Predicting Self-Reported Social Risk in Medically Complex Adults Using Electronic Health Data.

BACKGROUND: Social barriers to health care, such as food insecurity, financial distress, and housing instability, may impede effective clinical management for individuals with chronic illness. Systematic strategies are needed to more efficiently identify at-risk individuals who may benefit from proactive outreach by health care systems for screening and referral to available social resources. OBJECTIVE: To create a predictive model to identify a higher likelihood of food insecurity, financial distress, and/or housing instability among adults with multiple chronic medical conditions. RESEARCH DESIGN AND SUBJECTS: We developed and validated a predictive model in adults with 2 or more chronic conditions who were receiving care within Kaiser Permanente Northern California (KPNC) between January 2017 and February 2020. The model was developed to predict the likelihood of a "yes" response to any of 3 validated self-reported survey questions related to current concerns about food insecurity, financial distress, and/or housing instability. External model validation was conducted in a separate cohort of adult non-Medicaid KPNC members aged 35-85 who completed a survey administered to a random sample of health plan members between April and June 2021 (n = 2820). MEASURES: We examined the performance of multiple model iterations by comparing areas under the receiver operating characteristic curves (AUCs). We also assessed algorithmic bias related to race/ethnicity and calculated model performance at defined risk thresholds for screening implementation. RESULTS: Patients in the primary modeling cohort (n = 11,999) had a mean age of 53.8 (±19.3) years, 64.7% were women, and 63.9% were of non-White race/ethnicity. The final, simplified model with 30 predictors (including utilization, diagnosis, behavior, insurance, neighborhood, and pharmacy-based variables) had an AUC of 0.68. The model remained robust within different race/ethnic strata. CONCLUSIONS: Our results demonstrated that a predictive model developed using information gleaned from the medical record and from public census tract data can be used to identify patients who may benefit from proactive social needs assessment. Depending on the prevalence of social needs in the target population, different risk output thresholds could be set to optimize positive predictive value for successful outreach. This predictive model-based strategy provides a pathway for prioritizing more intensive social risk outreach and screening efforts to the patients who may be in greatest need.

Telehealth During COVID-19 for Adults with Multiple Chronic Conditions: Associations with Self-Reported Food Insecurity and with Physical Limitations.

Background: Adults with chronic medical conditions complicated by food insecurity or physical limitations may have higher barriers to accessing telehealth implemented during the COVID-19 pandemic. Objective: To examine the relationships of self-reported food insecurity and physical limitations with changes in health care utilization and medication adherence comparing the year before (March 2019-February 2020) and the first year of the COVID-19 pandemic (April 2020-March 2021) among patients with chronic conditions insured by Medicaid or Medicare Advantage. Methods: A prospective cohort study of 10,452 Kaiser Permanente Northern California members insured by Medicaid and 52,890 Kaiser Permanente Colorado members insured by Medicare Advantage was conducted. Difference-in-differences (DID) between the pre-COVID and COVID years in telehealth versus in-person health care utilization and adherence to chronic disease medicines by food insecurity and by physical limitation status were measured. Results: Food insecurity and physical limitations were each associated with small but significantly greater shifts from in-person to telehealth. Medicare Advantage members with physical limitations also had significantly greater decline in adherence to chronic medications from year to year compared with those without physical limitations (DID from pre-COVID year to COVID year ranged from 0.7% to 3.6% greater decline by medication class, p < 0.01). Conclusions: Food insecurity and physical limitations did not present significant barriers to the transition to telehealth during the COVID pandemic. The greater decrease in medication adherence among older patients with physical limitations suggests that care systems must further address the needs of this high-risk population.

Associations Between Different Self-reported Social Risks and Neighborhood-level Resources in Medicaid Patients.

