跳至主要内容
临床试验/NCT02172612
NCT02172612已完成不适用

Evaluation of a Patient-Centered Medication Therapy Management Intervention to Reduce Inappropriate Anticholinergic Prescribing in the Elderly

Daniela Moga1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Change in appropriateness of anticholinergic medication prescribing practices.

研究概览

简要总结

This will be an eight-week, prospective, placebo-controlled, randomized trial to evaluate a patient-centered team (pharmacist-physician) intervention to improve medication appropriateness and reduce the use of inappropriate anticholinergic medications in elderly patients enrolled in the Sanders-Brown Alzheimer's Disease Center (ADC) cohort.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •Are younger than 65 years of age
  • •Have moderate to severe cognitive impairment
  • •Live in a long-term care facility

研究组 & 干预措施

Arm 1 - Intervention

Experimental

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.

干预措施: Arm 1 Education Session (Other)

Arm 2 - Control

No Intervention

Those included in the control group will receive a generic brochure about medication safety and inappropriate medication use in the elderly.

结局指标

主要结局

Change in appropriateness of anticholinergic medication prescribing practices.

时间窗: Two years

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)

次要结局

  • Change in Anticholinergic Burden(2 years)

研究者

发起方
Daniela Moga
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Daniela Moga

Principal Investigator

University of Kentucky

研究点 (1)

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