Improving Dementia Care in Primary Practice

NCT07526480 | Not Yet Recruiting

• 1 other identifier: iRISID-2025-0888
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This clinical trial will evaluate a multi-level scalable intervention called Improving Dementia Care (IDC). The investigators hypothesize that IDC will increase dementia detection in patients with impaired cognition more than the control condition, Enhanced Usual Care (EUC), over 6 months.

Conditions

Alzheimer Disease (AD); Mild Cognitive Impairment (MCI); Dementia

Outcome Measures

Primary Outcomes (1)

• Incident cognitive diagnoses.

  Chart reviews will identify the number of patients with a new cognitive diagnosis in each arm.

  6 months

Secondary Outcomes (4)

• Orders for Alzheimer's disease-relevant lab and neuroimaging

  6 months

• Prescribed Alzheimer's disease (AD) medications.

  6 months

• Referrals to Alzheimer's disease specialists

  6 months

• Completed AD-relevant lab and neuroimaging studies

  6 months

Study Arms (2)

Improving Dementia Care (IDC)

EXPERIMENTAL

During a phone session, participants receive ADRD Education and Personalized Decision Counseling, which consists of eliciting values and goals to reach informed, preference-based decisions on whether to have an ADRD evaluation. Participants' primary care physicians are sent cognitive screening results and a smart order set (i.e., orders for ADRD-relevant lab and neuroimaging) via the electronic health record (EHR).

Other: Improving Dementia Care

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

Usual care enhanced with notices sent to participants' primary care physicians with cognitive screening results and a smart order set (i.e., orders for ADRD-relevant lab and neuroimaging) via the electronic health record (EHR).

Other: Enhanced Usual Care

Interventions

Improving Dementia Care OTHER

During a phone session, participants receive ADRD Education and Personalized Decision Counseling, which consists of eliciting values and goals to reach informed, preference-based decisions on whether to have an ADRD evaluation. Participants' primary care physicians are sent cognitive screening results and a smart order set (i.e., orders for ADRD-relevant lab and neuroimaging) via the electronic health record (EHR).

Also known as: IDC

Improving Dementia Care (IDC)

Enhanced Usual Care OTHER

Usual care enhanced with notices sent to participants' primary care physicians with cognitive screening results and a smart order set (i.e., orders for ADRD-relevant lab and neuroimaging) via the electronic health record (EHR).

Also known as: EUC

Enhanced Usual Care (EUC)

Eligibility Criteria

• Age: 66 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• No previous diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease (AD).
• Have a scheduled PCP visit in the next 4-6 weeks
• Have subjective cognitive impairment
• Score ≥ 26 on the Telephone Interview for Cognitive Status (TICS)

You may not qualify if:

• EHR evidence or previous cognitive evaluations, diagnosis of MCI or AD, or use of AD medications
• TICS score of ≤ 11.00
• Inability to provide informed consent

Sponsors & Collaborators

• Independence Blue Cross: collaborator
• Thomas Jefferson University: lead

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

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

Study Officials

• Barry Rovner, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Diamond, MPH

CONTACT

267-872-1302; nina.diamond@jefferosn.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to treatment group in a 1:1 allocation ratio. The research team anticipates randomizing 40 participants to each treatment group (i.e., IDC and EUC). After randomization, the research team will send participants' PCPs cognitive screen results and a smart order set for Alzheimer's Disease and Related Dementias (ADRD)-relevant lab tests and neuroimaging that meets current clinical practice guidelines. This information will be sent to PCPs regardless of treatment group assignment.

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): May 3, 2027
• Study Completion (Estimated): May 3, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share