A study protocol for a cluster randomized pragmatic trial for comparing strategies for implementing primary HPV testing for routine cervical cancer screening in a large health care system.

BACKGROUND: Limited guidance exists regarding implementation strategies that best facilitate cancer screening practice substitution and achieve optimal stakeholder-centered outcomes. Here we describe the protocol for a randomized pragmatic trial comparing two implementation strategies to facilitate substitution of primary HPV screening for Pap and HPV co-testing to perform routine cervical cancer screening of women aged 30-65 years at Kaiser Permanente Southern California (KPSC). METHODS: Twelve service areas within KPSC will be randomized to a "centrally-administered system-wide implementation + local-tailored implementation" strategy or a "centrally-administered system-wide implementation only" strategy. The centrally-administered strategy comprises clinician and staff educational activities. Sites in the local-tailored arm will then conduct a structured local needs assessment followed by site-specific selection and deployment of implementation interventions. Surveys and interviews will be conducted among women and providers from the primary care and ob/gyn departments prior to the system-wide transition, shortly after the transition, and after the completion of local-tailored interventions. A stakeholder advisory committee will assist with study design, defining stakeholder-centered outcomes, and developing data collection tools. RESULTS: The primary outcome of interest is uptake of primary HPV screening. Secondary provider-centered outcomes include provider knowledge, delivery of patient education, satisfaction with the practice substitution process, and resistance to primary HPV screening. Secondary patient-centered outcomes include patient knowledge, stigma, and satisfaction with the screening process. Intervention fidelity will also be measured via surveys. CONCLUSIONS: Findings from this study will help inform future use of a local-tailored implementation strategy for adopting primary HPV screening at large health care systems. Findings may also be applicable to other types of practice substitution.

De-implementation and substitution of clinical care processes: stakeholder perspectives on the transition to primary human papillomavirus (HPV) testing for cervical cancer screening.

BACKGROUND: New cervical cancer screening guidelines recommend primary human papillomavirus (HPV) testing for women age 30-65 years. Healthcare organizations are preparing to de-implement the previous recommended strategies of Pap testing or co-testing (Pap plus HPV test) and substitute primary HPV testing. However, there may be significant challenges to the replacement of this entrenched clinical practice, even with an evidence-based substitution. We sought to identify stakeholder-perceived barriers and facilitators to this substitution within a large healthcare system, Kaiser Permanente Southern California. METHODS: We conducted semi-structured qualitative interviews with clinician, administrative, and patient stakeholders regarding (a) acceptability and feasibility of the planned substitution; (b) perceptions of barriers and facilitators, with an emphasis on those related to the de-implementation/implementation cycle of substitution; and (c) perceived readiness to change. Our interview guide was informed by the Consolidated Framework for Implementation Research (CFIR). Using a team coding approach, we developed an initial coding structure refined during iterative analysis; the data were subsequently organized thematically into domains, key themes, and sub-themes using thematic analysis, followed by framework analysis informed by CFIR. RESULTS: We conducted 23 interviews: 5 patient and 18 clinical/administrative. Clinicians perceived that patients feel more tests equals better care, and clinicians and patients expressed fear of missed cancers ("…it'll be more challenging convincing the patient that only one test is…good enough to detect cancer."). Patients perceived practice changes resulting in "less care" are driven by the desire to cut costs. In contrast, clinicians/administrators viewed changing from two tests to one as acceptable and a workflow efficiency ("…It's very easy and half the work."). Stakeholder-recommended strategies included focusing on the increased efficacy of primary HPV testing and developing clinician talking points incorporating national guidelines to assuage "cost-cutting" fears. CONCLUSIONS: Substitution to replace an entrenched clinical practice is complex. Leveraging available facilitators is key to ease the process for clinical and administrative stakeholders-e.g., emphasizing the efficiency of going from two tests to one. Identifying and addressing clinician and patient fears regarding cost-cutting and perceived poorer quality of care is critical for substitution. Multicomponent and multilevel strategies for engagement and education will be required. TRIAL REGISTRATION: ClinicalTrials.gov, # NCT04371887.

Understanding the characteristics of US cancer survivors with informal caregivers.

