Early Detection of Cognitive Decline

NCT05804981 | Withdrawn

• 2 other identifiers: HCQMI0655R61AG069776-02
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Impairment

Keywords

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

Outcome Measures

Primary Outcomes (2)

• specialist referrals

  referrals 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.

  within one month post AWV

• diagnostic orders

  diagnostic orders to rule out reversible causes of CI as found in patient EMR. Orders include those for TSH, B12, RPR, or head imaging

  within one month post AWV

Study Arms (2)

new screener group

patients completing annual wellness visits after the new screener is adopted by the UPMC health system

Other: PRO-CS

pre screener group

patients completing annual wellness visits before the new screener is adopted by the UPMC health system

Interventions

PRO-CS OTHER

4 questions about cognitive function added to annual wellness visit protocol

new screener group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

all patients aged 65 and older who completed annual wellness visits within the study period at participating clinics within the UPMC system

You may qualify if:

• has AWV within study period

You may not qualify if:

• provider uses non-digital AWV form

Sponsors & Collaborators

• RAND: lead
• National Institute on Aging (NIA): collaborator
• University of Pittsburgh Medical Center: collaborator
• Northwestern University: collaborator

Study Sites (1)

University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Maria Edelen, PhD

  RAND

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: April 7, 2023
• Study Start: June 1, 2022
• Primary Completion: January 19, 2024
• Study Completion: January 19, 2024
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)