Randomized-controlled trial of a whole-family obesity prevention and treatment intervention designed for low-income Hispanic families: HeLP the healthy living program.

BACKGROUND: Low-income Hispanic families face marked disparities in obesity, but interventions for obesity prevention and treatment have rarely been designed with this population as a focus. Hispanic culture is characterized by Familism, a value that prioritizes familial respect, cooperation, and togetherness. We describe the rationale and design of a trial of the Healthy Living Program (HeLP), a bilingual whole-family behavioral obesity prevention and treatment intervention designed around the value Familism and addressing food insecurity. METHODS/DESIGN: This two-group randomized comparative effectiveness trial will compare the effects of HeLP versus a primary care counseling intervention (Recommended Treatment of Obesity in Primary Care, or RTOP) on decreasing body mass index (BMI; kg/m2) in Hispanic children 2-16 years of age with obesity and preventing BMI increase among siblings without obesity. 164 families per arm will be recruited from primary care practices. Families randomized to HeLP will participate in 12 two-hour sessions, followed by booster sessions. HeLP sessions include family meals and instruction in parenting skills, nutrition, culinary skills, fitness, and mindfulness delivered at community recreation centers by bilingual health educators and athletic trainers. Families randomized to RTOP will be offered individual visits in primary care every 3 months throughout the 18-month follow-up period. Secondary outcomes include changes to objectively measured child fitness, the home environment related to nutrition, physical activity, and media usage, food insecurity, child eating behaviors, quality of life, parent BMI and waist circumference, and implementation outcomes. DISCUSSION: This protocol paper describes the rationale and planned methods for the comparative effectiveness trial. TRIAL REGISTRATION: Clinicaltrials.gov Identifier NCT05041855 (6/13/2023).

Primary care provider uptake of intensive behavioral therapy for obesity in Medicare patients, 2013-2019.

BACKGROUND: The delivery of Intensive Behavioral Therapy (IBT) for obesity by primary care providers (PCPs) has been covered by Medicare to support elderly individuals with obesity (BMI > 30 kg/m2) in managing their weight since 2011 for individual therapy and 2015 for group therapy. We conducted a cohort study of PCPs in an attempt to understand patterns of uptake of IBT for obesity services among PCPs serving the Medicare population across the U.S. METHODS: We used the Centers for Medicare and Medicaid Services Provider Utilization and Payment Data from 2013 to 2019 to identify all PCPs who served more than 10 Medicare beneficiaries in each of the seven-year period to form a longitudinal panel. The procedure codes G0447 and G0473 were used to identify PCPs who provided IBT; and the characteristics of these providers were compared by the IBT-uptake status. RESULTS: Of the 537,754 eligible PCPs who served Medicare patients in any of the seven years, only 1.2% were found to be IBT service providers in at least one year from 2013 through 2019 (246 always users, 1,358 early adopters, and 4,563 late adopters). IBT providers shared a few common characteristics: they were more likely to be male, internal medicine providers, saw a higher number of Medicare beneficiaries, and practiced in the South and Northeast regions. Having higher proportion of patients with hyperlipidemia was associated with higher likelihood of a provider being an IBT-user. CONCLUSIONS: Very few PCPs continuously billed IBT services for Medicare patients with obesity. Further investigation is needed to mitigate barriers to the uptake of IBT services among PCPs.

Baseline Characteristics of PATHWEIGH: A Stepped-Wedge Cluster Randomized Study for Weight Management in Primary Care.

Context: Despite the fact that obesity is both treatable and preventable, treating the comorbidities, rather than obesity per se remains the mainstay of therapy. Objective: To evaluate the efficacy and implementation of a pragmatic approach to weight management in primary care that prioritizes treatment of weight rather than weight-related diseases (PATHWEIGH). Study Design and Analysis: PATHWEIGH is a hybrid type 1 cluster randomized stepped wedge clinical trial. Clinics were enrolled and randomized to three sequences using covariate constrained randomization. Descriptive statistics were used to summarize clinic and patient characteristics with t-tests, Wilcoxon rank sums or Fisher's exact tests used to compare groups. Setting: Fifty-seven primary care clinics in rural, suburban and urban Colorado in a single healthcare system were utilized. Population Studied: Patients age >18 years and body mass index (BMI) >25 kg/m2 who had a weight-prioritized visit (WPV) in the prior year were enrolled. A WPV was defined as a chief complaint or reason for visit that included "weight", ICD-10 codes for weight or use of an intake questionnaire for weight. Intervention: None. This abstract describes the baseline (pre-intervention) characteristics of the clinics and patients treated with standard-of-care (SOC) for weight management. Outcome Measures: Baseline characteristics of the clinics and patients undergoing a WPV from March 17, 2020 - March 16, 2021. Results: 20,410 patients met these eligibility requirements representing 12% of patients >18 years and body mass index (BMI) >25 kg/m2 seen at the clinic during this baseline period. The three randomization sequences of 20, 18, and 19 sites were similar with an overall median age of 53 years (IQR: 39-65), 58% women, 76% non-Hispanic whites, 64% commercial insurance, and median BMI of 36 kg/m2 (IQR: 32-41). No sequence differences were seen for vital signs, relevant laboratory values, or numbers of comorbidities or medications that cause weight loss or weight gain. Referral for anything weight-related was low (<6%) and only 334 prescriptions of an anti-obesity medication were noted. Conclusions: Of patients >18 years and body mass index (BMI) >25 kg/m2 seen in the 57 primary care clinics, 12% had a weight-prioritized visit during the baseline period. Despite most being commercially insured, referral to any weight-related service or prescription of anti-obesity medication was uncommon.

