Use of 2-Stage Modeling to Identify How Colorectal Cancer Risk Changes With Period and Cohort.

Colorectal cancer (CRC) incidence rates have decreased among adults aged 50 years or older while increasing in adults under age 50 years. Understanding these trends is challenging because of the multiple related time scales of age, diagnosis period, and birth cohort. We analyzed incidence rates of rectal, distal colon, and proximal colon cancer for individuals aged 20 years or more from the Surveillance, Epidemiology, and End Results Program for diagnosis years 1978-2017. We used a 2-stage generalized linear model to determine age, period, and cohort effects for CRC incidence. We first estimated birth cohort effects among people under age 45 years. We used these results to specify prior distributions for cohort effects in a Bayesian model to estimate period effects among people aged 45 years or more. There was no evidence of period effects for people under age 45 years. Risks of rectal and distal colon cancer increased for later birth cohorts. Compared with the 1943-1952 birth cohort, the 1983-1992 birth cohort had 2.2 times the risk of rectal cancer, 1.9 times the risk of distal colon cancer, and 1.3 times the risk of proximal colon cancer. For people aged ≥45 years, period effects showed declines in CRC risk that were attributable to screening.

Use of and Attitudes About Telelactation Services among New Parents.

Background: We conducted a national, cross-sectional survey among new parents to explore use and acceptability of telelactation. Methods: Recruitment occurred between October 2021 and January 2022 on Ovia's parenting mobile phone application. Poststratification survey weights were used, and logistic and linear regression models estimated associations between demographics and telelactation use. Results: Among 1,617 respondents, 33.8% had at least one telelactation visit. Odds of any telelactation visit(s) were greater for parents who gave birth in 2021 versus 2019 (odds ratio [OR]: 1.69, 95% confidence interval [CI]: 1.26-2.25), insured by Medicaid (OR: 1.43, 95% CI: 1.02-2.02), and younger parents (OR: 2.07, 95% CI: 1.32-3.34). In total, 56.0% agreed that they would be comfortable breastfeeding over video to get help, and 27.6% agreed that lactation support over video is as good as in-person support. Conclusions: Telelactation is increasingly common and acceptable to many parents.

Is Bigger Better?: A Closer Look at Small Health Systems in the United States.

BACKGROUND: Research on US health systems has focused on large systems with at least 50 physicians. Little is known about small systems. OBJECTIVES: Compare the characteristics, quality, and costs of care between small and large health systems. RESEARCH DESIGN: Retrospective, repeated cross-sectional analysis. SUBJECTS: Between 468 and 479 large health systems, and between 608 and 641 small systems serving fee-for-service Medicare beneficiaries, yearly between 2013 and 2017. MEASURES: We compared organizational, provider and beneficiary characteristics of large and small systems, and their geographic distribution, using multiple Medicare and Internal Revenue Service administrative data sources. We used mixed-effects regression models to estimate differences between small and large systems in claims-based Healthcare Effectiveness Data and Information Set (HEDIS) quality measures and HealthPartners' Total Cost of Care measure using a 100% sample of Medicare fee-for-service claims. We fit linear spline models to examine the relationship between the number of a system's affiliated physicians and its quality and costs. RESULTS: The number of both small and large systems increased from 2013 to 2017. Small systems had a larger share of practice sites (43.1% vs. 11.7% for large systems in 2017) and beneficiaries (51.4% vs. 15.5% for large systems in 2017) in rural areas or small towns. Quality performance was lower among small systems than large systems (-0.52 SDs of a composite quality measure) and increased with system size up to ∼75 physicians. There was no difference in total costs of care. CONCLUSIONS: Small systems are a growing source of care for rural Medicare populations, but their quality performance lags behind large systems. Future studies should examine the mechanisms responsible for quality differences.

Substance Use and Mental Health Outcomes from a Text Messaging-Based Intervention for Smoking Cessation Among Young People Experiencing Homelessness.

