ALIGN:根据最重要的事情调整药物(演示)
ALIGN 演示:根据最重要的情况调整药物
该临床试验的目的是测试由药剂师主导、基于初级保健的取消处方干预措施对痴呆症患者 (PLWD) 及其护理伙伴的有效性。
干预措施包括以下策略:1)旨在激活患者和护理伙伴的取消处方教育手册; 2) 单次远程医疗就诊,现场临床药剂师根据患者的目标和偏好与患者和护理伙伴讨论患者药物的益处和危害; 3) 药剂师与 PCP 的沟通,其中药剂师提供量身定制的取消处方建议,旨在对 PCP 有用且可操作。
研究人员将比较干预组与候补对照组,看看主要结局(即 3 个月内停用至少一种药物的患者比例)是否存在差异。
研究概览
详细说明
PLWD 的多重用药率很高。 这是由于高度的合并症以及具有挑战性的行为和心理症状,如冷漠和烦躁。 针对个人情况编写的指南增加了多重用药和潜在的不当药物 (PIM) 使用,其中药物的风险超过了益处,或者药物可能与治疗目标不一致。 PLWD 中的 PIM 包括抗胆碱药、精神药物和阿片类药物,尽管与跌倒、负面认知影响、心脏传导异常、呼吸抑制和死亡。 PLWD 中的多种药物和 PIM 的使用与药物不良事件、急诊就诊、住院治疗和治疗负担有关,这表明在某些情况下,“治疗方法可能变成了疾病”。
使用这些药物和其他药物需要做出细致入微的决策,以平衡对 PLWD 的潜在益处和危害。 根据以人为本的护理原则,人们应该服用有助于实现个人目标的药物,而不是可能有害或无益的药物。
事实证明,在老年人中停用他汀类药物、抗高血压药物和精神药物是安全的,并且可能会改善生活质量、减少跌倒次数以及改善认知和精神运动功能。 成功干预措施的经验教训包括需要针对初级保健临床医生和患者,并针对不止一类药物。 大多数处方干预措施发生在医院、长期护理机构或家庭医疗保健中,而不是初级保健中——通常是 PLWD 与医疗保健系统的第一个接触点。 尽管由于与药物相关的任务以及该人的特定信息和决策需求和冲突而面临巨大压力,但很少有针对 PLWD 的护理伙伴的取消处方研究。 这些是拟议研究将解决的差距。
研究人员之前的研究表明,护理合作伙伴希望初级保健提供者 (PCP) 讨论随着痴呆症进展而进行的与药物相关的护理目标,并承认在 PLWD 中使用药物进行症状管理时隐含的权衡。 但 PCP 指出时间压力以及缺乏何时以及如何停止 PLWD 药物的指导是进行这些对话的障碍。 药剂师非常适合通过提供基于证据的个性化处方取消建议来帮助解决这些问题,同时不会增加对 PCP 时间的需求。
临床试验包括以下策略:1)直接面向消费者的处方教育材料,旨在激活护理伙伴和 PLWD; 2) 远程医疗就诊,其中药剂师根据患者的目标和偏好与患者和护理伙伴讨论药物的益处和危害; 3) 药剂师与 PCP 的沟通,其中药剂师提供 PCP 可采取行动的量身定制的停用建议。 药剂师将收到一份层压提示表并参加 20 分钟的网络研讨会。 关于停止或继续用药的决定最终将由 PCP 和患者/护理合作伙伴做出。
该试验被设计为具有延迟(候补名单)控制的整群随机试验,其中随机化单位为诊所。 研究人员将招募 280 名患者,每组 140 名(干预组和候补对照组)。 PLWD 可以独立注册或与护理伙伴一起注册。 护理伙伴不需要参与,但如果需要,可以独立或与 PLWD 一起参与。 每个参与者将参与大约 3 个月的研究(干预期和额外的随访)。
该协议采用了务实的设计。 干预措施由临床药剂师提供,他们融入初级保健诊所或通过集中远程医疗模式进行实践。
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Maryland
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Baltimore、Maryland、美国、21209
- Johns Hopkins Community Physicians
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参与标准
资格标准
适合学习的年龄
- 年长者
接受健康志愿者
描述
纳入标准:
- 年龄≥65岁
- 根据国际疾病分类 (ICD-10) 就诊代码或 EHR 问题列表诊断痴呆症
- 五种或更多药物
- 仅包括活跃患者(定义为过去一年内到初级保健诊所就诊次数> 1 次)
关爱伙伴:
- 定期帮助患者管理药物的 >21 岁的家人或其他同伴。
排除标准:
- 由于务实试验将基于初级保健,居住在长期护理机构或参加临终关怀机构的个人将被排除在外。
- 参与者必须有足够的听力才能用英语通过电话进行交流。
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:干涉
干预措施包括以下内容:
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干预措施包括以下策略: 1) 药剂师将参加 20 分钟的网络研讨会并收到有关该研究的层压提示表; 2) 符合条件的患者及其护理伙伴将通过邮寄方式收到一份处方取消教育手册; 3) 患者及其护理伙伴将进行一次远程医疗就诊,药剂师将进行药物协调并确定与药物相关的潜在不良反应和疑虑; 4) 药剂师将使用标准化模板在 EHR 中向 PCP 发送最多 3 条取消处方的建议; 5) 经 PCP 批准后,药剂师将致电患者或护理伙伴以实施取消处方的建议并在 EHR 中记录更改。
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有源比较器:延迟干预(等候名单控制)
干预措施包括以下内容:
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干预措施包括以下策略: 1) 药剂师将参加 20 分钟的网络研讨会并收到有关该研究的层压提示表; 2) 符合条件的患者及其护理伙伴将通过邮寄方式收到一份处方取消教育手册; 3) 患者及其护理伙伴将进行一次远程医疗就诊,药剂师将进行药物协调并确定与药物相关的潜在不良反应和疑虑; 4) 药剂师将使用标准化模板在 EHR 中向 PCP 发送最多 3 条取消处方的建议; 5) 经 PCP 批准后,药剂师将致电患者或护理伙伴以实施取消处方的建议并在 EHR 中记录更改。
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patients Who Stop One or More Medications - Per Protocol
大体时间:3 months
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The primary outcome for the study will be the patients who stop ≥1 medication, assessed at 3 months, analyzed per protocol and reported as count of participants.
Discontinuation will be defined as a medication that is listed on the medication list at one time point and not listed at the subsequent time point.
Discontinued medications will be measured using data obtained from the Electronic Health Record (EHR).
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3 months
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Patients Who Stop One or More Medications - Intention-to-Treat
大体时间:3 months
