Qualitative Interviews to Add Patient Perspectives in Colorectal Cancer Screening: Improvements in a Learning Health System.

Health systems are interested in increasing colorectal cancer (CRC) screening rates as CRC is a leading cause of preventable cancer death. Learning health systems are ones that use data to continually improve care. Data can and should include qualitative local perspectives to improve patient and provider education and care. This study sought to understand local perspectives on CRC screening to inform future strategies to increase screening rates across our integrated health system. Health insurance plan members who were eligible for CRC screening were invited to participate in semi-structured phone interviews. Qualitative content analysis was conducted using an inductive approach. Forty member interviews were completed and analyzed. Identified barriers included ambivalence about screening options (e.g., "If it had the same performance, I'd rather do home fecal sample test. But I'm just too skeptical [so I do the colonoscopy]."), negative prior CRC screening experiences, and competing priorities. Identified facilitators included a positive general attitude towards health (e.g., "I'm a rule follower. There are certain things I'll bend rules. But certain medical things, you just got to do."), social support, a perceived risk of developing CRC, and positive prior CRC screening experiences. Study findings were used by the health system leaders to inform the selection of CRC screening outreach and education strategies to be tested in a future simulation model. For example, the identified barrier related to ambivalence about screening options led to a proposed revision of outreach materials that describe screening types more clearly.

Patient Experiences and Perceptions of Care Coordination in Primary Care.

BACKGROUND: Understanding patient perceptions of care coordination in primary care can help improve responsiveness to patients' needs, outcomes, and quality of care. PURPOSE: The purpose of this study was to explore patient experiences and perceptions of care coordination in primary care. METHOD: Interviews with 13 patients from 10 clinics were conducted and analyzed using directed content analysis. RESULTS: Three primary themes arose: care coordinators provide a gateway to accessing needed care; patients needed and valued the support and trusted advice of their care coordinators; and patients valued care coordinators' help with navigating, engaging, and educating them about their care. CONCLUSIONS: Understanding what patients value in care delivery can help frame a vision for a more responsive approach in delivering primary care, as well as create a pathway to quality improvement, moving toward a truly patient-centered focus in primary care.

In Their Own Words: Content Analysis of Open-Ended Survey Responses for a More Nuanced, Local Understanding of Mental Illness Stigma.

This content analysis seeks to extend what is already known in nursing and public health about the stigma attached to mental illness, and further understand the following evaluation question: How do members of communities targeted by Make It OK, a community initiative to reduce mental illness stigma, describe that stigma? The analysis of responses to open-ended questions included in a community-based survey followed deductive and inductive coding based on published frameworks and survey responses. The domains of stigma were categorized as actions toward people living with mental illness, beliefs about mental illness, and beliefs about people living with mental illness. These identified constructs build on the existing literature base of mental illness stigma in nursing and public health, illuminate the nuance of stigma, and can help tailor anti-stigma efforts.

The most common medications dispensed to lactating persons: An electronic health record-based approach.

PURPOSE: Using a novel, electronic health record (EHR)-based approach, to estimate the prevalence of prescription medication use at 2, 4, and 6 months postpartum among lactating individuals. METHODS: We utilized automated EHR data from a US health system that records infant feeding information at well-child visits. We linked mothers who received prenatal care to their infants born May 2018-June 2019, and we required infants to have ≥1 well-child visit between 31 and 90 days of life (i.e., 2-month well-child visit with a ±1 month window). Mothers were classified as lactating at the 2-month well-child visit if their infant received breast milk at the 2-month well-child visit. For subsequent well-child visits at 4 and 6 months, mothers were considered lactating if their infant was still receiving breast milk. RESULTS: We identified 6013 mothers meeting inclusion criteria, and 4158 (69.2%) were classified as lactating at the 2-month well-child visit. Among those classified as lactating, the most common medication classes dispensed around the 2-month well-child visit were oral progestin contraceptives (19.1%), selective serotonin reuptake inhibitors (8.8%), first generation cephalosporins (4.3%), thyroid hormones (3.5%), nonsteroidal anti-inflammatory agents (3.4%), penicillinase-resistant penicillins (3.1%), topical corticosteroids (2.9%), and oral imidazole-related antifungals (2.0%). The most common medication classes were similar around the 4 and 6-month well-child visits although prevalence estimates were often lower. CONCLUSIONS: Progestin-only contraceptives, antidepressants, and antibiotics were the most dispensed medications among lactating mothers. With routine collection of breastfeeding information, mother-infant linked EHR data may overcome limitations in previous studies of medication utilization during lactation. These data should be considered for studies of medication safety during lactation given the need for human safety data.

