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NCT Number: NCT06397339

Indian Transforming Alzheimer's Care Training (INTACT)

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

INTACT Program

Other

The INTACT Program has three components:

  • provide a training for Primary Care Providers (PCPs) training in screening, diagnosis, and care for ADRD,
  • 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.
  • 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

Primary outcomes

  1. Clinic Level - new diagnoses of ADRD and MCI (Aim 2)

    Time frame: 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.

  2. PCP level - care confidence (Aim 1)

    Time frame: 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:

    • Confidence in Clinical Abilities for which a lower score means a better outcome
    • Attitude to Care for which a lower score means a better outcome
    • Engagement for which a higher score means a better outcome

  3. Patient level - quality of care 1 (Aim 3)

    Time frame: Baseline and a 12-month follow-up

    Primary outcome (as obtained directly from EHRs) will reflect the number and type of ADRD diagnostic tests.

  4. Patient level - quality of care 2 (Aim 3)

    Time frame: 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.

  5. Patient level - quality of care 3 (Aim 3)

    Time frame: Baseline and a 12-month follow-up

    Primary outcome (as obtained directly from EHRs) will reflect the number of annual cognitive assessments.

  6. Patient level - quality of care 4 (Aim 3)

    Time frame: Baseline and a 12-month follow-up

    Primary outcome (as obtained directly from EHRs) will reflect the number advance care directive.

  7. Patient level - quality of care 5 (Aim 3)

    Time frame: Baseline and a 12-month follow-up

    Primary outcome (as obtained directly from EHRs) will reflect the number of annual evauations of functional status.

  8. Patient level - quality of care 5 (Aim 3)

    Time frame: Baseline and a 12-month follow-up

    Primary outcome (as obtained directly from EHRs) will reflect the number of pharmacoligical treatment changes.

Study contacts

Contact information is provided by the study sponsor or research team.

Odile Z Madesclaire, MPH

CONTACT

[email protected]

206-708-8617

Patrik Johansson, MD, MPH

CONTACT

[email protected]

206-708-8623

Sponsors and collaborators

Lead sponsor

Washington State University

Other

Collaborators

  • University of Miami
  • University of Minnesota
  • University of Washington

Registry information

Acronym: INTACT

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 2, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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