Reducing Central Nervous System-Active Medications to Prevent Falls and Injuries Among Older Adults: A Cluster Randomized Clinical Trial.

Importance: High-risk medications that contribute to adverse health outcomes are frequently prescribed to older adults. Deprescribing interventions reduce their use, but studies are often not designed to examine effects on patient-relevant health outcomes. Objective: To test the effect of a health system-embedded deprescribing intervention targeting older adults and their primary care clinicians for reducing the use of central nervous system-active drugs and preventing medically treated falls. Design, Setting, and Participants: In this cluster randomized, parallel-group, clinical trial, 18 primary care practices from an integrated health care delivery system in Washington state were recruited from April 1, 2021, to June 16, 2022, to participate, along with their eligible patients. Randomization occurred at the clinic level. Patients were community-dwelling adults aged 60 years or older, prescribed at least 1 medication from any of 5 targeted medication classes (opioids, sedative-hypnotics, skeletal muscle relaxants, tricyclic antidepressants, and first-generation antihistamines) for at least 3 consecutive months. Intervention: Patient education and clinician decision support. Control arm participants received usual care. Main Outcomes and Measures: The primary outcome was medically treated falls. Secondary outcomes included medication discontinuation, sustained medication discontinuation, and dose reduction of any and each target medication. Serious adverse drug withdrawal events involving opioids or sedative-hypnotics were the main safety outcome. Analyses were conducted using intent-to-treat analysis. Results: Among 2367 patient participants (mean [SD] age, 70.6 [7.6] years; 1488 women [63%]), the adjusted cumulative incidence rate of a first medically treated fall at 18 months was 0.33 (95% CI, 0.29-0.37) in the intervention group and 0.30 (95% CI, 0.27-0.34) in the usual care group (estimated adjusted hazard ratio, 1.11 (95% CI, 0.94-1.31) (P = .11). There were significant differences favoring the intervention group in discontinuation, sustained discontinuation, and dose reduction of tricyclic antidepressants at 6 months (discontinuation adjusted rate: intervention group, 0.23 [95% CI, 0.18-0.28] vs usual care group, 0.13 [95% CI, 0.09-0.17]; adjusted relative risk, 1.79 [95% CI, 1.29-2.50]; P = .001) and secondary time points (9, 12, and 15 months). Conclusions and Relevance: In this randomized clinical trial of a health system-embedded deprescribing intervention targeting community-dwelling older adults prescribed central nervous system-active medications and their primary care clinicians, the intervention was no more effective than usual care in reducing medically treated falls. For health systems that attend to deprescribing as part of routine clinical practice, additional interventions may confer modest benefits on prescribing without a measurable effect on clinical outcomes. Trial Registration: ClinicalTrials.gov Identifier: NCT05689554.

Government Direct-to-Consumer Education to Reduce Prescription Opioid Use: A Cluster Randomized Clinical Trial.

Importance: Direct-to-consumer education reduces chronic sedative use. The effectiveness of this approach for prescription opioids among patients with chronic noncancer pain remains untested. Objectives: To evaluate the effectiveness of a government-led educational information brochure mailed to community-dwelling, long-term opioid consumers to reduce prescription opioid use compared with usual care. Design, Setting, and Participants: This cluster randomized clinical trial was conducted from July 2018 to January 2019 in Manitoba, Canada. All adults with long-term opioid prescriptions were enrolled (n = 4225). Participants were identified via the Manitoba Drug Program Information Network. Individuals receiving palliative care or with a diagnosis of cancer or dementia were excluded. Data were analyzed from July 2019 to March 2020. Intervention: Participants were clustered according to their primary care clinic and randomized to the intervention (a codesigned direct-to-consumer educational brochure sent by mail) or usual care (comparator group). Main Outcomes and Measures: The main outcome was discontinuation of opioid prescriptions at the participant level after 6 months, ascertained by pharmacy drug claims. Secondary outcomes included dose reduction (in morphine milligram equivalents [MME]) and/or therapeutic switch. Reduction in opioid use was assessed using generalized estimating equations to account for clustering, with prespecified subgroup analyses by age and sex. Analysis was intention to treat. Results: Of 4206 participants, 2409 (57.3%) were male; mean (SD) age was 60.0 (14.4) years. Mean (SD) baseline opioid use was comparable between groups (intervention, 157.7 [179.7] MME/d; control, 153.4 [181.8] MME/d). After 6 months, 235 of 2136 participants (11.0%) in 127 clusters in the intervention group no longer filled opioid prescriptions compared with 228 of 2070 (11.0%) in 124 clusters in the comparator group (difference, 0.0%; 95% CI, -1.9% to 1.9%). More participants in the intervention group than in the control group reduced their dose (1410 [66.0%] vs 1307 [63.1%]; difference, 2.8% [95% CI, 0.0%-5.7%]). Receipt of the brochure led to greater dose reductions for participants who were male (difference, 3.9%; 95% CI, 0.1%-7.7%), aged 18 to 64 years (difference, 3.7%; 95% CI, 0.2%-7.2%), or living in urban areas (difference, 5.9%; 95% CI, 1.9%-9.9%) compared with usual care. Conclusions and Relevance: In this cluster randomized clinical trial, no significant difference in the prevalence of opioid cessation was observed after 6 months between the intervention and usual care groups; however, the intervention resulted in more adults reducing their opioid dose compared with usual care. Trial Registration: ClinicalTrials.gov Identifier: NCT03400384.