Cost and Return on Investment of a Team-Based Palliative Care Program for Parkinson Disease.

Implementation of palliative care (PC) in neurology settings may improve symptom control and quality of life and reduce acute care admissions. The benefits of team-based PC for patients with Parkinson disease have been established through rigorous evidence standards including randomized controlled trials. However, evidence on implementation costs and return on investment (ROI) is unknown and may guide other providers and systems considering this model of care. We applied time-driven activity-based costing with reimbursable visits calculated using Medicare reimbursement rates in Colorado and current procedural technology codes to 2 outpatient clinics at the University of Colorado Hospital: neurology PC and movement disorders. Per-patient ROI was calculated as the ratio of the incremental difference in financial revenues divided by the incremental difference in investment to expand PC services. The cost per new patient was $154 and $98 for neuropalliative and movement disorders clinics, respectively. Established patient visit costs were $82 and $41 for the neuropalliative care and movement disorders clinics, respectively. The neurology PC clinic had per-patient revenue for new and established visits of $297 and $147, respectively, compared with $203 and $141 for new and established visits, respectively, at the comparator clinic. Based on our assumptions, for every $1 invested in expanding PC services, a projected $1.68 will be recouped by the hospital system for new patient visits, and $0.13 will be recouped for established patient visits. These amounts are context dependent, and a calculator was created to allow other systems to estimate costs and ROI. Our results suggest that in an academic medical setting, both neurology PC and movement disorders clinics provided increased revenue to the health system. Opportunities to improve ROI include efficient allocation of personnel to new and established visits, expanding telemedicine, and other cost offsets for complex patients not estimated in this analysis. ROI may also be greater in health systems that benefit from cost savings such as accountable care organizations. Our approach may be applied to other novel care models. Future research efforts will focus on estimating the continued sustainability of this innovative outpatient care model.

No-Show Rates for Telemedicine Versus In-Person Appointments During the COVID-19 Pandemic: Implications for Medicaid Populations.

The objective of this study was to assess no-show rates among in-person and telemedicine visits during the COVID-19 pandemic among Medicaid members. We analyzed data from an urban safety net hospital in Denver, Colorado. Using multivariable binomial regression models, we estimated differences in probability of no shows by patient characteristics and assessed for effect modification by telemedicine use. Overall, the no-show rate was 20.5% with increased probability of no show among Hispanic (2.3%) and non-Hispanic, Black (7.4%) patients compared with their non-Hispanic, White counterparts. Modification by telemedicine was observed, decreasing no-show rates among both groups (P < .0001). Similar patterns were observed among medically complex patients. Audio-only telemedicine significantly impacted no-show rates within certain populations.

Pragmatic considerations and approaches for measuring staff time as an implementation cost in health systems and clinics: key issues and applied examples.

