SAGE for the Early Detection of Cognitive Impairment at Primary Care Provider Visits

Cognitive Impairment Clinical Trial

Official title:

Self-Administered Gerocognitive Examination (SAGE) for the Early Detection of Cognitive Impairment at Primary Care Provider Visits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04063371
• Other study ID #: NEW-33307
• Status: Completed
• Start date: October 14, 2019
• Est. completion date: July 7, 2020

Study information

• Verified date: May 2024
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Thus far no large randomized trial has demonstrated a correlation between screening and improved outcomes. This would need to be done to gain widespread acceptance of screening and case finding programs. Early detection of cognitive impairment could potentially result in the appropriate treatment of reversible cognitive impairment conditions or earlier initiation of pharmacological interventions for the management of a variety of other dementia or Mild Cognitive Impairment (MCI) conditions. A screening approach that reduces the number of false positive screens would improve the comfort level of physicians and patients with cognitive screening programs.

The investigators propose to use the Self-Administered Gerocognitive Examination (SAGE) and the Electronic Self-Administered Gerocognitive Examination (eSAGE) to identify patients who score in the cognitive impairment range during an office visit with their primary care provider. Conversation with an individual who knows the patient well (if possible) will be performed to ascertain a significant change in the patient's cognitive skills over the previous year. The investigators wish to determine if screening for cognitive impairment in this way leads to new diagnoses and management outcomes compared to a group of primary care providers who use their current usual method in screening for cognitive impairment during office visits.

Description:

The Ohio State University Wexner Medical Center has over 100 primary care providers who see patients at 14 offices in central Ohio. These providers routinely see geriatric patients and routinely conduct Annual Wellness Visits.

At least two primary care offices will be involved in this trial. At least one location will serve as the control office and will continue to conduct their visits including screening for cognitive impairment as they normally do using their usual method based on the primary care provider's normal practice. At least one different location will serve as the intervention office where all the providers, as their standard of care, use a standardized method for screening for cognitive impairment consisting of using the SAGE or eSAGE test and having a conversation with an individual who knows the patient well (if possible) to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year.

Chart reviews will be conducted on all of the patients who meet the inclusion/exclusion criteria for the trial using a 60 day window from the initial visit. The demographics, medical history and list of current medications will be reviewed. SAGE or eSAGE test results and the primary care provider's opinion of the informant information regarding the patient's cognitive change over the previous year will be obtained. Additionally, the charts will be reviewed for the number of referrals for further evaluation/management of potential cognitive impairment (including lab work, neuroimaging, neuropsychology testing, neurology/psychiatry, occupational therapy, physical therapy, speech therapy, counseling, respite care, legal assistance (DPOA or living will), day care, home health, social work, financial planning, and cognitive research), the initiation of pharmacological interventions for the management of cognitive impairment and the diagnosis of cognitive impairment. Charts will also be screened to assess the number of follow up visits that were scheduled after the office visit for follow up regarding cognitive issues. For the intervention office, chart reviews will be conducted on patients who complete the SAGE or eSAGE and on patients who do not complete the SAGE or eSAGE. Possible reasons for why patients would not complete the SAGE or eSAGE include: time constraints, patient noncompliance and provider oversight.

There will be 2 control groups. Control group 1 consists of primary care offices that did not use SAGE or eSAGE for any of their patients and Control group 2 consists of patients handled by the intervention office who did not complete the SAGE or eSAGE. Intervention group consists of patients handled by the intervention office who did complete the SAGE or eSAGE.

SAGE and eSAGE test scoring will be compared between the intervention office and the research site.

Upon completion of the trial, the providers from the intervention group will be requested to complete a questionnaire to evaluate the practicality and ease of use of the SAGE and eSAGE test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: July 7, 2020
• Est. primary completion date: April 6, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 89 Years

Eligibility

Inclusion Criteria:

• Adults 65-89 years of age who complete a non-acute care office visit.

Exclusion Criteria:

• Diagnosis of mild cognitive impairment or dementia in the medical records.

• Diagnosis of visual loss or conditions causing visual loss in the medical records unless it is clear that the loss would not be sufficient to preclude reading standard medical forms with or without the use of visual aids.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Other:
• Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE)
The Self-Administered Gerocognitive Examination (SAGE) is a reliable and valid assessment that is used to detect MCI and early dementia. It is a pen and paper assessment that has 4 interchangeable versions. The digital version of SAGE (eSAGE; commercially known as BrainTest®) is made for tablet use, consists of the identical test questions as SAGE, and is strongly associated with the validated SAGE.
• Informant Conversation
If possible, the provider will have a conversation with an individual who knows the patient will to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year.

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a Diagnosis of a Cognitive Impairment Disorder Measured by Pharmacological Interventions for the Management of Cognitive Impairment.	Number of participants in the intervention and the two control groups with diagnosis of a cognitive impairment disorder as measured by pharmacological interventions for the management of cognitive impairment.	60 days
Primary	Number of Participants in the Intervention and Control Groups With Any Referral for Further Evaluation/Management of Potential Cognitive Impairment	Number of participants in the intervention and the two control groups with any referral for further evaluation/management of potential cognitive impairment.	60 days
Primary	Number of Participants in the Intervention and the Control Groups With at Least One Follow-up Visit for Additional Investigation of a Cognitive Impairment Disorder.	Number of participants in the intervention and the two control groups with at least one follow-up visit for additional investigation of a cognitive impairment disorder.	60 days
Secondary	Number of Referrals Used for Subjects in the Intervention and Control Groups for Further Evaluation/Management of Potential Cognitive Impairment.	Number of referrals used for subjects in the intervention and two control groups for further evaluation/management of potential cognitive impairment.	60 days
Secondary	Number of Participants With Pharmacological Interventions for the Management of the Cognitive Impairment in the Subgroups of the Intervention Arm With and Without Additional Inputs From Informants	Number of participants with pharmacological interventions for the management of the cognitive impairment in the two subgroups of the intervention arm with and without additional inputs from informants	60 days
Secondary	Scoring	Differences of SAGE and eSAGE scoring between intervention office and research site.	60 days
Secondary	Questionnaires	Results of the questionnaire to evaluate the practicality and ease of use of the SAGE and eSAGE test by primary care providers and staff.	60 days