coverage pre-NCD over a 25-month period and 48% post-NCD over 17 months.

Conclusions

We found an increase, but continued variability, in coverage over 3.5 years. Temporal analyses revealed important trends: the possible contribution of the CMS NCD to a faster pace of coverage adoption, the interdependence in coverage timing among BlueCross BlueShield members, the impact of using a third-party policy on coverage timing, and the importance of small payers in early adoption. Our study is a step toward systematic temporal research of coverage for precision medicine, which will inform policy and affordability assessments.

Older patients and those who require interpreters are least likely to use telehealth for gynecologic oncology care, showing disparities which continued after statewide vaccinations.