"I know my body better than you:" patient focus groups to inform a decision aid on oral corticosteroid use during pregnancy.

PURPOSE: There is unmet need for decision support regarding medication use during pregnancy. We aimed to inform the development of a decision aid on oral corticosteroid (OCS) use during pregnancy through focus groups. METHODS: We invited patients from one health system who had a recent live birth and a condition for which OCSs may be prescribed (ie, asthma or other autoimmune disease) to participate in focus groups. We conducted conventional qualitative content analysis of verbatim transcripts of the focus groups using inductive coding. RESULTS: There were 30 participants across five focus groups from May to June 2019. Women endorsed the need for patient-provider discussions about OCS use during pregnancy in which the provider shares risks and benefits and the patient makes her decision. Furthermore, women generally expressed support for patient-centered handouts about OCS use during pregnancy that the provider discusses with the patient. When considering whether to take OCSs in pregnancy, women had concerns about: the medication's impact on their baby (eg, miscarriage, birth defects, long-term effects), themselves (eg, effects on mood, sleep, weight gain), pregnancy complications (eg, preterm birth, increased blood pressure), and lactation. Women wanted information on OCSs (eg, indications, length of treatment, and cost), alternative treatments, and risks of not taking OCSs. CONCLUSIONS: We established patient need for a decision aid on OCS use during pregnancy that providers can discuss with patients. To address patient concerns, the aid should at a minimum describe the medication's impact on baby, including long-term effects, maternal health, pregnancy complications, and lactation.

Primary care physician perspectives on using team care in clinical practice.

BACKGROUND: Primary care physicians were prompted to refer eligible patients with uncontrolled hypertension (HTN) to a program that offered home blood pressure telemonitoring and pharmacist care management. Understanding attitudes, barriers and facilitators, and use of team care in this program provides insight into how physicians incorporate team care into their practice. OBJECTIVE: To understand physician attitudes and use of team care in the context of a study intervention that included telehealth care with pharmacist care management. METHODS: Clinicians who were part of the telehealth intervention arm of the Hyperlink 3 study and had at least 20 opportunities to refer an eligible patient with HTN to a clinical pharmacist were invited to be interviewed. Nine physician interviews were conducted, recorded, and transcribed. Each interview lasted approximately 30 minutes and followed an interview guide, allowing for some variation and deeper dives into content on the basis of the clinician response. Three research staff coded each interview and sorted coded text to identify patterns at the physician level and then identified themes across interviews using a comparative process. RESULTS: Physicians had an overall positive attitude about team care. Communication, access, trust, and perceived role competency of team members influenced physician engagement in team care. Individualized practice styles influenced how physicians used team care and which care team members they involved most often. All physicians felt that their individual style best achieved high-quality care. CONCLUSION: For health care teams to be most effective, an understanding of how a physician's practice style influences their use of team care is likely to be more successful than a one-size-fits-all approach. Incorporating practice style into the key factors necessary for high-functioning teams, such as communication, access, and trust, is necessary for health care teams to thrive.

Multicomponent Obesity Prevention Intervention in Low-Income Preschoolers: Primary and Subgroup Analyses of the NET-Works Randomized Clinical Trial, 2012-2017.