BACKGROUND: Adverse social conditions are a key contributor to health disparities. Improved understanding of how social risk factors interact with each other and with neighborhood characteristics may inform efforts to reduce health disparities. DATA: A questionnaire of 29,281 patients was collected through the enrollment of Medicaid beneficiaries in a large Northern California integrated health care delivery system between May 2016 and February 2020. EXPOSURES: Living in the least resourced quartile of neighborhoods as measured by a census-tract level Neighborhood Deprivation Index score. MAIN OUTCOMES: Five self-reported social risk factors: financial need, food insecurity, housing barriers, transportation barriers, and functional limitations. RESULTS: Nearly half (42.0%) of patients reported at least 1 social risk factor; 22.4% reported 2 or more. Mean correlation coefficient between social risk factors was ρ=0.30. Multivariable logistic models controlling for age, race/ethnicity, sex, count of chronic conditions, and insurance source estimated that living in the least resourced neighborhoods was associated with greater odds of food insecurity (adjusted odds ratio=1.07, 95% confidence interval: 1.00-1.13) and transportation barriers (adjusted odds ratio=1.20, 95% confidence interval: 1.11-1.30), but not financial stress, housing barriers, or functional limitations. CONCLUSIONS AND RELEVANCE: We found that among 5 commonly associated social risk factors, Medicaid patients in a large Northern California health system typically reported only a single factor and that these factors did not correlate strongly with each other. We found only modestly greater social risk reported by patients in the least resourced neighborhoods. These results suggest that individual-level interventions should be targeted to specific needs whereas community-level interventions may be similarly important across diverse neighborhoods.

Accounting for Social Risk Does not Eliminate Race/Ethnic Disparities in COVID-19 Infection Among Insured Adults: a Cohort Study.

BACKGROUND: Communities of color have been disproportionately impacted by the COVID-19 epidemic in the USA. OBJECTIVES: To examine the relationship of self-reported social health needs with SARS-COV-2 infection by race/ethnicity among insured adults with access to high-quality health care. DESIGN AND PARTICIPANTS: A prospective cohort study of 26,741 adult Kaiser Permanente Northern California members insured by Medicaid and 58,802 Kaiser Permanente Colorado members insured by Medicare Advantage who completed social risk assessments prior to the onset of the COVID-19 pandemic. MAIN MEASURES: We examined the independent relationships of demographic, medical, and social factors on SARS-COV-2 testing and positivity between March 1, 2020, and November 30, 2020, by race/ethnicity. KEY RESULTS: Findings were similar in the two cohorts, with Latino (16-18%), Asian (11-14%), and Black (11-12%) members having the highest prevalence of SARS-COV-2 infection (ORs adjusted for age, gender, and use of interpreter ranging from 1.68 to 2.23 compared to White member [7-8%], p < 0.001). Further adjustment for medical comorbidity (e.g., obesity, diabetes, chronic lung disease); neighborhood measures; and self-reported social risk factors (e.g., trouble paying for basics, food insecurity, housing concerns, transportation barriers) did not appreciably change these results. CONCLUSIONS: Compared to non-Latino White members, members of other race/ethnic groups had higher positivity rates that were only minimally reduced after controlling for medical and neighborhood conditions and self-reported social risk factors. These findings suggest that traditional infection transmission factors such as essential work roles and household size that have disproportionate representation among communities of color may be important contributors to SARS-COV-2 infection among insured adults.

Engaging patients in population-based chronic disease management: A qualitative study of barriers and intervention opportunities.

OBJECTIVE: Cardiovascular disease (CVD) continues to be a leading cause of morbidity in the U.S. Managing CVD risk factors, such as diabetes or hypertension, can be challenging for many individuals. We investigated the barriers experienced by patients who persistently struggled to reach their CVD risk factor control goals. METHODS: This qualitative study examined patient, clinician, and researcher observations of individuals' experiences in a chronic disease management program. All participants (n = 332) were enrolled in a clinical trial testing a skills-based group intervention seeking to improve healthcare engagement. Data were analyzed through a general inductive approach and resulting themes were structured along the Capability-Opportunity-Motivation-Behavior framework. RESULTS: Analyses identified care engagement barriers related to participants' communication skills and activation, care team relationship processes, and emotional factors. Although most participants reported benefitting from skills training, persistent barriers included distrust of their providers, shame about health challenges, and dissatisfaction with care team interactions that were described as impersonal or unresponsive. CONCLUSIONS AND PRACTICE IMPLICATIONS: Efforts to support engagement in CVD risk factor management programs should address whether patients and their care team have the necessary skills, opportunities and confidence to proactively communicate health needs and engage in non-judgmental interactions for goal-setting, rapport-building, and shared decision-making.

