Acceptability and Adherence to Home, Kiosk, and Clinic Blood Pressure Measurement Compared to 24-H Ambulatory Monitoring.

BACKGROUND: The US Preventive Services Task Force recommends measuring blood pressure (BP) outside of clinic/office settings. While various options are available, including home devices, BP kiosks, and 24-h ambulatory BP monitoring (ABPM), understanding patient acceptability and adherence is a critical factor for implementation. OBJECTIVE: To compare the acceptability and adherence of clinic, home, kiosk, and ABPM measurement. DESIGN: Comparative diagnostic accuracy study which randomized adults to one of three BP measurement arms: clinic, home, and kiosk. ABPM was conducted on all participants. PARTICIPANTS: Adults (18-85 years) receiving care at 12 Kaiser Permanente Washington primary care clinics (Washington State, USA) with a high BP (≥ 138 mmHg systolic or ≥ 88 mmHg diastolic) in the electronic health record with no hypertension diagnosis and on no hypertensive medications and with high BP at a research screening visit. MEASURES: Patient acceptability was measured using a validated survey which was used to calculate an overall acceptability score (range 1-7) at baseline, after completing their assigned BP measurement intervention, and after completing ABPM. Adherence was defined based on the pre-specified number of BP measurements completed. KEY RESULTS: Five hundred ten participants were randomized (mean age 59 years), with mean BP of 150/88. Overall acceptability score was highest (i.e. most acceptable) for Home BP (mean 6.2, SD 0.7) and lowest (least acceptable) for ABPM (mean 5.0, SD 1.0); scores were intermediate for Clinic (5.5, SD 1.1) and Kiosk (5.4, SD 1.0). Adherence was higher for Home (154/170, 90.6%) and Clinic (150/172, 87.2%) than for Kiosk (114/168, 67.9%)). The majority of participants (467/510, 91.6%) were adherent to ABPM. CONCLUSIONS: Participants found home BP measurement most acceptable followed by clinic, BP kiosks, and ABPM. Our findings, coupled with recent evidence regarding the accuracy of home BP measurement, further support the routine use of home-based BP measurement in primary care practice in the US. TRIAL REGISTRATION: ClinicalTrials.gov NCT03130257 https://clinicaltrials.gov/ct2/show/NCT03130257.

Using Protection Motivation Theory to Predict Intentions for Breast Cancer Risk Management: Intervention Mechanisms from a Randomized Controlled Trial.

The purpose of this study is to evaluate the direct and indirect effects of a web-based, Protection Motivation Theory (PMT)-informed breast cancer education and decision support tool on intentions for risk-reducing medication and breast MRI among high-risk women. Women with ≥ 1.67% 5-year breast cancer risk (N = 995) were randomized to (1) control or (2) the PMT-informed intervention. Six weeks post-intervention, 924 (93% retention) self-reported PMT constructs and behavioral intentions. Bootstrapped mediations evaluated the direct effect of the intervention on behavioral intentions and the mediating role of PMT constructs. There was no direct intervention effect on intentions for risk-reducing medication or MRI (p's ≥ 0.12). There were significant indirect effects on risk-reducing medication intentions via perceived risk, self-efficacy, and response efficacy, and on MRI intentions via perceived risk and response efficacy (p's ≤ 0.04). The PMT-informed intervention effected behavioral intentions via perceived breast cancer risk, self-efficacy, and response efficacy. Future research should extend these findings from intentions to behavior. ClinicalTrials.gov Identifier: NCT03029286 (date of registration: January 24, 2017).

Clinic, Home, and Kiosk Blood Pressure Measurements for Diagnosing Hypertension: a Randomized Diagnostic Study.