INTRODUCTION: Cigarette smoking and associated high-risk behaviors are prevalent among youth experiencing homelessness (YEH), making appropriately tailored interventions targeting smoking behavior important for this group. We pilot tested a brief text-messaging intervention (TMI) as an adjunct to standard care for YEH who smoke and found promising preliminary effects of the intervention on smoking cessation. The purpose of the present study was to test the TMI's effect on the secondary outcomes of other substance use (including use of other tobacco/nicotine devices) and mental health symptoms. METHODS: A total of 77 participants completed the pilot randomized controlled trial, with 40 receiving the TMI (174 automated text messages plus a group smoking counseling session and provision of nicotine patches). They completed an assessment at baseline and another three months later that evaluated use of other tobacco/nicotine devices, alcohol, marijuana, and anxiety and depression symptoms. RESULTS: We found that the TMI helped to reduce secondary substance use behaviors and mental health symptoms among the participants; mainly there were medium effects of the intervention on changes in other tobacco/nicotine use, drinking, and anxiety and depression symptoms. The intervention did not have an effect on number of marijuana use days in the past month; however, past 30-day marijuana users who received the intervention benefited by reducing the number of times they used marijuana per day. CONCLUSIONS: In addition to helping reduce cigarette smoking, we found that a TMI for YEH was helpful in improving secondary outcomes, suggesting the promise of the TMI on benefiting YEH even beyond targeted smoking behavior. IMPLICATIONS: This pilot study demonstrates that by targeting cigarette smoking using a text message-based intervention among youth experiencing homelessness, effects may be seen in other areas of functioning such as other substance use and mental health. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03874585. Registered March 14, 2019, https://clinicaltrials.gov/ct2/show/record/NCT03874585.

Sequentially calibrating a Bayesian microsimulation model to incorporate new information and assumptions.

BACKGROUND: Microsimulation models are mathematical models that simulate event histories for individual members of a population. They are useful for policy decisions because they simulate a large number of individuals from an idealized population, with features that change over time, and the resulting event histories can be summarized to describe key population-level outcomes. Model calibration is the process of incorporating evidence into the model. Calibrated models can be used to make predictions about population trends in disease outcomes and effectiveness of interventions, but calibration can be challenging and computationally expensive. METHODS: This paper develops a technique for sequentially updating models to take full advantage of earlier calibration results, to ultimately speed up the calibration process. A Bayesian approach to calibration is used because it combines different sources of evidence and enables uncertainty quantification which is appealing for decision-making. We develop this method in order to re-calibrate a microsimulation model for the natural history of colorectal cancer to include new targets that better inform the time from initiation of preclinical cancer to presentation with clinical cancer (sojourn time), because model exploration and validation revealed that more information was needed on sojourn time, and that the predicted percentage of patients with cancers detected via colonoscopy screening was too low. RESULTS: The sequential approach to calibration was more efficient than recalibrating the model from scratch. Incorporating new information on the percentage of patients with cancers detected upon screening changed the estimated sojourn time parameters significantly, increasing the estimated mean sojourn time for cancers in the colon and rectum, providing results with more validity. CONCLUSIONS: A sequential approach to recalibration can be used to efficiently recalibrate a microsimulation model when new information becomes available that requires the original targets to be supplemented with additional targets.

Pilot Randomized Clinical Trial of a Text Messaging-Based Intervention for Smoking Cessation Among Young People Experiencing Homelessness.

INTRODUCTION: Smoking rates are alarmingly high among young people experiencing homelessness (YEH), yet there are no evidence-based cessation programs for this population. This paper presents results from a pilot evaluation of a text messaging-based smoking cessation treatment, as an adjunct to brief group cessation counseling, to improve abstinence rates among 18-25-year-old smokers experiencing homelessness. The goal of this study was to estimate effect sizes for a larger trial and it was not powered to detect group differences. AIMS AND METHODS: YEH smokers who had a working cell phone with them at recruitment were randomized to receive a group counseling session, nicotine patches, and written material on quitting (n = 37) or a similar program that also included a 6-week automated text messaging intervention (TMI) to provide ongoing support for quitting (n = 40). Smoking outcomes were evaluated through a 90-day follow-up. RESULTS: Seven-day point prevalence abstinence at 90-day follow-up was higher in the TMI condition than standard condition (17.50% vs. 8.11%, respectively; Cohen's h = .37); however, the 90-day continuous abstinence rate was not statistically different from zero in either condition. Reductions in the number of days smoked in the past 30 days from baseline to follow-up were greater in the TMI condition than the standard condition (-14.24 vs. -8.62, respectively; Cohen's d = .49). CONCLUSIONS: Adding a 6-week TMI support to a brief group counseling and pharmacotherapy protocol holds promise for smoking reduction and abstinence among YEH smokers. Results indicate that further development and evaluation of the TMI in this population is warranted. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03874585. Registered March 14, 2019, https://clinicaltrials.gov/ct2/show/record/NCT03874585. IMPLICATIONS: This is the first study to evaluate the feasibility of using a text messaging-based intervention (TMI) for behavior change with 18-25 year olds experiencing homelessness, and more specifically, the first to test a TMI to provide ongoing support for smoking cessation. Small to medium effect sizes for the TMI are promising in terms of implementing a TMI using participants' own cell phones, as well as the efficacy of this approach as an adjunct to standard care (brief group counseling and pharmacotherapy) for smoking cessation among YEH.

