Deprescribing Bisphosphonates in Older Nursing Home Residents with Dementia

停用患有痴呆症的老年疗养院居民的双磷酸盐处方

• 批准号: 10596132
• 负责人: Joshua David Niznik
• 金额: $ 14.57万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10596132
• 关键词: Adult; Adverse effects; Alzheimer' s Disease; Alzheimer' s disease related dementia; Award; Benefits and Risks; Caregivers; Caring; Clinical; Clinical Trials; Communities; Complex; Cost Effectiveness Analysis; Data; Decision Making; Decision Modeling; Deglutition Disorders; Dementia; Development; Diagnosis; Elderly; Enrollment; Esophagitis; Exclusion; Family; Family Caregiver; Fracture; Future; Goals; Guidelines; Health Services; Healthcare; Impaired cognition; Individual; Intervention; Interview; Knowledge; Life Expectancy; Measures; Medical; Medicare; Medicare claim; Methods; Nursing Homes; Observational Study; Outcome; Perception; Pharmaceutical Preparations; Pharmacists; Polypharmacy; Population; Positioning Attribute; Prevention; Preventive; Principal Investigator; Provider; Qualitative Research; Quality of life; Quality-Adjusted Life Years; Randomized; Recommendation; Research; Research Methodology; Research Personnel; Sampling; Severities; Structure; Subgroup; Techniques; Time; Training; Uncertainty; bisphosphonate; bone turnover; clinical heterogeneity; cost; cost effective; cost effectiveness; cost-effectiveness evaluation; cost-effectiveness ratio; disorder prevention; end of life; fracture risk; gastrointestinal; health care service utilization; human old age (65+); improved; incremental cost-effectiveness; informal caregiver; osteoporosis with pathological fracture; patient oriented; prevent; programs; residence; side effect; skills

PROJECT SUMMARY/ABSTRACT. Polypharmacy is a highly prevalent problem in older adults, particularly in those with Alzheimer’s Disease (AD) and AD-Related Dementias (AD/ADRD) and those residing in the nursing home (NH). Many older adults continue to receive medications originally prescribed for disease prevention until the end of life, despite a lack of sufficient evidence to justify their continued use in advanced age. The use of bisphosphonates for fracture prevention is one example. Although bisphosphonates are effective in reducing fractures in healthier, community-dwelling individuals, there is insufficient evidence of continued benefits that is generalizable for NH residents with AD/ADRD. There is also substantial clinical heterogeneity in this population with regards to fracture risk, mobility, and life expectancy, creating further uncertainty as to whether all NH residents with AD/ADRD benefit from bisphosphonate use. Deprescribing is a patient-centered approach to reduce or stop medications that are no longer appropriate considering goals of care, time until benefit, and life expectancy. Considering the lack of strong generalizable evidence and potential for side effects, bisphosphonates may be targeted for deprescribing in NH residents with AD/ADRD. Deprescribing may also be justifiable considering the extended period of benefit of bisphosphonates, which may last for up to 2 years after discontinuation exceeding the life expectancy of many residents with AD/ADRD. However, no studies to date have evaluated the appropriateness of deprescribing bisphosphonates as a means to reduce the burden of polypharmacy and adverse effects in this population. Large observational studies of secondary data are uniquely positioned to evaluate the benefits and harms of medication use and deprescribing in older NH residents with AD/ADRD, given the barriers to conducting randomized studies in this population. This study will evaluate determinants, clinical outcomes, and cost-effectiveness of deprescribing bisphosphonates in NH residents with AD/ADRD. In Aim 1, we will conduct a qualitative study using semi-structured interviews to identify determinants of deprescribing bisphosphonates from the perspectives of family/informal caregivers and prescribers of NH residents with AD/ADRD. In Aim 2, we will conduct an observational study of Medicare administrative data to evaluate clinical outcomes (fractures and adverse effects) associated with deprescribing bisphosphonates in a sample of older NH residents with AD/ADRD. In Aim 3, we will evaluate the cost-effectiveness of deprescribing bisphosphonates in NH residents with AD/ADRD, considering medication costs and utilization for fractures and adverse effects. This study will address a critical gap in knowledge and inform future recommendations for optimizing bisphosphonate use to prevent fractures in this vulnerable and medically complex population. This award will also provide the principal investigator with protected time to develop skills in qualitative research methods, advanced techniques to reduce confounding in observational studies, and methods for cost-effectiveness analyses.

项目总结/摘要。 多药治疗是老年人中一个非常普遍的问题，特别是那些患有阿尔茨海默病（AD）的人 和AD相关痴呆（AD/ADRD）和居住在疗养院（NH）的人。许多老年人 继续接受最初用于预防疾病的药物治疗，直到生命结束，尽管缺乏 有足够的证据证明他们在老年人中继续使用。双膦酸盐在骨折中的应用 预防就是一个例子。虽然双膦酸盐在减少骨折方面是有效的， 社区居住的个人，没有足够的证据表明持续的好处，是普遍的NH AD/ADRD患者。该人群在以下方面也存在显著的临床异质性： 骨折风险，流动性和预期寿命，创造了进一步的不确定性，是否所有NH居民与 AD/ADRD受益于双膦酸盐的使用。取消处方是一种以患者为中心的方法， 考虑到护理目标、受益时间和预期寿命，不再适当的药物。 考虑到缺乏强有力的可推广的证据和潜在的副作用，双膦酸盐可能是 目标是在患有AD/ADRD的NH居民中取消处方。考虑到以下因素，取消处方也是合理的 双膦酸盐的获益期延长，停药后可持续长达2年 超过了许多AD/ADRD患者的预期寿命。然而，迄今为止还没有研究评估 取消双膦酸盐处方作为减轻多药治疗负担的方法的适当性， 对这一人群的负面影响。对次要数据的大型观察性研究具有独特的优势， 评估药物使用的益处和危害，并在患有AD/ADRD的老年NH居民中取消处方， 考虑到在这一人群中进行随机研究的障碍。这项研究将评估决定因素， 临床结果，和成本效益的取消处方双膦酸盐在NH居民与AD/ADRD。在 目标1，我们将使用半结构化访谈进行定性研究，以确定 从家庭/非正式护理者和处方者的角度， AD/ADRD患者。在目标2中，我们将对医疗保险进行观察性研究， 管理数据，以评价与下列因素相关的临床结局（骨折和不良反应）： 在患有AD/ADRD的老年NH居民样本中停用双膦酸盐。在目标3中，我们 评估NH AD/ADRD居民停用双膦酸盐的成本效益， 考虑到药物费用和骨折的利用率和不良反应。这项研究将解决一个 关键的知识差距，并为优化双膦酸盐的使用提供未来的建议，以防止 在这个脆弱和医学上复杂的人群中发生骨折。该奖项还将提供主要的 研究人员有受保护的时间来发展定性研究方法的技能， 减少观察性研究中的混淆，以及成本效益分析方法。