Early Detection of Cognitive Decline

NCT ID: NCT05804981

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-30

Study Completion Date

2024-01-19

Brief Summary

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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

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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

Conditions

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Cognitive Impairment

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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new screener group

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

PRO-CS

Intervention Type OTHER

4 questions about cognitive function added to annual wellness visit protocol

pre screener group

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

No interventions assigned to this group

Interventions

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PRO-CS

4 questions about cognitive function added to annual wellness visit protocol

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* has AWV within study period

Exclusion Criteria

* provider uses non-digital AWV form
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Pittsburgh Medical Center

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role collaborator

RAND

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria Edelen, PhD

Role: PRINCIPAL_INVESTIGATOR

RAND

Locations

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University of Pittsburg Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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5R61AG069776-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HCQMI065

Identifier Type: -

Identifier Source: org_study_id

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