Clinical trial NCT06397339: Indian Transforming Alzheimer's Care Training (INTACT)
Official title: Indian Transforming Alzheimer's Care Training (INTACT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Keywords: ADRD, MCI
Lead sponsor: Washington State University
Sponsor class: OTHER
Collaborators: name: University of Washington
name: University of Miami
name: University of Minnesota
First posted: 2024-05-02
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group Randomized Trial with 28 urban and rural clinics that serve AI/ANs in 11 states. INTACT will be randomized at the clinic level and delivered to PCPs in clinics. Most outcome data will be derived from EHRs and PCP surveys. The study will use an immediate intervention and waitlist control randomization pattern with clinics randomized to the immediate intervention group receiving the INTACT program after the baseline data collection and the waitlist control group after the 12-month follow-up data collection is complete.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinic Level - new diagnoses of ADRD and MCI (Aim 2)
timeFrame: Baseline and 12-month follow-up
measure: PCP level - care confidence (Aim 1)
timeFrame: Baseline and a 12-month follow-up
measure: Patient level - quality of care 1 (Aim 3)
timeFrame: Baseline and a 12-month follow-up
measure: Patient level - quality of care 2 (Aim 3)
timeFrame: Baseline and a 12-month follow-up
measure: Patient level - quality of care 3 (Aim 3)
timeFrame: Baseline and a 12-month follow-up
measure: Patient level - quality of care 4 (Aim 3)
timeFrame: Baseline and a 12-month follow-up
measure: Patient level - quality of care 5 (Aim 3)
timeFrame: Baseline and a 12-month follow-up
measure: Patient level - quality of care 5 (Aim 3)
timeFrame: Baseline and a 12-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Washington State University
state: Washington
Study officials:
References: