Trial Outcomes & Findings for The Brain Health Study: A Pragmatic, Patient-Centered Trial (NCT NCT05356702)

Results Overview

Rate of new dementia diagnoses identified from the electronic health record (EHR) using a prespecified set of ICD-10 codes

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3417 participants

Primary outcome timeframe

12 months after index date

Results posted on

2026-07-06

Participant Flow

This embedded pragmatic trial included eligible patients at 5 primary care clinics at Kaiser Permanente Washington. Patients were identified from the electronic health record, eligibility criteria were applied, and then patients were randomized in clusters. The cluster was the primary care provider (PCP) panel, to avoid contamination. PCPs were not enrolled or studied in this trial. Patients were initiated into the study between 6/29/2022 and 10/16/2023.

Unit of analysis: PCP Panel

Participant milestones

Participant milestones
Measure	Brain Health Intervention Participants in the intervention arm were invited to attend a "brain health" visit with a trained research interventionist who was a licensed clinician (e.g., social worker.) They were sent a mailed outreach letter and information sheet, with follow-up phone calls. At the visit, the research interventionist asked about memory symptoms and ability to perform instrumental activities of daily living (IADLs) and screened for cognitive impairment and depression. Results were shared with the participant and their primary care physician, who was responsible for follow up and more evaluation if needed and for making a final diagnosis of dementia, if applicable.	Usual Care Individuals in this arm did not receive any intervention but rather usual care. Kaiser Permanente Washington does not routinely screen for cognitive impairment (in line with current guidelines from the US Preventive Services Task Force).
Overall Study STARTED	1715 41	1702 38
Overall Study COMPLETED	1713 41	1701 38
Overall Study NOT COMPLETED	2 0	1 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Brain Health Intervention Participants in the intervention arm were invited to attend a "brain health" visit with a trained research interventionist who was a licensed clinician (e.g., social worker.) They were sent a mailed outreach letter and information sheet, with follow-up phone calls. At the visit, the research interventionist asked about memory symptoms and ability to perform instrumental activities of daily living (IADLs) and screened for cognitive impairment and depression. Results were shared with the participant and their primary care physician, who was responsible for follow up and more evaluation if needed and for making a final diagnosis of dementia, if applicable.	Usual Care Individuals in this arm did not receive any intervention but rather usual care. Kaiser Permanente Washington does not routinely screen for cognitive impairment (in line with current guidelines from the US Preventive Services Task Force).
Overall Study Found to have died prior to initiation into study	2	1

