Research Protocol Adaptations During the COVID-19 Pandemic: A Process Evaluation.

In general, COVID-19-related adaptations that transitioned in-person assessments and interventions to a virtual format were not routinely evaluated. We aimed to conduct a process evaluation to examine the impact of COVID-19-related adaptations on a behavior change intervention designed to increase exercise adherence among Veterans with mobility difficulty. We used secondary data from a nonrandomized study to complete a process evaluation examining the intervention's reach, recruitment, fidelity, dose delivered by physical therapists, and the dose received by the 14 participating Veterans. The physical therapist delivered 95% (133/140) of the study's 10 sessions. Sessions with the lowest delivery dose included Sessions 1 and 10 (86%; n = 12/14). The elements with the lowest dose received included using an exercise journal and developing a postintervention plan (86%; n = 12/14). Our COVID-19 adaptations allowed us to provide our intervention to the majority (67%) of eligible participants without a negative impact on fidelity, dose delivered, or dose received.

Deprescribing medications among patients with multiple prescribers: A socioecological model.

Deprescribing is the intentional dose reduction or discontinuation of a medication. The development of deprescribing interventions should take into consideration important organizational, interprofessional, and patient-specific barriers that can be further complicated by the presence of multiple prescribers involved in a patient's care. Patients who receive care from an increasing number of prescribers may experience disruptions in the timely transfer of relevant healthcare information, increasing the risk of exposure to drug-drug interactions and other medication-related problems. Furthermore, the fragmentation of healthcare information across health systems can contribute to the refilling of discontinued medications, reducing the effectiveness of deprescribing interventions. Thus, deprescribing interventions must carefully consider the unique characteristics of patients and their prescribers to ensure interventions are successfully implemented. In this special article, an international working group of physicians, pharmacists, nurses, epidemiologists, and researchers from the United States Deprescribing Research Network (USDeN) developed a socioecological model to understand how multiple prescribers may influence the implementation of a deprescribing intervention at the individual, interpersonal, organizational, and societal level. This manuscript also includes a description of the concept of multiple prescribers and outlines a research agenda for future investigations to consider. The information contained in this manuscript should be used as a framework for future deprescribing interventions to carefully consider how multiple prescribers can influence the successful implementation of the service and ensure the intervention is as effective as possible.

Rural Veterans' Experiences with Social Risk Factors: Impacts, Challenges, and Care System Recommendations.

BACKGROUND: Social risk factors, such as food insecurity and financial needs, are associated with increased risk of cardiovascular diseases, health conditions that are highly prevalent in rural populations. A better understanding of rural Veterans' experiences with social risk factors can inform expansion of Veterans Health Administration (VHA) efforts to address social needs. OBJECTIVE: To examine social risk and need from rural Veterans' lived experiences and develop recommendations for VHA to address social needs. DESIGN: We conducted semi-structured interviews with participants purposively sampled for racial diversity. The interview guide was informed by Andersen's Behavioral Model of Health Services Use and the Outcomes from Addressing Social Determinants of Health in Systems framework. PARTICIPANTS: Rural Veterans with or at risk of cardiovascular disease who participated in a parent survey and agreed to be recontacted. APPROACH: Interviews were recorded and transcribed. We analyzed transcripts using directed qualitative content analysis to identify themes. KEY RESULTS: Interviews (n = 29) took place from March to June 2022. We identified four themes: (1) Social needs can impact access to healthcare, (2) Structural factors can make it difficult to get help for social needs, (3) Some Veterans are reluctant to seek help, and (4) Veterans recommended enhancing resource dissemination and navigation support. CONCLUSIONS: VHA interventions should include active dissemination of information on social needs resources and navigation support to help Veterans access resources. Community-based organizations (e.g., Veteran Service Organizations) could be key partners in the design and implementation of future social need interventions.

Addressing clinician moral distress: Implications from a mixed methods evaluation during Covid-19.