It takes a village: A pilot study of a group telehealth intervention for support persons affected by opioid use disorder.

INTRODUCTION: Opioid use disorder (OUD) has devastating effects on individuals, families, and communities. The Community Reinforcement and Family Training (CRAFT) is a Support Person (SP)-focused intervention that aims to increase SPs' communication strategies, positive reinforcement/rewards, and social support. This pilot study, called eINSPIRE (INtegrating Support Persons Into REcovery), adapted CRAFT for delivery via group telehealth. The aims were to evaluate the feasibility, acceptability, and preliminary effectiveness of this intervention on patient buprenorphine retention and SP mental health. METHODS: The study recruited patients receiving buprenorphine treatment in a primary care setting across five community health centers with their SP (N = 100 dyads). SP participants were randomly assigned to receive usual care (UC) or the eINSPIRE intervention. We interviewed Patients and SPs at baseline and three months later. The study collected patient buprenorphine retention data from the electronic medical record three months post-baseline. RESULTS: About 88 % (656/742) of potentially eligible patients were able to nominate a SP and 69 % (100/145) of nominated SPs were eligible and consented to the study. eINSPIRE groups had low reach (25 % of SPs attended), but high exposure (M = 7 of 10 sessions attended) and acceptability (classes helped them with their patient's OUD). The proportion of eINSPIRE patients (68 %) and UC patients (53 %) retained on buprenorphine at follow-up were similar (p = 0.203). SPs in both conditions reported similar reductions in their depression, anxiety, and impairment symptoms. CONCLUSIONS: Preliminary data suggest that eINSPIRE groups may not be feasible in primary care without further adaptations for this population. A future study with a larger sample size is needed to elucidate the observed distribution differences in buprenorphine retention. Future research should also explore methods to reduce barriers to SP session attendance to improve the reach of this evidence-based intervention.

Trends in Geographic Proximity to Substance Use Disorder Treatment.

INTRODUCTION: This study aims to assess the trends in the number and characteristics of substance use disorder (SUD) treatment facilities within the county of residence of adults aged 50+ years over time. METHODS: Using retrospective longitudinal data from the 1992-2018 Health and Retirement Study merged with the county-level data on all licensed treatment facilities in the country, linear mixed models were estimated to calculate geographic accessibility to SUD treatment, adjusted for person-level demographics, state-level controls, and calendar year-fixed effects. Analysis was conducted in 2022. RESULTS: Overall, older adults experienced a decline in the average number of SUD treatment facilities within their counties of residence from 4.80 per 100,000 residents (95% CI=4.69, 4.92) in 1992 to 4.50 (95% CI=4.35, 4.64) in 2018. However, the number accepting Medicare increased from 0.26 (95% CI=0.21, 0.30) in 1992 to 1.88 (95% CI=1.80, 1.96) facilities per 100,000 (42% of facilities); Medicaid increased from 0.20 (95% CI=0.13, 0.26) in 1992 to 3.50 (95% CI=3.39, 3.62) facilities per 100,000 (78% of facilities) in 2018. Older adults living in more rural areas experienced the most growth in SUD treatment facilities per capita in their counties but with less significant growth in facilities offering medication for opioid use disorder than those living in more urban areas. CONCLUSIONS: Despite increases in the number of SUD treatment facilities in rural areas, there has been less growth in nearby facilities offering evidence-based medication treatment for opioid use disorder.

Changes in Breastfeeding and Lactation Support Experiences During COVID.

