Early Detection of Cognitive Decline

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

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

Conditions
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Cognitive Impairment

Intervention / Treatment
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* Other: PRO-CS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: has AWV within study period Exclusion Criteria: provider uses non-digital AWV form

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: a new questionnaire is integrated into the annual wellness visit. the questionnaire screens patients for cognitive decline
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: new screener group<br>this is the group that has annual wellness visits after the new screener is adopted by the UPMC health system | Other: PRO-CS<br>* 4 questions about cognitive function added to annual wellness visit protocol<br>|
| No Intervention: pre screener group<br>this is the group that has annual wellness visits before the new screener is adopted by the UPMC health system | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |