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| Name | Class |
|---|---|
| University of Washington | OTHER |
| University of Miami | OTHER |
| University of Minnesota | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | The INTACT Program has three components:
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| Waitlist | Other | The INTACT Program has three components:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| INTACT Program | Other | The INTACT Program has three components:
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| Measure | Description | Time Frame |
|---|---|---|
| Clinic Level - new diagnoses of ADRD and MCI (Aim 2) | 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. | Baseline and 12-month follow-up |
| PCP level - care confidence (Aim 1) | 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:
| Baseline and a 12-month follow-up |
| Patient level - quality of care 1 (Aim 3) | Primary outcome (as obtained directly from EHRs) will reflect the number and type of ADRD diagnostic tests. | Baseline and a 12-month follow-up |
| Patient level - quality of care 2 (Aim 3) | Primary outcome (as obtained directly from EHRs) will reflect the number of prescriptions of appropriate medications for cognitive and mood symptoms. | Baseline and a 12-month follow-up |
| Patient level - quality of care 3 (Aim 3) | Primary outcome (as obtained directly from EHRs) will reflect the number of annual cognitive assessments. | Baseline and a 12-month follow-up |
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CLINIC Eligibility criteria
To be eligible to participate in INTACT a clinic must be:
PCP
Eligibility criteria:
To be eligible to participate in the baseline and follow-up surveys a primary care provider must be:
PATIENTS
We will only collect patient EHR data from eligible patients who:
There are no exclusion criteria for the clinic, PCPs and patients.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patrik Johansson, MD, MPH | Contact | 206-708-8623 | patrik.johansson@wsu.edu | |
| Odile Z Madesclaire, MPH | Contact | 206-708-8617 | odile.madesclaire@wsu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington State University | Recruiting | Seattle | Washington | 98101 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2022 | Apr 22, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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.
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| Patient level - quality of care 4 (Aim 3) |
Primary outcome (as obtained directly from EHRs) will reflect the number advance care directive. |
| Baseline and a 12-month follow-up |
| Patient level - quality of care 5 (Aim 3) | Primary outcome (as obtained directly from EHRs) will reflect the number of annual evauations of functional status. | Baseline and a 12-month follow-up |
| Patient level - quality of care 5 (Aim 3) | Primary outcome (as obtained directly from EHRs) will reflect the number of pharmacoligical treatment changes. | Baseline and a 12-month follow-up |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |