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In the United States, adherence for cervical cancer screening decreased from 86% to 77% between 2005 and 2019. Over 50% of cervical cancers are diagnosed in individuals overdue for screening, and promoting access and adherence is essential. Unlike traditional Papanicolaou testing, human papillomavirus (HPV) screening can use self-collected samples, which have comparable sensitivity and specificity to clinician-collected samples. Self-collecting has been shown to increase screening adherence, possibly by circumventing important barriers such as scheduling clinic appointments and negativity about pelvic examinations. Despite this, most individuals in prior studies remained unscreened with low follow-up of HPV-positive results, and kit uptake among populations that are screening adherent or have unknown screening history is unknown.The STEP trial (self-testing options in the era for primary HPV screening for cervical cancer) was a parallel, single-blind, randomized clinical trial comparing cervical cancer screening completion across groups of individuals with due (screening-adherent), overdue, or unknown screening history. Participants were randomized to traditional care (patient reminders and clinician electronic health record [HER] alerts), education (usual care plus educational materials about screening), direct mail (traditional care plus educational materials plus a mailed HPV self-collection kit), or to opt in (traditional care plus educational materials plus the option to request a self-collection kit). Patients were identified using the Kaiser Permanente Washington HER and administrative claims. Eligible participants were females aged 30 to 64 years with current Kaiser Permanente Washington insurance and primary care, intact cervix, who were either due or overdue for screening. The primary study outcome was screening completion within 6 months after randomization, which could be done either in clinic or using the self-collection kit. Modified Poisson regression was used to estimate relative risk (RR) of screening completion for the direct-mail and opt-in groups, relative to the education group.A total of 32,771 participants were randomized between November 2020 and January 2022, of which 13,356 were due for screening, 8682 were overdue, and 10,733 had unknown screening history. Of those due for screening, the RR for screening completion was 1.30 (95% confidence interval [CI], 1.23–1.36; absolute difference, 14.1% [95% CI, 11.2%–16.9%]) for direct mail and 1.07 (95% CI, 1.02–1.12; absolute difference, 3.5% [95% CI, 1.2%–5.7%]) for the opt-in group compared with education. Of those overdue for screening, the RR for screening completion was 1.90 (95% CI, 1.68–2.16; absolute difference 16.9% [95% CI, 13.8%–20.0%]) for direct mail compared with education. Of those with unknown screening history, the RR for screening completion was 1.14 (95% CI, 1.03–1.25; absolute difference 2.2% [95% CI, 0.5%–3.9%]) for the opt-in group compared with education.The results of this randomized controlled trial showed that directly mailing HPV self-collection kits increased cervical cancer screening by over 14% compared with education alone. The effect was similar between participants that were due or overdue for screening, and an opt-in approach was found to minimally increase screening.

Purpose: To explore financial incentives as an intervention to improve colorectal cancer screening (CRCS) adherence among traditionally disadvantaged patients who have never been screened or are overdue for screening.Approach: We used qualitative methods to describe patients’ attitudes toward the offer of incentives, plans for future screening, and additional barriers and facilitators to CRCS.Setting: Kaiser Permanente Washington (KPWA).Participants: KPWA patients who were due or overdue for CRCS.Method: We conducted semi-structured qualitative interviews with 37 patients who were randomized to 1 of 2 incentives (guaranteed $10 or a lottery for $50) to complete CRCS. Interview transcripts were analyzed using a qualitative content approach.Results: Patients generally had positive attitudes toward both types of incentives, however, half did not recall the incentive offer at the time of the interview. Among those who recalled the offer, 95% were screened compared to only 25% among those who did not remember the offer. Most screeners stated that staying healthy was their primary motivator for screening, but many suggested that the incentive helped them prioritize and complete screening.Conclusions: Incentives to complete CRCS may help motivate patients who would like to screen but have previously procrastinated. Future studies should ensure that the incentive offer is noticeable and shorten the deadline for completion of FIT screening.

