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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
RAND
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cognitive Impairment

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
September 30, 2022
Last Updated
March 27, 2023
Sponsor
RAND
Collaborators
University of Pittsburgh Medical Center, Northwestern University
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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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