BACKGROUND: The US Preventive Services Task Force recommends blood pressure (BP) measurements using 24-h ambulatory monitoring (ABPM) or home BP monitoring before making a new hypertension diagnosis. OBJECTIVE: Compare clinic-, home-, and kiosk-based BP measurement to ABPM for diagnosing hypertension. DESIGN, SETTING, AND PARTICIPANTS: Diagnostic study in 12 Washington State primary care centers, with participants aged 18-85 years without diagnosed hypertension or prescribed antihypertensive medications, with elevated BP in clinic. INTERVENTIONS: Randomization into one of three diagnostic regimens: (1) clinic (usual care follow-up BPs); (2) home (duplicate BPs twice daily for 5 days); or (3) kiosk (triplicate BPs on 3 days). All participants completed ABPM at 3 weeks. MAIN MEASURES: Primary outcome was difference between ABPM daytime and clinic, home, and kiosk mean systolic BP. Differences in diastolic BP, sensitivity, and specificity were secondary outcomes. KEY RESULTS: Five hundred ten participants (mean age 58.7 years, 80.2% white) with 434 (85.1%) included in primary analyses. Compared to daytime ABPM, adjusted mean differences in systolic BP were clinic (-4.7mmHg [95% confidence interval -7.3, -2.2]; P<.001); home (-0.1mmHg [-1.6, 1.5];P=.92); and kiosk (9.5mmHg [7.5, 11.6];P<.001). Differences for diastolic BP were clinic (-7.2mmHg [-8.8, -5.5]; P<.001); home (-0.4mmHg [-1.4, 0.7];P=.52); and kiosk (5.0mmHg [3.8, 6.2]; P<.001). Sensitivities for clinic, home, and kiosk compared to ABPM were 31.1% (95% confidence interval, 22.9, 40.6), 82.2% (73.8, 88.4), and 96.0% (90.0, 98.5), and specificities 79.5% (64.0, 89.4), 53.3% (38.9, 67.2), and 28.2% (16.4, 44.1), respectively. LIMITATIONS: Single health care organization and limited race/ethnicity representation. CONCLUSIONS: Compared to ABPM, mean BP was significantly lower for clinic, significantly higher for kiosk, and without significant differences for home. Clinic BP measurements had low sensitivity for detecting hypertension. Findings support utility of home BP monitoring for making a new diagnosis of hypertension. TRIAL REGISTRATION: ClinicalTrials.gov NCT03130257 https://clinicaltrials.gov/ct2/show/NCT03130257.

Knowledge and Perception of Breast Density, Screening Mammography, and Supplemental Screening: in Search of "Informed".

BACKGROUND: As of 2019, 37 US states have breast density notification laws. No qualitative study to date has examined women's perspectives about breast density in general or by states with and without notification laws. OBJECTIVE: Explore women's knowledge and perceptions of breast density and experiences of breast cancer screening across three states with and without notification laws. DESIGN: Qualitative research design using four focus groups conducted in 2017. PARTICIPANTS: Forty-seven women who had a recent normal mammogram and dense breasts in registry data obtained through the Breast Cancer Surveillance Consortium. APPROACH: Focus groups were 90 min, audio recorded, and transcribed for analysis. Data were analyzed using mixed deductive and inductive coding. KEY RESULTS: Women reported variable knowledge levels of personal breast density and breast density in general, even among women living in states with a notification law. A number of women were aware of the difficulty of detecting cancer with dense breasts, but only one knew that density increased breast cancer risk. Across all states, very few women reported receiving information about breast density during healthcare visits beyond being encouraged to get supplemental imaging or to pay for new mammography technology (i.e., breast tomosynthesis). Women offered more imaging or different technology held strong convictions that these were "better," even though knowledge of differences, effectiveness, or harms across technologies seemed limited. Women from all states expressed a strong desire for more information about breast density. CONCLUSIONS: More research needs to be done to understand how the medical community can best assist women in making informed decisions related to breast density, mammography, and supplemental screening. Options to explore include improved breast density notifications and education materials about breast density, continued development of personalized risk information tools, strategies for providers to discuss evidence and options based on risk stratification, and shared decision-making.

Actions and processes that patients, family members, and physicians associate with patient- and family-centered care.

BACKGROUND: Patient- and family-centered care (PFCC) is increasingly linked to improved communication, care quality, and patient decision making. However, in order to consistently implement and study PFCC, health care systems and researchers need a solid evidentiary base. Most current definitions and models of PFCC are broad and conceptual, and difficult to translate into measurable behaviors and actions. This paper provides a brief overview of all actions that focus group respondents associated with PFCC in ambulatory (outpatient) care settings and then explores actions associated with the concept of "dignity and respect" in greater detail. METHODS: We conducted nine focus groups with patients, family members, and physicians in three metropolitan regions across the United States. Group discussions were transcribed and analyzed using a thematic analysis approach. RESULTS: We identified 14 domains and 47 specific actions that patients, family members, and physicians associate with PFCC. In addition to providing a detailed matrix of these domains and actions, this paper details the actions associated with the "dignity and respect" concept. Key domains identified under "dignity and respect" include: 1) building relationships, 2) providing individualized care, and 3) respecting patients' time. Within these domains we identified specific actions that break down these abstract ideas into explicit and measurable units such as taking time, listening, including family, and minimizing wait times. We identified 9, 6, and 3 specific actions associated, respectively, with building relationships, providing individualized care, and respecting patients' time. CONCLUSIONS: Our work fills a critical gap in our ability to understand and measure PFCC in ambulatory care settings by breaking down abstract concepts about PFCC into specific measurable actions. Our findings can be used to support research on how PFCC affects clinical outcomes and develop innovative tools and policies to support PFCC.