Strategies to guide the successful implementation of deprescribing in community practice: Lessons learned from the front line.

Background: Sustainable implementation of new professional services into clinical practice can be difficult. In 2019, a population-wide initiative called SaferMedsNL was implemented across the province of Newfoundland and Labrador (NL), to promote appropriate medication use. Two evidence-based interventions were adapted to the context of NL to promote deprescribing of proton pump inhibitors and sedatives. The objective of this study was to identify and prioritize which actions supported the implementation of deprescribing in community practice for pharmacists, physicians and nurse practitioners across the province. Methods: Community pharmacists, physicians and nurse practitioners were invited to participate in virtual focus groups. Nominal Group Technique was used to elicit responses to the question: "What actions support the implementation of deprescribing into the daily workflow of your practice?" Participants prioritized actions within each group while thematic analysis permitted comparison across groups. Results: Five focus groups were held in fall 2020 involving pharmacists (n = 11), physicians (n = 7) and nurse practitioners (n = 4). Participants worked in rural (n = 10) and urban (n = 12) settings. The different groups agreed on what the top 5 actions were, with the top 5 receiving 68% of the scores: (1) providing patient education, (2) allocating time and resources, (3) building interprofessional collaboration and communication, (4) fostering patient relationships and (5) aligning with public awareness strategies. Conclusion: Pharmacists, physicians and nurse practitioners identified similar actions that supported implementing evidence-based deprescribing into routine clinical practice. Sharing these strategies may help others embed deprescribing into daily practice and assist the uptake of medication appropriateness initiatives by front-line providers. Can Pharm J (Ott) 2024;157:xx-xx.

Reducing potentially inappropriate polypharmacy at a national and international level: the impact of deprescribing networks.

INTRODUCTION: Over the past decade, polypharmacy has increased dramatically. Measurable harms include falls, fractures, cognitive impairment, and death. The associated costs are massive and contribute substantially to low-value health care. Deprescribing is a promising solution, but there are barriers. Establishing a network to address polypharmacy can help overcome barriers by connecting individuals with an interest and expertise in deprescribing and can act as an important source of motivation and resources. AREAS COVERED: Over the past decade, several deprescribing networks were launched to help tackle polypharmacy, with evidence of individual and collective impact. A network approach has several advantages; it can spark interest, ideas and enthusiasm through information sharing, meetings and conversations with the public, providers, and other key stakeholders. In this special report, the details of how four deprescribing networks were established across the globe are detailed. EXPERT OPINION: Networks create links between people who lead existing and/or budding deprescribing practices and policy initiatives, can influence people with a shared passion for deprescribing, and facilitate sharing of intellectual capital and tools to take initiatives further and strengthen impact.This report should inspire others to establish their own deprescribing networks, a critical step in accelerating a global deprescribing movement.

Factors influencing the effects of policies and interventions to promote the appropriate use of medicines in high-income countries: A rapid realist review.

