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印度阿尔茨海默病护理转型培训 (INTACT) (INTACT)

2026年9月23日 更新者：Patrik Johansson、Washington State University

INTACT will utilize a group-randomized trial, to test the effectiveness of a culturally informed provider training and "dementia friendly clinic" intervention for detection and appropriate management of AI/AN patients with ADRD and MCI in 28 urban and rural clinics serving AI/ANs.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The INTACT team will conduct a group-randomized trial (GRT) to test the effectiveness of the INTACT program, a culturally informed primary care provider training and clinic level workflow intervention for detection and appropriate management of AI/AN patients with Mild Cognitive Impairment (MCI) and ADRD in 28 urban and rural clinics serving AI/ANs. The clinics are the primary unit of randomization. Within each participating clinic, PCPs who are routinely seeing AI/AN patients ages 55 years and older will be recruited for data collection at baseline and 1-year follow-up. Each clinic will be randomized either to the immediate intervention or to a wait-list control arm. Data will be collected from PCP questionnaires, Electronic Health Records (EHR) data extraction and manual medical chart reviews. At the clinic level, we will rely on EHRs to document INTACT's effect on new ADRD diagnoses. At the PCP level, we will test whether INTACT increases knowledge and confidence in dementia assessment, ADRD care, and caregiver support. Patient-level data will be collected from the EHR and by manual chart review.

Once enrolled, clinics will complete a clinic profile interview and clinic and patient population information form, PCPs will be consented and complete a baseline survey. Next the clinics will be randomized into the immediate intervention or the wait-list control arms. Data collection will be conducted at baseline and 1-year follow-up. After completing the 1-year study period, clinics in the wait-list arm will have the opportunity to receive the INTACT intervention.

研究类型

介入性

注册 (实际的)

7

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • Washington
      • Seattle、Washington、美国、98101
        • Washington State University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

CLINIC Eligibility criteria

To be eligible to participate in INTACT a clinic must be:

  1. A primary care clinic
  2. Have at least 20 AI/AN active patients 55 years or older
  3. Have an EHR system
  4. Not intending to change EHR systems in the next year
  5. Willing to conduct a total of 40 limited patient chart reviews to assess quality of care metrics for AI/AN patients with MCI and ADRD, staff permitting

PCP

Eligibility criteria:

To be eligible to participate in the baseline and follow-up surveys a primary care provider must be:

  1. have a title of MD, DO, Nurse Practitioner, or PA, and
  2. regularly provides care to AI/ANs aged 65 and older.

PATIENTS

We will only collect patient EHR data from eligible patients who:

  1. Recorded as AI/AN in the EHR system
  2. Active clinic patient with prevalent ADRD as of the first day of the time period each data extraction will cover
  3. Age 55 or older at the start of the surveillance interval
  4. At least one primary care clinic visit during the time period each data extraction will cover.

There are no exclusion criteria for the clinic, PCPs and patients.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

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
实验性的：Intervention

The INTACT Program has three components:

  1. provide a training for Primary Care Providers (PCPs) training in screening, diagnosis, and care for ADRD,
  2. at the PCP level, provide quarterly webinars. Topics will address driving and dementia; communication tips for someone with dementia; eating and drinking in advanced dementia; and advanced care planning for dementia.
  3. At the clinic level, provide a workflow model for cognitive evaluation and setting a plan for the newly diagnosed patient. The INTACT intervention lasts 12 months and Continuing Medical Education credits will be available to PCPs who complete the INTACT training program
其他：INTACT Program

The INTACT Program has three components:

  1. provide a training for Primary Care Providers (PCPs) training in screening, diagnosis, and care for ADRD,
  2. at the PCP level, provide three optional webinars scheduled within the intervention time period. Webinars will address topics such as driving and dementia; communication tips for someone with dementia; and eating and drinking in advanced dementia.
  3. At the clinic level, provide a workflow model for cognitive evaluation and setting a plan for the newly diagnosed patient. The INTACT intervention lasts 12 months and Continuing Medical Education credits will be available to PCPs who complete the INTACT training program
其他：Waitlist