Young Women's Perspectives on Being Screened for Hereditary Breast and Ovarian Cancer Risk During Routine Primary Care.

PURPOSE: The U.S. Preventive Services Task Force recommends screening women to identify individuals eligible for genetic counseling based on a priori hereditary breast and ovarian cancer syndrome (HBOC) risk (i.e., risk assessment). However, risk assessment has not been widely integrated into primary care. This qualitative study explored young women's views on implementing routine HBOC risk assessment with a focus on equity and patient-centeredness. METHODS: We conducted group discussions with young women (aged 21-40 years) receiving care in an integrated health care system. Discussion groups occurred in two phases and used a modified deliberative approach that included a didactic component and prioritized developing consensus. Twenty women participated in one of three initial small group discussions (phase one). All 20 were invited to participate in a subsequent large group discussion (phase two), and 15 of them attended. FINDINGS: Key themes and recommendations were as follows. Risk assessment should be accessible, contextualized, and destigmatized to encourage participation and reduce anxiety, particularly for women who do not know their family history. Providers conducting risk assessments must be equipped to address women's informational needs, relieve emotionality, and plan next steps after positive screens. Finally, to minimize differential screening uptake, health care systems must prioritize equity in program design and contribute to external educational and outreach efforts. CONCLUSION: Young women see pragmatic opportunities for health systems to optimize HBOC screening implementation.

Relationship of Blood Pressure, Health Behaviors, and New Diagnosis and Control of Hypertension in the BP-CHECK Study.

BACKGROUND: Undiagnosed hypertension and uncontrolled blood pressure (BP) are common and contribute to excess cardiovascular morbidity and mortality. We examined whether BP control, changes in BP, and patient behaviors and attitudes were associated with a new hypertension diagnosis. METHODS: We performed a post hoc analysis of 323 participants from BP-CHECK (Blood Pressure Checks for Diagnosing Hypertension), a randomized diagnostic study of BP measuring methods in adults without diagnosed hypertension with elevated BP recruited from 12 primary care clinics of an integrated health care system in Washington State during 2017 to 2019. All 323 participants returned a positive diagnostic test for hypertension based on 24-hour ambulatory BP monitoring and were followed for 6 months. We used linear regression to examine the relationships between a new hypertension diagnosis (primary independent variable) and differences in the change in study outcomes from baseline to 6-month. RESULTS: Mean age of study participants was 58.3 years (SD, 13.1), 147 (45%) were women, and 253 (80%) were of non-Hispanic White race. At 6 months, 154 of 323 (48%) participants had a new hypertension diagnosis of whom 88 achieved target BP control. Participants with a new hypertension diagnosis experienced significantly larger declines from baseline in BP (adjusted mean difference: systolic BP, -7.6 mm Hg [95% CI, -10.3 to -4.8]; diastolic BP, -3.8 mm Hg [95% CI, -5.6 to -2.0]) compared with undiagnosed peers. They were also significantly more likely to achieve BP control by 6 months compared with undiagnosed participants (adjusted relative risk, 1.5 [95% CI, 1.1 to 2.0]). At 6 months, 101 of 323 participants (31%) with a positive ambulatory BP monitoring diagnostic test remained with undiagnosed hypertension, uncontrolled BP, and no antihypertensive medications. CONCLUSIONS: Approximately one-third of participants with high BP on screening and ambulatory BP monitoring diagnostic testing remained with undiagnosed hypertension, uncontrolled BP, and no antihypertensive medications after 6 months. New strategies are needed to enhance integration of BP diagnostic testing into clinical practice. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT03130257.

Preventing severe hypoglycemia in adults with type 2 diabetes (PHT2): Design, delivery and evaluation framework for a randomized controlled trial.