BACKGROUND: The appropriate use of medicines has long been recognized as a fundamental component of medicine policies. We aimed to extract lessons from published research on how policy contexts and mechanisms can affect the outcomes of national- or health-system level interventions to promote appropriate medicine use (defined as an increase in underutilized medications or decrease in inappropriate medication use). METHODS: We conducted a rapid realist review of published evidence concerning system-level policies to promote the appropriate use of medicines in high-income countries with universal prescription drug coverage. We searched MEDLINE and Embase to identify relevant publications. We used a realist evaluation framework to identify contexts, mechanisms, and outcomes for each intervention and to hypothesize which policy contexts and mechanisms supported successful outcomes in terms of relative changes in the prevalence of use of the specific medication classes targeted. RESULTS: From 1,318 identified studies, 18 met our inclusion criteria. 13 distinct policies were identified. Three main policy-related factors underpinned successful interventions: involving providers and patients through program interventions; central coordination through national agencies dedicated to medicine policies; and the establishment of an explicit and integrated national medicine policy strategy. CONCLUSION: Policymakers can improve coordination of national pharmaceutical policies to reduce harms from inappropriate medicines use, thus improving health outcomes through cost-effective programs.

Provider knowledge, beliefs, and self-efficacy to deprescribe opioids and sedative-hypnotics.

BACKGROUND: While many studies have assessed and measured patient attitudes toward deprescribing, less quantitative research has addressed the provider perspective. We thus sought to describe provider knowledge, beliefs, and self-efficacy to deprescribe, with a focus on opioids and sedative-hypnotics. METHODS: An electronic anonymous survey was distributed to primary care providers at Kaiser Permanente Washington. Two reminder emails were sent. The survey included 10 questions on general deprescribing, and six questions each specific to opioid and sedative-hypnotic deprescribing. Knowledge questions used a multiple-choice response option format. Questions addressing beliefs and self-efficacy (i.e., confidence) used a 0-10 Likert scale. Scales were dichotomized at ≥7 to define agreement (belief questions) or confidence (self-efficacy questions). We calculated descriptive statistics to summarize the responses. RESULTS: Of 370 eligible primary care providers, 95 (26%) completed the survey. For general deprescribing questions, a majority believed that lack of patient willingness, withdrawal symptoms and fear of symptom return, and time constraints impeded deprescribing. Approximately half chose the correct answers about opioid deprescribing, 21% were confident that they could alleviate patient concerns about opioid tapering, and 32% were confident managing chronic non-cancer pain without opioids. For sedative-hypnotics, 64%-87% of respondents correctly answered questions about risks and the relative effectiveness of alternatives, but only one-third correctly answered a question about sedative-hypnotic tapering. Roughly half were confident in their ability to successfully engage patients in sedative deprescribing conversations and select alternatives. Only 54% and 34% were confident in writing a tapering protocol for opioids and sedative-hypnotics, respectively. CONCLUSION: Results suggest that raising provider awareness of patient willingness to deprescribe, addressing knowledge gaps, and increasing self-efficacy for deprescribing are important targets for improving deprescribing. Support for writing tapering protocols and prescribing evidence-based drug and non-drug alternatives may be important to improve care.

Addressing Barriers to Reducing Prescribing and Implementing Deprescribing of Sedative-Hypnotics in Primary Care.

OBJECTIVE: To describe interventions that target patient, provider, and system barriers to sedative-hypnotic (SH) deprescribing in the community and suggest strategies for healthcare teams. DATA SOURCES: Ovid MEDLINE ALL and EMBASE Classic + EMBASE (March 10, 2021). STUDY SELECTION AND DATA EXTRACTION: English-language studies in primary care settings. DATA SYNTHESIS: 20 studies were themed as patient-related and prescriber inertia, physician skills and awareness, and health system constraints. Patient education strategies reduced SH dose for 10% to 62% of participants, leading to discontinuation in 13% to 80% of participants. Policy interventions reduced targeted medication use by 10% to 50%. RELEVANCE TO PATIENT CARE AND CLINICAL PRACTICE: Patient engagement and empowerment successfully convince patients to deprescribe chronic SHs. Quality improvement strategies should also consider interventions directed at prescribers, including education and training, drug utilization reviews, or computer alerts indicating a potentially inappropriate prescription by medication, age, dose, or disease. Educational interventions were effective when they facilitated patient engagement and provided information on the harms and limited evidence supporting chronic use as well as the effectiveness of alternatives. Decision support tools were less effective than prescriber education with patient engagement, although they can be readily incorporated in the workflow through prescribing software. CONCLUSIONS: Several strategies with demonstrated efficacy in reducing SH use in community practice were identified. Education regarding SH risks, how to taper, and potential alternatives are essential details to provide to clinicians, patients, and families. The strategies presented can guide community healthcare teams toward reducing the community burden of SH use.