OBJECTIVES: To evaluate a multicomponent obesity prevention intervention among diverse, low-income preschoolers. METHODS: Parent-child dyads (n = 534) were randomized to the Now Everybody Together for Amazing and Healthful Kids (NET-Works) intervention or usual care in Minneapolis, MN (2012-2017). The intervention consisted of home visits, parenting classes, and telephone check-ins. The primary outcomes were adjusted 24- and 36-month body mass index (BMI). RESULTS: Compared with usual care, the NET-Works intervention showed no significant difference in BMI change at 24 (-0.12 kg/m2; 95% confidence interval [CI] = -0.44, 0.19) or 36 months (-0.19 kg/m2; 95% CI = -0.64, 0.26). Energy intake was significantly lower in the NET-Works group at 24 (-90 kcal/day; 95% CI = -164, -16) and 36 months (-101 kcal/day; 95% CI = -164, -37). Television viewing was significantly lower in the NET-Works group at 24 (rate ratio = 0.84; 95% CI = 0.75, 0.93) and 36 months (rate ratio = 0.88; 95% CI = 0.78, 0.99). Children with baseline overweight or obesity had lower BMI in the NET-Works group than those in usual care at 36 months (-0.71 kg/m2; 95% CI = -1.30, -0.12). Hispanic children had lower BMI in the NET-Works group than those in usual care at 36 months (-0.59 kg/m2; 95% CI = -1.14, -0.04). CONCLUSIONS: In secondary analyses, NET-Works significantly reduced BMI over 3 years among Hispanic children and children with baseline overweight or obesity. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01606891.

The dose of behavioral interventions to prevent and treat childhood obesity: a systematic review and meta-regression.

BACKGROUND: A better understanding of the optimal "dose" of behavioral interventions to affect change in weight-related outcomes is a critical topic for childhood obesity intervention research. The objective of this review was to quantify the relationship between dose and outcome in behavioral trials targeting childhood obesity to guide future intervention development. METHODS: A systematic review and meta-regression included randomized controlled trials published between 1990 and June 2017 that tested a behavioral intervention for obesity among children 2-18 years old. Searches were conducted among PubMed (Web-based), Cumulative Index to Nursing and Allied Health Literature (EBSCO platform), PsycINFO (Ovid platform) and EMBASE (Ovid Platform). Two coders independently reviewed and abstracted each included study. Dose was extracted as intended intervention duration, number of sessions, and length of sessions. Standardized effect sizes were calculated from change in weight-related outcome (e.g., BMI-Z score). RESULTS: Of the 258 studies identified, 133 had sufficient data to be included in the meta-regression. Average intended total contact (# sessions x length of sessions) was 27.7 (SD 32.2) hours and average duration was 26.0 (SD 23.4) weeks. When controlling for study covariates, a random-effects meta-regression revealed no significant association between contact hours, intended duration or their interaction and effect size. CONCLUSIONS: This systematic review identified wide variation in the dose of behavioral interventions to prevent and treat pediatric obesity, but was unable to detect a clear relationship between dose and weight-related outcomes. There is insufficient evidence to provide quantitative guidance for future intervention development. One limitation of this review was the ability to uniformly quantify dose due to a wide range of reporting strategies. Future trials should report dose intended, delivered, and received to facilitate quantitative evaluation of optimal dose. TRIAL REGISTRATIONS: The protocol was registered on PROSPERO (Registration # CRD42016036124 ).

Feasibility of standardized methods to specify behavioral pediatric obesity prevention interventions.

Standardized methods are needed to evaluate what occurs within the 'black box' of behavioral interventions to prevent pediatric obesity. The purpose of this research is to evaluate methods to specify the behavior change techniques used and the amount of time spent discussing target weight-related behaviors in an intervention for parents of children at risk for becoming overweight or obese. Independent coders were trained to identify behavior change techniques and time spent discussing weight-related behaviors in audio recordings and transcripts of intervention sessions from 100 randomly selected participants. The behavior change technique taxonomy (BCTTv1) was used to code techniques present in sessions. A newly-developed tool was used to code time spent discussing each target weight-related behavior (e.g., physical activity, screen time). Sessions from a subset of these participants (N = 20) were double coded to evaluate inter-rater reliability. After revisions to coding protocols, coders reliably coded behavior change techniques used and time spent discussing target weight-related behaviors in sessions from the subset of 20 participants. The most commonly discussed target weight-related behavior was physical activity followed by energy intake and fruit and vegetable intake. On average, 13.9 (SD = 2.8) unique behavior change techniques were present across sessions for a given participant. These results offer reliable methods for systematically identifying behavior change techniques used and time spent discussing weight-related behaviors in a pediatric obesity prevention intervention. This work paves the way for future research to identify which specific target behaviors and techniques are most associated with the prevention of unhealthy weight gain in children.

Predicting dietary intake among children classified as overweight or at risk for overweight: Independent and interactive effects of parenting practices and styles.