Background: We surveyed parents who gave birth from 2019 to 2021 to examine changes in breastfeeding experiences and professional and lay breastfeeding support services due to the coronavirus disease 2019 (COVID-19) pandemic. We also examined racial and ethnic disparities in breastfeeding support. Materials and Methods: A cross-sectional opt-in survey of 1,617 parents was administered on Ovia's parenting app in January 2022. Respondents were 18-45 years of age and delivered in one of three birth cohorts: August-December 2019, March-May 2020, or June-August 2021. We fit linear and logistic regression models wherein the outcomes were six breastfeeding support and experience measures, adjusting for birth cohort and respondent demographics. Results: Parents who gave birth in the early pandemic versus those in the prepandemic had reduced odds of interacting with lactation consultants (odds ratio [OR]: 0.63; 95% confidence interval [CI]: 0.44-0.90), attending breastfeeding classes (OR: 0.71; 95% CI: 0.54-0.94), meeting breastfeeding goals (OR: 0.65; 95% CI: 0.46-0.92), and reporting it was easy to get breastfeeding help (estimate: -0.36; 95% CI: -0.55 to -0.17). Birth cohort was not associated with use of donor milk or receipt of in-hospital help. The later pandemic cohort differed from the prepandemic cohort for one outcome: they were less likely to meet their breastfeeding goals (OR: 0.67; 95% CI: 0.48-0.95). There were racial and ethnic disparities in the use of multiple types of breastfeeding support. Although one-third of respondents felt that the pandemic facilitated breastfeeding because of more time at home, 18% felt the pandemic posed additional challenges including disruptions to lactation support. Conclusions: Parents who gave birth in the later pandemic did not report significant disruptions to professional breastfeeding support, likely as a result of the growth of virtual services. However, disparities in receipt of support require policy attention and action.

Understanding the social risk factor adjustment's effect on Star Ratings.

OBJECTIVES: CMS implemented the Categorical Adjustment Index (CAI) to address measurement bias in the Medicare Advantage (MA) Star Ratings, as unadjusted scores may disadvantage MA contracts serving more enrollees at greater social risk. CAI values are added to a contract's Star Ratings to adjust for the mean within-contract performance disparity associated with its percentage of enrollees with low socioeconomic status (ie, receipt of a Part D low-income subsidy or dual eligibility for Medicare and Medicaid [LIS/DE]) and who are disabled. We examined the CAI's effect on Star Ratings and the type of contracts affected. STUDY DESIGN: Observational study of MA contracts with health and prescription drug coverage. METHODS: We compared adjusted and unadjusted 2017-2020 Star Ratings overall and by contracts' proportion of LIS/DE and disabled enrollees. We assessed the CAI's effect on qualifying for quality bonus payments (QBPs), eligibility for rebate payments, and high-performing and low-performing designations. RESULTS: The CAI's impact was modest overall (3.2%-14.9% of contracts experienced one-half Star Rating changes). Upward changes were concentrated among contracts with high percentages of LIS/DE or disabled enrollees (7.7%-32.3% of these contracts saw increased Star Ratings). In 2020, 26.0% of contracts with a high proportion of LIS/DE or disabled enrollees that qualified for a QBP did so because of the CAI. CONCLUSIONS: The CAI primarily affected contracts with high LIS/DE or disabled enrollment, which received higher Star Ratings because of the CAI. The adjustment helps ensure that such contracts' performance is not understated and reduces incentives for MA contracts to avoid patients at greater social risk.

Study protocol for a sequential multiple assignment randomized trial to reduce risky drinking among service members and their partners.

BACKGROUND: Military spouses and partners in relationships with a heavy drinking service member report high levels of mental health concerns and consequences, which are compounded when both partners drink heavily. Military spouses and partners -termed "concerned partners" (CPs)-may be an important gateway for motivating service members (SMs) to seek care. However, CPs may first need to reduce their own drinking and improve their communication to effectively support and encourage changes for their service member partner. Partners Connect is a web-based intervention aimed at improving communication and relationship quality and increasing SM help-seeking. METHODS: The current study design is a two-stage Sequential Multiple Assignment Randomized Trial (SMART) to develop an adaptive CP intervention to decrease CP drinking and increase SM help-seeking. CPs aged 18 and older (n = 408) will be recruited via social media and followed for six months. In stage one, we will randomize CPs to either a 4-session web-based intervention (Partners Connect) or to receive communication resources from the Gottman Institute website. The goal is to have CPs invite their SM to complete an online personalized normative feedback (PNF) session. If their SM completes the PNF at stage one, CPs will be considered "responders," if the SM does not complete, CPs who are "non-responders" will be re-randomized during stage two to receive either (1) a CRAFT workbook or (2) phone-based CRAFT if in Partners Connect; or (1) Partners Connect or (2) a CRAFT workbook if in Gottman. DISCUSSION: By first intervening with the service member's CP, we aim to better equip them to engage their service member partner in treatment services. In doing so, we develop a model that increases treatment accessibility and appeal among a group that may not otherwise seek care. CLINICALTRIALS: gov Identifier: NCT05619185.