The Integration of Sex and Gender Considerations Into Biomedical Research: Lessons From International Funding Agencies.

To improve the outcomes of research and medicine, government-based international research funding agencies have implemented various types of policies and mechanisms with respect to sex as a biological variable and gender as a sociocultural factor. After the 1990s, the US National Institutes of Health (NIH), the Canadian Institutes of Health Research (CIHR), and the European Commission (EC) began requesting that applicants address sex and gender considerations in grant proposals, and offering resources to help the scientific community integrate sex and gender into biomedical research. Although it is too early to analyze data on the success of all of the policies and mechanisms implemented, here we review the use both of carrots (incentives) and sticks (requirements) developed to motivate researchers and the entire scientific research enterprise to consider sex and gender influences on health and in science. The NIH focused on sex as a biological variable (SABV) aligned with an initiative to enhance reproducibility through rigor and transparency; CIHR instituted a sex- and gender-based analysis (SGBA) policy; and the EC required the integration of the "gender dimension," which incorporates sex, gender, and intersectional analysis into research and innovation. Other global efforts are briefly summarized. Although we are still learning what works, we share lessons learned to improve the integration of sex and gender considerations into research. In conjunction with refining and expanding the policies of funding agencies and mechanisms, private funders/philanthropic groups, editors of peer-reviewed journals, academic institutions, professional organizations, ethics boards, health care systems, and industry also need to make concerted efforts to integrate sex and gender into research, and we all must bridge across silos to promote systemwide solutions throughout the biomedical enterprise. For example, policies that encourage researchers to disaggregate data by sex and gender, the development of tools to better measure gender effects, or policies similar to SABV and/or SGBA adopted by private funders would accelerate progress. Uptake, accountability for, and a critical appraisal of sex and gender throughout the biomedical enterprise will be crucial to achieving the goal of relevant, reproducible, replicable, and responsible science that will lead to better evidence-based, personalized care for all, but especially for women.

A 10-year longitudinal evaluation of science policy interventions to promote sex and gender in health research.

BACKGROUND: Over the past decade, the Canadian Institutes of Health Research (CIHR) has implemented multicomponent interventions to increase the uptake of sex and gender in grant applications. Interventions included mandatory reporting on applicant forms, development of resources for applicants and evaluators, and grant review requirements. Here, we aim to inform science policy implementation by describing the 10-year outcomes and lessons learned from these interventions. METHODS: This is a prospective longitudinal study. The population is all applicants across 15 investigator-initiated CIHR competitions from 2011 to 2019 and grant evaluators from 2018 to 2019. Quantitative data were derived from applicants' and grant evaluators' mandatory reporting of sex and gender integration in the grants management database. The application was the unit of analysis. Trends in sex and gender uptake in applications were plotted over time, stratified by research area. Univariate logistic regression was used to assess associations between the sex of the applicant and the uptake of sex and gender, and the latter with funding success. Qualitative review of the quality and appropriateness of evaluators' comments informed the development of discipline-specific training to peer review committee members. Feedback was compiled from a subset of evaluators on the perceived usefulness of the educational materials using a brief questionnaire. RESULTS: Since 2011, 39,390 applications were submitted. The proportion that reported integration of sex rose from 22 to 83%, and gender from 12 to 33%. Population health research applications paid the greatest attention to gender (82%). Across every competition, applications with female principal investigators were more likely to integrate sex (odds ratio [OR] 1.60, 95% confidence interval [CI] 1.50-1.63) and gender (OR 2.40, 95% CI 2.29-2.51) than those who identified as male. Since 2018, applications that scored highly for the integration of sex (OR 1.92, 95% CI 1.50-2.50) and gender (OR 2.53, 95% CI 1.83-3.50) were more likely to be funded. Qualitative observations revealed persistent conflation of the terms sex and gender. Eighty-six percent of evaluators appreciated the tailored discipline-specific coaching. CONCLUSIONS: A number of policy interventions improved sex and gender uptake in grant applications, with higher success rates observed over time for applications that integrated sex and gender. Other funders' action plans around sex and gender integration may be informed from our experiences of the timing, type and targets of the different interventions, specifically those directed at evaluators.

