PReventing Injury in Skilled nursing facilities through optimizing Medications (PRISM), a protocol for a cluster randomized trial to reduce injurious falls in post-acute care.

IF 2 4区 医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL
Trials Pub Date : 2025-09-26 DOI:10.1186/s13063-025-09122-z
Sarah D Berry, Mark Toles, Thomas G Travison, Eleanor S McConnell, Andrew R Zullo, Milta O Little, Lisa Gwyther, Cara McDermott, Richard Lee, Michael Cary, Maggie Syme, Stephanie Kissam, Emily Hecker, Kylee G MacLean, Cathleen Colón-Emeric
{"title":"PReventing Injury in Skilled nursing facilities through optimizing Medications (PRISM), a protocol for a cluster randomized trial to reduce injurious falls in post-acute care.","authors":"Sarah D Berry, Mark Toles, Thomas G Travison, Eleanor S McConnell, Andrew R Zullo, Milta O Little, Lisa Gwyther, Cara McDermott, Richard Lee, Michael Cary, Maggie Syme, Stephanie Kissam, Emily Hecker, Kylee G MacLean, Cathleen Colón-Emeric","doi":"10.1186/s13063-025-09122-z","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Patients who receive post-acute care in a skilled nursing facility (SNF) following a fracture are at high risk for subsequent fall-related injuries. Optimizing medication management may mitigate this risk. This manuscript describes the protocol for a cluster crossover randomized controlled trial titled, PReventing Injury in Skilled Nursing Facilities through optimizing Medications (PRISM), designed to compare the effectiveness of three care models on the rates of injurious falls and other patient-centered outcomes.</p><p><strong>Methods: </strong>We will enroll 42 SNFs that are sharing electronic health record data with the Long-Term Care Data Cooperative (LTCDC). Matched control facilities will be identified at a ratio of 3:1 based on rural/urban location, profit status, and annual number of post-acute care admissions. Over 6-month periods, in random order, the participating SNFs will sequentially implement three evidence-based care models in a random order: a Deprescribing model, a Bone Health model, and a combined model (referred to as an Injury Prevention model). Patients with recent fractures admitted to participating SNFs for post-acute care during the intervention period will be eligible (target n = 3780). A remote nurse fracture consultant will review medical records, engage in shared decision-making, develop and coordinate a medication optimization plan with SNF and primary care providers, and follow up with the patient and primary care provider upon discharge. The primary outcome is incident injurious falls, measured using Medicare claims data (mean 2-year follow-up). Secondary outcomes include process measures (e.g., adherence with recommendations) and patient-reported outcomes ascertained by telephone survey at 90 days (e.g., medication burden, anxiety, depression, pain, sleep). Safety outcomes will be compared between the three models using Medicare claims data to identify events.</p><p><strong>Discussion: </strong>This cluster crossover trial aims to compare patient outcomes between each of the three care models and against matched control facilities. Results will inform patients, payors, health systems, and SNF chains of the most effective model to improve outcomes for older adults receiving post-acute care following a fracture.</p><p><strong>Trial registration: </strong>NCT06304428. Registered on February 25, 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"367"},"PeriodicalIF":2.0000,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12465586/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Trials","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1186/s13063-025-09122-z","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICINE, RESEARCH & EXPERIMENTAL","Score":null,"Total":0}
引用次数: 0

Abstract

Background: Patients who receive post-acute care in a skilled nursing facility (SNF) following a fracture are at high risk for subsequent fall-related injuries. Optimizing medication management may mitigate this risk. This manuscript describes the protocol for a cluster crossover randomized controlled trial titled, PReventing Injury in Skilled Nursing Facilities through optimizing Medications (PRISM), designed to compare the effectiveness of three care models on the rates of injurious falls and other patient-centered outcomes.

Methods: We will enroll 42 SNFs that are sharing electronic health record data with the Long-Term Care Data Cooperative (LTCDC). Matched control facilities will be identified at a ratio of 3:1 based on rural/urban location, profit status, and annual number of post-acute care admissions. Over 6-month periods, in random order, the participating SNFs will sequentially implement three evidence-based care models in a random order: a Deprescribing model, a Bone Health model, and a combined model (referred to as an Injury Prevention model). Patients with recent fractures admitted to participating SNFs for post-acute care during the intervention period will be eligible (target n = 3780). A remote nurse fracture consultant will review medical records, engage in shared decision-making, develop and coordinate a medication optimization plan with SNF and primary care providers, and follow up with the patient and primary care provider upon discharge. The primary outcome is incident injurious falls, measured using Medicare claims data (mean 2-year follow-up). Secondary outcomes include process measures (e.g., adherence with recommendations) and patient-reported outcomes ascertained by telephone survey at 90 days (e.g., medication burden, anxiety, depression, pain, sleep). Safety outcomes will be compared between the three models using Medicare claims data to identify events.

Discussion: This cluster crossover trial aims to compare patient outcomes between each of the three care models and against matched control facilities. Results will inform patients, payors, health systems, and SNF chains of the most effective model to improve outcomes for older adults receiving post-acute care following a fracture.

Trial registration: NCT06304428. Registered on February 25, 2025.

通过优化药物预防熟练护理机构中的伤害(PRISM),这是一项旨在减少急性后护理中伤害性跌倒的聚类随机试验方案。
背景:骨折后在专业护理机构(SNF)接受急性后护理的患者随后发生跌倒相关损伤的风险很高。优化药物管理可以减轻这种风险。本文描述了一项名为“通过优化药物在熟练护理设施中预防伤害”(PRISM)的聚类交叉随机对照试验的方案,该试验旨在比较三种护理模式在伤害性跌倒率和其他以患者为中心的结果方面的有效性。方法:我们将招募42名与长期护理数据合作(LTCDC)共享电子健康记录数据的snf。匹配的对照设施将根据农村/城市位置、盈利状况和每年急症后护理入院人数以3:1的比例确定。在6个月的时间里,参与的snf将按随机顺序依次实施三种循证护理模式:处方解除模式、骨骼健康模式和联合模式(称为伤害预防模式)。近期骨折的患者在干预期间接受snf的急性后护理(目标n = 3780)。远程骨折咨询护士将审查医疗记录,参与共同决策,与SNF和初级保健提供者制定和协调药物优化计划,并在出院后对患者和初级保健提供者进行随访。主要结局是意外伤害性跌倒,使用医疗保险索赔数据测量(平均2年随访)。次要结局包括过程测量(如依从建议)和通过90天电话调查确定的患者报告的结局(如药物负担、焦虑、抑郁、疼痛、睡眠)。使用医疗保险索赔数据来确定事件,将比较三种模型之间的安全性结果。讨论:本集群交叉试验旨在比较三种护理模式之间的患者结果,并与匹配的对照设施进行比较。研究结果将为患者、付款人、卫生系统和SNF链提供最有效的模型,以改善骨折后接受急性后护理的老年人的预后。试验注册:NCT06304428。于2025年2月25日注册。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Trials
Trials 医学-医学:研究与实验
CiteScore
3.80
自引率
4.00%
发文量
966
审稿时长
6 months
期刊介绍: Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信