Screening rates for colorectal cancer (CRC) remain low, especially among certain populations. Mailed fecal immunochemical testing (FIT) outreach initiated by U.S. health plans could reach underserved individuals, while solving CRC screening data and implementation challenges faced by health clinics. We report the models and motivations of two health insurance plans implementing a mailed FIT program for age-eligible U.S. Medicaid and Medicare populations. One health plan operates in a single state with ~220,000 enrollees; the other operates in multiple states with ~2 million enrollees. We conducted in-depth qualitative interviews with key stakeholders and observed leadership and clinic staff planning during program development and implementation. Interviews were transcribed and coded using a content analysis approach; coded interview reports and meeting minutes were iteratively reviewed and summarized for themes. Between June and September 2016, nine participants were identified, and all agreed to the interview. Interviews revealed that organizational context was important to both organizations and helped shape program design. Both organizations were hoping this program would address barriers to their prior CRC screening improvement efforts and saw CRC screening as a priority. Despite similar motivations to participate in a mailed FIT intervention, contextual features of the health plans led them to develop distinct implementation models: a collaborative model using some health clinic staffing versus a centralized model operationalizing outreach primarily at the health plan. Data are not yet available on the models' effectiveness. Our findings might help inform the design of programs to deliver mailed FIT outreach.

The Hyperlink trial tested a 12-month intervention of home blood pressure (BP) telemonitoring with pharmacist case management in adults with uncontrolled hypertension. The intervention resulted in improved BP control compared with usual care at both 6 (72% vs. 45%; P< 0.001) and 12 months (71% vs. 53%; P = 0.005). We sought to investigate factors contributing to intervention success.

IMPORTANCE: Approximately 24 million US individuals receive care at federally qualified health centers, which historically have low rates of colorectal cancer screening. The US Preventive Services Task Force recommends routine colorectal cancer screening for individuals aged 50 to 75 years. OBJECTIVE: To determine the effectiveness of an electronic health record (EHR)-embedded mailed fecal immunochemical test (FIT) outreach program implemented in health centers as part of standard care. DESIGN, SETTING, AND PARTICIPANTS: This cluster randomized pragmatic clinical trial was conducted in 26 federally qualified health center clinics, representing 8 health centers in Oregon and California, randomized to intervention (n = 13) or usual care (n = 13). All participants were overdue for colorectal cancer screening during the accrual interval (February 4, 2014 to February 3, 2015). INTERVENTIONS: Electronic health record-embedded tools to identify eligible adults and to facilitate implementation of a stepwise mailed intervention involving (1) an introductory letter, (2) a mailed FIT, and (3) a reminder letter; training, collaborative learning, and facilitation through a practice improvement process. MAIN OUTCOMES AND MEASURES: Effectiveness was measured as clinic-level proportions of adults who completed a FIT, and secondarily, any colorectal cancer screening within 12 months of accrual or by August 3, 2015. Implementation was measured as clinic-level proportions of adults who were mailed an introductory letter and ordered a FIT. RESULTS: Twenty-six clinics with 41 193 adults (mean [SD] age, 58.5 [6.3] years; 22 994 women) were randomized to receive the direct mail colorectal screening intervention (13 clinics; 21 134 patients) or usual care (13 clinics; 20 059 patients). Compared with usual care clinics, intervention clinics had significantly higher adjusted clinic-level proportion of participants who completed a FIT (13.9% vs 10.4%; difference, 3.4 percentage points; 95% CI, 0.1%-6.8%) and any colorectal cancer screening (18.3% vs 14.5%; difference, 3.8 percentage points; 95% CI, 0.6%-7.0%). We observed large variation across health centers in effectiveness (FIT completion differences range, −7.4 percentage points to 17.6 percentage points) and implementation (proportion who were mailed a FIT range, 6.5% to 68.2%). The number needed to mail to achieve a completed FIT was 4.8 overall, and 4.0 in clinics that mailed a FIT reminder. CONCLUSIONS AND RELEVANCE: An EHR-embedded mailed FIT outreach intervention significantly improved rates of FIT completion and rates of any colorectal cancer screening. Higher rates of colorectal cancer screening occurred in clinics that successfully implemented the mailed outreach program. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01742065