COVID-19 vaccine uptake and attitudes among pregnant and postpartum parents.

BACKGROUND: Pregnancy poses increased risks from COVID-19, including hospitalization and premature delivery. Yet pregnant individuals are less likely to have received a COVID-19 vaccine. OBJECTIVE: This study aimed to investigate COVID-19 vaccine uptake and reasons for delay or refusal among perinatal parents. STUDY DESIGN: A total of 1542 eligible parents who delivered between 2019 and 2021 were surveyed through the Ovia parenting app, which has a nationally representative user base. Adjusted and nationally weighted means were calculated. Multivariate logistic regression and survival models were used to examine uptake. RESULTS: At least 1 dose of the COVID-19 vaccine was received by 70% of the parents. Those with a bachelor's or graduate degree were significantly more likely to have received a vaccine relative to those with some college or less (adjusted odds ratio for bachelor's degree, 1.854; 95% confidence interval, 1.19-2.90; adjusted odds ratio for graduate degree, 2.833; 95% confidence interval, 1.69-4.75). Parents living in rural areas were significantly less likely to have received a vaccine relative to those living in urban areas (adjusted odds ratio for small city, 0.62; 95% confidence interval, 0.45-0.86; adjusted odds ratio for rural area, 0.56; 95% confidence interval, 0.35-0.89); 56% (281/502) of unvaccinated parents considered that the vaccine "was too new." Among those pregnant in 2021, 44% (258/576) received at least 1 dose, and 34% (195/576) reported that pregnancy had "no impact" on their vaccine decision. CONCLUSION: There was significant heterogeneity in vaccine uptake and attitudes toward vaccines during pregnancy by sociodemographics and over time. Public health experts need to consider and test more tailored approaches to reduce vaccine hesitancy in this population.

Impact of telelactation services on breastfeeding outcomes among Black and Latinx parents: protocol for the Tele-MILC randomized controlled trial.

BACKGROUND: Breastfeeding offers many medical and neurodevelopmental advantages for birthing parents and infants; however, the majority of parents stop breastfeeding before it is recommended. Professional lactation support by the International Board Certified Lactation Consultants (IBCLCs) increases breastfeeding rates; however, many communities lack access to IBCLCs. Black and Latinx parents have lower breastfeeding rates, and limited access to professional lactation support may contribute to this disparity. Virtual "telelactation" consults that use two-way video have the potential to increase access to IBCLCs among disadvantaged populations. We present a protocol for the digital Tele-MILC trial, which uses mixed methods to evaluate the impact of telelactation services on breastfeeding outcomes. The objective of this pragmatic, parallel design randomized controlled trial is to assess the impact of telelactation on breastfeeding duration and exclusivity and explore how acceptability of and experiences with telelactation vary across Latinx, Black, and non-Black and non-Latinx parents to guide future improvement of these services. METHODS: 2400 primiparous, pregnant individuals age > 18 who intend to breastfeed and live in the USA underserved by IBCLCs will be recruited. Recruitment will occur via Ovia, a pregnancy tracker mobile phone application (app) used by over one million pregnant individuals in the USA annually. Participants will be randomized to (1) on-demand telelactation video calls on personal devices or (2) ebook on infant care/usual care. Breastfeeding outcomes will be captured via surveys and interviews and compared across racial and ethnic groups. This study will track participants for 8 months (including 6 months postpartum). Primary outcomes include breastfeeding duration and breastfeeding exclusivity. We will quantify differences in these outcomes across racial and ethnic groups. Both intention-to-treat and as-treated (using instrumental variable methods) analyses will be performed. This study will also generate qualitative data on the experiences of different subgroups of parents with the telelactation intervention, including barriers to use, satisfaction, and strengths and limitations of this delivery model. DISCUSSION: This is the first randomized study evaluating the impact of telelactation on breastfeeding outcomes. It will inform the design and implementation of future digital trials among pregnant and postpartum people, including Black and Latinx populations which are historically underrepresented in clinical trials. TRIAL REGISTRATION: ClinicalTrials.gov NCT04856163. Registered on April 23, 2021.