Using baseline data from a randomized controlled pediatric obesity prevention trial, this study sought to examine general parenting style as a potential moderator of the association between feeding-specific parenting practices and child dietary intake. Four hundred and twenty-one parent-child dyads served as participants (49% girls and 93% mothers). Children were, on average, 6.6 years old and either overweight or at-risk for overweight (mean BMI percentile = 84.9). Data were collected in participants' homes. Study staff measured children's height and weight. Parents completed questionnaires designed to assess general parenting styles (authoritative, authoritarian and permissive) and child feeding practices (restriction and monitoring). Child dietary intake was assessed using a 24-h recall system. Outcomes were daily servings of fruits and vegetables, sugar-sweetened beverages (SSB), and unhealthy snacks. Results were as follows: Permissive parenting was inversely associated with fruit and vegetable consumption, and parental monitoring was inversely associated with SSB consumption. There were no other main effects of parenting style or feeding practice on child dietary consumption. Authoritarian parenting moderated the association between restriction and SSB intake (a marginally significant effect after correcting for multiple comparisons). Restriction was inversely associated with SSB consumption when authoritarianism was high but unassociated with SSB consumption when authoritarianism was low. Findings indicate that the parenting practice of monitoring child dietary intake was associated with more healthful consumption regardless of parenting style; interventions may thus benefit from encouraging parental monitoring. The parenting strategy of restricting child dietary intake, in contrast, was associated with lower SSB intake in the context of higher parental authoritarianism but inconsequential in the context of lower parental authoritarianism. This exploratory finding warrants further investigation.

Evidence to support health system prioritization of health behaviors in the COVID-19 era.

BACKGROUND: Since the COVID-19 pandemic health systems have shifted necessarily from chronic to infectious disease treatment, but chronic disease remains critical. One large health system uniquely tracks member health behaviors. This analysis compares data from select months of an ongoing monthly cross-sectional survey before and during the pandemic. METHODS: Responses in April 2019 (pre-pandemic), April 2020 (early pandemic) or April 2021 (later pandemic) were included in the primary analysis (N = 252). Differences in meeting health behavior guidelines were analyzed via logistic regression. RESULTS: A significant decline was seen for physical activity (19% not meeting guidelines pre-pandemic vs. 41% later pandemic) but not fruit/vegetable, alcohol, or sleep from early to later pandemic. Prevalence of women not meeting tobacco guidelines increased from early (5%) to later pandemic (10%) while prevalence in men decreased (10% vs 4% respectively). The percent of people not thinking about the good things that happen to them fluctuated closely with reports of new COVID-19 cases. CONCLUSIONS: Findings show the nuance of changing health behaviors throughout the pandemic. Results should be used by health systems to tailor support based on insights from the pandemic experience.

"I'm Torn": Qualitative Analysis of Dental Practitioner-Perceived Barriers, Facilitators, and Solutions to HPV Vaccine Promotion.

The human papillomavirus (HPV) vaccine can prevent HPV-related oropharyngeal cancers. Dental practitioners are uniquely positioned to promote HPV vaccines during routine dental care but experience barriers to doing so. Qualitative interviews were conducted with dental practitioners to understand barriers and inform intervention strategies to promote HPV vaccines. Dental practitioners were invited to participate in phone interviews about knowledge, self-efficacy, and the fear of negative consequences related to HPV vaccine promotion as well as feedback on potential interventions to address these barriers. Interviews were audio recorded, transcribed, and analyzed using rapid qualitative analysis with a sort-and-sift matrix approach. Interviews were completed with 11 practitioners from six dental clinics (avg. 31 min). Though most thought HPV vaccination was important, they lacked detailed knowledge about when and to whom the vaccine should be recommended. This led to a hypothesized need for discussions of sexual history, feelings of limited self-efficacy to make the recommendation, and fear of patient concerns. Still, practitioners were supportive of additional training opportunities and provided input into specific interventions. The nuance of how these barriers were described by practitioners, as well as the possible solutions they identified, will help shape future interventions supporting HPV vaccine promotion in dental care.

Survey-based Evaluation of a Fish Consumption Information Dissemination Campaign Within an Integrated Health System: Learnings From ChooseYourFish.