Aligning care with the personal values of patients with complex care needs.

OBJECTIVE: To identify opportunities to align care with the personal values of patients from three distinct groups with complex medical, behavioral, and social needs. DATA SOURCES/STUDY SETTING: Between June and August 2019, we conducted semi-structured interviews with individuals with complex care needs in two integrated health care delivery systems. STUDY DESIGN: Qualitative study using semi-structured interviews. DATA COLLECTION METHODS: We interviewed three groups of patients at Kaiser Permanente Washington and Kaiser Permanente Colorado representing three distinct profiles of complex care needs: Group A ("obesity, opioid prescription, and low-resourced neighborhood"), Group B ("older, high medical morbidity, emergency department, and hospital use"), and Group C ("older, mental and physical health concerns, and low-resourced neighborhood"). These profiles were identified based on prior work and prioritized by internal primary care stakeholders. Interview transcripts were analyzed using thematic analysis. PRINCIPAL FINDINGS: Twenty-four patients participated; eight from each complex needs profile. Mean age across groups was 71 (range 48-86) years. We identified five themes common across the three groups that captured patients' views regarding values-aligned care. These themes focused on the importance of care teams exploring and acknowledging a patient's values, providing access to nonphysician providers who have different perspectives on care delivery, offering values-aligned mental health care, ensuring connection to community-based resources that support values and address needs, and providing care that supports the patient plus their family and caregivers. CONCLUSIONS: Our results suggest several opportunities to improve how care is delivered to patients with different complex medical, behavioral, and social needs. Future research is needed to better understand how to incorporate these opportunities into health care.

Changing Results-Engage and Activate to Enhance Wellness: A Randomized Clinical Trial to Improve Cardiovascular Risk Management.

Background Despite the success of current cardiovascular disease (CVD) management programs, many patients do not achieve optimal control of CVD-related risk factors. New strategies are needed to better activate and engage these patients. Methods and Results We conducted a parallel, 2-arm, randomized controlled trial, CREATE Wellness (Changing Results-Engage and Activate to Enhance Wellness) from February 2015 to September 2017 with 12-month follow-up to September 2018. Eligible participants had ≥1 uncontrolled CVD risk factors (hyperlipidemia, hypertension, or diabetes mellitus) for at least 2 years before study enrollment. The control group (n=315) received usual care within an existing CVD population-based disease management program. The intervention group (n=332) received usual care plus a group-based behavioral intervention focused on patient activation and engagement. Study outcomes included patient activation and patient-centered care processes (6 months) and healthcare system engagement, medication adherence, and control of CVD risk factors (12 months). Compared with the control group at follow-up, the intervention group had greater improvement in patient activation (adjusted mean difference=2.8, P=0.01), patient-centered care (adjusted mean difference=0.19, P=0.003), and 2 out of 3 measures of healthcare system engagement (eg, secure messages exchanged with a population health manager; adjusted incidence rate ratio=1.7, P=0.01). Intervention and control arms did not differ on improvement in 1-year CVD risk factor control. Conclusions Further work is needed to more effectively connect increased patient activation and engagement to downstream changes in risk factor control. Clinical Trial Registration URL: http://www.clinicaltrials.gov. Unique identifier: NCT02302612.

Patient-Defined Visit Priorities in Primary Care: Psychosocial Versus Medically-Related Concerns.

