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Sponsored by: |
Department of Veterans Affairs |
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Information provided by: | Department of Veterans Affairs |
ClinicalTrials.gov Identifier: | NCT00289471 |
The purpose of this study is determine the acceptability of cognitive screening to patients and to identify feasible and 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.
Condition | Intervention |
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Dementia Memory Disorders |
Other: No intervention delivered. |
Study Type: | Observational |
Study Design: | Cross-Sectional |
Official Title: | Dementia in Primary Care: Setting the Stage for Quality Improvement |
Estimated Enrollment: | 800 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Cognitive screening
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Other: No intervention delivered.
No intervention delivered.
|
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 U.S., dementia is particularly relevant to the 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 Aims1.Primary 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 (CIND).Primary 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. 2.Secondary 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 characteristics/clinical information and screening results will more accurately discriminate between demented and non-demented patients than screening results alone.3.Secondary 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. 4.Exploratory 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 sensitivity/specificity, 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 and/or 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 the DSS.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Veterans' age 65 and older who fit the GEMS criteria for participation.
Inclusion Criteria:
Exclusion Criteria:
Contact: Ann W Charles, BFA | (919) 668-8207 | ann.charles@duke.edu |
Contact: Lisa A McPhatter, MS | (866) 439-7207 | lisa.mcphatter@va.gov |
United States, North Carolina | |
Durham VA Medical Center | Recruiting |
Durham, North Carolina, United States, 27705 | |
Contact: John W Williams, MD MHS (919) 286-6936 willi007@mc.duke.edu | |
Contact: Tracey Holsinger, MD (919) 286-6936 tracey.holsinger@med.va.gov | |
Principal Investigator: John Wiley Williams, MD MHS | |
Sub-Investigator: Tracey Holsinger, MD |
Principal Investigator: | John Wiley Williams, MD MHS | Durham VA Medical Center |
Responsible Party: | Department of Veterans Affairs ( Williams, John - Principal Investigator ) |
Study ID Numbers: | IIR 05-112 |
Study First Received: | February 8, 2006 |
Last Updated: | August 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00289471 |
Health Authority: | United States: Federal Government |
Sensitivity and specificity Physician's practice patterns Health Care costs Quality of Health Care |
Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Diseases Neurologic Manifestations Brain Diseases |
Dementia Neurobehavioral Manifestations Memory Disorders Cognition Disorders Delirium |
Nervous System Diseases |