Adjusting for Patient Characteristics to Compare Quality of Care Provided by Serious Illness Programs.

Background: To compare serious illness programs (SIPs) using recently developed patient experience measures, adjustment must be made for patient characteristics not under control of the programs. Objectives: To develop a case-mix adjustment model to enable fair comparison of patient experience between SIPs by investigating the roles of patient characteristics, proxy response, and mode of survey administration (mail-only vs. mail with telephone follow-up) in survey responses. Methods: Using survey data from 2263 patients from 32 home-based SIPs across the United States, we fit regression models to assess the association between patient-level variables and scores for seven quality measures (Communication, Care Coordination, Help for Symptoms, Planning for Care, Support for Family and Friends, and two global assessments of care). Characteristics that are not consequences of the care the program delivered were considered as adjustors. Results: Final recommended case-mix adjustors are age, education, primary diagnosis, self-reported functional status, self-rated physical health, self-rated mental health, proxy respondent use, and response percentile (a measure of how soon a person responded compared with others in the same program and mode). Age, primary diagnosis, self-rated mental health, and proxy respondent use had the most impact on program-level scores. We also recommend adjusting for mode of survey administration. We find that up to 12 percent of pairs of programs would have their rankings reversed by adjustment. Conclusions: To ensure fair comparison of programs, scores should be case-mix adjusted for variables that influence patients' reports about care quality, but are not under the control of the program administering care.

Patterns in Geographic Distribution of Substance Use Disorder Treatment Facilities in the US and Accepted Forms of Payment From 2010 to 2021.

Importance: The drug overdose crisis is a continuing public health problem and is expected to grow substantially in older adults. Understanding the geographic accessibility to a substance use disorder (SUD) treatment facility that accepts Medicare can inform efforts to address this crisis in older adults. Objective: To assess whether geographic accessibility of services was limited for older adults despite the increasing need for SUD and opioid use disorder treatments in this population. Design, Setting, and Participants: This longitudinal cross-sectional study obtained data on all licensed SUD treatment facilities for all US counties and Census tracts listed in the National Directory of Drug and Alcohol Abuse Treatment Programs from 2010 to 2021. Main Outcomes and Measures: Measures included the national proportion of treatment facilities accepting Medicare, Medicaid, private insurance, or cash as a form of payment; the proportion of counties with a treatment facility accepting each form of payment; and the proportion of the national population with Medicare, Medicaid, private insurance, or cash payment residing within a 15-, 30-, or 60-minute driving time from an SUD treatment facility accepting their form of payment in 2021. Results: A total of 11 709 SUD treatment facilities operated across the US per year between 2010 and 2021 (140 507 facility-year observations). Cash was the most commonly accepted form of payment (increasing slightly from 91.0% in 2010 to 91.6% by 2021), followed by private insurance (increasing from 63.5% to 75.3%), Medicaid (increasing from 54.0% to 71.8%), and Medicare (increasing from 32.1% to 41.9%). The proportion of counties with a treatment facility that accepted Medicare as a form of payment also increased over the same study period from 41.2% to 53.8%, whereas the proportion of counties with a facility that accepted Medicaid as a form of payment increased from 53.5% to 67.1%. The proportion of Medicare beneficiaries with a treatment facility that accepted Medicare as a form of payment within a 15-minute driving time increased from 53.3% to 57.0%. The proportion of individuals with a treatment facility within a 15-minute driving time that accepted their respective form of payment was 73.2% for those with Medicaid, 69.8% for those with private insurance, and 71.4% for those with cash payment in 2021. Conclusions and Relevance: Results of this study suggest that Medicare beneficiaries have less geographic accessibility to SUD treatment facilities given that acceptance of Medicare is low compared with other forms of payment. Policy makers need to consider increasing reimbursement rates and using additional incentives to encourage the acceptance of Medicare.

Reliable and Valid Survey-Based Measures to Assess Quality of Care in Home-Based Serious Illness Programs.

Background: There is a pressing need for standardized measures to assess the quality of home-based serious illness care. Currently, there are no validated quality measures that are specific to home-based serious illness programs (SIPs) and the unique needs of their patients. Objective: To develop and evaluate standardized survey-based measures of serious illness care experiences for assessing and comparing quality of home-based serious illness care programs. Methods: From October 2019 through January 2020, we administered a survey to patients who received care from 32 home-based SIPs across the United States. Using the 2263 survey responses, we assessed item performance and constructed composite measures via factor analysis, evaluated item-scale correlations, estimated reliability, and examined validity by regressing overall ratings and willingness to recommend care on each composite. Results: The overall survey response rate was 36%. Confirmatory factor analyses supported five composite quality measures: Communication, Care Coordination, Help for Symptoms, Planning for Care, and Support for Family and Friends. Cronbach's alpha estimates for the composite measures ranged from 0.69 to 0.85, indicating adequate internal consistency in assessing their underlying constructs. Interprogram reliability ranged from 0.67 to 0.80 at 100 completed surveys per measure, meeting common standards for distinguishing between programs' performance. Together, the composites explained 45% of the variance in patients' overall care ratings. Communication, Care Coordination, and Planning for Care were the strongest predictors of overall ratings. Conclusion: Our analyses provide evidence of the feasibility, reliability, and validity of proposed survey-based measures to assess the quality of home-based serious illness care from the perspective of patients and their families.

Text Messaging Intervention for Young Smokers Experiencing Homelessness: Lessons Learned From a Randomized Controlled Trial.

BACKGROUND: Smoking rates are significantly higher among young people experiencing homelessness than in the general population. Despite a willingness to quit, homeless youth have little success in doing so on their own, and existing cessation resources tailored to this population are lacking. Homeless youth generally enjoy the camaraderie and peer support that group-based programs offer, but continuous in-person support during a quit attempt can be prohibitively expensive. OBJECTIVE: This study aimed to assess the feasibility and acceptability of an automated text messaging intervention (TMI) as an adjunct to group-based cessation counseling and provision of nicotine patches to help homeless youth quit smoking. This paper outlines the lessons learned from the implementation of the TMI intervention. METHODS: Homeless youth smokers aged 18 to 25 years who were interested in quitting (n=77) were recruited from drop-in centers serving homeless youth in the Los Angeles area. In this pilot randomized controlled trial, all participants received a group-based cessation counseling session and nicotine patches, with 52% (40/77) randomly assigned to receive 6 weeks of text messages to provide additional support for their quit attempt. Participants received text messages on their own phone rather than receiving a study-issued phone for the TMI. We analyzed baseline and follow-up survey data as well as back-end data from the messaging platform to gauge the acceptability and feasibility of the TMI among the 40 participants who received it. RESULTS: Participants had widespread (smart)phone ownership-16.4% (36/219) were ineligible for study participation because they did not have a phone that could receive text messages. Participants experienced interruptions in their phone use (eg, 44% [16/36] changed phone numbers during the follow-up period) but reported being able to receive the majority of messages. These survey results were corroborated by back-end data (from the program used to administer the TMI) showing a message delivery rate of about 95%. Participant feedback points to the importance of carefully crafting text messages, which led to high (typically above 70%) approval of most text messaging components of the intervention. Qualitative feedback indicated that participants enjoyed the group counseling session that preceded the TMI and suggested including more such group elements into the intervention. CONCLUSIONS: The TMI was well accepted and feasible to support smoking cessation among homeless youth. Given high rates of smartphone ownership, the next generation of phone-based smoking cessation interventions for this population should consider using approaches beyond text messages and focus on finding ways to develop effective approaches to include group interaction using remote implementation. Given overall resource constraints and in particular the exigencies of the currently ongoing COVID-19 epidemic, phone-based interventions are a promising approach to support homeless youth, a population urgently in need of effective smoking cessation interventions. TRIAL REGISTRATION: ClinicalTrials.gov NCT03874585; https://clinicaltrials.gov/ct2/show/NCT03874585. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13722-020-00187-6.

Health system affiliation of physician organizations and quality of care for Medicare beneficiaries who have high needs.