Baseline Characteristics

After adding the numbers, they appear to agree with the overall n=3414

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brain Health Intervention n=1713 Participants Participants in the intervention arm were invited to attend a "brain health" visit with a trained research interventionist who was a licensed clinician (e.g., social worker.) They were sent a mailed outreach letter and information sheet, with follow-up phone calls. At the visit, the research interventionist asked about memory symptoms and ability to perform instrumental activities of daily living (IADLs) and screened for cognitive impairment and depression. Results were shared with the participant and their primary care physician, who was responsible for follow up and more evaluation if needed and for making a final diagnosis of dementia, if applicable.	Usual Care n=1701 Participants Individuals in this arm did not receive any intervention but rather usual care. Kaiser Permanente Washington does not routinely screen for cognitive impairment (in line with current guidelines from the US Preventive Services Task Force).	Total n=3414 Participants Total of all reporting groups
Age, Continuous	84.44 Years STANDARD_DEVIATION 5.95 • n=9 Participants	84.28 Years STANDARD_DEVIATION 5.88 • n=27 Participants	84.36 Years STANDARD_DEVIATION 5.91 • n=267 Participants
Sex: Female, Male Female	1008 Participants n=9 Participants	915 Participants n=27 Participants	1923 Participants n=267 Participants
Sex: Female, Male Male	705 Participants n=9 Participants	786 Participants n=27 Participants	1491 Participants n=267 Participants
Race/Ethnicity, Customized Non-Hispanic White	1311 Participants n=9 Participants • After adding the numbers, they appear to agree with the overall n=3414	1368 Participants n=27 Participants • After adding the numbers, they appear to agree with the overall n=3414	2679 Participants n=267 Participants • After adding the numbers, they appear to agree with the overall n=3414
Race/Ethnicity, Customized Non-Hispanic Black/African American	77 Participants n=9 Participants • After adding the numbers, they appear to agree with the overall n=3414	71 Participants n=27 Participants • After adding the numbers, they appear to agree with the overall n=3414	148 Participants n=267 Participants • After adding the numbers, they appear to agree with the overall n=3414
Race/Ethnicity, Customized Non-Hispanic Asian	158 Participants n=9 Participants • After adding the numbers, they appear to agree with the overall n=3414	123 Participants n=27 Participants • After adding the numbers, they appear to agree with the overall n=3414	281 Participants n=267 Participants • After adding the numbers, they appear to agree with the overall n=3414
Race/Ethnicity, Customized Hispanic/Latino	58 Participants n=9 Participants • After adding the numbers, they appear to agree with the overall n=3414	60 Participants n=27 Participants • After adding the numbers, they appear to agree with the overall n=3414	118 Participants n=267 Participants • After adding the numbers, they appear to agree with the overall n=3414
Race/Ethnicity, Customized Other race	49 Participants n=9 Participants • After adding the numbers, they appear to agree with the overall n=3414	45 Participants n=27 Participants • After adding the numbers, they appear to agree with the overall n=3414	94 Participants n=267 Participants • After adding the numbers, they appear to agree with the overall n=3414
Race/Ethnicity, Customized Missing/Declined	60 Participants n=9 Participants • After adding the numbers, they appear to agree with the overall n=3414	34 Participants n=27 Participants • After adding the numbers, they appear to agree with the overall n=3414	94 Participants n=267 Participants • After adding the numbers, they appear to agree with the overall n=3414
Prior MCI diagnosis	122 Participants n=9 Participants	116 Participants n=27 Participants	238 Participants n=267 Participants
Prior other memory diagnosis	279 Participants n=9 Participants	248 Participants n=27 Participants	527 Participants n=267 Participants
Elixhauser comorbidity score mean	7.16 Score on a scale STANDARD_DEVIATION 8.49 • n=9 Participants	7.06 Score on a scale STANDARD_DEVIATION 8.57 • n=27 Participants	7.11 Score on a scale STANDARD_DEVIATION 8.53 • n=267 Participants
eRADAR score mean	0.06 Score on a scale STANDARD_DEVIATION 0.04 • n=9 Participants	0.06 Score on a scale STANDARD_DEVIATION 0.05 • n=27 Participants	0.06 Score on a scale STANDARD_DEVIATION 0.04 • n=267 Participants

PRIMARY outcome

Timeframe: 12 months after index date

Rate of new dementia diagnoses identified from the electronic health record (EHR) using a prespecified set of ICD-10 codes

Outcome measures

Outcome measures
Measure	Brain Health Intervention n=1713 Participants * Calculate eRADAR scores using EHR data to identify eligible individuals * Invite eligible individuals for brain health assessment visit * Enter results of brain health assessment visit into EHR * Provide summary of results and recommended next steps to the Primary Care Physician and participant	Usual Care n=1701 Participants Individuals who meet eligibility criteria will receive usual care.
New Dementia Diagnoses	99 Participants	82 Participants

SECONDARY outcome

Timeframe: 12 months after index date

Population: The analysis population excludes 1 person in the control arm and 2 people in the intervention arm who were randomized to the study but were later found to have died before the study initiation date.

Number of new diagnoses of mild cognitive impairment in the 12 months following study initiation, defined from EHR data

Outcome measures

Outcome measures
Measure	Brain Health Intervention n=1713 Participants * Calculate eRADAR scores using EHR data to identify eligible individuals * Invite eligible individuals for brain health assessment visit * Enter results of brain health assessment visit into EHR * Provide summary of results and recommended next steps to the Primary Care Physician and participant	Usual Care n=1701 Participants Individuals who meet eligibility criteria will receive usual care.
Number of Patients Who Received a New Diagnosis of Mild Cognitive Impairment or Dementia	198 Participants	158 Participants

SECONDARY outcome

Timeframe: 18 months after index date

Dementia diagnosis rate in 18 months defined from EHR data

Outcome measures

Outcome measures
Measure	Brain Health Intervention n=1713 Participants * Calculate eRADAR scores using EHR data to identify eligible individuals * Invite eligible individuals for brain health assessment visit * Enter results of brain health assessment visit into EHR * Provide summary of results and recommended next steps to the Primary Care Physician and participant	Usual Care n=1701 Participants Individuals who meet eligibility criteria will receive usual care.
Number of Patients Who Received New Dementia Diagnoses in 18 Months of Follow-up	149 Participants	125 Participants

SECONDARY outcome

Timeframe: 6 months

Number of patients with a new dementia diagnosis in 6 months of follow-up defined from the EHR.