BACKGROUND: Primary care providers (PCPs) are often challenged to address multiple patient concerns during time-limited visits. The need for PCPs to limit the number of issues addressed may have a negative impact on discussion of patient-defined visit priorities. METHODS: Using data from a recent clinical trial (Aligning Patients and Providers, ClinicalTrials.gov: NCT02707146), we examined the association between patient-defined visit priorities and subsequent provider actions taken during and after the visit. We tested the hypothesis that psychosocial concerns (eg, stress, anxiety, caregiving demands) are less likely to be addressed than traditional medical concerns. RESULTS: We analyzed 147 patient-defined visit priorities submitted just before the visit by 109 patients (mean age, 59.0 ± 12.7 years; including 73.4% women, 47.7% non-White race/ethnicity). Nearly one quarter of patient-defined visit priorities were related to psychosocial concerns (35/147; 23.8%). In models adjusting for age, gender, race/ethnicity, and familiarity with PCP, patients' psychosocial priorities were significantly less likely than medical priorities to be addressed during the visit (63% vs. 88%; adjusted odds ratio [aOR], 0.16; 95% CI, 0.06 to 0.41; P < .001), to receive clinical action (51% vs. 82%; aOR, 0.15; 95% CI, 0.06 to 0.38; P < .001), or to receive post visit information from the primary care doctor (17% vs. 32%; aOR, 0.39; 95% CI, 0.14 to 1.08; P = .07). CONCLUSIONS: Patient-defined psychosocial priorities are less likely to be addressed during (or immediately after) primary care visits compared with patient-defined medical priorities.

Translating/Creating a Culturally Responsive Spanish-Language Mobile App for Visit Preparation: Case Study of "Trans-Creation".

BACKGROUND: Health information technology (IT) tools are increasingly used to improve patient care. However, implementation of English-only health IT tools could potentially worsen health disparities for non-English speakers. OBJECTIVE: We aim to describe the "trans-creation" process of developing linguistically and culturally appropriate health IT tools through a detailed case analysis of a waiting room health mobile app designed to help Spanish-speaking Latino people prepare for primary care visits. METHODS: We adapted the English-language Visit Planner mobile app for Spanish-speaking Latino patients. We applied culturally defined themes derived from prior published research and input by both skilled linguists and potential end users. Initial changes were iteratively reviewed and edited by a team of writers, health care educators, subject matter experts, patients, and providers. RESULTS: The trans-creation process resulted in the following key culturally mediated changes to the tool: replacing the "provider" actors with "patient" actors; changing the choice of "Stress at Home or Work" (represented by an icon of a house) to "Mi Familia" (translation: my family; icon is an outline of family members holding hands); replacing the English terms "anxiety" and "depression" with "Me siento desanimado"(translation: I am feeling down) to avoid mental health stigma; and using more concise text translation to ensure the wording fit the available on-screen space. CONCLUSIONS: The trans-creation process of cultural and linguistic adaptation led to several design changes that would not have been implemented if we had simply translated the words from English to Spanish.

Knowing How to Ask Good Questions: Comparing Latinos and Non-Latino Whites Enrolled in a Cardiovascular Disease Prevention Study.

INTRODUCTION: Latinos face unique challenges engaging with their health care providers for risk management of cardiovascular disease (CVD). OBJECTIVE: To better understand differences in how Latinos and non-Latino whites (NLWs) experience CVD care. METHODS: We examined self-reported activation, engagement, confidence, and communication comparing Latinos (n = 194) and NLWs (n = 208). Data were taken from baseline survey assessments of participants in the CREATE Wellness Study (NCT02302612), designed to help patients with poorly controlled CVD risk factors more actively engage in their care. The groups were compared using χ2 tests and separate logistic regression models adjusting for age, age and income, and age and educational attainment. RESULTS: Latinos in this cohort were younger, were less educated, and had lower incomes than did NLWs. In age-adjusted models, Latinos were significantly less likely to report knowing how to ask good questions about their health (71.1% vs 83.7% for NLW, p < 0.01; adjusted odds ratio = 0.49, 95% confidence interval = 0.29-0.83). Further adjustment by educational attainment or income did not attenuate this association. Latinos were also significantly more likely to report positive experiences and confidence with several measures of chronic illness care (adjusted odds ratio range = 1.57-2.01). Further adjustment by educational attainment eliminated these associations. CONCLUSION: We found notable differences between Latinos and NLWs in their experience of health care. These results provide insights into how CVD risk management programs can be tailored for Latinos. Interventions to improve patient activation and engagement for Latinos with CVD should emphasize question-asking skills.

