Early Detection of Cognitive Decline (EDCD)
Primary Purpose
Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PRO-CS
Sponsored by

About this trial
This is an interventional screening trial for Cognitive Impairment
Eligibility Criteria
Inclusion Criteria: has AWV within study period Exclusion Criteria: provider uses non-digital AWV form
Sites / Locations
- University of Pittsburg Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
new screener group
pre screener group
Arm Description
this is the group that has annual wellness visits after the new screener is adopted by the UPMC health system
this is the group that has annual wellness visits before the new screener is adopted by the UPMC health system
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05804981
First Posted
September 30, 2022
Last Updated
March 27, 2023
Sponsor
RAND
Collaborators
University of Pittsburgh Medical Center, Northwestern University
1. Study Identification
Unique Protocol Identification Number
NCT05804981
Brief Title
Early Detection of Cognitive Decline
Acronym
EDCD
Official Title
Using the PROMIS Cognition Item Bank for Early Detection of Cognitive Decline in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
June 8, 2022 (Actual)
Primary Completion Date
January 19, 2023 (Actual)
Study Completion Date
February 19, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RAND
Collaborators
University of Pittsburgh Medical Center, Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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-CIS) into their workflows; and evaluate the effect of implementing brief standardized PRO-CIS with interpretive guidance on primary care providers' behaviors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
a new questionnaire is integrated into the annual wellness visit. the questionnaire screens patients for cognitive decline
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8723 (Actual)
8. Arms, Groups, and Interventions
Arm Title
new screener group
Arm Type
Other
Arm Description
this is the group that has annual wellness visits after the new screener is adopted by the UPMC health system
Arm Title
pre screener group
Arm Type
No Intervention
Arm Description
this is the group that has annual wellness visits before the new screener is adopted by the UPMC health system
Intervention Type
Other
Intervention Name(s)
PRO-CS
Intervention Description
4 questions about cognitive function added to annual wellness visit protocol
Primary Outcome Measure Information:
Title
specialist referrals
Description
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.
Time Frame
within one month post AWV
Title
diagnostic orders
Description
diagnostic orders to rule out reversible causes of CI as found in patient EMR. Orders include those for TSH, B12, RPR, or head imaging
Time Frame
within one month post AWV
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
has AWV within study period
Exclusion Criteria:
provider uses non-digital AWV form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Edelen, PhD
Organizational Affiliation
RAND
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pittsburg Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Detection of Cognitive Decline
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