Cognitive ImpairmentEDCDNCT05804981
Early Detection of Cognitive Decline
An observational study of Cognitive Impairment, run by RAND at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment
- What is being tested?
- PRO-CS
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2022to 19 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: all patients aged 65 and older who completed annual wellness visits within the study period at participating clinics within the UPMC system
Who may be able to join
- has AWV within study period
Who cannot join
- provider uses non-digital AWV form
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Using the PROMIS Cognition Item Bank for Early Detection of Cognitive Decline in Primary Care
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.
Read the 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
- Conditions
- Cognitive Impairment
- Being tested
- PRO-CS
- Keywords
- cognitive decline, self-reported cognitive screener, annual wellness visit
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRO-CSOther
4 questions about cognitive function added to annual wellness visit protocol
| Study group | Role | What they receive |
|---|---|---|
| new screener group | patients completing annual wellness visits after the new screener is adopted by the UPMC health system Receives: Other: PRO-CS | |
| pre screener group | patients completing annual wellness visits before the new screener is adopted by the UPMC health system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: within one month post AWV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study startJun 2022 (estimated)
- Primary completion19 Jan 2024 (estimated)
- Study completion19 Jan 2024 (estimated)
Why it stopped: study design revised and no longer fits definition of a clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- RAND
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Pittsburgh Medical Center, Northwestern University
- Responsible party
- Sponsor
- Investigators
- Maria Edelen, PhD, Principal investigator, RAND
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05804981
- Sponsor's protocol ID
- HCQMI065
- Other IDs
- 5R61AG069776-02
- Acronym
- EDCD
- Status last verified
- Nov 2025
- First submitted
- 30 Sep 2022
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the PROMIS Cognition Item Bank for Early Detection of Cognitive Decline in Primary Care
- ClinicalTrials.gov ID
- NCT05804981
- Acronym / sponsor ID
- EDCD / HCQMI065
- Conditions
- Cognitive Impairment
- Keywords
- cognitive decline, self-reported cognitive screener, annual wellness visit
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: study design revised and no longer fits definition of a clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- RANDUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of Pittsburgh Medical Center, Northwestern University
- Study start
- Jun 2022 (estimated)
- Primary completion
- 19 Jan 2024 (estimated)
- Study completion
- 19 Jan 2024 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| new screener group | – | Other: PRO-CSpatients completing annual wellness visits after the new screener is adopted by the UPMC health system |
| pre screener group | – | –patients completing annual wellness visits before the new screener is adopted by the UPMC health system |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- all patients aged 65 and older who completed annual wellness visits within the study period at participating clinics within the UPMC system
Key inclusion criteria (1 listed)
- has AWV within study period
Key exclusion criteria (1 listed)
- provider uses non-digital AWV form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRO-CS4 questions about cognitive function added to annual wellness visit protocol | Other | new screener group |
Primary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Edelen, PhD principal investigator
RAND
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment, run by RAND at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
specialist referrals (time frame: within one month post AWV). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.