Identifying Patients With Dementia in Primary Care

Dementia Clinical Trial

— GEMS  

Official title:

Dementia in Primary Care: Setting the Stage for Quality Improvement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289471
• Other study ID #: IIR 05-112
• Status: Completed
• Phase: N/A
• First received: February 8, 2006
• Last updated: April 10, 2015
• Start date: October 2009
• Est. completion date: October 2010

Study information

• Verified date: April 2015
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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 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 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 administrative data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: October 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Dementia
• Memory Disorders

Intervention

Other:
• No intervention delivered.
No intervention delivered.

Locations

Country	Name	City	State
United States	Durham VA Medical Center HSR&D COE	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

Holsinger T, Plassman BL, Stechuchak KM, Burke JR, Coffman CJ, Williams JW Jr. Screening for cognitive impairment: comparing the performance of four instruments in primary care. J Am Geriatr Soc. 2012 Jun;60(6):1027-36. doi: 10.1111/j.1532-5415.2012.03967 — View Citation

Plassman BL, Williams JW Jr, Burke JR, Holsinger T, Benjamin S. Systematic review: factors associated with risk for and possible prevention of cognitive decline in later life. Ann Intern Med. 2010 Aug 3;153(3):182-93. doi: 10.7326/0003-4819-153-3-20100803 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance Characteristics	Sensitivity and Specificity for Modified Mini-Mental Status Examination (MMSE), a measure scored 0-100 to assess cognitive impairment	Cross-sectional [at baseline; no longitudinal component]	No