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Recruiting NCT06397339

Indian Transforming Alzheimer's Care Training (INTACT)

No phase Interventional Alzheimer Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: INTACT Program.
Who it may be relevant to
Registry conditions: Alzheimer Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

  • Other 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 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

Primary outcome measures

  • Clinic Level - new diagnoses of ADRD and MCI (Aim 2) [Time frame: Baseline and 12-month follow-up]
  • PCP level - care confidence (Aim 1) [Time frame: Baseline and a 12-month follow-up]
  • Patient level - quality of care 1 (Aim 3) [Time frame: Baseline and a 12-month follow-up]
  • Patient level - quality of care 2 (Aim 3) [Time frame: Baseline and a 12-month follow-up]
  • Patient level - quality of care 3 (Aim 3) [Time frame: Baseline and a 12-month follow-up]
  • Patient level - quality of care 4 (Aim 3) [Time frame: Baseline and a 12-month follow-up]
  • Patient level - quality of care 5 (Aim 3) [Time frame: Baseline and a 12-month follow-up]
  • Patient level - quality of care 5 (Aim 3) [Time frame: Baseline and a 12-month follow-up]

Eligibility criteria

CLINIC Eligibility criteria

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

  • A primary care clinic
  • Have at least 20 AI/AN active patients 55 years or older
  • Have an EHR system
  • Not intending to change EHR systems in the next year
  • 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:

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

PATIENTS

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

  • Recorded as AI/AN in the EHR system
  • Active clinic patient with prevalent ADRD as of the first day of the time period each data extraction will cover
  • Age 55 or older at the start of the surveillance interval
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

United States · 1 center
  • Washington State University — Seattle

Identifiers

NCT: NCT06397339 · 19630

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