- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07526480
Improving Dementia Care in Primary Practice (IDC)
April 14, 2026 updated by: Thomas Jefferson University
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
Detailed Description
This pilot RCT (N = 80) will evaluate the feasibility and effectiveness of a new multi-level intervention-Improving Dementia Care (IDC)-which aims to increase detection of Alzheimer disease (AD) in older primary care patients with impaired cognition.
In IDC, investigators will screen older primary care patients for subjective cognitive concerns and objective cognitive impairment on the Telephone Interview for Cognitive Status (TICS).
To eligible patients, the research team will deliver AD Education and Personalized Decision Counseling-eliciting values and goals to reach informed, preference-based decisions on whether to have an AD evaluation.
In IDC, investigators will also send to primary care physicians (PCPs) the TICS results and a smart order set (i.e., orders for AD-relevant lab and neuroimaging) via the electronic health record (EHR).
The research team posits that IDC-a patient-level and PCP-level intervention-will increase AD detection more than Enhanced Usual Care (EUC), which is usual care enhanced with sending the TICS results and smart order set to the PCPs of controls-solely a PCP-level intervention.
At 6 months, investigators will compare IDC's vs. EUC's effectiveness to increase rates of: 1) Incident cognitive diagnoses (e.g., Mild Cognitive Impairment, AD); 2) Orders for AD-relevant lab and neuroimaging studies, 3) Completed AD-relevant lab and neuroimaging studies; 4) Prescribed AD medications; and 5) Referrals to AD specialists, masked to treatment assignment.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nina Diamond, MPH
- Phone Number: 267-872-1302
- Email: nina.diamond@jefferosn.edu
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Improving Dementia Care (IDC)
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).
|
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 Names:
|
|
Active Comparator: Enhanced Usual Care (EUC)
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).
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incident cognitive diagnoses.
Time Frame: 6 months
|
Chart reviews will identify the number of patients with a new cognitive diagnosis in each arm.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Orders for Alzheimer's disease-relevant lab and neuroimaging
Time Frame: 6 months
|
Chart reviews will identify the number of patients with a new relevant lab and imaging tests.
|
6 months
|
|
Prescribed Alzheimer's disease (AD) medications.
Time Frame: 6 months
|
Chart reviews will identify the number of patients with a new AD medications.
|
6 months
|
|
Referrals to Alzheimer's disease specialists
Time Frame: 6 months
|
Chart reviews will identify the number of patients with relevant referrals.
|
6 months
|
|
Completed AD-relevant lab and neuroimaging studies
Time Frame: 6 months
|
Chart reviews will identify the number of patients with completed orders.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Barry Rovner, MD, Thomas Jefferson University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 4, 2026
Primary Completion (Estimated)
May 3, 2027
Study Completion (Estimated)
May 3, 2027
Study Registration Dates
First Submitted
April 6, 2026
First Submitted That Met QC Criteria
April 6, 2026
First Posted (Actual)
April 13, 2026
Study Record Updates
Last Update Posted (Actual)
April 17, 2026
Last Update Submitted That Met QC Criteria
April 14, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- iRISID-2025-0888
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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