Outcome measures

Outcome measures
Measure	Brain Health Intervention n=1713 Participants * Calculate eRADAR scores using EHR data to identify eligible individuals * Invite eligible individuals for brain health assessment visit * Enter results of brain health assessment visit into EHR * Provide summary of results and recommended next steps to the Primary Care Physician and participant	Usual Care n=1701 Participants Individuals who meet eligibility criteria will receive usual care.
Number of Patients Who Received a New Dementia Diagnosis in 6 Months of Follow-up	59 Participants	52 Participants

SECONDARY outcome

Timeframe: 12 months after index date

Population: The analysis population excludes 1 person in the control arm and 2 people in the intervention arm who were randomized to the study but were later found to have died before the study initiation date.

Receipt of new medications for dementia in 12 months, defined from medication orders or dispensings in the electronic health record

Outcome measures

Outcome measures
Measure	Brain Health Intervention n=1713 Participants * Calculate eRADAR scores using EHR data to identify eligible individuals * Invite eligible individuals for brain health assessment visit * Enter results of brain health assessment visit into EHR * Provide summary of results and recommended next steps to the Primary Care Physician and participant	Usual Care n=1701 Participants Individuals who meet eligibility criteria will receive usual care.
Number of Patients Who Received a New Dementia Medication	31 Participants	21 Participants

SECONDARY outcome

Timeframe: 1 year after index date

Number of participants who had at least 1 urgent care or emergency department visit in the 12 months following study initiation.

Outcome measures

Outcome measures
Measure	Brain Health Intervention n=1713 Participants * Calculate eRADAR scores using EHR data to identify eligible individuals * Invite eligible individuals for brain health assessment visit * Enter results of brain health assessment visit into EHR * Provide summary of results and recommended next steps to the Primary Care Physician and participant	Usual Care n=1701 Participants Individuals who meet eligibility criteria will receive usual care.
Number of Patients With Urgent Care/Emergency Department Visits	817 Participants	833 Participants

SECONDARY outcome

Timeframe: 1 year after index date

Population: Defined as the number of inpatient admissions in 1 year following study initiation.

Average number of hospitalizations (inpatient stays) per participant in the 1 year after study initiation.

Outcome measures

Outcome measures
Measure	Brain Health Intervention n=1713 Participants * Calculate eRADAR scores using EHR data to identify eligible individuals * Invite eligible individuals for brain health assessment visit * Enter results of brain health assessment visit into EHR * Provide summary of results and recommended next steps to the Primary Care Physician and participant	Usual Care n=1701 Participants Individuals who meet eligibility criteria will receive usual care.
Average Number of Hospitalizations	0.266 inpatient stays Standard Deviation 0.707	0.287 inpatient stays Standard Deviation 0.677

SECONDARY outcome

Timeframe: 1 year after index date

Average number of scheduled clinic visits missed per participant

Outcome measures

Outcome measures
Measure	Brain Health Intervention n=1713 Participants * Calculate eRADAR scores using EHR data to identify eligible individuals * Invite eligible individuals for brain health assessment visit * Enter results of brain health assessment visit into EHR * Provide summary of results and recommended next steps to the Primary Care Physician and participant	Usual Care n=1701 Participants Individuals who meet eligibility criteria will receive usual care.
Average Number of "no Shows" for Scheduled Clinic Visits	0.64 number of visits Standard Deviation 1.74	0.58 number of visits Standard Deviation 1.33

SECONDARY outcome

Timeframe: 6 months

Average number of visits in primary care in the 6 months after study initiation

Outcome measures

Outcome measures
Measure	Brain Health Intervention n=1713 Participants * Calculate eRADAR scores using EHR data to identify eligible individuals * Invite eligible individuals for brain health assessment visit * Enter results of brain health assessment visit into EHR * Provide summary of results and recommended next steps to the Primary Care Physician and participant	Usual Care n=1701 Participants Individuals who meet eligibility criteria will receive usual care.
Average Number of Visits in Primary Care - 6 Months	3.97 visits Standard Deviation 4.15	4.00 visits Standard Deviation 4.10

SECONDARY outcome

Timeframe: 12 months

Average number of visits in primary care in the 12 months after study initiation

Outcome measures

Outcome measures
Measure	Brain Health Intervention n=1713 Participants * Calculate eRADAR scores using EHR data to identify eligible individuals * Invite eligible individuals for brain health assessment visit * Enter results of brain health assessment visit into EHR * Provide summary of results and recommended next steps to the Primary Care Physician and participant	Usual Care n=1701 Participants Individuals who meet eligibility criteria will receive usual care.
Average Number of Visits in Primary Care - 12 Months	7.94 visits Standard Deviation 7.14	8.06 visits Standard Deviation 7.09

SECONDARY outcome

Timeframe: 12 months

Number of participants with at least 1 B12 lab test in the 12 months after study initiation.

