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临床试验/NCT05766423
NCT05766423已完成不适用

Phenotyping Adherence Through Technology-Enabled Reports and Navigation: The PATTERN Study

Northwestern University1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2024年1月18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
73
试验地点
1
主要终点
Medication Adherence

研究概览

简要总结

This study is being conducted to adapt and pilot test a technology-enabled, primary care strategy for routinely monitoring medication use and adherence among older adults with multiple chronic conditions and polypharmacy.

详细描述

Our study aims are to:

Aim 1: Adapt the PATTERN intervention for use in primary care using input from key stakeholders. During Aim 1, the Northwestern research team will solicit opinions from key informants (patients, clinicians, practice administrators) to ensure PATTERN meets the needs of primary care.

Aim 2: Assess the PATTERN intervention's feasibility and acceptability for use in primary care. During Aim 2, the investigators will conduct a 2-arm, patient-randomized controlled trial at a Northwestern Medicine primary care practice. Participants will be recruited and randomly assigned, using a random number generator application, to either the PATTERN intervention or usual care. Usual care refers to the normal standard clinical practices at the participating practice. Participants will be followed for 6 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

  • •Each participant must:
  • •Be an adult aged 65 or older
  • •Speak English as their primary language
  • •Have multiple chronic conditions
  • •Be prescribed 8 or more medications
  • •Be primarily responsible for administering own medication
  • •Receive medical care at the participating primary care practice
  • •Have access to the internet and an active email address
  • •Be signed up for the patient portal (MyChart)

排除标准

  • •No participant can:
  • •Have severe, uncorrectable visual, hearing or cognitive impairments that would preclude study consent or participation

研究组 & 干预措施

Usual Care

No Intervention

Usual care includes:

  1. The normal standard clinical practices at the participating practice.
  2. No specific materials to promote PATTERN, and no additional materials that include adherence assessments or care alert notifications.

The PATTERN Intervention

Active Comparator

The intervention components include:

  1. An adherence assessment completed by participants ahead of a regularly scheduled clinic visit.
  2. Care alert notifications directed to a nurse pool and/or member of the clinical care team.

干预措施: The PATTERN Intervention (Behavioral)

结局指标

主要结局

Medication Adherence

时间窗: About 2-4 Weeks

Participants' medication adherence will be measured at about 2-4 weeks after their clinic visit using a validated self-report measure: ASK-12. The 12-item measure assesses general medication attitudes and beliefs across three domains: 1) inconvenience/forgetfulness, 2) treatment beliefs, and 3) behaviors. Response options range from "Strongly Disagree" to "Strongly Agree". Scores can range from 12-60 with higher scores representing greater barriers to adherence.

次要结局

  • Fidelity(By the scheduled clinic visit (baseline))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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