The OPTIMIZE patient- and family-centered, primary care-based deprescribing intervention for older adults with dementia or mild cognitive impairment and multiple chronic conditions: study protocol for a pragmatic cluster randomized controlled trial.

BACKGROUND: Most individuals with dementia or mild cognitive impairment (MCI) have multiple chronic conditions (MCC). The combination leads to multiple medications and complex medication regimens and is associated with increased risk for significant treatment burden, adverse drug events, cognitive changes, hospitalization, and mortality. Optimizing medications through deprescribing (the process of reducing or stopping the use of inappropriate medications or medications unlikely to be beneficial) may improve outcomes for MCC patients with dementia or MCI. METHODS: With input from patients, family members, and clinicians, we developed and piloted a patient-centered, pragmatic intervention (OPTIMIZE) to educate and activate patients, family members, and primary care clinicians about deprescribing as part of optimal medication management for older adults with dementia or MCI and MCC. The clinic-based intervention targets patients on 5 or more medications, their family members, and their primary care clinicians using a pragmatic, cluster-randomized design at Kaiser Permanente Colorado. The intervention has two components: a patient/ family component focused on education and activation about the potential value of deprescribing, and a clinician component focused on increasing clinician awareness about options and processes for deprescribing. Primary outcomes are total number of chronic medications and total number of potentially inappropriate medications (PIMs). We estimate that approximately 2400 patients across 9 clinics will receive the intervention. A comparable number of patients from 9 other clinics will serve as wait-list controls. We have > 80% power to detect an average decrease of - 0.70 (< 1 medication). Secondary outcomes include the number of PIM starts, dose reductions for selected PIMs (benzodiazepines, opiates, and antipsychotics), rates of adverse drug events (falls, hemorrhagic events, and hypoglycemic events), ability to perform activities of daily living, and skilled nursing facility, hospital, and emergency department admissions. DISCUSSION: The OPTIMIZE trial will examine whether a primary care-based, patient- and family-centered intervention educating patients, family members, and clinicians about deprescribing reduces numbers of chronic medications and PIMs for older adults with dementia or MCI and MCC. TRIAL REGISTRATION: NCT03984396. Registered on 13 June 2019.

Recruitment and Retention for a Weight Loss Maintenance Trial Involving Weight Loss Prior to Randomization.

OBJECTIVE: A weight loss maintenance trial involving weight loss prior to randomization is challenging to implement due to the potential for dropout and insufficient weight loss. We examined rates and correlates of non-initiation, dropout, and insufficient weight loss during a weight loss maintenance trial. METHODS: The MAINTAIN trial involved a 16-week weight loss program followed by randomization among participants losing at least 4 kg. Psychosocial measures were administered during a screening visit. Weight was obtained at the first group session and 16 weeks later to determine eligibility for randomization. RESULTS: Of 573 patients who screened as eligible, 69 failed to initiate the weight loss program. In adjusted analyses, failure to initiate was associated with lower age, lack of a support person, and less encouragement for making dietary changes. Among participants who initiated, 200 dropped out, 82 lost insufficient weight, and 222 lost sufficient weight for randomization. Compared to losing sufficient weight, dropping out was associated with younger age and tobacco use, whereas losing insufficient weight was associated with non-White race and controlled motivation for physical activity. CONCLUSIONS: Studies should be conducted to evaluate strategies to maximize recruitment and retention of subgroups that are less likely to initiate and be retained in weight loss maintenance trials.

Impact of morbid obesity on medical expenditures in adults.

CONTEXT: Morbid obesity (body mass index (BMI) > or =40 kg/m2) is associated with substantially increased morbidity and mortality from chronic health conditions and with poorer health-related quality of life; however, less is known about the impact of morbid obesity on healthcare expenditures. OBJECTIVE: To examine the impact of morbid obesity on healthcare expenditures using a nationally representative sample of US adults. DESIGN, SETTING, AND PARTICIPANTS: We performed a cross-sectional analysis of 16 262 adults from the 2000 Medical Expenditure Panel Survey, a nationally representative survey of the noninstitutionalized civilian population of the United States. Per capita healthcare expenditures were calculated for National Institutes of Health BMI categories, based on self-reported height and weight, using a two-part, multivariable model adjusted for age, gender, race, income, education level, type of health insurance, marital status, and smoking status. MAIN OUTCOME MEASURES: Odds of incurring any healthcare expenditure and per capita healthcare expenditures associated with morbid obesity in 2000. RESULTS: When compared with normal-weight adults, the odds of incurring any healthcare expenditure in 2000 were two-fold greater among adults with morbid obesity. Per capita healthcare expenditures for morbidly obese adults were 81% (95% confidence interval (CI): 48-121%) greater than normal-weight adults, 65% (95% CI: 37-110%) greater than overweight adults, and 47% (95% CI: 11-96%) greater than adults with class I obesity. Excess costs among morbidly obese adults resulted from greater expenditures for office-based visits, outpatient hospital care, in-patient care, and prescription drugs. Aggregate US healthcare expenditures associated with excess body weight among morbidly obese US adults exceeded $11 billion in 2000. CONCLUSIONS: The economic burden of morbid obesity among US adults is substantial. Further research is needed to identify interventions to reduce the incidence and prevalence of morbid obesity and improve the health and economic outcomes of morbidly obese adults.

Comparing mortality and time until death for medicare HMO and FFS beneficiaries.

OBJECTIVE: To compare adjusted mortality rates of TEFRA-risk HMO enrollees and disenrollees with rates of beneficiaries enrolled in the Medicare fee-for-service sector (FFS), and to compare the time until death for decedents in these three groups. DATA SOURCE: Data are from the 124 counties with the largest TEFRA-risk HMO enrollment using 1993-1994 Medicare Denominator files for beneficiaries enrolled in the FFS and TEFRA-risk HMO sectors. STUDY DESIGN: A retrospective study that tracks the mortality rates and time until death of a random sample of 1,240,120 Medicare beneficiaries in the FFS sector and 1,526,502 enrollees in HMOs between April 1, 1993 and April 1, 1994. A total of 58,201 beneficiaries switched from an HMO to the FFS sector and were analyzed separately. PRINCIPAL FINDINGS: HMO enrollees have lower relative odds of mortality than a comparable group of FFS beneficiaries. Conversely, HMO disenrollees have higher relative odds of mortality than comparable FFS beneficiaries. Among decedents in the three groups, HMO enrollees lived longer than FFS beneficiaries, who in turn lived longer than HMO disenrollees. CONCLUSIONS: Medicare TEFRA-risk HMO enrollees appear to be, on average, healthier than beneficiaries enrolled in the FFS sector, who appear to be in turn healthier than HMO disenrollees. These health status differences persist, even after controlling for beneficiary demographics and county-level variables that might confound the relationship between mortality and the insurance sector.

How do states buy health insurance for their own employees?

State governments play many roles in local health insurance markets. This paper focuses on the role of states as employers. As managed care and health care costs continue to grow, state governments engage in a variety of health insurance purchasing practices that influence the structure of health benefits offered to state employees. Descriptive analysis shows that many states have adopted managed competition to some degree, as well as traditional cost-reducing measures such as utilization review and self insurance. The experience of state governments can provide a benchmark for other public and private employers.