NCT06397339 · Washington State University
Indian Transforming Alzheimer's Care Training (INTACT)
(INTACT)
What this study is about
INTACT will utilize a group-randomly assigned 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.
View original scientific description
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.
Interventions
OTHER
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 measures
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 annual evauations of functional status.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- CLINIC Eligibility criteria To be eligible to participate in INTACT a clinic must be:
- A primary care clinic
- Have at least 20 AI/AN active patients 55 years or older
- Have an EHR system
- Not intending to change EHR systems in the next year
- 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:
- have a title of MD, DO, Nurse Practitioner, or PA, and
- regularly provides care to AI/ANs aged 65 and older. PATIENTS We will only collect patient EHR data from eligible patients who:
- Recorded as AI/AN in the EHR system
- Active clinic patient with prevalent ADRD as of the first day of the time period each data extraction will cover
- Age 55 or older at the start of the surveillance interval
- 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.
Exclusion criteria
- for the clinic, PCPs and patients.
Where
- Seattle, Washington
Collaborators
University of Washington, University of Miami, University of Minnesota
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2024 · Source of record for eligibility and locations