Recruiting

Alzheimer's Care

Sponsor:

Washington State University

Code:

NCT06397339

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

INTACT Program

Study Details

Brief summary:

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.

Conditions

Alzheimer Disease

Study ID

NCT06397339

Start date

Oct 5, 2022

Status verified date

Aug, 2024

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

28 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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

other: 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

Interventions

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 INTACT intervention lasts 12 months and Continuing Medical Education credits will be available to PCPs who complete the INTACT training program

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Washington State University

Recruiting

Seattle, Washington, United States, 98101

Contacts

Principal Investigator:

Patrik Johansson, MD, MPH

More Information

Sponsor

Washington State University

Last update posted

Aug 19, 2024

Last verified

Aug, 2024

Keywords

  • ADRD, MCI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Washington State University on 2024-08-19.