The INTACT Program has three components:

  1. provide a training for Primary Care Providers (PCPs) training in screening, diagnosis, and care for ADRD,
  2. at the PCP level, provide quarterly webinars. Topics will address driving and dementia; communication tips for someone with dementia; eating and drinking in advanced dementia; and advanced care planning for dementia.
  3. At the clinic level, provide a workflow model for cognitive evaluation and setting a plan for the newly diagnosed patient. The INTACT intervention lasts 12 months and Continuing Medical Education credits will be available to PCPs who complete the INTACT training program
其他：INTACT Program

The INTACT Program has three components:

  1. provide a training for Primary Care Providers (PCPs) training in screening, diagnosis, and care for ADRD,
  2. at the PCP level, provide three optional webinars scheduled within the intervention time period. Webinars will address topics such as driving and dementia; communication tips for someone with dementia; and eating and drinking in advanced dementia.
  3. At the clinic level, provide a workflow model for cognitive evaluation and setting a plan for the newly diagnosed patient. The INTACT intervention lasts 12 months and Continuing Medical Education credits will be available to PCPs who complete the INTACT training program

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
Clinic Level - new diagnoses of ADRD and MCI (Aim 2)
大体时间：Baseline and 12-month follow-up

Primary outcome (as obtained directly from EHRs) will reflect the aggregate counts of new diagnoses (MCI, ADRD, other dementia) during the study period, based on the ICD-10 codes for these diagnoses.
Baseline and 12-month follow-up
PCP level - care confidence (Aim 1)
大体时间：Baseline and a 12-month follow-up

Within each clinic, each participating PCP will complete a baseline and a 12-month follow-up survey. The PCP level primary outcome is care confidence in providing dementia care to patients and their families. Care confience wil be measured using the General Practitioners Confidence and Attitude scale for Dementia (GPACS-D) whic uses a 5 point Likert scale from 1 (strongly agree) to 5 (strongly disagree). The GPACS-D scale has 3 subscales:

  1. Confidence in Clinical Abilities for which a lower score means a better outcome
  2. Attitude to Care for which a lower score means a better outcome
  3. Engagement for which a higher score means a better outcome
Baseline and a 12-month follow-up
Patient level - quality of care 1 (Aim 3)
大体时间：Baseline and a 12-month follow-up

Primary outcome (as obtained directly from EHRs) will reflect the number and type of ADRD diagnostic tests.
Baseline and a 12-month follow-up
Patient level - quality of care 2 (Aim 3)
大体时间：Baseline and a 12-month follow-up

Primary outcome (as obtained directly from EHRs) will reflect the number of prescriptions of appropriate medications for cognitive and mood symptoms.
Baseline and a 12-month follow-up
Patient level - quality of care 3 (Aim 3)
大体时间：Baseline and a 12-month follow-up

Primary outcome (as obtained directly from EHRs) will reflect the number of annual cognitive assessments.
Baseline and a 12-month follow-up
Patient level - quality of care 4 (Aim 3)
大体时间：Baseline and a 12-month follow-up

Primary outcome (as obtained directly from EHRs) will reflect the number advance care directive.
Baseline and a 12-month follow-up
Patient level - quality of care 5 (Aim 3)
大体时间：Baseline and a 12-month follow-up

Primary outcome (as obtained directly from EHRs) will reflect the number of annual evauations of functional status.
Baseline and a 12-month follow-up
Patient level - quality of care 5 (Aim 3)
大体时间：Baseline and a 12-month follow-up

Primary outcome (as obtained directly from EHRs) will reflect the number of pharmacoligical treatment changes.
Baseline and a 12-month follow-up

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Washington State University

合作者

University of Washington
University of Minnesota

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2022年10月5日

初级完成 (实际的)

2026年4月30日

研究完成 (实际的)

2026年4月30日

研究注册日期

首次提交

2024年3月15日

首先提交符合 QC 标准的

2024年4月29日

首次发布 (实际的)

2024年5月2日

研究记录更新

最后更新发布 (实际的)

2026年9月29日

上次提交的符合 QC 标准的更新

2026年9月23日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 19630

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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