Clinician moral distress has been documented over the past several decades as occurring within numerous healthcare disciplines, often in relation to clinicians' involvement in patients' end-of-life decision-making. The resulting harms impact clinician well-being, patient well-being, and healthcare system functioning. Given Covid-19's catastrophic death toll and associated demands on end-of-life decision-making processes, the pandemic represents a particularly important context within which to understand clinician moral distress. Thus, we conducted a convergent mixed methods study to examine its prevalence, associations with clinicians' demographic and professional characteristics, and contributing circumstances among Veterans Health Administration (VA) clinicians. The study, conducted in April 2021, consisted of a cross-sectional on-line survey of VA clinicians at 20 VA Medical Centers with professional jurisdiction to place life-sustaining treatment orders working who were from a number of select specialties. The survey collected quantitative data on respondents' demographics, clinical practice characteristics, attitudes and behaviors related to goals of care conversations, intensity of moral distress during "peak-Covid," and qualitative data via an open-ended item asking for respondents to describe contributing circumstances if they had indicated any moral distress. To understand factors associated with heightened moral distress, we analyzed quantitative data using bivariate and multivariable regression analyses and qualitative data using a hybrid deductive/inductive thematic approach. Mixed methods analysis followed, whereby we compared the quantitative and qualitative datasets and integrated findings at the analytic level. Out of 3,396 eligible VA clinicians, 323 responded to the survey (9.5% adjusted response rate). Most respondents (81%) reported at least some moral distress during peak-Covid. In a multivariable logistic regression, female gender (OR 3.35; 95% CI 1.53-7.37) was associated with greater odds of moral distress, and practicing in geriatrics/palliative care (OR 0.40; 95% CI 0.18-0.87) and internal medicine/family medicine/primary care (OR 0.46; 95% CI 0.22-0.98) were associated with reduced odds of moral distress compared to medical subspecialties. From the 191 respondents who completed the open-ended item, five qualitative themes emerged as moral distress contributors: 1) patient visitation restrictions, 2) anticipatory actions, 3) clinical uncertainty related to Covid, 4) resource shortages, and 5) personal risk of contracting Covid. Mixed methods analysis found that quantitative results were consistent with these last two qualitative themes. In sum, clinician moral distress was prevalent early in the pandemic. This moral distress was associated with individual-, system-, and situation-level contributors. These identified contributors represent leverage points for future intervention to mitigate clinician moral distress and its negative outcomes during future healthcare crises and even during everyday clinical care.

Prevalence and Determinants of Unmet Social Needs Among Rural and Urban Veterans.

PURPOSE: To examine the prevalence and determinants of nine unmet social needs among rural compared with urban Veterans. METHODS: Retrospective study using survey data collected in 2020 merged with Veterans Health Administration (VA) administrative data. For each unmet need, separate logistic regression modes were run predicting the odds of rural compared with urban Veterans endorsing the need adjusting for sociodemographic characteristics and comorbidities. FINDINGS: 2,801 Veterans responded to the survey (53.7% response rate). Veterans experienced high rates of need (e.g., 22% reported food insecurity). Unmet need prevalence varied minimally between rural and urban Veterans and where they did, rural Veterans were less likely to endorse the need (e.g., loneliness). For many unmet needs, Black compared with White Veterans were at higher risk. Regional unmet need disparities were also observed. CONCLUSIONS: As VA considers expanding unmet need interventions, tailoring interventions to the sub-populations most at risk may be warranted.

Relationship Between Unmet Social Needs and Care Access in a Veteran Cohort.

BACKGROUND: The association between unmet social needs (e.g., food insecurity) and adverse health outcomes is well-established, especially for patients with and at risk for cardiovascular disease (CVD). This has motivated healthcare systems to focus on unmet social needs. Yet, little is known about the mechanisms by which unmet social needs impact health, which limits healthcare-based intervention design and evaluation. One conceptual framework posits that unmet social needs may impact health by limiting care access, but this remains understudied. OBJECTIVE: Examine the relationship between unmet social needs and care access. DESIGN: Cross-sectional study design using survey data on unmet needs merged with administrative data from the Veterans Health Administration (VA) Corporate Data Warehouse (September 2019-March 2021) and multivariable models to predict care access outcomes. Pooled and separate rural and urban logistic regression models were utilized with adjustments from sociodemographics, region, and comorbidity. SUBJECTS: A national stratified random sample of VA-enrolled Veterans with and at risk for CVD who responded to the survey. MAIN MEASURES: No-show appointments were defined dichotomously as patients with one or more missed outpatient visits. Medication non-adherence was measured as proportion of days covered and defined dichotomously as adherence less than 80%. KEY RESULTS: Greater burden of unmet social needs was associated with significantly higher odds of no-show appointments (OR = 3.27, 95% CI = 2.43, 4.39) and medication non-adherence (OR = 1.59, 95% CI = 1.19, 2.13), with similar associations observed for rural and urban Veterans. Social disconnection and legal needs were especially strong predictors of care access measures. CONCLUSIONS: Findings suggest that unmet social needs may adversely impact care access. Findings also point to specific unmet social needs that may be especially impactful and thus might be prioritized for interventions, in particular social disconnection and legal needs.