BACKGROUND: Severe hypoglycemia is a common and feared complication of medications used to lower blood glucose levels in individuals with diabetes. Psychoeducational interventions can prevent severe hypoglycemia in individuals with type 1 diabetes (T1D). We aim to determine the effectiveness of this approach among adults with type 2 diabetes (T2D) at elevated risk for severe hypoglycemia. METHODS: Preventing Hypoglycemia in Type 2 diabetes (PHT2) is a two-arm, parallel, randomized controlled trial. Participants are eligible if they are adults with T2D receiving care at an integrated group practice in Washington state and have experienced one or more episodes of severe hypoglycemia in the prior 12 months or have impaired awareness of hypoglycemia (Gold score ≥ 4). Participants are randomized to proactive nurse care management with or without my hypo compass, an evidence-based, psychoeducational intervention combining group and individual self-management training. For this study, my hypo compass was adapted to be suitable for adults with T2D and from an in-person to a virtual intervention over videoconference and telephone. The primary outcome is any self-reported severe hypoglycemia in the 12 months following the start of the intervention. Secondary outcomes include biochemical measures of hypoglycemia, self-reported hypoglycemia awareness, fear of hypoglycemia, and emergency department visits and hospitalizations for severe hypoglycemia. The study includes a process evaluation to assess implementation fidelity and clarify the causal pathway. CONCLUSION: The PHT2 trial will compare the effectiveness of two approaches for reducing severe hypoglycemia in adults with T2D. TRIAL REGISTRATION: clinicaltrials.gov, # NCT04863872.

Spreading a medical home redesign: effects on emergency department use and hospital admissions.

PURPOSE: The patient-centered medical home (PCMH) is being rapidly deployed in many settings to strengthen US primary care, improve quality, and control costs; however, evidence supporting this transformation is still lacking. We describe the Group Health experience in attempting to replicate the effects on health care use seen in a PCMH prototype clinic via a systemwide spread using Lean as the change strategy. METHODS: We used an interrupted time series analysis with a patient-month unit of analysis over a 4-year period that included baseline, implementation, and stabilization periods for 412,943 patients. To account for secular trends across these periods, we compared changes in use of face-to-face primary care visits, emergency department visits, and inpatient admissions with those of a nonequivalent comparison group of patients served by community network practices. RESULTS: After accounting for secular trends among network patients, patients empaneled to the PCMH clinics had 5.1% and 6.7% declines in primary care office visits in early and later stabilization years, respectively, after the implementation year. This trend was accompanied by a 123% increase in the use of secure electronic message threads and a 20% increase in telephone encounters. Declines were also seen in emergency department visits at 1 and 2 years (13.7% and 18.5%) compared with what would be expected based on secular trends in network practices. No statistically significant changes were found for hospital admissions. CONCLUSIONS: The Group Health experience shows it is possible to reduce emergency department use with PCMH transformation across a diverse set of clinics using a clear change strategy (Lean) and sufficient resources and supports.

Primary care physician beliefs and practices regarding blood pressure measurement: results from BP-CHECK qualitative interviews.

BACKGROUND: Early identification and control of hypertension is critical to reducing cardiovascular disease events and death. U.S. Preventive Services Task Force guidelines recommend health care professionals screen all adults for hypertension, yet 1 in 4 adults with hypertension are unaware of their condition. This gap between guidelines and clinical practices highlights an important opportunity to improve blood pressure (BP) screening and hypertension diagnosis, including measurement outside of clinic settings. To identify targets for future diagnostic interventions, we sought to understand primary care physicians' (PCPs) beliefs and practices regarding use of common forms of BP measurement. METHODS: Study participants were PCPs (N = 27) who had patients enrolled in the BP-CHECK trial. The trial compared the accuracy of 24-h ambulatory BP monitoring (ABPM) to: 1) clinic-based monitoring, 2) home BP monitoring (HBPM), or 3) use of a BP kiosk in clinics or pharmacies. Physicians were interviewed by phone and compensated for their participation. Interviews were recorded, transcribed, and analyzed using a template analysis approach. RESULTS: Overall, PCPs preferred and trusted clinic BP measurement for diagnosing hypertension, particularly when measured with a manual sphygmomanometer. Concerns with HBPM included the belief that patients did not follow protocols for rest and body positioning at home, that home machines were not accurate, that home BPs could not be entered into the medical record, and that HBPM would make some patients anxious. Issues regarding kiosk measurement included beliefs that the public setting created stress for patients, that patients did not follow resting protocols when using kiosks, and concerns about the maintenance of these machines. ABPM was recognized as highly accurate but was not perceived as accessible. Additionally, some PCPs found it challenging to interpret the multiple readings generated by ABPM and HBPM, especially when these readings differed from clinic BPs. CONCLUSIONS: Our findings suggest that both additional physician education and training and investments in equipment and system-level processes are needed to increase the acceptance and utilization of out of office BP measurement for identification and treatment of hypertension. These changes are needed to improve ensure everyone in the U.S receive optimal care for hypertension. TRIAL REGISTRATION: ClinicalTrials.gov NCT03130257 . Initial registration date: 4/21/2017.