BACKGROUND: Although informal caregivers such as family and friends provide people with cancer needed physical care and emotional support, little is known about which individuals have access to such caregivers. The purpose of this article is to provide a nationally representative description of the sociodemographic characteristics of cancer survivors who have or had an informal caregiver in the United States. METHODS: Cross-sectional data were taken from the Experiences With Cancer Survivorship Supplement of the Medical Expenditure Panel Survey in 2011, 2016, and 2017. People were cancer survivors from diagnosis until the end of life. The study population consisted of adult survivors of cancer other than nonmelanoma skin cancer who were treated for cancer less than 3 years before the survey and were living in the community (n = 720). The main outcome measure was whether or not the cancer survivor reported having an informal caregiver. RESULTS: In the United States, 55.2% of cancer survivors reported having an informal caregiver during or after their cancer treatment. The relationship of the caregiver to the survivor varied by sex: males were more likely to have a spouse as their caregiver, and females were more likely to have a child as their caregiver. In multivariate analyses, cancer survivors who were female, were married, were of a race/ethnicity other than White, or were in poor health were more likely to have an informal caregiver. CONCLUSIONS: Future research can examine whether those without informal caregivers might need more formal support as they undergo cancer treatment and transition into cancer survivorship.

Impact of COVID-19 on Cervical Cancer Screening Rates Among Women Aged 21-65 Years in a Large Integrated Health Care System - Southern California, January 1-September 30, 2019, and January 1-September 30, 2020.

On March 19, 2020, the governor of California issued a statewide stay-at-home order to contain the spread of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19).* The order reduced accessibility to and patient attendance at outpatient medical visits,† including preventive services such as cervical cancer screening. In-person clinic visits increased when California reopened essential businesses on June 12, 2020.§ Electronic medical records of approximately 1.5 million women served by Kaiser Permanente Southern California (KPSC), a large integrated health care system, were examined to assess cervical cancer screening rates before, during, and after the stay-at-home order. KPSC policy is to screen women aged 21-29 years every 3 years with cervical cytology alone (Papanicolaou [Pap] test); those aged 30-65 years were screened every 5 years with human papillomavirus (HPV) testing and cytology (cotesting) through July 15, 2020, and after July 15, 2020, with HPV testing alone, consistent with the latest recommendations from U.S. Preventive Services Task Force.¶ Compared with the 2019 baseline, cervical cancer screening rates decreased substantially during the stay-at-home order. Among women aged 21-29 years, cervical cytology screening rates per 100 person-months declined 78%. Among women aged 30-65 years, HPV test screening rates per 100 person-months decreased 82%. After the stay-at-home order was lifted, screening rates returned to near baseline, which might have been aided by aspects of KPSC's integrated, organized screening program (e.g., reminder systems and tracking persons lost to follow-up). As the pandemic continues, groups at higher risk for developing cervical cancers and precancers should be evaluated first. Ensuring that women receive preventive services, including cancer screening and appropriate follow-up in a safe and timely manner, remains important.

Developing Primary Care-Based Recommendations for Social Determinants of Health: Methods of the U.S. Preventive Services Task Force.

The purpose of the U.S. Preventive Services Task Force (USPSTF) is to provide evidence-based recommendations on primary care screening, behavioral counseling, and preventive medications. A person's health is strongly influenced by social determinants of health, such as economic and social conditions; therefore, preventive recommendations that address these determinants would be ideal. However, differing social determinants have been proposed by a wide range of agencies and organizations, little prevention evidence is available, and responsible parties are in competition, all of which make the creation of evidence-based prevention recommendations for social determinants of health challenging. This article highlights social determinants already included in USPSTF recommendations and proposes a process by which others may be considered for primary care preventive recommendations. In many ways, incorporating social determinants of health into evidence-based recommendations is an evolving area. By reviewing the evidence on the effects of screening and interventions on social determinants relevant to primary care, the USPSTF will continue to provide recommendations on clinical preventive services to improve the health of all Americans.

Implementation of Evidence-Based Recommendations for Preventive Services in the Veterans Health Administration.

INTRODUCTION: The Veterans Health Administration (VHA) is the largest integrated health care system in the United States. To date, there has been scant research on how VHA adopts clinical preventive services guidelines and how U.S. Preventive Services Task Force recommendations factor into the process. METHODS: Researchers conducted semistructured interviews with eight VHA leaders to examine how they adopt, disseminate, and measure adherence to recommendations. Interviews were recorded, transcribed, and aggregated into a database to enable sorting and synthesis. Themes were identified across the key informant interviews. RESULTS: The development of VHA clinical prevention guidelines is coordinated by the National Center for Health Promotion and Disease Prevention. A VHA Advisory Committee discusses and votes to approve or disapprove each guideline. Several factors can impact the ability of a veterans affairs medical center to implement a guideline, such as local system capacity and priorities for quality improvement. Methods to promote implementation include electronic reminders, educational events, and a robust performance measurement system. CONCLUSIONS: Provision of evidence-based clinical preventive services is an important part of VHA's effort to provide high-quality care for Veterans. Recent achievements in lung cancer, colorectal cancer, and Hepatitis C screening highlight VHA's successful approach to implementation of preventive services guidance.

Novel Health Information Technology to Aid Provider Recognition and Treatment of Major Depressive Disorder and Posttraumatic Stress Disorder in Primary Care.

BACKGROUND: Millions of traumatized refugees worldwide have resettled in the United States. For one of the largest, the Cambodian community, having their mental health needs met has been a continuing challenge. A multicomponent health information technology screening tool was designed to aid provider recognition and treatment of major depressive disorder and posttraumatic stress disorder (PTSD) in the primary care setting. METHODS: In a clustered randomized controlled trial, 18 primary care providers were randomized to receive access to a multicomponent health information technology mental health screening intervention, or to a minimal intervention control group; 390 Cambodian American patients empaneled to participating providers were assigned to the providers' randomized group. RESULTS: Electronic screening revealed that 65% of patients screened positive for depression and 34% screened positive for PTSD. Multilevel mixed effects logistic models, accounting for clustering structure, indicated that providers in the intervention were more likely to diagnose depression [odds ratio (OR), 6.5; 95% confidence interval (CI), 1.48-28.79; P=0.013] and PTSD (OR, 23.3; 95% CI, 2.99-151.62; P=0.002) among those diagnosed during screening, relative to the control group. Providers in the intervention were more likely to provide evidence-based guideline (OR, 4.02; 95% CI, 1.01-16.06; P=0.049) and trauma-informed (OR, 15.8; 95% CI, 3.47-71.6; P<0.001) care in unadjusted models, relative to the control group. Guideline care, but not trauma-informed care, was associated with decreased depression at 12 weeks in both study groups (P=0.003), and neither was associated with PTSD outcomes at 12 weeks. CONCLUSIONS: This innovative approach offers the potential for training primary care providers to diagnose and treat traumatized patients, the majority of whom seek mental health care in primary care (ClinicalTrials.gov number, NCT03191929).

The Practice Gap: National Estimates of Screening and Counseling for Alcohol, Tobacco, and Obesity.

Tobacco use, lack of physical activity and poor diet, and alcohol consumption are leading causes of death in the United States. We estimated screening and counseling rates by using a nationally representative sample of adults aged 35 years and older with a preventive care supplement to the 2014 Medical Expenditure Panel Survey. Receipt of the recommended level of services ranged from nearly two-thirds (64.2% for obesity, 61.9% for tobacco use) to less than one-half (41.0% for alcohol misuse). There is significant room for improving care delivery, but primary care practices probably also need additional resources to raise screening and counseling rates.

Few Americans Receive All High-Priority, Appropriate Clinical Preventive Services.

As of 2015, only 8 percent of US adults ages thirty-five and older had received all of the high-priority, appropriate clinical preventive services recommended for them. Nearly 5 percent of adults did not receive any such services. Further delivery system-level efforts are needed to increase the use of preventive services.

Missed Opportunities for Depression Screening and Treatment in the United States.

PURPOSE: This study estimates the prevalence of depression assessment in adults age 35 and older and how prevalence varies by sociodemographic characteristics and depressive symptoms. METHODS: We used a nationally representative survey, the Agency for Healthcare Research and Quality's Medical Expenditure Panel Survey, to evaluate if adults 35+ were being assessed for depression by their health care providers in 2014 and 2015. Using multivariate logistic regression, we examined the health and sociodemographic characteristics of patients associated with depression assessment. RESULTS: Approximately 50% of US adults aged 35+ were being assessed for depression (48.6%; 95% CI, 45.5%-51.6%). The following were less likely to be assessed: men compared with women (OR, 0.58; 95% CI, 0.46-0.72), adults 75+ compared with adults 50 to 64 years old (OR, 0.47; 95% CI, 0.32-0.69), the uninsured compared with those with private insurance (OR, 0.30; 95% CI, 0.18-0.51), and adults without recognized depressive symptoms compared with those with recognized symptoms (OR, 0.39; 95% CI, 0.24-0.63). Compared with non-Hispanic whites, the following were less likely to be assessed: Asian (OR, 0.35; 95% CI, 0.19-0.67), Hispanic (OR, 0.47; 95% CI, 0.29-0.75), and African American (OR, 0.42; 95% CI, 0.27-0.67). CONCLUSIONS: Many Americans are not having their depression needs assessed. Certain populations are more likely to be missed, including men, people over 75 years old, minorities, and the uninsured. Additional efforts are needed to determine methods to increase screening recommended by the United States Preventive Services Task Force and to ensure that all Americans have their mental health needs met.