INTRODUCTION/OBJECTIVES: Safe fish consumption is important for people who are or could become pregnant. A health system in Minnesota partnered with the Minnesota Department of Health to develop and disseminate messages to promote safe fish consumption for this population via the ChooseYourFish initiative. The ChooseYourFish message was delivered through 5 channels: the Healthy Pregnancy Program (HPP) with phone-based coaching, a clinic brochure, in the clinic after visit summary (AVS), direct mailing of the brochure with a letter, and in images on clinic waiting room monitors. METHODS: We designed a pragmatic evaluation to understand the likelihood that each channel would result in awareness of the message and increase a recipient's intent to act on the information. We surveyed 1050 women aged 18 to 40 in March-May 2020. Results are reported with descriptive statistics. RESULTS: The survey was completed by 524 respondents (51%). Respondents receiving the ChooseYourFish message through any channel except clinic monitors reported a higher awareness of recommendations about eating fish (42%-56%) than respondents in the no-message comparison group (21%). The after visit summary and Healthy Pregnancy Program channels had more confidence in following recommendations (50%-54%) and showed more intention to eat fish (61%-62%) compared to lower-intensity channels (24%-31% and 19%-32%, respectively). CONCLUSIONS: Messages delivered by an often-trusted source (eg, healthcare provider) were more likely to increase confidence and intent. Despite the trend toward online health information, physical brochures still have large reach. Repetition of exposure may be important. Because all communication channels have advantages and drawbacks, using multiple delivery channels is appropriate in communication campaigns.

The Impact of COVID-19 on Patients Receiving Care Coordination in Primary Care: A Qualitative Study.

INTRODUCTION: Care coordination addresses the needs of patients with complex chronic illness and psychosocial issues, coordinating their care and social needs. It is not known how such patients receiving these services managed during the COVID-19 pandemic. The objective of this study was to learn how the health, health care, social needs, and finances of patients receiving care coordination were affected by the disruptions caused by the COVID-19 pandemic. METHOD: We conducted semistructured interviews with 19 patients receiving care coordination in primary care across a statewide sample about how the COVID-19 pandemic affected their life in general, including their overall health, social connections, finances and employment, and mental health. A content analysis approach was applied in the data analysis. RESULTS: We identified 4 primary themes in patient interviews including: (1) patients reported few to no impacts on their physical health status or health care services; (2) patients felt disconnected from family, friends, and community in ways that affected their mental health and wellbeing; (3) there were little to no pandemic related impacts for those on fixed incomes or government supports; and (4) care coordinators provided a significant and reliable source of help, support, and comfort. CONCLUSIONS: Care coordination provided a supporting framework for the health and the health care needs of these patients, helping them navigate resources and maintain their physical health during the pandemic. Care coordinators were seen as providing needed communication, connection, and support that was especially needed during a time of social isolation and disconnection.

America's Racial Reckoning Within Perinatal Communication: A Rapid Review Using Sociotechnical Systems Theory to Compare Publications Before and After 2020.

Perinatal communication is one factor driving racial disparities in maternal and infant morbidity. The murder of George Floyd in May 2020, in addition to the disproportionate impacts of the Covid-19 pandemic on communities of color, was a catalyst for American society to address racial injustices with a renewed sense of urgency. Drawing upon sociotechnical systems (STS) theory, this rapid review describes changes in the literature regarding the organizational, social, technical, and external subsystems that affect communication between perinatal providers and their Black patients. The goal of this work is to support health system optimization of health communication initiatives and, as a result, improve patient experience and parent and child outcomes. As part of a multi-year project designed to improve health communications about safe fish consumption during pregnancy, and in response to racial disparities among our health system's patient population related to receipt of nutrition messages during prenatal visits, we conducted a rapid review of literature on Black parents' experience of all communication while receiving perinatal care. A search of PubMed identified relevant articles published in English since 2000. Articles were screened to include articles that focused on Black people receiving perinatal care. Article content was then coded using deductive content analysis guided by STS theory to inform healthcare system improvement efforts. Differences in the prevalence of codes pre- and post-2020 are compared using chi-square statistics. The search in PubMed yielded 2419 articles. After screening, 172 articles were included in the rapid review. There was an increased recognition of communication as a key component of quality perinatal care after 2020 (P = .012) and of the limitations of standardized technical communication (P = .002) after 2020. Emerging literature suggests improving perinatal health communication and relationships with Black parents would address disparities in perinatal patient and baby outcomes. Healthcare systems must address the racial disparities in maternal and child outcomes. Since 2020, public attention and published research on this issue has increased. Understanding perinatal communication using STS theory aligns subsystems in service of racial justice.

Care coordination in primary care: mapping the territory.

OBJECTIVE: To document the current approaches to care coordination among different types of care systems in Minnesota. STUDY DESIGN: Observational survey of leaders of most of the care systems in Minnesota that have implemented care coordination. METHODS: Survey questions about organizational structure, size, and approach to care coordination were sent to the leaders of 42 care systems with a total of 327 primary care clinics. RESULTS: Surveys were completed by leaders at every care system participating in this study (100% response rate); 16 small care systems (each with 1-2 clinics) had a total of 26 primary care clinics, 15 medium care systems (3-9 clinics) had 57 clinics, and 11 large care systems (> 9 clinics) had 244 clinics. The large care systems had larger clinics (clinicians per clinic, 8.6 in large vs 4.3 in small and 5.2 in medium; P = .03) and more clinicians per care coordinator (5.7 vs 3.3 and 4.0; P = .04). They also more frequently included a social worker in their care coordination team: 82% vs 25% of small and 40% of medium care systems (P = .01). However, the services provided and complexity tools used were similar. Nearly all reported addressing both medical and social needs for their complex patients with multiple chronic conditions. CONCLUSIONS: Although there are large differences in resources and capabilities between large and small care systems, they were not associated with much difference in the approach taken to care coordination. This map of the care coordination territory in Minnesota has the potential to be valuable to researchers and care system leaders for understanding current implementation trends and directing further evaluations.

Behaviors, Beliefs, and Recommendations to Optimize Promotion of Safe Fish Consumption Before and During Pregnancy: A Physician Survey.

INTRODUCTION: Eating fish before and during pregnancy is important but care must be taken to choose fish which maximize developmental outcomes. Physicians, a trusted health information source, could provide this nuanced communication. This cross-sectional survey of a representative sample of 400 family medicine and obstetrics and gynecology (OB-GYN) physicians in Minnesota was designed to understand physician behaviors and beliefs about safe fish consumption, describe barriers to physician-patient conversations about safe fish consumption generally and as part of prenatal care and to identify resources to help facilitate conversations on this topic. METHODS: Data was collected January to April 2020. Two hundred nineteen surveys were completed (55% response rate) with 194 reporting seeing patients at least 1 day a week. Descriptive survey results from all were summarized and analyzed overall and by physician specialty. Responses to 3 open-ended questions were thematically coded to enrich the quantitative results. RESULTS: While 62% of these reported discussing nutrition topics, only about one-third reported discussing with patients the benefits and about one-quarter the risks of eating fish. Despite the relative infrequency of fish discussions, almost all (>90%) respondents agreed that it is important to discuss fish consumption with people who are or may become pregnant. The largest reported barrier to these conversations was time (82%), and the most endorsed resource to overcome identified barriers was talking points (72%). CONCLUSIONS: Because physicians report limited time, resources that facilitate fish consumption should be succinct while serving to both nudge the message and direct clinicians and their patients to robust information.

Comparison of explanatory and pragmatic design choices in a cluster-randomized hypertension trial: effects on enrollment, participant characteristics, and adherence.

BACKGROUND: Explanatory trials are designed to assess intervention efficacy under ideal conditions, while pragmatic trials are designed to assess whether research-proven interventions are effective in "real-world" settings without substantial research support. METHODS: We compared two trials (Hyperlink 1 and 3) that tested a pharmacist-led telehealth intervention in adults with uncontrolled hypertension. We applied PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) scores to describe differences in the way these studies were designed and enrolled study-eligible participants, and the effect of these differences on participant characteristics and adherence to study interventions. RESULTS: PRECIS-2 scores demonstrated that Hyperlink 1 was more explanatory and Hyperlink 3 more pragmatic. Recruitment for Hyperlink 1 was conducted by study staff, and 2.9% of potentially eligible patients enrolled. Enrollees were older, and more likely to be male and White than non-enrollees. Study staff scheduled the initial pharmacist visit and adherence to attending this visit was 98%. Conversely for Hyperlink 3, recruitment was conducted by clinic staff at routine encounters and 81% of eligible patients enrolled. Enrollees were younger, and less likely to be male and White than non-enrollees. Study staff did not assist with scheduling the initial pharmacist visit and adherence to attending this visit was only 27%. Compared to Hyperlink 1, patients in Hyperlink 3 were more likely to be female, and Asian or Black, had lower socioeconomic indicators, and were more likely to have comorbidities. Owing to a lower BP for eligibility in Hyperlink 1 (>140/90 mm Hg) than in Hyperlink 3 (>150/95 mm Hg), mean baseline BP was 148/85 mm Hg in Hyperlink 1 and 158/92 mm Hg in Hyperlink 3. CONCLUSION: The pragmatic design features of Hyperlink 3 substantially increased enrollment of study-eligible patients and of those traditionally under-represented in clinical trials (women, minorities, and patients with less education and lower income), and demonstrated that identification and enrollment of a high proportion of study-eligible subjects could be done by usual primary care clinic staff. However, the trade-off was much lower adherence to the telehealth intervention than in Hyperlink 1, which is likely to reflect uptake under real-word conditions and substantially dilute intervention effect on BP. TRIAL REGISTRATION: The Hyperlink 1 study (NCT00781365) and the Hyperlink 3 study (NCT02996565) are registered at ClinicalTrials.gov.

Comparing Pharmacist-Led Telehealth Care and Clinic-Based Care for Uncontrolled High Blood Pressure: The Hyperlink 3 Pragmatic Cluster-Randomized Trial.

BACKGROUND: A team approach is one of the most effective ways to lower blood pressure (BP) in uncontrolled hypertension, but different models for organizing team-based care have not been compared directly. METHODS: A pragmatic, cluster-randomized trial compared 2 interventions in adult patients with moderately severe hypertension (BP≥150/95 mm Hg): (1) clinic-based care using best practices and face-to-face visits with physicians and medical assistants; and (2) telehealth care using best practices and adding home BP telemonitoring with home-based care coordinated by a clinical pharmacist or nurse practitioner. The primary outcome was change in systolic BP over 12 months. Secondary outcomes were change in patient-reported outcomes over 6 months. RESULTS: Participants (N=3071 in 21 primary care clinics) were on average 60 years old, 47% male, and 19% Black. Protocol-specified follow-up within 6 weeks was 32% in clinic-based care and 27% in telehealth care. BP decreased significantly during 12 months of follow-up in both groups, from 157/92 to 139/82 mm Hg in clinic-based care patients (adjusted mean difference -18/-10 mm Hg) and 157/91 to 139/81 mm Hg in telehealth care patients (adjusted mean difference -19/-10 mm Hg), with no significant difference in systolic BP change between groups (-0.8 mm Hg [95% CI, -2.84 to 1.32]). Telehealth care patients were significantly more likely than clinic-based care patients to report frequent home BP measurement, rate their BP care highly, and report that BP care visits were convenient. CONCLUSIONS: Telehealth care that includes extended team care is an effective and safe alternative to clinic-based care for improving patient-centered care for hypertension. REGISTRATION: URL: https://www. CLINICALTRIALS: gov; Unique identifier: NCT02996565.

Pragmatic Evaluation of a Health System-Based Employee Weight Management Program.

Objective: We aimed to evaluate the fidelity and estimate the effectiveness of a novel health system employee weight-management program. Methods: Employees participating in a weight loss program consisting of self-monitoring, health coaching and meal replacements optionally enrolled in the 12-month study. Longitudinal, single-arm analyses were conducted evaluating change over time via survey, claims and programmatic data. Token participation incentives were offered for survey completion. Results: In total, 140 participants enrolled (51.2 ± 9.8 years; BMI = 33.2 ± 6.5 kg/m2; 89.3% female). During 1 year, participants attended 18.0 ± 12.2 coaching appointments and self-reported significant improvements in weight (-8.2 ± 10.5% body weight), BMI (-3.9 ± 6.5 kg/m2), fruit/vegetable intake, home food preparation, added sugar, sugar sweetened beverages and life satisfaction (all p < 0.05). No significant changes were reported in physical activity, weight-related social support, self-efficacy or healthcare utilization (all p > 0.05). Conclusions: The findings from this evaluation establish implementation fidelity. Clinically significant self-reported weight loss, coupled with improvements in many weight-related behaviors, suggest the program is an effective weight management tool when offered as an employee well-being program.