Outcome measures

Outcome measures
Measure	Brain Health Intervention n=1713 Participants * Calculate eRADAR scores using EHR data to identify eligible individuals * Invite eligible individuals for brain health assessment visit * Enter results of brain health assessment visit into EHR * Provide summary of results and recommended next steps to the Primary Care Physician and participant	Usual Care n=1701 Participants Individuals who meet eligibility criteria will receive usual care.
Number of Patients Who Received a B12 Lab Test	527 Participants	459 Participants

SECONDARY outcome

Timeframe: 12 months

Number of patients with at least 1 Neuroimaging study (CT head, MRI brain) in 12 months following study initiation.

Outcome measures

Outcome measures
Measure	Brain Health Intervention n=1713 Participants * Calculate eRADAR scores using EHR data to identify eligible individuals * Invite eligible individuals for brain health assessment visit * Enter results of brain health assessment visit into EHR * Provide summary of results and recommended next steps to the Primary Care Physician and participant	Usual Care n=1701 Participants Individuals who meet eligibility criteria will receive usual care.
Number of Patients Who Received Neuroimaging	386 Participants	399 Participants

SECONDARY outcome

Timeframe: 12 months

At least one referral to Neurology or Speech, Language, \& Learning in 12 months following study initiation.

Outcome measures

Outcome measures
Measure	Brain Health Intervention n=1713 Participants * Calculate eRADAR scores using EHR data to identify eligible individuals * Invite eligible individuals for brain health assessment visit * Enter results of brain health assessment visit into EHR * Provide summary of results and recommended next steps to the Primary Care Physician and participant	Usual Care n=1701 Participants Individuals who meet eligibility criteria will receive usual care.
Number of Patients Who Received Neurology Referrals	225 Participants	236 Participants

Adverse Events

Brain Health Intervention

Serious events: 291 serious events

Other events: 169 other events

Deaths: 152 deaths

Usual Care

Serious events: 331 serious events

Other events: 206 other events

Deaths: 161 deaths

Serious adverse events

Serious adverse events
Measure	Brain Health Intervention n=1713 participants at risk Participants in the intervention arm were invited to attend a "brain health" visit with a trained research interventionist who was a licensed clinician (e.g., social worker.) They were sent a mailed outreach letter and information sheet, with follow-up phone calls. At the visit, the research interventionist asked about memory symptoms and ability to perform instrumental activities of daily living (IADLs) and screened for cognitive impairment and depression. Results were shared with the participant and their primary care physician, who was responsible for follow up and more evaluation if needed and for making a final diagnosis of dementia, if applicable.	Usual Care n=1701 participants at risk Individuals in this arm did not receive any intervention but rather usual care. Kaiser Permanente Washington does not routinely screen for cognitive impairment (in line with current guidelines from the US Preventive Services Task Force).
General disorders Hospitalizations	17.0% 291/1713 • Number of events 456 • Adverse event data was collected over a period of 1 year and 6 months for each participant. The number at risk for certain AEs is less than the total number of people in each arm because not everyone is eligible. People who already had a depression diagnosis were not at risk for a new depression diagnosis, and people who already were on antidepressant medication at baseline were not at risk for a new antidepressant start. For total SAEs, we report number of people with at least one inpatient stay, because we do not have counts for the combined death/hospitalization variable.	19.5% 331/1701 • Number of events 489 • Adverse event data was collected over a period of 1 year and 6 months for each participant. The number at risk for certain AEs is less than the total number of people in each arm because not everyone is eligible. People who already had a depression diagnosis were not at risk for a new depression diagnosis, and people who already were on antidepressant medication at baseline were not at risk for a new antidepressant start. For total SAEs, we report number of people with at least one inpatient stay, because we do not have counts for the combined death/hospitalization variable.

