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Clinical Trials/NCT06397339
NCT06397339
Recruiting
Not Applicable

Indian Transforming Alzheimer's Care Training (INTACT)

Washington State University1 site in 1 country28 target enrollmentOctober 5, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alzheimer Disease
Sponsor
Washington State University
Enrollment
28
Locations
1
Primary Endpoint
Clinic Level - new diagnoses of ADRD and MCI (Aim 2)
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 5, 2022
End Date
April 30, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Patrik Johansson

Associate Professor

Washington State University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

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: 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)

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.

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.

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.

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.

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 Sites (1)

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