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临床试验/NCT04717297
NCT04717297已完成不适用

A Tailored Medication Management Intervention for Older Adults

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2021年2月19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
入组人数
33
试验地点
1
主要终点
Recruitment

研究概览

简要总结

Successful medication management is an essential instrumental activity of daily living (IADL) for older adults with polypharmacy; however, between 40%-70% of older adults fail to take their medications as prescribed. Providing interventions to address medication management and restore performance for this IADL is within the scope of practice for occupational therapy (OT), however, there is paucity of evidence for OT interventions to improve medication management in community-dwelling older adults. We have developed a tailored medication management intervention (TIMM) for community-dwelling older adults which recognizes the unique context in which medication management occurs (the home) and addresses the personal and environmental barriers experienced by older adults. TIMM is delivered in the home, by an OT, and in collaboration with a pharmacist to reduce inappropriate polypharmacy.

详细描述

Almost 70% of older adults experience multimorbidity and medication is often the first intervention used to manage it. In fact, 90% of older adults take at least one medication and 36% take 5 or more, commonly known as polypharmacy. When taken correctly, medication can extend life-expectancy and improve quality of life. However, estimates show 40-75% of community-dwelling older adults are nonadherent, or deviate from their medication regimen. These older adults are at an increased risk of nonadherence because the physical changes associated with multimorbidity including decreased memory, fine motor skills, and visual acuity and because of the complexity polypharmacy adds to a medication routine. Nearly 43% of older adults with polypharmacy take medications that are inappropriate and can cause negative long term physical and cognitive function, which further complicates the mediation management process.

Nonadherence has significant consequences which include increased health care costs, falls, institutionalization, and decreased medication effectiveness, quality of life. In fact, improving medication adherence has been identified as a public health concern by the World Health Organization. Despite this, interventions designed to improve adherence in older adults remain largely ineffective. The majority of interventions are disease or medication specific or are implemented with a "one size fits all" approach (e.g. providing standard pill organizers that may be difficult for some older adults to open). Furthermore, interventions are often implemented in a clinical setting such as doctor's office or hospital and do not consider the unique home environment where medication management typically occurs. Home environments can offer support (i.e. caregiver to set up medications) or barriers (i.e. low lighting that makes medications difficult to see) to medication management. Given the complexity of each older adult's risk factors and home environment, a more tailored, individualized approach must be considered.

Tailored, individualized interventions aimed at remediating the environmental barriers in the home have been successful in improving daily activity performance for older adults. However, this type of intervention has not been tested specifically to improve medication adherence in older adults with multimorbidity and polypharmacy. We propose a tailored, individualized medication management intervention (TIMM) for community-dwelling older adults with multimorbidity and polypharmacy. TIMM is an interdisciplinary, compensatory intervention which consists of: 1) an initial in-home evaluation of medication management ability, individual risk factors, and identification of environmental barriers to independence; 2) a medication review by a pharmacist to address polypharmacy; and 3) tailored intervention by an occupational therapist to improve adherence by reducing barriers to medication management.

We will conduct an equivalency randomized control trial to examine the feasibility, acceptability and preliminary efficacy of TIMM delivered remotely and in-person. The use of telehealth to deliver occupational therapy interventions for older adults has become more widely utilized, especially during the last two years. Remote interventions remove many of the barriers to in-home care including access and cost and have been shown to be an effective delivery method for OT and other medical services for older adults. Participants in the treatment group will receive the intervention delivered remotely, and participants in the waitlist control group will receive the intervention in-person, upon completion of their control period.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
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

  • •65 and older
  • •takes 5 or more medications
  • •Decreased medication adherence (one or more "yes" responses on Medication Adherence Rating Scale (MARS))

排除标准

  • •Cognitive impairment as indicated by Short Blessed Test (SBT) score of 10 or more
  • •Lives in institutional setting

研究组 & 干预措施

Tailored Medication Management Remote Intervention Treatment Arm

Experimental

Participants receive a total of three visits (one evaluation/pre-treatment visit and 2 treatment visits) that last 75 minutes each over 4 weeks. Sessions/visits are spaced 1 week apart and will be delivered remotely.

干预措施: Medication Management Remote Intervention (Behavioral)

Waitlist Attention Control Arm

Sham Comparator

The attention control group will receive two, 75-minute attention visits with a trained research assistant. Upon completion of waitlist period, the participants in the waitlist group will be offered the intervention in person.

干预措施: Waitlist Control (Behavioral)

Tailored Medication Management In-Person Intervention Treatment Arm

Experimental

Participants receive a total of three visits (one evaluation/pre-treatment visit and 2 treatment visits) that last 75 minutes each over 4 weeks. Sessions/visits are spaced 1 week apart and will be delivered in-person.

干预措施: Medication Management In-Person Intervention (Behavioral)

结局指标

主要结局

Recruitment

时间窗: 6 months

Recruitment and retention rate

Intervention Safety- Falls

时间窗: 6 months

Number of falls

Intervention Safety

时间窗: 6 months

Number of therapy visits

Intervention Pharmacy Cost

时间窗: 6 months

Pharmacist time

Intervention Modification Cost

时间窗: 6 months

adaptive equipment cost

Intervention Safety- Hospitalizations

时间窗: 6 months

Number of unplanned hospitalizations

Intervention Safety- Doctor Visits

时间窗: 6 months

Number of unplanned doctor visits

Dose

时间窗: 6 months

Treatment minutes and number of treatment sessions

Intervention Safety- ER Visits

时间窗: 6 months

Number of ER visits

Intervention OT Cost

时间窗: 6 months

OT time

Treatment Fidelity

时间窗: 6 months

Ability to deliver required treatment session elements

次要结局

  • Equivalency(6 months)
  • Medication Management Ability(6 months)
  • Potentially Inappropriate Medications(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily Somerville

Instructor of Occupational Therapy and Neurology

Washington University School of Medicine

研究点 (1)

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