Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00289471
Status:
COMPLETED
Last Update Posted:
2015-05-01
First Post:
2006-02-08
Brief Title:
Identifying Patients With Dementia in Primary Care
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Dementia in Primary Care Setting the Stage for Quality Improvement
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GEMS
Brief Summary:
Veterans who completed GEMS-Phase 1 will be asked to participate in GEMS-Phase 2 to determine the accuracy of methods used to assess mild memory problems This will better help us evaluate the screening test completed in GEMS-Phase 1 The goals are
1 Compare the assessment of memory made at the initial visit to assessments of memory made at the second evaluation
2 Determine of veterans with mild memory problems have improvement or worsening of these memory problems over time Our long-term goal remains to optimize the quality of care for veterans with cognitive impairment We will also determine if patient characteristics can be used to target case-finding describe the current process of care and evaluate the association between cognitive impairment and overall- and dementia-related health care utilization and costs
1 Compare the assessment of memory made at the initial visit to assessments of memory made at the second evaluation
2 Determine of veterans with mild memory problems have improvement or worsening of these memory problems over time Our long-term goal remains to optimize the quality of care for veterans with cognitive impairment We will also determine if patient characteristics can be used to target case-finding describe the current process of care and evaluate the association between cognitive impairment and overall- and dementia-related health care utilization and costs
Detailed Description:
Dementia has high public health significance due to its prevalence adverse impact on patients and caregivers high economic cost to society and the rapidly expanding numbers of individuals age 65 and older As the largest provider of geriatric care in the US dementia is particularly relevant to the Veterans Health Administration VHA However only a small proportion of patients with dementia are diagnosed early when treatments are most effective and the opportunity for careful life planning remains in part because of the absence of feasible well-validated case-finding instruments Our long-term objective is to improve the care and outcomes of veterans with clinically significant cognitive impairment The first steps towards realizing this objective are to determine the acceptability of cognitive screening to patients and to identify feasible valid case-finding tools for primary care We will also determine if patient characteristics can be used to target case-finding describe the current process of care and evaluate the association between cognitive impairment and overall- and dementia-related health care utilization and costs Our research team located in the Center for Health Services Research in Primary Care brings together researchers uniquely suited to achieving this objective Specific Aims1Primary Aim To determine if cognitive screening is acceptable to patients and whether brief cognitive screeners perform as well as the longer Modified Mini-Mental Status Exam 3MS for dementia and cognitive impairment-not dementia CINDPrimary Hypothesis 1 Higher perceived risk of dementia higher perceived benefits and fewer perceived harms from screening will be positively associated with screening acceptance Primary Hypotheses 2 Compared to the 3MS the Mini-Cog Memory Impairment Screen and 2-item functional screen will have similar performance characteristics 2Secondary Aim 1 To determine if sociodemographic and clinical characteristics available in the electronic medical record can be used to target individuals for cognitive screening and improve screening accuracy Hypothesis The combination of sociodemographic characteristicsclinical information and screening results will more accurately discriminate between demented and non-demented patients than screening results alone3Secondary Aim 2 To describe current care for an inception cohort with dementia or cognitive impairment-not dementia Hypothesis Compared to patients with dementia patients with cognitive impairment-not dementia will undergo less diagnostic testing be less likely to complete an advanced directive and be less likely to receive dementia specific medications 4Exploratory Aim To evaluate the association between cognitive impairment and overall- and dementia-related health care utilization and costs Exploratory Hypothesis Controlling for sociodemographic characteristics and medical comorbidity overall healthcare utilization and costs will increase as cognitive impairment increases In phase 1 a random sample of primary care patients age 65 years will be recruited from 3 primary care clinics to complete the Modified Dementia Screening Acceptance and Perceived Harms Questionnaire In phase 2 patients will complete three brief instruments and the standard 15-item 3MS that will be compared to a criterion standard interview for dementia We project 140-200 patients will have dementia 200-300 CIND and approximately 600 will be cognitively normal Instruments will be compared using sensitivityspecificity likelihood ratios and receiver operating characteristic curves The emotional impact of screening will be assessed following screening Clinical and sociodemographic characteristics available in the Computerized Patient Record System together with cognitive screening results will be analyzed with logistic regression models to identify risk factors that may be used to target individuals for cognitive screening andor improve screening accuracy Care patterns for patients with dementia and CIND will be described based on detailed chart abstractions For the exploratory analysis on cognitive impairment and utilization two-part utilization models will be estimated for each utilization type outpatient clinic visits inpatient visits pharmacy utilization and other utilization types utilization data will be obtained from administrative data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None