Automated Office Blood Pressure and the Impact of Attendance and Rest on Diagnostic Accuracy.

BACKGROUND: Automated office blood pressure (AOBP) using 3-5 measurements taken with an oscillometric device with or without an attendant in the room may decrease "white coat" effect. We evaluated the impact of the presence or absence of the attendant and rest on BP and diagnosis of hypertension. METHODS: We randomly assigned 133 adults aged 18-85 with high BP at baseline (≥140/90 mm Hg), no hypertensive diagnosis and no antihypertensive medications to either attended AOBP first, unattended second, or unattended AOBP first, attended second. Outcomes included within-person BP difference for attended vs. unattended measurements; 5 vs. 15 minutes of rest; and the diagnostic performance of AOBP compared with daytime automated blood pressure measurement (ABPM). RESULTS: We found no significant differences between attended and unattended AOBP (mean difference attended - unattended [95% confidence interval, CI], systolic 0.14 mm Hg [-0.78, 1.06]; diastolic 0.16 mm Hg [-0.45, 0.78]) or by rest time (mean difference 15 - 5 minutes [95% CI], systolic -0.45 mm Hg [-1.36, 0.47]; diastolic 0.61 mm Hg [-1.23, 0.003]). AOBP was lower than mean daytime ABPM, regardless of attendance or rest (after 5 minutes rest systolic -3.6 and diastolic -2.55 mm Hg, P = 0.001 for both comparisons). Using daytime ABPM of ≥135/85 mm Hg as the diagnostic threshold, AOBP sensitivity and specificity after 5 minutes of rest were 71.0% and 54.1%, respectively. CONCLUSIONS: The presence or absence of a clinic attendant during AOBP measurement and the amount of rest time before AOBP measurements had no effects on BP. AOBP measurements have low sensitivity and specificity for making a new diagnosis of hypertension.

Blood Pressure Checks for Diagnosing Hypertension: Health Professionals' Knowledge, Beliefs, and Practices.

INTRODUCTION: The US Preventive Services Task Force recommends out-of-office blood pressure (BP) measurement before making a new hypertension diagnosis and initiating treatment, using 24-hour ambulatory (ABPM) or home BP monitoring. However, this approach is not common. METHODS: e-mail-linked surveys were sent to primary care team members (n = 421) from 10 clinics. The sample included medical assistants, licensed practical nurses, registered nurses, and advanced practice registered nurses (LPN/RN/APRNs), physician assistants (PAs), and physicians. Those licensed to diagnosis hypertension (physician/PA/APRNs) received additional questions. Data were collected from November 2017 to July 2019. RESULTS: 2-thirds of invitees responded (163 MA/LPN/RNs, 86 physicians, and 33 PA/APRNs). When making a new hypertension diagnosis, most respondents believed that BP measured manually with a stethoscope (78.6%) or ABPM (84.2%) were very or highly accurate. In contrast, most did not believe that automated clinic BPs, home BP, or kiosk BP measurements were very or highly accurate. Almost all reported always or almost always relying on clinic BP measurements in making a diagnosis (95.7%), but most physician/PA/APRNs (60.5%) would prefer ABPM if it was readily available. Very few physician/PA/APRNs used the guideline-concordant diagnostic threshold (135/85 mmHg) with home monitoring (14.0%) or ABPM (8.4%), with 140/90 mmHg the most commonly reported threshold for home (59.4%) and ABPM (49.6%). DISCUSSION: Our study found health care professional knowledge, beliefs, and practices gaps in diagnosing hypertension. These gaps could lead to clinical care that is not aligned with guidelines. CONCLUSION: System changes and interventions to increase use of evidence-based practices could improve hypertension diagnosis and outcomes.

Understanding Patient and Clinical Stakeholder Perspectives to Improve Adherence to Lung Cancer Screening.

