Using the PROMIS Cognition Item Bank for Early Detection of Cognitive Decline in Primary Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- RAND
- Enrollment
- 8,723
- Locations
- 1
- Primary Endpoint
- specialist referrals
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •has AWV within study period
Exclusion Criteria
- •provider uses non-digital AWV form
Outcomes
Primary Outcomes
specialist referrals
Time Frame: within one month post AWV
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.
diagnostic orders
Time Frame: within one month post AWV
diagnostic orders to rule out reversible causes of CI as found in patient EMR. Orders include those for TSH, B12, RPR, or head imaging
Secondary Outcomes
No secondary outcomes reported