Visit Planning Using a Waiting Room Health IT Tool: The Aligning Patients and Providers Randomized Controlled Trial.

PURPOSE: Time during primary care visits is limited. We tested the hypothesis that a waiting room health information technology (IT) tool to help patients identify and voice their top visit priorities would lead to better visit interactions and improved quality of care. METHODS: We designed a waiting room tool, the Visit Planner, to guide adult patients through the process of identifying their top priorities for their visit and effectively expressing these priorities to their clinician. We tested this tool in a cluster-randomized controlled trial with usual care as the control. Eligible patients had at least 1 clinical care gap (eg, overdue for cancer screening, suboptimal chronic disease risk factor control, or medication nonadherence). RESULTS: The study (conducted March 31, 2016 through December 31, 2017) included 750 English- or Spanish-speaking patients. Compared with usual care patients, intervention patients more often reported "definitely" preparing questions for their doctor (59.5% vs 45.1%, P <.001) and "definitely" expressing their top concerns at the beginning of the visit (91.3% vs 83.3%, P = .005). Patients in both arms reported high levels of satisfaction with their care (86.8% vs 89.9%, P = .20). With 6 months of follow-up, prevalence of clinical care gaps was reduced by a similar amount in each study arm. CONCLUSIONS: A simple waiting room-based tool significantly improved visit communication. Patients using the Visit Planner were more prepared and more likely to begin the visit by communicating their top priorities. These changes did not, however, lead to further reduction in aggregate clinical care gaps beyond the improvements seen in the usual care arm.

Prompting Patients with Poorly Controlled Diabetes to Identify Visit Priorities Before Primary Care Visits: a Pragmatic Cluster Randomized Trial.

BACKGROUND: Most patients with diabetes do not meet all evidence-based goals of care, and many patients report poor communication and lack of involvement in decision-making during primary care visits. OBJECTIVE: To test the hypothesis that a "Pre-Visit Prioritization" secure email message could improve visit communication and glycemic control among patients with type 2 diabetes. DESIGN: We conducted a pragmatic, provider-randomized, multi-site clinical trial from March 2015 to October 2016 across 30 primary care practices within Kaiser Permanente Northern California (KPNC), a large integrated care delivery system. PARTICIPANTS: Eligible patients had at least 1 year of KPNC membership, type 2 diabetes with most recently measured hemoglobin A1c (HbA1c) > = 8.0%, and were registered users of the KPNC online patient portal. INTERVENTIONS: Patients in the intervention arm, upon booking an appointment, received a secure email through the KPNC online portal with a link to the EHR allowing them to submit their top one or two priorities prior to the visit. Control patients received usual care. MAIN MEASURES: Glycemic control; change in HbA1c 6 and 12 months after the initial visit; patient-reported outcomes related to patient-provider communication and patient care experiences. KEY RESULTS: During the study period, 1276 patients had at least one eligible visit. In post-visit surveys (n = 457), more intervention arm patients reported preparing questions for their visit (72% vs 63%, p = 0.048) and being given treatment choices to consider (81% vs 73%, p = 0.041). Patients in both arms had similar reductions in HbA1c over the 12-month study period (0.56% ± 1.45%), with no significant differences between arms. CONCLUSIONS: A "light touch" email-based pre-visit intervention resulted in improved measures of visit interaction but did not significantly improve glycemic control relative to usual care. Improving diabetes clinical outcomes through more effective primary care visits may require more intensive approaches to patient visit preparation. TRIAL REGISTRY: NCT02375932.

Which Complex Patients Should Be Referred for Intensive Care Management? A Mixed-Methods Analysis.

