Early Detection of Cognitive Decline

Cognitive Impairment Clinical Trial

— EDCD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05804981
• Other study ID #: HCQMI065
• Status: Completed
• Phase: N/A
• Start date: June 8, 2022
• Est. completion date: January 19, 2024

Study information

• Verified date: April 2024
• Source: RAND
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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-CIS) into their workflows; and evaluate the effect of implementing brief standardized PRO-CIS with interpretive guidance on primary care providers' behaviors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8723
• Est. completion date: January 19, 2024
• Est. primary completion date: January 19, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• has AWV within study period

Exclusion Criteria:

• provider uses non-digital AWV form

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Other:
• PRO-CS
4 questions about cognitive function added to annual wellness visit protocol

Locations

Country	Name	City	State
United States	University of Pittsburg Medical Center	Pittsburgh	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
RAND	Northwestern University, University of Pittsburgh Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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