Indian Transforming Alzheimer's Care Training (INTACT)

NCT06397339 | Recruiting DMC

• 1 other identifier: 19630
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease

Keywords

ADRD, MCI

Outcome Measures

Primary Outcomes (8)

• 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: 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

  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

• 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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Other: INTACT Program

Waitlist

OTHER

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

Other: INTACT Program

Interventions

INTACT Program OTHER

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

Intervention; Waitlist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Washington State University: lead
• University of Washington: collaborator
• University of Miami: collaborator
• University of Minnesota: collaborator

Study Sites (1)

Washington State University

Seattle, Washington, 98101, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Patrik Johansson, MD, MPH

CONTACT

206-708-8623; patrik.johansson@wsu.edu

Odile Z Madesclaire, MPH

CONTACT

206-708-8617; odile.madesclaire@wsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: May 2, 2024
• Study Start: October 5, 2022
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)