BACKGROUND: A large and increasing proportion of health care costs are spent caring for a small segment of medically and socially complex patients. To date, it has been difficult to identify which patients are best served by intensive care management. OBJECTIVE: To characterize factors that best identify which complex patients are most suited for intensive care management. DESIGN: We conducted a mixed-methods study involving 35 care managers (CMs; 10 licensed social workers and 25 registered nurses) working in intensive care management programs within Kaiser Permanente Northern California (KPNC) outpatient medical centers. We asked CMs to review a randomly selected list of up to 50 patients referred to them in the prior year and to categorize each patient as either (1) "good candidates" for care management, (2) "not needing" intensive care management, or (3) "needing more" than traditional care management could provide. We then conducted semi-structured interviews to understand how CMs separated patients into these three groups. RESULTS: CMs assigned 1178 patients into the 3 referral categories. Less than two thirds (62%, n = 736) of referred patients were considered good candidates, with 18% (n = 216) categorized as not needing care management and 19% (n = 226) as needing more. Compared to the other two categories, good candidates were older (76.2 years vs. 73.2 for not needing and 69.8 for needing more, p < 0.001), prescribed more medications (p = 0.02) and had more prior year outpatient visits (p = 0.04), while the number of prior year hospital and emergency room admissions were greater than not needing but less than needing more (p < 0.001). A logistic regression model using available electronic record data predicted good candidate designation with a c statistic of 0.75. Several qualitative themes emerged that helped define appropriateness for referral, including availability of social support, patient motivation, non-medical transitions, recent trajectory of medical condition, and psychiatric or substance use issues. CONCLUSION: Many apparently complex patients are not good candidates for intensive care management. Current electronic medical records do not capture several of the most salient characteristics that determine appropriateness for care management. Our findings suggest that systematic collection of social support, patient motivation, and recent non-medically related life change information may help identify which complex patients are most likely to benefit from care management.

'The Hand on the Doorknob': Visit Agenda Setting by Complex Patients and Their Primary Care Physicians.

BACKGROUND: Choosing which issues to discuss in the limited time available during primary care visits is an important task for complex patients with chronic conditions. DESIGN, SETTING, AND PARTICIPANTS: We conducted sequential interviews with complex patients (n = 40) and their primary care physicians (n = 17) from 3 different health systems to investigate how patients and physicians prepare for visits, how visit agendas are determined, and how discussion priorities are established during time-limited visits. KEY RESULTS: Visit flow and alignment were enhanced when both patients and physicians were effectively prepared before the visit, when the patient brought up highest-priority items first, the physician and patient worked together at the beginning of the visit to establish the visit agenda, and other team members contributed to agenda setting. A range of factors were identified that undermined the ability of patient and physicians to establish an efficient working agenda: the most prominent were time pressure and short visit lengths, but also included differing visit expectations, patient hesitancy to bring up embarrassing concerns, electronic medical record/documentation requirements, differences balancing current symptoms versus future medical risk, nonactionable items, differing philosophies about medications and lifestyle interventions, and difficulty by patients in prioritizing their top concerns. CONCLUSIONS: Primary care patients and their physicians adopt a range of different strategies to address the time constraints during visits. The primary factor that supported well-aligned visits was the ability for patients and physicians to proactively negotiate the visit agenda at the beginning of the visit. Efforts to optimize care within time-constrained systems should focus on helping patients more effectively prepare for visits. Physicians should ask for the patient's agenda early, explain visit parameters, establish a reasonable number of concerns that can be discussed, and collaborate on a plan to deal with concerns that cannot be addressed during the visit.

CREATE Wellness: A multi-component behavioral intervention for patients not responding to traditional Cardiovascular disease management.

