Indian Transforming Alzheimer's Care Training (INTACT)

Not Applicable

Recruiting

• Conditions: Alzheimer Disease

• Registration Number: NCT06397339
• Lead Sponsor: Washington State University

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.

Study Timeline

• Study Start: 2022-10-05
• Study First Submitted: 2024-03-15
• Study First Submitted QC: 2024-04-29
• Study First Posted: 2024-05-02
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-14
• Last Update Posted: 2024-08-19
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Clinic Level - new diagnoses of ADRD and MCI (Aim 2)	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.
PCP level - care confidence (Aim 1)	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
Patient level - quality of care 1 (Aim 3)	Baseline and a 12-month follow-up	Primary outcome (as obtained directly from EHRs) will reflect the number and type of ADRD diagnostic tests.
Patient level - quality of care 2 (Aim 3)	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.
Patient level - quality of care 3 (Aim 3)	Baseline and a 12-month follow-up	Primary outcome (as obtained directly from EHRs) will reflect the number of annual cognitive assessments.
Patient level - quality of care 4 (Aim 3)	Baseline and a 12-month follow-up	Primary outcome (as obtained directly from EHRs) will reflect the number advance care directive.
Patient level - quality of care 5 (Aim 3)	Baseline and a 12-month follow-up	Primary outcome (as obtained directly from EHRs) will reflect the number of pharmacoligical treatment changes.

Trial Locations

Locations (1)

Washington State University; 🇺🇸 Seattle, Washington, United States