Little is known about the challenges faced by community clinics who must address clinical priorities first when participating in pragmatic studies. We report on implementation challenges faced by the eight community health centers that participated in Strategies and Opportunities to STOP Colon Cancer in Priority Populations (STOP CRC), a large comparative effectiveness cluster-randomized trial to evaluate a direct-mail program to increase the rate of colorectal cancer (CRC) screening. We conducted interviews, at the onset of implementation and 1 year later, with center leaders to identify challenges with implementing and sustaining an electronic medical record (EMR)-driven mailed program to increase CRC screening rates. We used the Consolidated Framework for Implementation Research to thematically analyze the content of meeting discussions and identify anticipated and experienced challenges. Common early concerns were patients' access to colonoscopy, patients' low awareness of CRC screening, time burden on clinic staff to carry out the STOP CRC program, inability to accurately identify eligible patients, and incompatibility of the program's approach with the patient population or organizational culture. Once the program was rolled out, time burden remained a primary concern and new organizational capacity and EMR issues were raised (e.g., EMR staffing resources and turnover in key leadership positions). Cited program successes were improved CRC screening processes and rates, more patients reached, reduced costs, and improved patient awareness, engagement, or satisfaction. These findings may inform any clinic considering mailed fecal testing programs and future pragmatic research efforts in community health centers.

Access to care significantly improved following the implementation of the Patient Protection and Affordable Care Act. Since its implementation, the number of uninsured Americans has significantly decreased. Medicaid expansion played an important role in community health centers, who serve historically marginalized populations, leading to increased clinic revenue, and improved access to care. As the continuous Medicaid enrollment provision established during the pandemic ended, and states have to make decisions about their program eligibility, exploring the impact of Medicaid expansion on the detection, and management of hypertension and diabetes could inform these decisions. We summarized the effect of Medicaid expansion on community health centers and their patients specific to hypertension and diabetes from existing literature. These studies suggest the beneficial impact of the Affordable Care Act and acquiring insurance on diabetes and hypertension disease detection, treatment, and control for patients receiving care in community health centers. Overall, these studies suggest the clear importance of health insurance coverage, and notably insurance stability, on diabetes and hypertension control.

•Study patients on average had blood pressure (BP) >150/100 mmHg.•BP declined overall by 21.7 mmHg systolic and 11.1 mmHg diastolic from 2012 to 2017.•Systolic BP decreased slightly more among publicly insured than among noninsured patients.•BP control was greater for public or commercially insured than for noninsured patients.•Neighborhood-level social deprivation was not associated with BP reduction/control.

Embedded pragmatic clinical trials (ePCTs) and quality improvement (QI) activities often occur simultaneously within healthcare systems (HCSs). Embedded PCTs within HCSs are conducted to test interventions and provide evidence that may impact public health, health system operations, and quality of care. They are larger and more broadly generalizable than QI initiatives, and may generate what is considered high-quality evidence for potential use in care and clinical practice guidelines. QI initiatives often co-occur with ePCTs and address the same high-impact health questions, and this co-occurrence may dilute or confound the ability to detect change as a result of the ePCT intervention.

Three hundred seventy-six infertile women in whom there was evidence of ovulatory dysfunction were compared to fertile controls to determine if being excessively under or overweight at the time of planned conception was associated with an increased risk of infertility. In nulligravid women (n=204), body weight for height 85% or less than “ideal” was associated with a 4.7-fold increase in risk (95% confidence interval=1.5 to 14.7) of infertility associated with ovulatory dysfunction. Nulligravid women who were 120% or more over their ideal weight were also at increased risk for ovulatory infertility (relative risk=2.1, 95% confidence interval=1.0 to 4.3). Neither association was seen among women who had been previously pregnant. The presence of abnormalities of endocrinologic reproductive function in underweight and overweight women argues that the associations we have noted in nulligravid women represent cause-and-effect relationships. If so, we estimate that 6% of primary infertility in which ovulatory dysfunction is present results from being excessively underweight, and another 6% from being excessively overweight.

