Evaluating the Safety of an Educational Deprescribing Intervention: Lessons from the Optimize Trial.

BACKGROUND: Patients, family members, and clinicians express concerns about potential adverse drug withdrawal events (ADWEs) following medication discontinuation or fears of upsetting a stable medical equilibrium as key barriers to deprescribing. Currently, there are limited methods to pragmatically assess the safety of deprescribing and ascertain ADWEs. We report the methods and results of safety monitoring for the OPTIMIZE trial of deprescribing education for patients, family members, and clinicians. METHODS: This was a pragmatic cluster randomized trial with multivariable Poisson regression comparing outcome rates between study arms. We conducted clinical record review and adjudication of sampled records to assess potential causal relationships between medication discontinuation and outcomes. This study included adults aged 65+ with dementia or mild cognitive impairment, one or more additional chronic conditions, and prescribed 5+ chronic medications. The intervention included an educational brochure on deprescribing that was mailed to patients prior to primary care visits, a clinician notification about individual brochure mailings, and an educational tip sheets was provided monthly to primary care clinicians. The outcomes of the safety monitoring were rates of hospitalizations and mortality during the 4 months following brochure mailings and results of record review and adjudication. The adjudication process was conducted throughout the trial and included classifications: likely, possibly, and unlikely. RESULTS: There was a total of 3012 (1433 intervention and 1579 control) participants. There were 420 total hospitalizations involving 269 (18.8%) people in the intervention versus 517 total hospitalizations involving 317 (20.1%) people in the control groups. Adjusted risk ratios comparing intervention to control groups were 0.92 [95% confidence interval (CI) 0.72, 1.16] for hospitalization and 1.19 (95% CI 0.67, 2.11) for mortality. Both groups had zero deaths "likely" attributed to a medication change prior to the event. A total of 3 out of 30 (10%) intervention group hospitalizations and 7 out of 35 (20%) control group hospitalizations were considered "likely" due to a medication change. CONCLUSIONS: Population-based deprescribing education is safe in the older adult population with cognitive impairment in our study. Pragmatic methods for safety monitoring are needed to further inform deprescribing interventions. TRIAL REGISTRATION: NCT03984396. Registered on 13 June 2019.

Ethical Aspects of Physician Decision-Making for Deprescribing Among Older Adults With Dementia.

Importance: Physicians endorse deprescribing of risky or unnecessary medications for older adults (aged ≥65 years) with dementia, but there is a lack of information on what influences decisions to deprescribe in this population. Objective: To understand how physicians make decisions to deprescribe for older adults with moderate dementia and ethical and pragmatic concerns influencing those decisions. Design, Setting, and Participants: A cross-sectional national mailed survey study of a random sample of 3000 primary care physicians from the American Medical Association Physician Masterfile who care for older adults was conducted from January 15 to December 31, 2021. Main Outcomes and Measures: The study randomized participants to consider 2 clinical scenarios in which a physician may decide to deprescribe a medication for older adults with moderate dementia: 1 in which the medication could cause an adverse drug event if continued and the other in which there is no evidence of benefit. Participants ranked 9 factors related to possible ethical and pragmatic concerns through best-worst scaling methods (from greatest barrier to smallest barrier to deprescribing). Conditional logit regression quantified the relative importance for each factor as a barrier to deprescribing. Results: A total of 890 physicians (35.0%) returned surveys; 511 (57.4%) were male, and the mean (SD) years since graduation was 26.0 (11.7). Most physicians had a primary specialty in family practice (50.4% [449 of 890]) and internal medicine (43.5% [387 of 890]). A total of 689 surveys were sufficiently complete to analyze. In both clinical scenarios, the 2 greatest barriers to deprescribing were (1) the patient or family reporting symptomatic benefit from the medication (beneficence and autonomy) and (2) the medication having been prescribed by another physician (autonomy and nonmaleficence). The least influential factor was ease of paying for the medication (justice). Conclusions and Relevance: Findings from this national survey study of primary care physicians suggests that understanding ethical aspects of physician decision-making can inform clinician education about medication management and deprescribing decisions for older adults with moderate dementia.

Telehealth During COVID-19 for Adults with Multiple Chronic Conditions: Associations with Self-Reported Food Insecurity and with Physical Limitations.