Central Nervous System-Active Prescriptions in Older Veterans: Trends in Prevalence, Prescribers, and High-risk Populations.

BACKGROUND: Little is known about the prevalence or chronicity of prescriptions of central nervous system-active (CNS-active) medications in older Veterans. OBJECTIVE: We sought to describe (1) the prevalence and trends in prescription of CNS-active medications in older Veterans over time; (2) variation in prescriptions across high-risk groups; and (3) where the prescription originated (VA or Medicare Part D). DESIGN: Retrospective cohort study from 2015 to 2019. PARTICIPANTS: Veterans age ≥ 65 enrolled in the Medicare and the VA residing in Veterans Integrated Service Network 4 (incorporating Pennsylvania and parts of surrounding states). MAIN MEASURES: Drug classes included antipsychotics, gabapentinoids, muscle relaxants, opioids, sedative-hypnotics, and anticholinergics. We described prescribing patterns overall and in three subgroups: Veterans with a diagnosis of dementia, Veterans with high predicted utilization, and frail Veterans. We calculated both prevalence (any fill) and percent of days covered (chronicity) for each drug class, and CNS-active polypharmacy (≥ 2 CNS-active medications) rates in each year in these groups. KEY RESULTS: The sample included 460,142 Veterans and 1,862,544 person-years. While opioid and sedative-hypnotic prevalence decreased, gabapentinoids exhibited the largest increase in both prevalence and percent of days covered. Each subgroup exhibited different patterns of prescribing, but all had double the rates of CNS-active polypharmacy compared to the overall study population. Opioid and sedative-hypnotic prevalence was higher in Medicare Part D prescriptions, but the percent of days covered of nearly all drug classes was higher in VA prescriptions. CONCLUSIONS: The concurrent increase of gabapentinoid prescribing paralleling a decrease in opioid and sedative-hypnotics is a new phenomenon that merits further evaluation of patient safety outcomes. In addition, we found substantial potential opportunities for deprescribing CNS-active medications in high-risk groups. Finally, the increased chronicity of VA prescriptions versus Medicare Part D is novel and should be further evaluated in terms of its mechanism and impact on Medicare-VA dual users.

Development and Validation of Quality Measures for Testosterone Prescribing.

Context: Accurate measures to assess appropriateness of testosterone prescribing are needed to improve prescribing practices. Objective: This work aimed to develop and validate quality measures around the initiation and monitoring of testosterone prescribing. Methods: This retrospective cohort study comprised a national cohort of male patients receiving care in the Veterans Health Administration who initiated testosterone during January or February 2020. Using laboratory data and diagnostic codes, we developed 9 initiation and 7 monitoring measures. These were based on the current Endocrine Society guidelines supplemented by expert opinion and prior work. We chose measures that could be operationalized using national VA electronic health record (EHR) data. We assessed criterion validity for these 16 measures by manual review of 142 charts. Main outcome measures included positive and negative predictive values (PPVs, NPVs), overall accuracy (OA), and Matthews Correlation Coefficients (MCCs). Results: We found high PPVs (>78%), NPVs (>98%), OA (≥94%), and MCCs (>0.85) for the 10 measures based on laboratory data (5 initiation and 5 monitoring). For the 6 measures relying on diagnostic codes, we similarly found high NPVs (100%) and OAs (≥98%). However, PPVs for measures of acute conditions occurring before testosterone initiation (ie, acute myocardial infarction or stroke) or new conditions occurring after initiation (ie, prostate or breast cancer) PPVs were much lower (0% to 50%) due to few or no cases. Conclusion: We developed several valid EHR-based quality measures for assessing testosterone-prescribing practices. Deployment of these measures in health care systems can facilitate identification of quality gaps in testosterone-prescribing and improve care of men with hypogonadism.

Impact of the COVID-19 Pandemic on Providing Recommendations During Goals-of-Care Conversations: A Multisite Survey.