BACKGROUND: As the field of implementation science wrestles with the need for system decision-makers to anticipate the budget impact of implementing new programs, there has been a push to report implementation costs more transparently. For this purpose, the method of time-driven activity-based costing (TDABC) has been heralded as a pragmatic advance. However, a recent TDABC review found that conventional methods for estimating staff time remain resource-intensive and called for simpler alternatives. Our objective was to conceptually compare conventional and emerging TDABC approaches to measuring staff time. METHODS: Our environmental scan of TDABC methods identified several categories of approaches for staff time estimation; across these categories, staff time was converted to cost as a pro-rated fraction of salary/benefits. Conventional approaches used a process map to identify each step of program delivery and estimated the staff time used at each step in one of 3 ways: (a) uniform estimates of time needed for commonly occurring tasks (self-report), (b) retrospective "time diary" (self-report), or (c) periodic direct observation. In contrast, novel semi-automated electronic health record (EHR) approaches "nudge" staff to self-report time for specific process map step(s)-serving as a contemporaneous time diary. Also, novel EHR-based automated approaches include timestamps to track specific steps in a process map. We compared the utility of these TDABC approach categories according to the 5 R's model that measures domains of interest to system decision-makers: relevance, rapidity, rigor, resources, and replicability, and include two illustrative case examples. RESULTS: The 3 conventional TDABC staff time estimation methods are highly relevant to settings but have limited rapidity, variable rigor, are rather resource-intensive, and have varying replicability. In contrast to conventional TDABC methods, the semi-automated and automated EHR-based approaches have high rapidity, similar rigor, similar replicability, and are less resource-intensive, but have varying relevance to settings. CONCLUSIONS: This synthesis and evaluation of conventional and emerging methods for staff time estimation by TDABC provides the field of implementation science with options beyond the current approaches. The field remains pressed to innovatively and pragmatically measure costs of program delivery that rate favorably across all of the 5 R's domains.

A Survey of Primary Care Practices on Their Use of the Intensive Behavioral Therapy for Obese Medicare Patients.

OBJECTIVE: To fill the gap in knowledge on systematic differences between primary care practices (PCP) that do or do not provide intensive behavioral therapy (IBT) for obese Medicare patients. METHODS: A mixed modality survey (paper and online) of primary care practices obtained from a random sample of Medicare databases and a convenience sample of practice-based research network practices. KEY RESULTS: A total of 287 practices responded to the survey, including 140 (7.4% response rate) from the random sample and 147 (response rate not estimable) from the convenience sample. We found differences between the IBT-using and non-using practices in practice ownership, patient populations, and participation in Accountable Care Organizations. The non-IBT-using practices, though not billing for IBT, did offer some other assistance with obesity for their patients. Among those who had billed for IBT, but stopped billing, the most commonly cited reason was billing difficulties. Many providers experienced denied claims due to billing complexities. CONCLUSIONS: Although the Centers for Medicare and Medicaid Services established payment codes for PCPs to deliver IBT for obesity in 2011, very few providers submitted fee-for-service claims for these services after almost 10 years. A survey completed by both a random and convenience sample of practices using and not using IBT for obesity payment codes revealed that billing for these services was problematic, and many providers that began using the codes discontinued using them over the past 7 years.

Design and Evaluation of Low-Fidelity Visual Display Prototypes for Multiple Hospital-Acquired Conditions.

Hospital-acquired conditions such as catheter-associated urinary tract infection, stage 3 or 4 hospital-acquired pressure injury, and falls with injury are common, costly, and largely preventable. This study used participatory design methods to design and evaluate low-fidelity prototypes of clinical dashboards to inform high-fidelity prototype designs to visualize integrated risks based on patient profiles. Five low-fidelity prototypes were developed through literature review and by engaging nurses, nurse managers, and providers as participants (N = 23) from two hospitals in different healthcare systems using focus groups and interviews. Five themes were identified from participatory design sessions: Need for Integrated Hospital-Acquired Condition Risk Tool, Information Needs, Sources of Information, Trustworthiness of Information, and Performance Tracking Perspectives. Participants preferred visual displays that represented patient comparative risks for hospital-acquired conditions using the familiar design metaphor of a gauge and green, yellow, and red "traffic light" colors scheme. Findings from this study were used to design a high-fidelity prototype to be tested in the next phase of the project. Visual displays of hospital-acquired conditions that are familiar in display and simplify complex information such as the green, yellow, and red dashboard are needed to assist clinicians in fast-paced clinical environments and be designed to prevent alert fatigue.

Correction to: The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments.

After publication of our article [1] the authors have notified us that the title for Figure 1 was incorrectly captioned.

The Invested in Diabetes Study Protocol: a cluster randomized pragmatic trial comparing standardized and patient-driven diabetes shared medical appointments.