Background: Adults with chronic medical conditions complicated by food insecurity or physical limitations may have higher barriers to accessing telehealth implemented during the COVID-19 pandemic. Objective: To examine the relationships of self-reported food insecurity and physical limitations with changes in health care utilization and medication adherence comparing the year before (March 2019-February 2020) and the first year of the COVID-19 pandemic (April 2020-March 2021) among patients with chronic conditions insured by Medicaid or Medicare Advantage. Methods: A prospective cohort study of 10,452 Kaiser Permanente Northern California members insured by Medicaid and 52,890 Kaiser Permanente Colorado members insured by Medicare Advantage was conducted. Difference-in-differences (DID) between the pre-COVID and COVID years in telehealth versus in-person health care utilization and adherence to chronic disease medicines by food insecurity and by physical limitation status were measured. Results: Food insecurity and physical limitations were each associated with small but significantly greater shifts from in-person to telehealth. Medicare Advantage members with physical limitations also had significantly greater decline in adherence to chronic medications from year to year compared with those without physical limitations (DID from pre-COVID year to COVID year ranged from 0.7% to 3.6% greater decline by medication class, p < 0.01). Conclusions: Food insecurity and physical limitations did not present significant barriers to the transition to telehealth during the COVID pandemic. The greater decrease in medication adherence among older patients with physical limitations suggests that care systems must further address the needs of this high-risk population.

Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial.

BACKGROUND: Medically tailored meals (MTM) may be beneficial to patients after hospital discharge. OBJECTIVE: To determine if 2 versus 4 weeks of MTM posthospitalization will improve patient outcomes. DESIGN: Randomized unblinded trial. SETTINGS AND PARTICIPANTS: Six hundred and fifty patients pending hospital discharge with at least one chronic condition. INTERVENTION: One MTM a day for 2 versus 4 weeks. MAIN OUTCOME AND MEASURES: The primary outcome was a change from baseline to 60 days in the Hospital Anxiety Depression Scale (HADS). Secondary outcomes measured change in the Katz activities of daily living (ADLs), DETERMINE nutritional risk, and all-cause emergency department (ED) visits and rehospitalizations. RESULTS: From baseline to 60 days the HADS anxiety subscale changed 5.4-4.9 in the 2-week group (p = .03) and 5.4-5.3 in the 4-week group (p = .49); the difference in change between groups 0.4 (p = .25). HADS changed 5.4-4.8 in the 2-week group (p = .005) and 5.3-5.1 in the 4-week group (p = .34); the difference in change between groups 0.4 (p = .18). ADL score changed from 5.3 to 5.6 in the 2-week group (p ≤ .0001) and 5.2-5.5 in the 4-week group (p ≤ .0001); the difference in change between groups -0.01 (p = .90). The DETERMINE changed in the 2-week group from 7.2 to 6.4 (p = .0006) and from 7 to 6.7 in the 4-week group (p = .19); the difference in change between groups 0.5 (p = .13). There was no difference in ED visits and rehospitalizations between groups or time to rehospitalization. CONCLUSIONS: Different durations of short-term MTM did not affect patient-centered or utilization outcomes.

Intervention design in cognitively impaired populations-Lessons learned from the OPTIMIZE deprescribing pragmatic trial.

BACKGROUND: Polypharmacy is common in older adults with cognitive impairment and multiple chronic conditions, increasing risks of adverse drug events, hospitalization, and death. Deprescribing, the process of reducing or stopping potentially inappropriate medications, may improve outcomes. The OPTIMIZE pragmatic trial examined whether educating and activating patients, family members and clinicians about deprescribing reduces number of chronic medications and potentially inappropriate medications. Acceptability and challenges of intervention delivery in cognitively impaired older adults are not well understood. METHODS: We explored mechanisms of intervention implementation through post hoc qualitative interviews and surveys with stakeholder groups of 15 patients, 7 caregivers, and 28 clinicians. We assessed the context in which the intervention was delivered, its implementation, and mechanisms of impact. RESULTS: Acceptance of the intervention was affected by contextual factors including cognition, prior knowledge of deprescribing, communication, and time constraints. All stakeholder groups endorsed the acceptability, importance, and delivery of the intervention. Positive mechanisms of impact included patients scheduling specific appointments to discuss deprescribing and providers being prompted to consider deprescribing. Recollection of intervention materials was inconsistent but most likely shortly after intervention delivery. Short visit times remained the largest provider barrier to deprescribing. CONCLUSIONS: Our work identifies key learnings in intervention delivery that can guide future scaling of deprescribing interventions in this population. We highlight the critical roles of timing and repetition in intervention delivery to cognitively impaired populations and the barrier posed by short consultation times. The acceptability of the intervention to patients and family members highlights the potential to incorporate deprescribing education into routine clinical practice and expand proven interventions to other vulnerable populations.

Deprescribing Education vs Usual Care for Patients With Cognitive Impairment and Primary Care Clinicians: The OPTIMIZE Pragmatic Cluster Randomized Trial.