Background: Goals-of-care conversations (GoCCs) are essential for individualized end-of-life care. Shared decision-making (SDM) that elicits patients' goals and values to collaboratively make life sustaining treatment (LST) decisions is best practice. However, it is unknown how the COVID-19 pandemic onset and associated changes to care delivery, stress on providers, and clinical uncertainty affected SDM and recommendation-making during GoCCs. Aim: To assess providers' attitudes and behaviors related to GoCCs during the COVID-19 pandemic and identify factors associated with provision of LST recommendations. Design: Survey of United States Veterans Health Administration (VA) health care providers. Setting/Participants: Health care providers from 20 VA facilities with high COVID-19 caseloads early in the pandemic who had authority to place LST orders and practiced in select specialties (n = 3398). Results: We had 323 respondents (9.5% adjusted response rate). Most were age ≥50 years (51%), female (63%), non-Hispanic white (64%), and had ≥1 GoCC per week during peak-COVID-19 (78%). Compared with pre-COVID-19, providers believed it was less appropriate and felt less comfortable giving an LST recommendation during peak-COVID-19 (p < 0.001). One-third (32%) reported either "never" or "rarely" giving an LST recommendation during GoCCs at peak-COVID-19. In adjusted regression models, being a physician and discussing patients' goals and values were positively associated with giving an LST recommendation (B = 0.380, p = 0.031 and B = 0.400, p < 0.001, respectively) at peak-COVID-19. Conclusion: Providers who discuss patients' preferences and values are more likely to report giving a recommendation; both behaviors are markers of SDM during GoCCs. Our findings suggest potential areas for training in conducting patient-centered GoCCs.

Does screening for PTSD lead to VA mental health care? Identifying the spectrum of initial VA screening actions.

Despite the active posttraumatic stress disorder (PTSD) screening program in Department of Veterans Affairs (VA) primary care clinics and the availability of empirically supported treatments for PTSD at VA, many veterans for whom screening suggests treatment may be indicated do not gain access to VA-based mental health care. To determine where we may be losing veterans to follow-up, we need to begin by identifying the initial action taken in response to a positive PTSD screen in primary care. Using VA administrative data and chart review, we identified the spectrum of initial actions taken after veterans screened positive for PTSD in VA primary care clinics nationwide between October 2017 and September 2018 (N = 41,570). We collapsed actions into those that could lead to VA-based mental health care (e.g., consult placed to a VA mental health clinic) versus not (e.g., veteran declined care), and then examined the association between these categories of actions and contextual- and individual-level variables. More than 61% of veterans with positive PTSD screens had evidence that an initial action toward VA-based mental health care was taken. Urban-dwelling and female veterans were significantly more likely to have evidence of these initial actions, whereas White and Vietnam-era veterans were significantly less likely to have this evidence. Our findings suggest that most veterans screening positive for PTSD in VA primary care clinics have evidence of initial actions taken toward VA-based mental health care; however, a substantial minority do not, making them unlikely to receive follow-up care. Findings highlight the potential benefit of targeted primary care-based access interventions. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Incorporating Physical Activity Assessments and Behavior Change Techniques Into Geriatrics.

Ninety-one percent of adults 65 years and older do not perform the recommended levels of physical activity (PA), resulting in increased risk of disability, morbidity, and mortality. Despite knowing the benefits of PA and acknowledging the importance of assessing and addressing inadequate PA levels, 50%-75% of health care providers do not incorporate behavior change techniques into clinical practice. This clinical gap can be explained by a lack of knowledge or confidence in (1) assessing PA levels; (2) addressing inadequate PA levels; and (3) justifying the time needed to use these techniques in clinical practice. In this special communication, we address this gap by providing a 3-step theoretical-based clinical decision pathway that guides health care providers on how to identify older adults with inadequate PA levels, determine readiness to increase PA, and empower patents to develop an action plan that will increase their PA levels. We also provide a conceptual model that supports the use of techniques that assess and address inadequate PA by tying PA to the Age-Friendly Health System's 4Ms (ie, What Matters to the older adult, Mentation, Mobility, and Medications).

Interaction between Legal and Social Needs in Their Association with Self-rated Health in a National Sample of Veterans.