INTRODUCTION: Limited evidence-based implementation strategies exist for maintaining lung cancer screening. We evaluated the Lung Cancer Screening Program at Kaiser Permanente Washington (KPWA) to develop multilevel interventions to improve screening adherence. METHODS: We conducted a concurrent mixed-methods study 1) to measure adherence to repeat screening with low-dose computed tomography (LDCT); 2) to interview KPWA stakeholders to understand the Lung Cancer Screening Program; and 3) to conduct codesign workshops with KPWA members and researchers. We used descriptive statistics to describe adherence, and rapid qualitative data analysis for stakeholder interviews and workshops. RESULTS: Between 2015 and 2019, 2089 KPWA members had initial LDCT scans with negative, benign or short-interval follow-up results. Among those with sufficient follow-up, the proportion with on-time repeat screening after a negative LDCT was 26.4% after the initial scan, and increased to 43.1% on subsequent scans. Opportunities for health-care system improvement included clarification of clinical roles and responsibilities, care coordination across providers, ongoing training in lung cancer screening, and revising electronic health record tools. From patient perspectives, facilitators to repeat screening were making screening personalized and convenient; offering consistent messages and reminders in different modes; increasing patient knowledge about benefits, harms, and expectations of LDCT; and providing nonfinancial and financial incentives for adherence. From a storyboard exercise, we identified 10 design features for lung cancer screening interventions, including versatility of communication, social support, and knowledge. CONCLUSION: We identified clear gaps in adherence to lung cancer screenings, organizational and clinical barriers to care, and design features for patient-centered interventions to improve lung cancer screening in US settings.

Effect of Personalized Breast Cancer Risk Tool on Chemoprevention and Breast Imaging: ENGAGED-2 Trial.

Background: Limited evidence exists about how to communicate breast density-informed breast cancer risk to women at elevated risk to motivate cancer prevention. Methods: We conducted a randomized controlled trial evaluating a web-based intervention incorporating personalized breast cancer risk, information on chemoprevention, and values clarification on chemoprevention uptake vs active control. Eligible women aged 40-69 years with normal mammograms and elevated 5-year breast cancer risk were recruited from Kaiser Permanente Washington from February 2017 to May 2018. Chemoprevention uptake was measured as any prescription for raloxifene or tamoxifen within 12 months from baseline in electronic health record pharmacy data. Secondary outcomes included breast magnetic resonance imaging (MRI), mammography use, self-reported distress, and communication with providers. We calculated unadjusted odds ratios (ORs) using logistic regression models and mean differences using analysis of covariance models with 95% confidence intervals (CIs) with generalized estimating equations. Results: We randomly assigned 995 women to the intervention arm (n = 492) or control arm (n = 503). The intervention (vs control) had no effect on chemoprevention uptake (OR = 1.04, 95% CI = 0.07 to 16.62). The intervention increased breast MRI use (OR = 5.65, 95% CI = 1.61 to 19.74) while maintaining annual mammography (OR = 0.98, 95% CI = 0.75 to 1.28). Women in the intervention (vs control) arm had 5.67-times higher odds of having discussed chemoprevention or breast MRI with provider by 6 weeks (OR = 5.67, 95% CI = 2.47 to 13.03) and 2.36-times higher odds by 12 months (OR = 2.36, 95% CI = 1.65 to 3.37). No measurable differences in distress were detected. Conclusions: A web-based, patient-level intervention activated women at elevated 5-year breast cancer risk to engage in clinical discussions about chemoprevention, but uptake remained low.

Effect of a Randomized Trial of a Web-Based Intervention on Patient-Provider Communication About Breast Density.

Background: Breast density increases breast cancer risk and decreases mammographic detection. We evaluated a personalized web-based intervention designed to improve breast cancer risk communication between women and their providers. Materials and Methods: This was a secondary outcome analysis of an online randomized trial. Women aged 40-69 years were randomized, February 2017-May 2018, to a control (n = 503) versus intervention website (n = 492). The intervention website included information about breast density, personalized breast cancer risk, chemoprevention, and magnetic resonance imaging. Participants self-reported communication about density with providers (yes/no) at 6 weeks and 12 months. We used logistic regression with generalized estimating equations to evaluate the association of study arm with density communication. In secondary analyses, we tested if the intervention was associated with indicators of patient activation (breast cancer worry, perceived risk, or health care use). Results: Women (mean age 62 years) in the intervention versus control arm were 2.39 times (95% confidence interval [CI] = 1.37-4.18) more likely to report density communication at 6 weeks; this effect persisted at 12 months (odds ratio [OR] = 1.71, 95% CI = 1.25-2.35). At 6 weeks, this effect was only significant among women who reported (OR = 3.23, 95% CI = 1.24-8.40) versus did not report any previous density discussions (OR = 1.64, 95% CI = 0.83-3.26). A quarter of women in each arm never had a density conversation at any time during the study. Conclusions: Despite providing personalized density and risk information, the intervention did not promote density discussions between women and their providers who had not had them previously. This intervention is unlikely to be used clinically to motivate density conversations in women who have not had them before. Clinical trial registration number NCT03029286.