BACKGROUND/AIMS: Cardiovascular disease (CVD) is the leading cause of death in the US. Many patients do not benefit from traditional disease management approaches to CVD risk reduction. Here we describe the rationale, development, and implementation of a multi-component behavioral intervention targeting patients who have persistently not met goals of CVD risk factor control. METHODS: Informed by published evidence, relevant theoretical frameworks, stakeholder advice, and patient input, we developed a group-based intervention (Changing Results: Engage and Activate to Enhance Wellness; "CREATE Wellness") to address the complex needs of patients with elevated or unmeasured CVD-related risk factors. We are testing this intervention in a randomized trial among patients with persistent (i.e > 2 years) sub-optimal risk factor control despite being enrolled in an advanced and highly successful CVD disease management program. RESULTS: The CREATE Wellness intervention is designed as a 3 session, group-based intervention combining proven elements of patient activation, health system engagement skills training, shared decision making, care planning, and identification of lifestyle change barriers. Our key learnings in designing the intervention included the value of multi-level stakeholder input and the importance of pragmatic skills training to address barriers to care. CONCLUSIONS: The CREATE Wellness intervention represents an evidence-based, patient-centered approach for patients not responding to traditional disease management. The trial is currently underway at three medical facilities within Kaiser Permanente Northern California and next steps include an evaluation of efficacy, adaptation for non-English speaking patient populations, and modification of the curriculum for web- or phone-based versions. CLINICALTRIALSGOV IDENTIFIER: NCT02302612.

Pre-Visit Prioritization for complex patients with diabetes: Randomized trial design and implementation within an integrated health care system.

BACKGROUND/AIMS: Despite robust evidence to guide clinical care, most patients with diabetes do not meet all goals of risk factor control. Improved patient-provider communication during time-limited primary care visits may represent one strategy for improving diabetes care. METHODS: We designed a controlled, cluster-randomized, multi-site intervention (Pre-Visit Prioritization for Complex Patients with Diabetes) that enables patients with poorly controlled type 2 diabetes to identify their top priorities prior to a scheduled visit and sends these priorities to the primary care physician progress note in the electronic medical record. In this paper, we describe strategies to address challenges to implementing our health IT-based intervention study within a large health care system. RESULTS: This study is being conducted in 30 primary care practices within a large integrated care delivery system in Northern California. Over a 12-week period (3/1/2015-6/6/2015), 146 primary care physicians consented to enroll in the study (90.1%) and approved contact with 2496 of their patients (97.6%). Implementation challenges included: (1) navigating research vs. quality improvement requirements; (2) addressing informed consent considerations; and (3) introducing a new clinical tool into a highly time-constrained workflow. Strategies for successfully initiating this study included engagement with institutional leaders, Institutional Review Board members, and clinical stakeholders at multiple stages both before and after notice of Federal funding; flexibility by the research team in study design; and strong support from institutional leadership for "self-learning health system" research. CONCLUSIONS: By paying careful attention to identifying and collaborating with a wide range of key clinical stakeholders, we have shown that researchers embedded within a learning care system can successfully apply rigorous clinical trial methods to test new care innovations.

Exercise as a vital sign: a quasi-experimental analysis of a health system intervention to collect patient-reported exercise levels.

BACKGROUND: Lack of regular physical activity is highly prevalent in U.S. adults and significantly increases mortality risk. OBJECTIVE: To examine the clinical impact of a newly implemented program ("Exercise as a Vital Sign" [EVS]) designed to systematically ascertain patient-reported exercise levels at the beginning of each outpatient visit. DESIGN AND PARTICIPANTS: The EVS program was implemented in four of 11 medical centers between April 2010 and October 2011 within a single health delivery system (Kaiser Permanente Northern California). We used a quasi-experimental analysis approach to compare visit-level and patient-level outcomes among practices with and without the EVS program. Our longitudinal observational cohort included over 1.5 million visits by 696,267 adults to 1,196 primary care providers. MAIN MEASURES: Exercise documentation in physician progress notes; lifestyle-related referrals (e.g. exercise programs, nutrition and weight loss consultation); patient report of physician exercise counseling; weight change among overweight/obese patients; and HbA1c changes among patients with diabetes. KEY RESULTS: EVS implementation was associated with greater exercise-related progress note documentation (26.2 % vs 23.7 % of visits, aOR 1.12 [95 % CI: 1.11-1.13], p < 0.001) and referrals (2.1 % vs 1.7 %; aOR 1.14 [1.11-1.18], p < 0.001) compared to visits without EVS. Surveyed patients (n = 6,880) were more likely to report physician exercise counseling (88 % vs. 76 %, p < 0.001). Overweight patients (BMI 25-29 kg/m(2), n = 230,326) had greater relative weight loss (0.20 [0.12 - 0.28] lbs, p < 0.001) and patients with diabetes and baseline HbA1c > 7.0 % (n = 30,487) had greater relative HbA1c decline (0.1 % [0.07 %-0.13 %], p < 0.001) in EVS practices compared to non-EVS practices. CONCLUSIONS: Systematically collecting exercise information during outpatient visits is associated with small but significant changes in exercise-related clinical processes and outcomes, and represents a valuable first step towards addressing the problem of inadequate physical activity.

