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Early Detection of Cognitive Decline

Using the PROMIS Cognition Item Bank for Early Detection of Cognitive Decline in Primary Care

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05804981
Acronym
EDCD
Enrollment
0
Registered
2023-04-07
Start date
2022-06-30
Completion date
2024-01-19
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment

Keywords

cognitive decline, self-reported cognitive screener, annual wellness visit

Brief summary

The goal of this clinical trial is to evaluate the impact of a brief cognitive screener on provider behavior in patients completing an annual wellness visit (AWV). The main question\[s\] it aims to answer are: * do appropriate referrals increase for patients using the new screener? * do appropriate diagnostic orders increase for patients using the new screener? Participants will respond to 4 questions about their cognitive abilities as part of a larger AWV protocol. Researchers will compare provider behavior for patients completing AWVs before and after implementation of the new screener to see if referral, diagnostic and prescribing behaviors differ.

Detailed description

In the course of this two-year project, the RAND team and partners (University of Pittsburgh Medical Center \[UPMC\] and Northwestern University \[NU\]) will conduct secondary data analysis to establish the validity of scores from the PCF item bank; use the resulting data to derive meaningful scoring criteria and interpretation guidance, and determine the best short form item set from the PCF item bank to use for standardized cognitive impairment screening during the Medicare Annual Wellness Visit (AWV); use qualitative methods to refine workflow for administering the screener in primary care; work with UPMC to integrate the resultant brief self-reported PROMIS cognition screener (PRO-CS) into their workflows; and evaluate the effect of implementing brief standardized PRO-CS with interpretive guidance on primary care providers' behaviors. The control group will consist of all digital records of annual wellness visits in the year prior to implementation of the PRO-CS

Interventions

OTHERPRO-CS

4 questions about cognitive function added to annual wellness visit protocol

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
University of Pittsburgh Medical Center
CollaboratorOTHER
Northwestern University
CollaboratorOTHER
RAND
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* has AWV within study period

Exclusion criteria

* provider uses non-digital AWV form

Design outcomes

Primary

MeasureTime frameDescription
specialist referralswithin one month post AWVreferrals to specialists for cognitive impairment (e.g., neurology, social work, geriatrics) as found in patient EMR. Specialist referrals include neurology, neuropsychology, psychiatry, psychology, social worker, geriatrics.
diagnostic orderswithin one month post AWVdiagnostic orders to rule out reversible causes of CI as found in patient EMR. Orders include those for TSH, B12, RPR, or head imaging

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026