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The primary outcome for the study will be the patients who stop ≥1 medication, assessed at 3 months, analyzed by intention-to-treat and reported as count of participants.
Discontinuation will be defined as a medication that is listed on the medication list at one time point and not listed at the subsequent time point.
Discontinued medications will be measured using data obtained from the Electronic Health Record (EHR).
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3 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Patients Who Start One or More New Medications - Per Protocol
大体时间:3 months
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The secondary outcome of patients who start ≥1 medication will be assessed at 3 months, analyzed per protocol and reported as count of participants.
The start of a medication will be defined as a medication that is not listed on the medication list at one time point and listed at the subsequent time point.
New medications started will be measured using data obtained from the EHR.
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3 months
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Patients Who Start One or More New Medications - Intention-to-Treat
大体时间:3 months
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The secondary outcome of patients who start ≥1 medication will be assessed at 3 months, analyzed by intention-to-treat and reported as count of participants.
The start of a medication will be defined as a medication that is not listed on the medication list at one time point and listed at the subsequent time point.
New medications started will be measured using data obtained from the EHR.
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3 months
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Patients Who Stop One or More Potentially Inappropriate Medication (PIM) - Per Protocol
大体时间:3 months
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The secondary outcome of patients who stop ≥1 potentially inappropriate medication (PIM) will be assessed at 3 months, analyzed per protocol and reported as count of participants.
Discontinuation of a PIM will be defined as a PIM that is listed on the medication list at one time point and not listed at the subsequent time point.
Discontinued PIM will be measured using data obtained from the EHR.
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3 months
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Patients Who Stop One or More Potentially Inappropriate Medication (PIM) - Intention-to-Treat
大体时间:3 months
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The secondary outcome of patients who stop ≥1 potentially inappropriate medication (PIM) will be assessed at 3 months, analyzed by intention-to-treat and reported as count of participants.
Discontinuation of a PIM will be defined as a PIM that is listed on the medication list at one time point and not listed at the subsequent time point.
Discontinued PIM will be measured using data obtained from the EHR.
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3 months
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Patients Who Start One or More Potentially Inappropriate Medication (PIM) - Per Protocol
大体时间:3 months
|
The secondary outcome of patients who start ≥1 potentially inappropriate medication (PIM) will be assessed at 3 months, analyzed per protocol and reported as count of participants.
The start of a PIM will be defined as a PIM that is not listed on the medication list at one time point and listed at the subsequent time point.
Discontinued PIM will be measured using data obtained from the EHR.