Many health-related social needs, such as financial insecurity, are interconnected with legal needs. However, little is known about which social needs are more likely to be associated with legal needs, or whether legal and other needs interact to affect health. Using data from a 2020 national mailed survey assessing social needs among Veterans who had or were at risk for cardiovascular disease (N=2,801) and linked administrative data, linear regression models tested interactions between legal and other social needs, and their associations with self-rated health. In a model examining the interaction of financial and legal needs, experiencing financial but not legal needs was as strongly associated with worse health (b=-0.58, 95% CI -0.69, -0.46) as experiencing both financial and legal needs (b= -0.55, 95% CI -0.70, -0.40). Financial needs are important to Veterans' health and further research is needed to determine how financial and legal needs should be triaged by providers.

Randomised controlled trial evaluating the effects of screening and referral for social determinants of health on Veterans' outcomes: protocol.

INTRODUCTION: Health policy leaders recommend screening and referral (S&R) for unmet social needs (eg, food) in clinical settings, and the American Heart Association recently concluded that the most significant opportunities for reducing cardiovascular disease (CVD) death and disability lie with addressing the social determinants of CVD outcomes. A limited but promising evidence base supports these recommendations, but more rigorous research is needed to guide health care-based S&R efforts. Funded by the Veteran Health Administration (VA), the study described in this paper will assess the efficacy of S&R on Veterans' connections to new resources to address social needs, reduction of unmet needs and health-related outcomes (adherence, utilisation and clinical outcomes). METHODS AND ANALYSIS: We will conduct a 1-year mixed-methods randomised controlled trial at three VA sites, enrolling Veterans with CVD and CVD-risk. 880 Veterans experiencing one or more social needs will be randomised within each site (n=293 per site) to one of three study arms representing referral mechanisms of varying intensity (screening only, screening and provision of resource sheet(s), screening and provision of resource sheet(s) plus social work assistance). For each Veteran, we will examine associations of unmet social needs with health-related outcomes at baseline, and longitudinally compare the impact of each approach on connection to new resources (primary outcome) and follow-up outcomes over a 12-month period. We will additionally conduct qualitative interviews with key stakeholders, including Veterans to identify potential explanatory factors related to the relative success of the interventions. ETHICS AND DISSEMINATION: Ethics approval was obtained from the VA Central Internal Review Board on 13 July 2021 (reference #: 20-07-Amendment No. 02). Findings will be disseminated through reports, lay summaries, policy briefs, academic publications, and conference presentations. TRIAL REGISTRATION NUMBER: NCT04977583.

The Perceived Effectiveness of Secure Messaging for Medication Reconciliation During Transitions of Care: Semistructured Interviews With Patients.

BACKGROUND: Medication discrepancies can lead to adverse drug events and patient harm. Medication reconciliation is a process intended to reduce medication discrepancies. We developed a Secure Messaging for Medication Reconciliation Tool (SMMRT), integrated into a web-based patient portal, to identify and reconcile medication discrepancies during transitions from hospital to home. OBJECTIVE: We aimed to characterize patients' perceptions of the ease of use and effectiveness of SMMRT. METHODS: We recruited 20 participants for semistructured interviews from a sample of patients who had participated in a randomized controlled trial of SMMRT. Interview transcripts were transcribed and then qualitatively analyzed to identify emergent themes. RESULTS: Although most patients found SMMRT easy to view at home, many patients struggled to return SMMRT through secure messaging to clinicians due to technology-related barriers. Patients who did use SMMRT indicated that it was time-saving and liked that they could review it at their own pace and in the comfort of their own home. Patients reported SMMRT was effective at clarifying issues related to medication directions or dosages and that SMMRT helped remove medications erroneously listed as active in the patient's electronic health record. CONCLUSIONS: Patients viewed SMMRT utilization as a positive experience and endorsed future use of the tool. Veterans reported SMMRT is an effective tool to aid patients with medication reconciliation. Adoption of SMMRT into regular clinical practice could reduce medication discrepancies while increasing accessibility for patients to help manage their medications. TRIAL REGISTRATION: ClinicalTrials.gov NCT02482025; https://clinicaltrials.gov/ct2/show/NCT02482025.

Recommendations for outcome measurement for deprescribing intervention studies.