Other adverse events

Other adverse events
Measure	Brain Health Intervention n=1713 participants at risk Participants in the intervention arm were invited to attend a "brain health" visit with a trained research interventionist who was a licensed clinician (e.g., social worker.) They were sent a mailed outreach letter and information sheet, with follow-up phone calls. At the visit, the research interventionist asked about memory symptoms and ability to perform instrumental activities of daily living (IADLs) and screened for cognitive impairment and depression. Results were shared with the participant and their primary care physician, who was responsible for follow up and more evaluation if needed and for making a final diagnosis of dementia, if applicable.	Usual Care n=1701 participants at risk Individuals in this arm did not receive any intervention but rather usual care. Kaiser Permanente Washington does not routinely screen for cognitive impairment (in line with current guidelines from the US Preventive Services Task Force).
Psychiatric disorders Depression	8.9% 107/1206 • Number of events 107 • Adverse event data was collected over a period of 1 year and 6 months for each participant. The number at risk for certain AEs is less than the total number of people in each arm because not everyone is eligible. People who already had a depression diagnosis were not at risk for a new depression diagnosis, and people who already were on antidepressant medication at baseline were not at risk for a new antidepressant start. For total SAEs, we report number of people with at least one inpatient stay, because we do not have counts for the combined death/hospitalization variable.	10.4% 119/1140 • Number of events 119 • Adverse event data was collected over a period of 1 year and 6 months for each participant. The number at risk for certain AEs is less than the total number of people in each arm because not everyone is eligible. People who already had a depression diagnosis were not at risk for a new depression diagnosis, and people who already were on antidepressant medication at baseline were not at risk for a new antidepressant start. For total SAEs, we report number of people with at least one inpatient stay, because we do not have counts for the combined death/hospitalization variable.
Psychiatric disorders Suicidal ideation	1.2% 20/1713 • Number of events 20 • Adverse event data was collected over a period of 1 year and 6 months for each participant. The number at risk for certain AEs is less than the total number of people in each arm because not everyone is eligible. People who already had a depression diagnosis were not at risk for a new depression diagnosis, and people who already were on antidepressant medication at baseline were not at risk for a new antidepressant start. For total SAEs, we report number of people with at least one inpatient stay, because we do not have counts for the combined death/hospitalization variable.	1.4% 24/1701 • Number of events 24 • Adverse event data was collected over a period of 1 year and 6 months for each participant. The number at risk for certain AEs is less than the total number of people in each arm because not everyone is eligible. People who already had a depression diagnosis were not at risk for a new depression diagnosis, and people who already were on antidepressant medication at baseline were not at risk for a new antidepressant start. For total SAEs, we report number of people with at least one inpatient stay, because we do not have counts for the combined death/hospitalization variable.
Psychiatric disorders Suicide attempt	0.00% 0/1713 • Adverse event data was collected over a period of 1 year and 6 months for each participant. The number at risk for certain AEs is less than the total number of people in each arm because not everyone is eligible. People who already had a depression diagnosis were not at risk for a new depression diagnosis, and people who already were on antidepressant medication at baseline were not at risk for a new antidepressant start. For total SAEs, we report number of people with at least one inpatient stay, because we do not have counts for the combined death/hospitalization variable.	0.18% 3/1701 • Number of events 3 • Adverse event data was collected over a period of 1 year and 6 months for each participant. The number at risk for certain AEs is less than the total number of people in each arm because not everyone is eligible. People who already had a depression diagnosis were not at risk for a new depression diagnosis, and people who already were on antidepressant medication at baseline were not at risk for a new antidepressant start. For total SAEs, we report number of people with at least one inpatient stay, because we do not have counts for the combined death/hospitalization variable.
Psychiatric disorders New start of antidepressant	7.4% 81/1095 • Number of events 81 • Adverse event data was collected over a period of 1 year and 6 months for each participant. The number at risk for certain AEs is less than the total number of people in each arm because not everyone is eligible. People who already had a depression diagnosis were not at risk for a new depression diagnosis, and people who already were on antidepressant medication at baseline were not at risk for a new antidepressant start. For total SAEs, we report number of people with at least one inpatient stay, because we do not have counts for the combined death/hospitalization variable.	9.3% 96/1028 • Number of events 96 • Adverse event data was collected over a period of 1 year and 6 months for each participant. The number at risk for certain AEs is less than the total number of people in each arm because not everyone is eligible. People who already had a depression diagnosis were not at risk for a new depression diagnosis, and people who already were on antidepressant medication at baseline were not at risk for a new antidepressant start. For total SAEs, we report number of people with at least one inpatient stay, because we do not have counts for the combined death/hospitalization variable.

Additional Information

Sascha Dublin, MD, PhD

Kaiser Permanente Washington Health Research Institute

Phone: 206-287-2870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place