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3 months
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Patients Who Start One or More Potentially Inappropriate Medication (PIM) - Intention-to-Treat
大体时间:3 months
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The secondary outcome of patients who start ≥1 potentially inappropriate medication (PIM) will be assessed at 3 months, analyzed by intention-to-treat and reported as count of participants.
The start of a PIM will be defined as a PIM that is not listed on the medication list at one time point and listed at the subsequent time point.
Discontinued PIM will be measured using data obtained from the EHR.
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3 months
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Total Number of Medications - Per Protocol
大体时间:3 months
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Total medication count will be measured using data obtained from the EHR, analyzed per protocol and reported as mean and standard deviation.
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3 months
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Total Number of Medications - Intention-to-Treat
大体时间:3 months
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Total medication count will be measured using data obtained from the EHR, analyzed by intention-to-treat and reported as mean and standard deviation.
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3 months
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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由 ColaboRATE 评估的共享决策
大体时间:药剂师干预前立即、药剂师干预后立即
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这是一项探索性的、由患者/护理合作伙伴报告的共同决策结果衡量标准。
COLLABORATE 使用 9 点李克特量表,包括 3 个问题。
分数范围 0-36。
分数越高代表结果越好。
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药剂师干预前立即、药剂师干预后立即
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合作者和调查者
调查人员
- 首席研究员:Ariel Green, MD, MPH, PhD、Johns Hopkins University
出版物和有用的链接
一般刊物
- Page AT, Clifford RM, Potter K, Schwartz D, Etherton-Beer CD. The feasibility and effect of deprescribing in older adults on mortality and health: a systematic review and meta-analysis. Br J Clin Pharmacol. 2016 Sep;82(3):583-623. doi: 10.1111/bcp.12975. Epub 2016 Jun 13.
- Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA. 2005 Aug 10;294(6):716-24. doi: 10.1001/jama.294.6.716.
- Iyer S, Naganathan V, McLachlan AJ, Le Couteur DG. Medication withdrawal trials in people aged 65 years and older: a systematic review. Drugs Aging. 2008;25(12):1021-31. doi: 10.2165/0002512-200825120-00004.
- Jansen J, Naganathan V, Carter SM, McLachlan AJ, Nickel B, Irwig L, Bonner C, Doust J, Colvin J, Heaney A, Turner R, McCaffery K. Too much medicine in older people? Deprescribing through shared decision making. BMJ. 2016 Jun 3;353:i2893. doi: 10.1136/bmj.i2893. No abstract available.
- Alzheimer's Association. 2015 Alzheimer's disease facts and figures. Alzheimers Dement. 2015 Mar;11(3):332-84. doi: 10.1016/j.jalz.2015.02.003.
- Hill-Taylor B, Sketris I, Hayden J, Byrne S, O'Sullivan D, Christie R. Application of the STOPP/START criteria: a systematic review of the prevalence of potentially inappropriate prescribing in older adults, and evidence of clinical, humanistic and economic impact. J Clin Pharm Ther. 2013 Oct;38(5):360-72. doi: 10.1111/jcpt.12059. Epub 2013 Apr 2.
- Gray SL, Anderson ML, Dublin S, Hanlon JT, Hubbard R, Walker R, Yu O, Crane PK, Larson EB. Cumulative use of strong anticholinergics and incident dementia: a prospective cohort study. JAMA Intern Med. 2015 Mar;175(3):401-7. doi: 10.1001/jamainternmed.2014.7663.
- Scott IA, Hilmer SN, Reeve E, Potter K, Le Couteur D, Rigby D, Gnjidic D, Del Mar CB, Roughead EE, Page A, Jansen J, Martin JH. Reducing inappropriate polypharmacy: the process of deprescribing. JAMA Intern Med. 2015 May;175(5):827-34. doi: 10.1001/jamainternmed.2015.0324.
- Green AR, Boyd CM, Gleason KS, Wright L, Kraus CR, Bedoy R, Sanchez B, Norton J, Sheehan OC, Wolff JL, Reeve E, Maciejewski ML, Weffald LA, Bayliss EA. Designing a Primary Care-Based Deprescribing Intervention for Patients with Dementia and Multiple Chronic Conditions: a Qualitative Study. J Gen Intern Med. 2020 Dec;35(12):3556-3563. doi: 10.1007/s11606-020-06063-y. Epub 2020 Jul 29.
- Davydow DS, Zivin K, Katon WJ, Pontone GM, Chwastiak L, Langa KM, Iwashyna TJ. Neuropsychiatric disorders and potentially preventable hospitalizations in a prospective cohort study of older Americans. J Gen Intern Med. 2014 Oct;29(10):1362-71. doi: 10.1007/s11606-014-2916-8.