BACKGROUND: Shared medical appointments (SMAs) have been shown to be an efficient and effective strategy for providing diabetes self-management education and self-management support. SMA features vary and it is not known which features are most effective for different patients and practice settings. The Invested in Diabetes study tests the comparative effectiveness of SMAs with and without multidisciplinary care teams and patient topic choice for improving patient-centered and clinical outcomes related to diabetes. METHODS: This study compares the effectiveness of two SMA approaches using the Targeted Training for Illness Management (TTIM) curriculum. Standardized SMAs are led by a health educator with a set order of TTIM topics. Patient-driven SMAs are delivered collaboratively by a multidisciplinary care team (health educator, medical provider, behavioral health provider, and a peer mentor); patients select the order and emphasis on TTIM topics. Invested in Diabetes is a cluster randomized pragmatic trial involving approximately 1440 adult patients with type 2 diabetes. Twenty primary care practices will be randomly assigned to either standardized or patient-driven SMAs. A mixed-methods evaluation will include quantitative (practice- and patient-level data) and qualitative (practice and patient interviews, observation) components. The primary patient-centered outcome is diabetes distress. Secondary outcomes include autonomy support, self-management behaviors, clinical outcomes, patient reach, and practice-level value and sustainability. DISCUSSION: Practice and patient stakeholder input guided protocol development for this pragmatic trial comparing SMA approaches. Implementation strategies from the enhanced Replicating Effective Programs framework will help ensure practices maintain fidelity to intervention protocols while tailoring workflows to their settings. Invested in Diabetes will contribute to the literature on chronic illness management and implementation science using the RE-AIM model. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03590041. Registered on 5 July 2018.

Does outpatient palliative care improve patient-centered outcomes in Parkinson's disease: Rationale, design, and implementation of a pragmatic comparative effectiveness trial.

Patients with Parkinson's disease and related disorders (PDRD) and their families have considerable unmet needs including non-motor symptom management, caregiver support, spiritual wellbeing, advance care planning, and end-of-life care. There is increasing interest in applying palliative care (PC) models to better meet these needs. While PC has been shown to improve care and quality of life (QOL) for people with cancer and heart failure, few studies have evaluated the role of PC for people with PDRD. Well-designed clinical trials are needed to optimize the PC approach for PDRD and to influence policy and implementation efforts. We initiated a randomized multicenter comparative effectiveness trial of team-based outpatient PC versus usual care for people with PDRD and their caregivers. The primary aims of this study are to determine the effects of PC on patient QOL and caregiver burden. Qualitative interviews will be utilized to gain additional insights into the impact of PC on participants, the outcomes that matter most to this population, and to find opportunities to refine future interventions and trials. As a novel application of PC, challenges involved in the design of this study include choosing appropriate inclusion criteria, standardizing the intervention, defining usual care, and choosing outcome measures suitable to our research questions. Challenges involved in implementation include participant recruitment, retention, and management of participant burden. We anticipate the results of this trial will have relevance for both clinical care and future clinical research trial design in evaluating models of PC for people with PDRD and other serious illnesses.

Nationwide analysis of hospital-to-hospital transfer in patients with aneurysmal subarachnoid hemorrhage requiring aneurysm repair.

OBJECTIVEAneurysmal subarachnoid hemorrhage (aSAH) has devastating consequences. The association between higher institutional volumes and improved outcomes for aSAH patients has been studied extensively. However, the literature exploring patterns of transfer in this context is sparse. Expansion of the endovascular workforce has raised concerns about the decentralization of care, reduced institutional volumes, and worsened patient outcomes. In this paper, the authors explored various patient and hospital factors associated with the transfer of aSAH patients by using a nationally representative database.METHODSThe 2013 and 2014 years of the National Inpatient Sample (NIS) were used to define an observational cohort of patients with ruptured brain aneurysms. The initial search identified patients with SAH (ICD-9-CM 430). Those with concomitant codes suggesting trauma or other intracranial vascular abnormalities were excluded. Finally, the patients who had not undergone a subsequent procedure to repair an intracranial aneurysm were excluded. These criteria yielded a cohort of 4373 patients, 1379 of whom had undergone microsurgical clip ligation and 2994 of whom had undergone endovascular repair. The outcome of interest was transfer status, and the NIS data element TRAN_IN was used to define this state. Multiple explanatory variables were identified, including age, sex, primary payer, median household income by zip code, race, hospital size, hospital control, hospital teaching status, and hospital location. These variables were evaluated using descriptive statistics, bivariate correlation analysis, and multivariable logistic regression modeling to determine their relationship with transfer status.RESULTSPatients with aSAH who were treated in an urban teaching hospital had higher odds of being a transfer (OR 2.15, 95% CI 1.71-2.72) than the patients in urban nonteaching hospitals. White patients were more likely to be transfer patients than were any of the other racial groups (p < 0.0001). Moreover, patients who lived in the highest-income zip codes were less likely to be transferred than the patients in the lowest income quartile (OR 0.78, 95% CI 0.64-0.95). Repair type (clip vs coil) and primary payer were not associated with transfer status.CONCLUSIONSA relatively high percentage of patients with aSAH are transferred between acute care hospitals. Race and income were associated with transfer status. White patients are more likely to be transferred than other races. Patients from zip codes with the highest income transferred at lower rates than those from the lowest income quartile. Transfer patients were preferentially sent to urban teaching hospitals. The modality of aneurysm treatment was not associated with transfer status.