Background Follow-up colonoscopy after a positive fecal immunochemical test (FIT) is necessary for colorectal cancer (CRC) screening to be effective. We report colonoscopy follow-up rates after a positive FIT overall and by population characteristics in the BeneFIT demonstration pilot, a Medicaid health insurance plan-delivered mailed FIT outreach program.Methods In 2016, 2 health insurance plans in Oregon and in Washington state mailed FIT kits to Medicaid patients who, based on claims data, were overdue for CRC screening. We report follow-up colonoscopy completion rates after positive FIT, and differences in completion rates by age, sex, race, ethnicity, preferred language, and number of primary care visits in the prior year. This research was human subjects approved with a waiver of consent for data collection.Results The FIT positivity rates in Health Plan Oregon and Health Plan Washington were 7.9% (39/488) and 14.6% (125/857), respectively. Colonoscopy completion rates within 12 months of the positive test were 35.9% (14/41) in Health Plan Oregon and 32.8% (41/125) in Health Plan Washington. Colonoscopy completion rates were higher among individuals who preferred a language other than English (Non-English speakers 70.0%, English speakers 31.3%, P= .04).Conclusion In a health plan-delivered mailed FIT outreach program, follow-up colonoscopy rates after a positive test were low. Additional interventions are needed to assure colonoscopy after a positive FIT test and to reap the benefits of screening.

Introduction:Uncontrolled hypertension is a leading contributor to cardiovascular (CV) disease. We previously reported that home blood pressure (BP) telemonitoring and pharmacist management intervention lowered BP more than usual care for 24 months.Hypothesis:The intervention group will have fewer CV events and lower costs over 5 years of follow-up.Methods:The Hyperlink trial randomized 16 primary care clinics with 450 patients with uncontrolled hypertension to Telemonitoring Intervention (TI, n=228) or usual care (UC, n=222). CV events were confirmed by medical records review by blinded adjudicators. The primary endpoint included non-fatal myocardial infarction (MI), non-fatal stroke, hospitalized heart failure (HF), and CV death. Coronary revascularization was included in a secondary endpoint. Generalized estimating equations with robust standard errors were used to test differences in CV incidence by treatment group. Literature-based event costs were applied to the observed outcomes to estimate net costs over 5 years of follow-up. A microsimulation model was used to predict outcomes up to 30 years, assuming only legacy effects of the intervention for the study population after the 5 years of observed follow-up.Results:There were 15 CV events (5 MI, 4 stroke, 5 HF, 1 CV death) among 10 patients in the TI group and 26 events (11 MI, 12 stroke, 3 HF) among 19 patients in the UC group. The incidence of the primary CV composite endpoint was 4.4% in the TI group vs. 8.6% in the UC group (OR = 0.49, 95% CI: 0.21 - 1.13, p=.09). Including 2 coronary revascularizations in the TI group and 10 in the UC group, the incidence of the secondary CV composite endpoint was 5.3% in the TI group vs. 10.4% in the UC group (OR = 0.48, 95% CI: 0.22-1.08, p=.08). Intervention costs (all in 2017 U.S. dollars) were $1,511 per patient. Over 5 years, event costs were estimated to total $758,000 in the TI group and $1,538,000 in the UC group for a return on investment of 126% and a net cost savings of about $1,900 per patient. Over 30 years, the TI group is predicted to live 4.5 months longer on average, with a savings of almost $6,000 per person in CV costs.Conclusions:The intervention lowered BP and reduced costs by avoiding CV events over 5 years, with enduring benefits predicted over 30 years.

The COVID-19 pandemic is a public health crisis, having killed more than 514 000 US adults as of March 2, 2021. COVID-19 mitigation strategies have unintended consequences on managing chronic conditions such as hypertension, a leading cause of cardiovascular disease and health disparities in the United States. During the first wave of the pandemic in the United States, the combination of observed racial/ethnic inequities in COVID-19 deaths and social unrest reinvigorated a national conversation about systemic racism in health care and society. The 4th Annual University of Utah Translational Hypertension Symposium gathered frontline clinicians, researchers, and leaders from diverse backgrounds to discuss the intersection of these 2 critical social and public health phenomena and to highlight preexisting disparities in hypertension treatment and control exacerbated by COVID-19. The discussion underscored environmental and socioeconomic factors that are deeply embedded in US health care and research that impact inequities in hypertension. Structural racism plays a central role at both the health system and individual levels. At the same time, virtual healthcare platforms are being accelerated into widespread use by COVID-19, which may widen the divide in healthcare access across levels of wealth, geography, and education. Blood pressure control rates are declining, especially among communities of color and those without health insurance or access to health care. Hypertension awareness, therapeutic lifestyle changes, and evidence-based pharmacotherapy are essential. There is a need to improve the implementation of community-based interventions and blood pressure self-monitoring, which can help build patient trust and increase healthcare engagement.