- Maust DT, Strominger J, Kim HM, Langa KM, Bynum JPW, Chang CH, Kales HC, Zivin K, Solway E, Marcus SC. Prevalence of Central Nervous System-Active Polypharmacy Among Older Adults With Dementia in the US. JAMA. 2021 Mar 9;325(10):952-961. doi: 10.1001/jama.2021.1195.
- Carnahan RM, Lund BC, Perry PJ, Chrischilles EA. The concurrent use of anticholinergics and cholinesterase inhibitors: rare event or common practice? J Am Geriatr Soc. 2004 Dec;52(12):2082-7. doi: 10.1111/j.1532-5415.2004.52563.x.
- Castelino RL, Hilmer SN, Bajorek BV, Nishtala P, Chen TF. Drug Burden Index and potentially inappropriate medications in community-dwelling older people: the impact of Home Medicines Review. Drugs Aging. 2010 Feb 1;27(2):135-48. doi: 10.2165/11531560-000000000-00000.
- Brown JD, Hutchison LC, Li C, Painter JT, Martin BC. Predictive Validity of the Beers and Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP) Criteria to Detect Adverse Drug Events, Hospitalizations, and Emergency Department Visits in the United States. J Am Geriatr Soc. 2016 Jan;64(1):22-30. doi: 10.1111/jgs.13884.
- Wimmer BC, Cross AJ, Jokanovic N, Wiese MD, George J, Johnell K, Diug B, Bell JS. Clinical Outcomes Associated with Medication Regimen Complexity in Older People: A Systematic Review. J Am Geriatr Soc. 2017 Apr;65(4):747-753. doi: 10.1111/jgs.14682. Epub 2016 Dec 19.
- van der Cammen TJ, Rajkumar C, Onder G, Sterke CS, Petrovic M. Drug cessation in complex older adults: time for action. Age Ageing. 2014 Jan;43(1):20-5. doi: 10.1093/ageing/aft166. Epub 2013 Nov 12.
- Elliott RA, O'Callaghan C, Paul E, George J. Impact of an intervention to reduce medication regimen complexity for older hospital inpatients. Int J Clin Pharm. 2013 Apr;35(2):217-24. doi: 10.1007/s11096-012-9730-3. Epub 2012 Dec 5.
- Sluggett JK, Hopkins RE, Chen EY, Ilomaki J, Corlis M, Van Emden J, Hogan M, Caporale T, Ooi CE, Hilmer SN, Bell JS. Impact of Medication Regimen Simplification on Medication Administration Times and Health Outcomes in Residential Aged Care: 12 Month Follow Up of the SIMPLER Randomized Controlled Trial. J Clin Med. 2020 Apr 8;9(4):1053. doi: 10.3390/jcm9041053.
- Sheehan OC, Kharrazi H, Carl KJ, Leff B, Wolff JL, Roth DL, Gabbard J, Boyd CM. Helping Older Adults Improve Their Medication Experience (HOME) by Addressing Medication Regimen Complexity in Home Healthcare. Home Healthc Now. 2018 Jan/Feb;36(1):10-19. doi: 10.1097/NHH.0000000000000632.
- Kerns JW, Winter JD, Winter KM, Kerns CC, Etz RS. Caregiver Perspectives About Using Antipsychotics and Other Medications for Symptoms of Dementia. Gerontologist. 2018 Mar 19;58(2):e35-e45. doi: 10.1093/geront/gnx042.
- Green AR, Lee P, Reeve E, Wolff JL, Chen CCG, Kruzan R, Boyd CM. Clinicians' Perspectives on Barriers and Enablers of Optimal Prescribing in Patients with Dementia and Coexisting Conditions. J Am Board Fam Med. 2019 May-Jun;32(3):383-391. doi: 10.3122/jabfm.2019.03.180335.
- Reeve E, Bell JS, Hilmer SN. Barriers to Optimising Prescribing and Deprescribing in Older Adults with Dementia: A Narrative Review. Curr Clin Pharmacol. 2015;10(3):168-77. doi: 10.2174/157488471003150820150330.
- Kutner JS, Blatchford PJ, Taylor DH Jr, Ritchie CS, Bull JH, Fairclough DL, Hanson LC, LeBlanc TW, Samsa GP, Wolf S, Aziz NM, Currow DC, Ferrell B, Wagner-Johnston N, Zafar SY, Cleary JF, Dev S, Goode PS, Kamal AH, Kassner C, Kvale EA, McCallum JG, Ogunseitan AB, Pantilat SZ, Portenoy RK, Prince-Paul M, Sloan JA, Swetz KM, Von Gunten CF, Abernethy AP. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med. 2015 May;175(5):691-700. doi: 10.1001/jamainternmed.2015.0289.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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