Identifying Patients With Dementia in Primary Care (GEMS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00289471
First received: February 8, 2006
Last updated: February 6, 2014
Last verified: February 2011
  Purpose

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.

Condition Intervention
Dementia
Memory Disorders
Other: No intervention delivered.

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Dementia in Primary Care: Setting the Stage for Quality Improvement

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Operation characteristics of cognitive screeners [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]

Enrollment: 640
Study Start Date: October 2009
Study Completion Date: October 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
Cognitive screening
Other: No intervention delivered.
No intervention delivered.

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 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Veterans' who have previously completed GEMS-Phase 1 testing, continues to be a VA clinic patient and identifies a key family member or friend who will answer questions about the veteran's memory and daily activities.

Criteria

Inclusion Criteria:

  • Previous participant who completed GEMS-Phase 1
  • Continues to be a VA clinic patient
  • Identifies a key informant with phone

Exclusion Criteria:

  • Severe hearing or visual impairment
  • Acute medical condition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289471

Locations
United States, North Carolina
VA Medical Center, Durham
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Investigators
Principal Investigator: John Wiley Williams, MD MHS Durham VA Medical Center
  More Information

Publications:
Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00289471     History of Changes
Other Study ID Numbers: IIR 05-112
Study First Received: February 8, 2006
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Sensitivity and specificity
Physician's practice patterns
Health Care costs
Quality of Health Care

Additional relevant MeSH terms:
Dementia
Memory Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on April 15, 2014