Characteristics Associated with Participation in ENGAGED 2 - A Web-based Breast Cancer Risk Communication and Decision Support Trial.

PURPOSE: We evaluated demographic and clinical characteristics associated with participation in a clinical trial testing the efficacy of an online tool to support breast cancer risk communication and decision support for risk mitigation to determine the generalizability of trial results. METHODS: Eligible women were members of Kaiser Permanente Washington aged 40-69 years with a recent normal screening mammogram, heterogeneously or extremely dense breasts and a calculated risk of > 1.67% based on the Breast Cancer Surveillance Consortium 5-year breast cancer risk model. Trial outcomes were chemoprevention and breast magnetic resonance imaging by 12-months post-baseline. Women were recruited via mail with phone follow-up using plain language materials notifying them of their density status and higher than average breast cancer risk. Multivariable logistic regression calculated independent odds ratios (ORs) for associations between demographic and clinical characteristics with trial participation. RESULTS: Of 2,569 eligible women contacted, 995 (38.7%) participated. Women with some college (OR = 1.99, 95% confidence interval [CI] 1.34-2.96) or college degree (OR = 3.35, 95% CI 2.29-4.90) were more likely to participate than high school-educated women. Race/ethnicity also was associated with participation (African-American OR = 0.50, 95% CI 0.29-0.87; Asian OR = 0.22, 95% CI 0.12-0.41). Multivariate adjusted ORs for family history of breast/ovarian cancer were not associated with trial participation. DISCUSSION: Use of plain language and potential access to a website providing personal breast cancer risk information and education were insufficient in achieving representative participation in a breast cancer prevention trial. Additional methods of targeting and tailoring, potentially facilitated by clinical and community outreach, are needed to facilitate equitable engagement for all women.

Blood pressure checks and diagnosing hypertension (BP-CHECK): Design and methods of a randomized controlled diagnostic study comparing clinic, home, kiosk, and 24-hour ambulatory BP monitoring.

BACKGROUND: The US Preventive Services Task Force recommends out-of-office blood pressure (BPs) before making a new diagnosis of hypertension, using 24-h ambulatory (ABPM) or home BP monitoring (HBPM), however this is not common in routine clinical practice. Blood Pressure Checks and Diagnosing Hypertension (BP-CHECK) is a randomized controlled diagnostic study assessing the comparability and acceptability of clinic, home, and kiosk-based BP monitoring to ABPM for diagnosing hypertension. Stakeholders including patients, providers, policy makers, and researchers informed the study design and protocols. METHODS: Adults aged 18-85 without diagnosed hypertension and on no hypertension medication with elevated BPs in clinic and at the baseline research visit are randomized to one of 3 regimens for diagnosing hypertension: (1) clinic BPs, (2) home BPs, or (3) kiosk BPs; all participants subsequently complete ABPM. The primary outcomes are the comparability (with daytime ABPM mean systolic and diastolic BP as the reference standard) and acceptability (e.g., adherence to, patient-reported outcomes) of each method compared to ABPM. Longer-term outcomes are assessed at 6-months including: patient-reported outcomes, primary care providers' diagnosis of hypertension; and BP control. We report challenges experienced and our response to these. RESULTS: Enrollment began in May of 2017 with a target of randomizing 510 participants. BP thresholds for diagnosing hypertension in the US changed after the trial started. We discuss the stakeholder process used to assess and respond to these changes. CONCLUSION AND PUBLIC HEALTH IMPACT: BP-CHECK will inform which hypertension diagnostic methods are most accurate, acceptable, and feasible to implement in primary care.

Vaginal, endometrial, and reproductive hormone findings: randomized, placebo-controlled trial of black cohosh, multibotanical herbs, and dietary soy for vasomotor symptoms: the Herbal Alternatives for Menopause (HALT) Study.