COVID-19 gender policy changes support female scientists and improve research quality.

With more time being spent on caregiving responsibilities during the COVID-19 pandemic, female scientists' productivity dropped. When female scientists conduct research, identity factors are better incorporated in research content. In order to mitigate damage to the research enterprise, funding agencies can play a role by putting in place gender equity policies that support all applicants and ensure research quality. A national health research funder implemented gender policy changes that included extending deadlines and factoring sex and gender into COVID-19 grant requirements. Following these changes, the funder received more applications from female scientists, awarded a greater proportion of grants to female compared to male scientists, and received and funded more grant applications that considered sex and gender in the content of COVID-19 research. Further work is urgently required to address inequities associated with identity characteristics beyond gender.

Predicting response to a community-based educational workshop on incontinence among community-dwelling older women: Post hoc analysis of the CACTUS-D trial.

AIMS: Our goal was to identify which women participating in an educational workshop on incontinence were most likely to benefit from it. METHODS: We included women aged 65 or older, living in the community, and not treated for incontinence despite reporting urinary leakage at least twice a week. The workshop's aims were to change beliefs about accepting incontinence as a normal part of ageing, explain that incontinence is not irreversible, and that solutions exist. We performed structured interviews at 6 and 12 months to assess impressions of improvement (PGI-I) and changes in both continence (ICIQ-FLUTS) and quality of life (I-QOL). RESULTS: The analysis included 392 women, 39% aged 80 or older and 57% with daily urinary incontinence. Twelve months after the workshop, 16% of women were "much better" (PGI-I); factors associated with impression of improvement were refusal to believe that incontinence is part of normal ageing at baseline and improvement of urinary symptoms. The median improvement was 4 points on the ICIQ-FLUTS and 8 on the I-QOL. Factors associated with a clinically significant improvement in urinary symptoms were more severe baseline urinary incontinence, obesity, and starting Kegel exercises. Factors associated with a clinically significant improvement in quality of life were a poor urinary quality of life at baseline and an age younger than 81 years. CONCLUSIONS: A short, inexpensive and nonmedical intervention can change the mind-set and behavior of older women with incontinence who are not seeking care. A clinically significant improvement is possible even in women with severe symptoms.

Predictors of long-term use of prescription opioids in the community-dwelling population of adults without a cancer diagnosis: a retrospective cohort study.

BACKGROUND: Long-term opioid use is a known risk factor for opioid-related harms. We aimed to identify risk factors for and predictors of long-term use of prescription opioids in the community-dwelling population of adults without a diagnosis of cancer, to inform practice change at the point of care. METHODS: Using Quebec administrative claims databases, we conducted a retrospective cohort study in a random sample of adult members (≥ 18 yr) of the public drug plan who did not have a cancer diagnosis and who initiated a prescription opioid in the outpatient setting between Jan. 1, 2012, and Dec. 31, 2016. The outcome of interest was long-term opioid use (≥ 90 consecutive days or ≥ 120 cumulative days over 12 mo). Potential predictors included sociodemographic factors, medical history, characteristics of the initial opioid prescription and prescriber's specialty. We used multivariable logistic regression to assess the association between each characteristic and long-term use. We used the area under the receiver operating characteristic curve to determine the predictive performance of full and parsimonious models. RESULTS: Of 124 664 eligible patients who initiated opioid therapy, 4172 (3.3%) progressed to long-term use of prescription opioids. The most important associated factors in the adjusted analysis were long-term prescription of acetaminophen-codeine (odds ratio [OR] 6.30, 95% confidence interval [CI] 4.99 to 7.96), prescription of a long-acting opioid at initiation (OR 6.02, 95% CI 5.31 to 6.84), initial supply of 30 days or more (OR 4.22, 95% CI 3.81 to 4.69), chronic pain (OR 2.41, 95% CI 2.16 to 2.69) and initial dose of at least 90 morphine milligram equivalents (MME) per day (OR 1.24, 95% CI 1.04 to 1.47). Our predictive model, including only the initial days' supply and chronic pain diagnosis, had area under the curve of 0.7618. INTERPRETATION: This study identified factors associated with long-term prescription opioid use. Limiting the initial supply to no more than 7 days and limiting doses to 90 MME/day or less are actions that could be undertaken at the point of care.