Interpreting results from deprescribing interventions to generate actionable evidence is challenging owing to inconsistent and heterogeneous outcome definitions between studies. We sought to characterize deprescribing intervention outcomes and recommend approaches to measure outcomes for future studies. A scoping literature review focused on deprescribing interventions for polypharmacy and informed a series of expert panel discussions and recommendations. Twelve experts in deprescribing research, policy, and clinical practice interventions participating in the Measures Workgroup of the US Deprescribing Research Network sought to characterize deprescribing outcomes and recommend approaches to measure outcomes for future studies. The scoping review identified 125 papers reflecting 107 deprescribing studies. Common outcomes included medication discontinuation, medication appropriateness, and a broad range of clinical outcomes potentially resulting from medication reduction. Panel recommendations included clearly defining clinically meaningful medication outcomes (e.g., number of chronic medications, dose reductions), ensuring adequate sample size and follow-up time to capture clinical outcomes resulting from medication discontinuation (e.g., quality of life [QOL]), and selecting appropriate and feasible data sources. A new conceptual model illustrates how downstream clinical outcomes (e.g., reduction in falls) should be interpreted in the context of initial changes in medication measures (e.g., reduction in mean total medications). Areas needing further development include implementation outcomes specific to deprescribing interventions and measures of adverse drug withdrawal events. Generating evidence to guide deprescribing is essential to address patient, caregiver, and clinician concerns about the benefits and harms of medication discontinuation. This article provides recommendations and an initial conceptual framework for selecting and applying appropriate intervention outcomes to support deprescribing research.

Leveraging the timing and frequency of patient decision aids in longitudinal shared decision-making: A narrative review and applied model.

INTRODUCTION: Shared decision-making (SDM) is intended to increase patient-centredness of medical decision-making for patients with acute and chronic conditions. Concurrently, patient decision aids (PtDAs) can supplement SDM by providing information to guide communication between patients and healthcare providers. Because of the prevalence of chronic conditions, where decisions may be extended or recurring, we sought to explore how effectively these tools have been leveraged in this context. METHODS: We conducted a narrative review of the literature on both SDM and PtDAs, searching PubMed and Boston University's library database search tool for English-language articles published from January 2005 until March 2021. Additional search terms focused on temporality. Drawing from our findings, we developed a combined framework to highlight areas for future research using the discussion of end-of-life decisions as an exemplar to illustrate its relevance to chronic care contexts. RESULTS: After screening 57 articles, we identified 25 articles that fulfilled the inclusion criteria on SDM, PtDA use and temporality for chronic care. The literature on SDM highlighted time outside of the medical visit and opportunity to include outside decision partners as important elements of the process. PtDAs were commonly evaluated for process-related and proximal outcomes, but less often for distal outcomes. Early evidence points to the value of comparative outcome evaluation based on the timing of PtDA distribution. CONCLUSION: Our review of the literature on SDM and PtDAs reveals less attention to the timing of PtDAs relative to that of SDM. We highlight the need for further study of timing in PtDA use to improve longitudinal SDM for chronic care. The model that we propose in our discussion provides a starting point for future research on PtDA efficacy. PATIENT OR PUBLIC CONTRIBUTION: Five patient consultants provided input and feedback on the development and utility of our model.

Maintaining Implementation through Dynamic Adaptations (MIDAS): protocol for a cluster-randomized trial of implementation strategies to optimize and sustain use of evidence-based practices in Veteran Health Administration (VHA) patients.

BACKGROUND: The adoption and sustainment of evidence-based practices (EBPs) is a challenge within many healthcare systems, especially in settings that have already strived but failed to achieve longer-term goals. The Veterans Affairs (VA) Maintaining Implementation through Dynamic Adaptations (MIDAS) Quality Enhancement Research Initiative (QUERI) program was funded as a series of trials to test multi-component implementation strategies to sustain optimal use of three EBPs: (1) a deprescribing approach intended to reduce potentially inappropriate polypharmacy; (2) appropriate dosing and drug selection of direct oral anticoagulants (DOACs); and (3) use of cognitive behavioral therapy as first-line treatment for insomnia before pharmacologic treatment. We describe the design and methods for a harmonized series of cluster-randomized control trials comparing two implementation strategies. METHODS: For each trial, we will recruit 8-12 clinics (24-36 total). All will have access to relevant clinical data to identify patients who may benefit from the target EBP at that clinic and provider. For each trial, clinics will be randomized to one of two implementation strategies to improve the use of the EBPs: (1) individual-level academic detailing (AD) or (2) AD plus the team-based Learn. Engage. Act. PROCESS: (LEAP) quality improvement (QI) learning program. The primary outcomes will be operationalized across the three trials as a patient-level dichotomous response (yes/no) indicating patients with potentially inappropriate medications (PIMs) among those who may benefit from the EBP. This outcome will be computed using month-by-month administrative data. Primary comparison between the two implementation strategies will be analyzed using generalized estimating equations (GEE) with clinic-level monthly (13 to 36 months) percent of PIMs as the dependent variable. Primary comparative endpoint will be at 18 months post-baseline. Each trial will also be analyzed independently. DISCUSSION: MIDAS QUERI trials will focus on fostering sustained use of EBPs that previously had targeted but incomplete implementation. Our implementation approaches are designed to engage frontline clinicians in a dynamic optimization process that integrates the use of actional clinical data and making incremental changes, designed to be feasible within busy clinical settings. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05065502 . Registered October 4, 2021-retrospectively registered.

