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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other: Improving Dementia Care
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:
  • IDC
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).
Other: Enhanced Usual Care
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:
  • EUC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Thomas Jefferson University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Independence Blue Cross

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 4, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 3, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 3, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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