Improving treatment intensification to reduce cardiovascular disease risk: a cluster randomized trial.

BACKGROUND: Blood pressure, lipid, and glycemic control are essential for reducing cardiovascular disease (CVD) risk. Many health care systems have successfully shifted aspects of chronic disease management, including population-based outreach programs designed to address CVD risk factor control, to non-physicians. The purpose of this study is to evaluate provision of new information to non-physician outreach teams on need for treatment intensification in patients with increased CVD risk. METHODS: Cluster randomized trial (July 1-December 31, 2008) in Kaiser Permanente Northern California registry of members with diabetes mellitus, prior CVD diagnoses and/or chronic kidney disease who were high-priority for treatment intensification: blood pressure ≥ 140 mmHg systolic, LDL-cholesterol ≥ 130 mg/dl, or hemoglobin A1c ≥ 9%; adherent to current medications; no recent treatment intensification). Randomization units were medical center-based outreach teams (4 intervention; 4 control). For intervention teams, priority flags for intensification were added monthly to the registry database with recommended next pharmacotherapeutic steps for each eligible patient. Control teams used the same database without this information. Outcomes included 3-month rates of treatment intensification and risk factor levels during follow-up. RESULTS: Baseline risk factor control rates were high (82-90%). In eligible patients, the intervention was associated with significantly greater 3-month intensification rates for blood pressure (34.1 vs. 30.6%) and LDL-cholesterol (28.0 vs 22.7%), but not A1c. No effects on risk factors were observed at 3 months or 12 months follow-up. Intervention teams initiated outreach for only 45-47% of high-priority patients, but also for 27-30% of lower-priority patients. Teams reported difficulties adapting prior outreach strategies to incorporate the new information. CONCLUSIONS: Information enhancement did not improve risk factor control compared to existing outreach strategies at control centers. Familiarity with prior, relatively successful strategies likely reduced uptake of the innovation and its potential for success at intervention centers. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00517686.

Adherence to cardiovascular disease medications: does patient-provider race/ethnicity and language concordance matter?

BACKGROUND: Patient-physician race/ethnicity and language concordance may improve medication adherence and reduce disparities in cardiovascular disease (CVD) by fostering trust and improved patient-physician communication. OBJECTIVE: To examine the association of patient race/ethnicity and language and patient-physician race/ethnicity and language concordance on medication adherence rates for a large cohort of diabetes patients in an integrated delivery system. DESIGN: We studied 131,277 adult diabetes patients in Kaiser Permanente Northern California in 2005. Probit models assessed the effect of patient and physician race/ethnicity and language on adherence to CVD medications, after controlling for patient and physician characteristics. RESULTS: Ten percent of African American, 11 % of Hispanic, 63% of Asian, and 47% of white patients had same race/ethnicity physicians. 24% of Spanish-speaking patients were linguistically concordant with their physicians. African American (46%), Hispanic (49%) and Asian (52%) patients were significantly less likely than white patients (58%) to be in good adherence to all of their CVD medications (p<0.001). Spanish-speaking patients were less likely than English speaking patients to be in good adherence (51% versus 57%, p<0.001). Race concordance for African American patients was associated with adherence to all their CVD medications (53% vs. 50%, p<0.05). Language concordance was associated with medication adherence for Spanish-speaking patients (51% vs. 45%, p<0.05). CONCLUSION: Increasing opportunities for patient-physician race/ethnicity and language concordance may improve medication adherence for African American and Spanish-speaking patients, though a similar effect was not observed for Asian patients or English-proficient Hispanic patients.