A Pilot Study to Reduce Inappropriate Anticholinergic Prescribing in the Elderly
Evaluation of a Patient-Centered Medication Therapy Management Intervention to Reduce Inappropriate Anticholinergic Prescribing in the Elderly
研究概览
详细说明
Screening: Patients seen in the Sanders-Brown clinic as part of the ADC cohort will be screened for eligibility in our study by the ADC study coordinator and the licensed prescriber involved in the scheduled ADC visit.
Enrollment: If the patient is considered eligible based on the screening, the study coordinator will introduce our study to the potential participant and will answer questions the patient might have. If the patient is interested, the study coordinator will obtain the informed consent and will proceed with the study related activities. Medication information and SF-36 are collected as part of the ADC cohort data collection; therefore, to reduce the burden on the participant, we are planning to work with the ADC team and use these data as baseline information for our study. For participants randomized to the intervention group, the two onsite study visits will be scheduled- the intervention visit will be planned within a week after enrollment and the end of study visit will be scheduled 8 weeks after enrollment. Participants randomized to the control group will have their end of study visit scheduled 8 weeks post-enrollment.
After enrollment, the study pharmacist will perform medication therapy management (MTM) to review all medications from the list provided by the patient. The pharmacist will identify any anticholinergic medication, will determine the medication appropriateness index and will prepare a report to include information on potential inappropriate medications to make recommendations for treatment discontinuation or change as considered appropriate. For participants included in the intervention group, the pharmacist will discuss the recommendations with one of the licensed prescribers before the scheduled visit by the participant. Final recommendations on discontinuing or changing inappropriate medications will be made by medical staff. In the case of medication necessity, safer alternatives will be sought and will be included in the proposed plan to be discussed with the patient assigned to the intervention arm.
Intervention visit: Those included in the intervention group will undergo an educational session with the study pharmacist and one of the licensed prescribers from Sanders-Brown to discuss recommended changes in their treatment plan. If changes in medications are indicated by the pharmacist-prescriber team, and accepted by the patient, new prescriptions will be provided and a letter will be sent to the primary care physicians detailing the changes made and the rationale behind such changes. Sending a letter to the primary care provider to inform of medication changes by the specialist is considered standard of care.
Both intervention and control group will receive a generic brochure that describes medication safety in the elderly in general terms.
End of study visit: At this visit, which will be scheduled eight weeks after enrollment, both the intervention and control group will complete SF-36 and will update the data on their current medication. They will also complete a questionnaire asking about their experience as part of the study.
Post-visit evaluation: The study pharmacist will review the new medication list and the follow-up MAI will be calculated through a similar procedure as detailed above.
Post-visit follow-up: All of the study participants will receive a thank you letter and will be informed of the availability of the study team to further discuss their medication plan and of the ADC prescribers to continue to support their ongoing care. The thank you letter will also include a check to compensate participants for being part of our study.
Intervention The intervention will be based on the pharmacist-physician team drug review. For patients randomized to the intervention group, the clinical pharmacist performed drug reviews will guide a revised medication plan that will be discussed with the patient. Specifically, the proposed plan will attempt to recommend discontinuation or replacement of any inappropriate drug with anticholinergic properties, with safer drug alternatives (i.e., with less or no anticholinergic activity). When drug alternatives are unavailable, reduction in dosage will be attempted to reduce the anticholinergic burden. As part of their routine clinical duties and care for ADC research participants, the prescribing team (ADC licensed practitioners) will make the recommendations to the patient, while the study pharmacist will be responsible for recommendations and provision of information to educate the patient about medication safety and the importance of patient involvement in medication awareness and oversight. Appropriate changes will be determined and carried out by the licensed prescriber and a letter will be sent informing the primary care physician of medication changes and rationale for such changes.
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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Kentucky
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Lexington、Kentucky、美国、40536
- Sander's BrownCenter on Aging
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Enrolled at the Sander's Brown Center on Aging Alzheimer Disease Center
- Are 65 years of age or older
- Are taking at least one anticholinergic medication
- No cognitive impairment or mild cognitive impairment
Exclusion Criteria:
- Are younger than 65 years of age
- Have moderate to severe cognitive impairment
- Live in a long-term care facility
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 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:Arm 1 - Intervention
Those included in the intervention group will undergo an educational session with the study pharmacist and one of the licensed prescribers from Sanders-Brown to discuss recommended changes in their treatment plan.
If changes in medications are indicated by the pharmacist-prescriber team, and accepted by the patient, new prescriptions will be provided and a letter will be sent to the primary care physicians detailing the changes made and the rationale behind such changes.
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Those included in the intervention group will undergo an educational session with the study pharmacist and one of the licensed prescribers from Sanders-Brown to discuss recommended changes in their treatment plan.
If changes in medications are indicated by the pharmacist-prescriber team, and accepted by the patient, new prescriptions will be provided and a letter will be sent to the primary care physicians detailing the changes made and the rationale behind such changes.
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无干预:Arm 2 - Control
Those included in the control group will receive a generic brochure about medication safety and inappropriate medication use in the elderly.
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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 |
---|---|---|
Change in appropriateness of anticholinergic medication prescribing practices.
大体时间:Two years
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This will be measured through the change in the appropriateness of anticholinergic medication prescribing from baseline to follow-up, as measured by the medication appropriateness index (MAI)
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Two years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in Anticholinergic Burden
大体时间:2 years
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The anticholinergic burden will be measured from baseline to follow-up, as measured by the anticholinergic drug scale (ADS).Anticholinergic burden (and change from baseline to follow-up) will be measure using the updated ADS score; the ADS has four levels for each included drug, ranging from 0 (no known anticholinergic activity) to 3 (markedly anticholinergic activity).
The summation of anticholinergic activity level for all the drugs taken by a patient reflects the total anticholinergic burden.
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2 years
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Change in perceived health status
大体时间:2 years
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Will be measured using the SF-36 at baseline and at the Week 8, End-of-study visit.
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2 years
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合作者和调查者
赞助
调查人员
- 首席研究员:Daniela C Moga, MD, PhD、University of Kentucky
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
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 (估计)
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
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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