SAGE for the Early Detection of Cognitive Impairment at Primary Care Provider Visits
Condition: Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Observational

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.
    

Detailed 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.
    

Intervention name(s): Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE); Informant Conversation
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adults 65-89 without a known diagnosis of cognitive impairment or dementia who complete a
        non-acute care office visit will be included in the trial.