OBJECTIVE: To evaluate vaginal, endometrial, and reproductive hormone effects of three herbal regimens compared with placebo and hormone therapy (HT). DESIGN: This was a 1-year, randomized, double-blind, placebo-controlled trial of 351 women, ages 45 to 55, with two or more vasomotor symptoms per day. Women were randomly assigned to (1) black cohosh, (2) a multibotanical containing black cohosh, (3) the same multibotanical plus dietary soy counseling, (4) HT, or (5) placebo. Women were ineligible if they had used HT in the previous 3 months or menopausal herbal therapies in the previous month. Data on vaginal cytology and dryness were collected (at baseline and 3 and 12 mo). Daily menstrual diaries were maintained by 313 women with a uterus, and abnormal bleeding was evaluated. Serum estradiol, follicle-stimulating hormone, luteinizing hormone, and steroid hormone-binding globulin were assessed (baseline and 12 mo) among 133 postmenopausal women. Gynecologic outcomes of the five groups were compared. RESULTS: The five groups did not vary in baseline vaginal cytology profiles, vaginal dryness, menstrual cyclicity, or hormone profiles. The HT group had a lower percentage of parabasal cells and vaginal dryness than the placebo group at 3 and 12 months (P < 0.05). Abnormal bleeding occurred in 53 of 313 (16.9%) women. There were no differences in frequency of abnormal bleeding between any of the herbal and placebo groups, whereas women in the HT group had a greater risk than those in the placebo group (P < 0.001). Among postmenopausal women, HT significantly decreased follicle-stimulating hormone and increased estradiol; none of the herbal interventions showed significant effects on any outcomes at any time point. CONCLUSION: Black cohosh, used alone or as part of a multibotanical product with or without soy dietary changes, had no effects on vaginal epithelium, endometrium, or reproductive hormones.

Reprint of The Herbal Alternatives for Menopause (HALT) Study: background and study design.

We designed a randomized double-blind randomized trial to examine the short and long-term effects of alternative approaches commonly used to manage menopause symptoms. Women were randomly assigned to: (1) black cohosh 160 mg daily; (2) multibotanical (50 mg black cohosh, alfalfa, chaste tree, dong quai, false unicorn, licorice, oats, pomegranate, Siberian ginseng, boron) four capsules daily; (3) multibotanical plus telephone counseling to increase dietary soy; (4) conjugated equine estrogen 0.625 mg +/- 2.5 mg medroxyprogesterone acetate; or (5) placebo. Working with a skilled CAM provider helped us choose interventions that reflected naturopathic practices worthy of study. Mass mailing, with careful tracking and rapid responses to recruitment rates, was an effective and cost-effective recruitment strategy. Creativity was necessary to construct methods for blinding capsules and the dietary soy intervention. Independent testing of herbal products was vital to confirming their constituents. The Data and Safety and Monitoring Committee, and project officers at the funding agency, were critical partners in designing responses to unanticipated Women's Health Initiative findings published during the HALT trial. Careful monitoring of adverse events may provide much needed information about side effects of herbal products and supplements. Despite inherent challenges, the study of alternative therapies for menopause symptoms is a rewarding and important area deserving of further inquiry.

Evaluation of the Learning to Integrate Neighborhoods and Clinical Care Project: Findings from Implementing a New Lay Role into Primary Care Teams to Address Social Determinants of Health.

INTRODUCTION: Health systems increasingly recognize the impact of social determinants of health such as access to housing, transportation, and nutritious food. Lay health workers have been used to address patients' social determinants of health through resource referral and goal setting in targeted populations, such as individuals with diabetes. However, we know of no studies that evaluate this type of role for a general primary care population. OBJECTIVE: To assess the implementation and impact of the Community Resource Specialist (CRS) role in Kaiser Permanente Washington. METHODS: We analyzed data from staff interviews, patient focus groups, clinic site visits, patient surveys, the electronic health record, and administrative sources. RESULTS: Satisfaction with CRSs was high, with 92% of survey respondents choosing "very satisfied" or "somewhat satisfied." Of patients with a resource referral and follow-up encounter, 45% reported using the resource (n = 229) and 86% who set a goal and had a follow-up encounter (n = 218) progressed toward their goal. Primary care teams reported workload easing. Patients who used CRSs and participated in focus groups reported behavior changes and improved health, although no changes were detected from electronic health records or patient survey data. Key learnings include the need to clearly define the CRS role, ensure high visibility to clinical staff, and facilitate personal introductions of patients (warm handoffs). CONCLUSION: Adding an individual to the primary care team with expertise in community resources can increase patient satisfaction, support clinicians, and improve patients' perceptions of their health and well-being.