Direct-to-consumer strategies to promote deprescribing in primary care: a pilot study.

BACKGROUND: Deprescribing, or the intentional discontinuation or dose-reduction of medications, is an approach to reduce harms associated with inappropriate medication use. We sought to determine how direct-to-patient educational materials impacted patient-provider discussion about and deprescribing of potentially inappropriate medications. METHODS: We conducted a pre-post pilot trial, using an historical control group, at an urban VA medical center. We included patients in one of two cohorts: 1) chronic proton pump inhibitor users (PPI), defined as use of any dose for 90 consecutive days, or 2) patients at hypoglycemia risk, defined by diabetes diagnosis; prescription for insulin or sulfonylurea; hemoglobin A1c < 7%; and age ≥ 65 years, renal insufficiency, or cognitive impairment. The intervention consisted of mailing medication-specific patient-centered EMPOWER (Eliminating Medications Through Patient Ownership of End Results) brochures, adapted to a Veteran patient population, two weeks prior to scheduled primary care appointments. Our primary outcome - deprescribing - was defined as clinical documentation of target medication discontinuation or dose-reduction. Our secondary outcome was documentation of a discussion about the target medication (yes/possible vs. no/absent). Covariates included age, sex, race, specified comorbidities, medications, and utilization. We used chi-square tests to examine the association of receiving brochures with each outcome. RESULTS: The 348 subjects (253 intervention, 95 historical control) were primarily age ≥ 65 years, white, and male. Compared to control subjects, intervention subjects were more likely to have deprescribing (36 [14.2%] vs. 4 [4.2%], p = 0.009) and discussions about the target medication (31 [12.3%] vs. 1 [1.1%], p = 0.001). CONCLUSIONS: Targeted mailings of EMPOWER brochures temporally linked to a scheduled visit in primary care clinics are a low-cost, low-technology method associated with increases in both deprescribing and documentation of patient-provider medication discussions in a Veteran population. Leveraging the potential for patients to initiate deprescribing discussions within clinical encounters is a promising strategy to reduce drug burden and decrease adverse drug effects and harms.

Development and validation of a tool to understand health care professionals' attitudes towards deprescribing (HATD) in older adults with limited life expectancy.

BACKGROUND: Understanding the perspective of health care professionals (HCPs) is significant to the implementation of deprescribing in older adults with limited life expectancy (LLE) but a tool to assess this is lacking. OBJECTIVE: This study aimed to develop and validate a survey tool for assessing HCPs attitudes towards deprescribing (HATD) in older adults with LLE. METHODS: An online survey was used to collect data to determine the psychometric properties of a 49-item questionnaire generated from literature review, expert opinion and pretesting. 108 HCPs (doctors, nurses and pharmacists) with experience or interest in palliative care or a member of a palliative care team/organisation completed the survey. RESULTS: Principal component analysis of the participants' data resulted in a 23-item questionnaire structured in five factors, named HATD tool. The factors were related to concerns about deprescribing (7 items), perceived burden of medications on patients (7 items), organisational support for deprescribing (4 items), assurance to deprescribing (2 items) and perceived involvement of patients in medication management (3 items). The HATD tool had valid descriptive statistics (Kaiser-Meyer-Olkin measure: 0.708; Bartlett's test of sphericity: p < 0.001, determinant: 1.35E-5; variance explained: 60.4%; nonredundant residuals with absolute values > 0.05: 39%). The reliability statistics of all the factors were ≥0.750 for both Cronbach's alpha (α) and composite reliability (CR) except for the patient-involvement factor (α = 0.644 but CR = 0.787). CONCLUSIONS: The 23-itemed HATD tool is a valid and reliable tool to assess the attitudes and beliefs of HCPs towards deprescribing in older adults with LLE in the Australian setting.