Developing Recommendations for Evidence-Based Clinical Preventive Services for Diverse Populations: Methods of the U.S. Preventive Services Task Force.

The U.S. Preventive Services Task Force (USPSTF) summarizes the principles and considerations that guide development of its recommendations for diverse U.S. populations. It uses these principles through each step in the evidence-based guideline process: developing the research plan, conducting the evidence review, developing the recommendation, and communicating to guideline users. Three recent recommendations provide examples of how the USPSTF has used these principles: the 2015 recommendation on screening for abnormal blood glucose and type 2 diabetes; the 2016 recommendation on screening for breast cancer; and the recommendation on screening for prostate cancer, which is currently in progress. A more comprehensive list of recommendations that includes considerations for specific populations is also provided.

Sexually Transmitted Infections: Recommendations from the U.S. Preventive Services Task Force.

The U.S. Preventive Services Task Force (USPSTF) has issued recommendations on behavioral counseling to prevent sexually transmitted infections (STIs) and recommendations about screening for individual STIs. Clinicians should obtain a sexual history to assess for behaviors that increase a patient's risk. Community and population risk factors should also be considered. The USPSTF recommends intensive behavioral counseling for all sexually active adolescents and for adults whose history indicates an increased risk of STIs. These interventions can reduce STI acquisition and risky sexual behaviors, and increase condom use and other protective behaviors. The USPSTF recommends screening for chlamydia and gonorrhea in all sexually active women 24 years and younger, and in older women at increased risk. It recommends screening for human immunodeficiency virus (HIV) infection in all patients 15 to 65 years of age regardless of risk, as well as in younger and older patients at increased risk of HIV infection. The USPSTF also recommends screening for hepatitis B virus infection and syphilis in persons at increased risk. All pregnant women should be tested for hepatitis B virus infection, HIV infection, and syphilis. Pregnant women 24 years and younger, and older women with risk factors should be tested for gonorrhea and chlamydia. The USPSTF recommends against screening for asymptomatic herpes simplex virus infection. There is inadequate evidence to determine the optimal interval for repeat screening; clinicians should rescreen patients when their sexual history reveals new or persistent risk factors.

Preventive Counseling Services during Primary Care Visits: A Comparison of Health Centers versus Other Physician Offices.

We compared preventive counseling services provided by health centers versus other physician offices. Cross-sectional data came from the 2008 National Ambulatory Medical Care Survey, including 25,177 patient visits in physician offices and 3,345 patient visits in health centers. Despite serving disproportionately more vulnerable patients, health centers provided comparable rates of preventive counseling services, compared with other physician offices: health education (39% vs. 36%), disease management (34% vs. 41%), asthma education (21% vs. 13%), tobacco education (19% for both), and weight reduction education (6% vs. 9%) (p>.05 for all). Adjusted analyses showed no association between health care setting and preventive counseling.

Cigarette Smoking, Desire to Quit, and Tobacco-Related Counseling Among Patients at Adult Health Centers.

Objectives. We determined cigarette smoking prevalence, desire to quit, and tobacco-related counseling among a national sample of patients at health centers. Methods. Data came from the 2009 Health Center Patient Survey and the 2009 National Health Interview Survey. The analytic sample included 3949 adult patients at health centers and 27 731 US adults. Results. Thirty-one percent of health center patients were current smokers, compared with 21% of US adults in general. Among currently smoking health center patients, 83% desired to quit and 68% received tobacco counseling. In multivariable models, patients had higher adjusted odds of wanting to quit if they had indications of severe mental illness (adjusted odds ratio [AOR] = 3.26; 95% confidence interval [CI] = 1.19, 8.97) and lower odds if they had health insurance (AOR = 0.43; 95% CI = 0.22, 0.86). Patients had higher odds of receiving counseling if they had 2 or more chronic conditions (AOR = 2.05; 95% CI = 1.11, 3.78) and lower odds if they were Hispanic (AOR = 0.57; 95% CI = 0.34, 0.96). Conclusions. Cigarette smoking prevalence is substantially higher among patients at health centers than US adults in general. However, most smokers at health centers desire to quit. Continued efforts are warranted to reduce tobacco use in this vulnerable group.