Background: Individuals with dementia or mild cognitive impairment frequently have multiple chronic conditions (defined as ≥2 chronic medical conditions) and take multiple medications, increasing their risk for adverse outcomes. Deprescribing (reducing or stopping medications for which potential harms outweigh potential benefits) may decrease their risk of adverse outcomes. Objective: To examine the effectiveness of increasing patient and clinician awareness about the potential to deprescribe unnecessary or risky medications among patients with dementia or mild cognitive impairment. Design, Setting, and Participants: This pragmatic, patient-centered, 12-month cluster randomized clinical trial was conducted from April 1, 2019, to March 31, 2020, at 18 primary care clinics in a not-for-profit integrated health care delivery system. The study included 3012 adults aged 65 years or older with dementia or mild cognitive impairment who had 1 or more additional chronic medical conditions and were taking 5 or more long-term medications. Interventions: An educational brochure and a questionnaire on attitudes toward deprescribing were mailed to patients prior to a primary care visit, clinicians were notified about the mailing, and deprescribing tip sheets were distributed to clinicians at monthly clinic meetings. Main Outcomes and Measures: The number of prescribed long-term medications and the percentage of individuals prescribed 1 or more potentially inappropriate medications (PIMs). Analysis was performed on an intention-to-treat basis. Results: This study comprised 1433 individuals (806 women [56.2%]; mean [SD] age, 80.1 [7.2] years) in 9 intervention clinics and 1579 individuals (874 women [55.4%]; mean [SD] age, 79.9 [7.5] years) in 9 control clinics who met the eligibility criteria. At baseline, both groups were prescribed a similar mean (SD) number of long-term medications (7.0 [2.1] in the intervention group and 7.0 [2.2] in the control group), and a similar proportion of individuals in both groups were taking 1 or more PIMs (437 of 1433 individuals [30.5%] in the intervention group and 467 of 1579 individuals [29.6%] in the control group). At 6 months, the adjusted mean number of long-term medications was similar in the intervention and control groups (6.4 [95% CI, 6.3-6.5] vs 6.5 [95% CI, 6.4-6.6]; P = .14). The estimated percentages of patients in the intervention and control groups taking 1 or more PIMs were similar (17.8% [95% CI, 15.4%-20.5%] vs 20.9% [95% CI, 18.4%-23.6%]; P = .08). In preplanned subgroup analyses, adjusted differences between the intervention and control groups were -0.16 (95% CI, -0.34 to 0.01) for individuals prescribed 7 or more long-term medications at baseline (n = 1434) and -0.03 (95% CI, -0.20 to 0.13) for those prescribed 5 to 6 medications (n = 1578) (P = .28 for interaction; P = .19 for subgroup interaction for PIMs). Conclusions and Relevance: This large-scale educational deprescribing intervention for older adults with cognitive impairment taking 5 or more long-term medications and their primary care clinicians demonstrated small effect sizes and did not significantly reduce the number of long-term medications and PIMs. Such interventions should target older adults taking relatively more medications. Trial Registration: ClinicalTrials.gov Identifier: NCT03984396.

Accounting for Social Risk Does not Eliminate Race/Ethnic Disparities in COVID-19 Infection Among Insured Adults: a Cohort Study.

BACKGROUND: Communities of color have been disproportionately impacted by the COVID-19 epidemic in the USA. OBJECTIVES: To examine the relationship of self-reported social health needs with SARS-COV-2 infection by race/ethnicity among insured adults with access to high-quality health care. DESIGN AND PARTICIPANTS: A prospective cohort study of 26,741 adult Kaiser Permanente Northern California members insured by Medicaid and 58,802 Kaiser Permanente Colorado members insured by Medicare Advantage who completed social risk assessments prior to the onset of the COVID-19 pandemic. MAIN MEASURES: We examined the independent relationships of demographic, medical, and social factors on SARS-COV-2 testing and positivity between March 1, 2020, and November 30, 2020, by race/ethnicity. KEY RESULTS: Findings were similar in the two cohorts, with Latino (16-18%), Asian (11-14%), and Black (11-12%) members having the highest prevalence of SARS-COV-2 infection (ORs adjusted for age, gender, and use of interpreter ranging from 1.68 to 2.23 compared to White member [7-8%], p < 0.001). Further adjustment for medical comorbidity (e.g., obesity, diabetes, chronic lung disease); neighborhood measures; and self-reported social risk factors (e.g., trouble paying for basics, food insecurity, housing concerns, transportation barriers) did not appreciably change these results. CONCLUSIONS: Compared to non-Latino White members, members of other race/ethnic groups had higher positivity rates that were only minimally reduced after controlling for medical and neighborhood conditions and self-reported social risk factors. These findings suggest that traditional infection transmission factors such as essential work roles and household size that have disproportionate representation among communities of color may be important contributors to SARS-COV-2 infection among insured adults.