OBJECTIVE: To test the hypothesis that health systems provide better care to patients with high needs by comparing differences in quality between system-affiliated and nonaffiliated physician organizations (POs) and to examine variability in quality across health systems. DATA SOURCES: 2015 Medicare Data on Provider Practice and Specialty linked physicians to POs. Medicare Provider Enrollment, Chain, and Ownership System (PECOS) and IRS Form 990 data identified health system affiliations. Fee-for-service Medicare enrollment and claims data were used to examine quality. STUDY DESIGN: This cross-sectional analysis of beneficiaries with high needs, defined as having more than twice the expected spending of an average beneficiary, examined six quality measures: continuity of care, follow-up visits after hospitalizations and emergency department (ED) visits, ED visits, all-cause readmissions, and ambulatory care-sensitive hospitalizations. Using a matched-pair design, we estimated beneficiary-level regression models with PO random effects to compare quality of care in system-affiliated and nonaffiliated POs. We then limited the sample to system-affiliated POs and estimated models with system random effects to examine variability in quality across systems. PRINCIPAL FINDINGS: Among 2 323 301 beneficiaries with high needs, 52.3% received care from system-affiliated POs. Rates of ED visits were statistically significantly different in system-affiliated POs (117.5 per 100) and nonaffiliated POs (106.8 per 100, P < .0001). Small differences in the other five quality measures were observed across a range of sensitivity analyses. Among systems, substantial variation was observed for rates of continuity of care (90% of systems had rates between 70.8% and 89.4%) and follow-up after ED visits (90% of systems had rates between 56.9% and 73.5%). CONCLUSIONS: Small differences in quality of care were observed among beneficiaries with high needs receiving care from system POs and nonsystem POs. Health systems may not confer hypothesized quality advantages to patients with high needs.

Validation of Colorectal Cancer Models on Long-term Outcomes from a Randomized Controlled Trial.

Microsimulation models are often used to predict long-term outcomes and guide policy decisions regarding cancer screening. The United Kingdom Flexible Sigmoidoscopy Screening (UKFSS) Trial examines a one-time intervention of flexible sigmoidoscopy that was implemented before a colorectal cancer (CRC) screening program was established. Long-term study outcomes, now a full 17 y following randomization, have been published. We use the outcomes from this trial to validate 3 microsimulation models for CRC to long-term study outcomes. We find that 2 of 3 models accurately predict the relative effect of screening (the hazard ratios) on CRC-specific incidence 17 y after screening. We find that all 3 models yield predictions of the relative effect of screening on CRC incidence and mortality (i.e., the hazard ratios) that are reasonably close to the UKFSS results. Two of the 3 models accurately predict the relative reduction in CRC incidence 17 y after screening. One model accurately predicted the absolute incidence and mortality rates in the screened group. The models differ in their estimates related to adenoma detection at screening. Although high-quality screening results help to inform models, trials are expensive, last many years, and can be complicated by ethical issues and technological changes across the duration of the trial. Thus, well-calibrated and validated models are necessary to predict outcomes for which data are not available. The results from this validation demonstrate the utility of models in predicting long-term outcomes and in collaborative modeling to account for uncertainty.

A text message intervention for quitting cigarette smoking among young adults experiencing homelessness: study protocol for a pilot randomized controlled trial.

BACKGROUND: Cigarette smoking is much more prevalent among young people experiencing homelessness than in the general population of adolescents and young adults. Although many young homeless smokers are motivated to quit, there are no empirically-evaluated smoking cessation programs for this population. It is important that any such program address the factors known to be associated with quitting-related outcomes among homeless young people, to provide ongoing support in a way that accommodates the mobility of this population, and does not rely on scarce service provider resources for its delivery. The objective of this project is to develop and pilot test a text messaging-based intervention (TMI), as an adjunct to brief cessation counseling and provision of nicotine patches, to help homeless young people who want to quit smoking. METHODS/DESIGN: This pilot study will utilize a cluster cross-over randomized controlled design with up to 80 current smokers who desire to quit and are recruited from three drop-in centers serving young people experiencing homelessness in the Los Angeles area. All participants will be provided with a minimum standard of care: a 30-min group-based smoking cessation counseling session and free nicotine replacement. Half of these smokers will then also receive the TMI, as an adjunct to this standard care, which will provide 6 weeks of ongoing support for quitting. This support includes continued and more intensive education regarding nicotine dependence, quitting smoking, and relapse; does not require additional agency resources; can be available "on demand" to users; and includes features to personalize the quitting experience. This study will investigate whether receiving the TMI adjunct to standard smoking cessation care results in greater reductions in cigarette smoking compared to standard care alone over a 3-month period. DISCUSSION: This study has the potential to address an important gap in the clinical research literature on cigarette smoking cessation and provide empirical support for using a TMI to provide ongoing assistance and support for quitting among young smokers experiencing homelessness. Trial registration ClinicalTrials.gov Identifier NCT03874585. Registered March 14, 2019, https://clinicaltrials.gov/ct2/show/record/NCT03874585.