DementiaGEMSNCT00289471
Identifying Patients With Dementia in Primary Care
An observational study of Dementia and Memory Disorders, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Memory Disorders
- How many people
- 630 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Oct 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- Previous participant who completed GEMS-Phase 1
- Continues to be a VA clinic patient
- Identifies a key informant with phone
Who cannot join
- Severe hearing or visual impairment
- Acute medical condition
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center HSR&D COE
Durham, North Carolina, 27705
About this study
Official title: Dementia in Primary Care: Setting the Stage for Quality Improvement
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:
- Compare the assessment of memory made at the initial visit to assessments of memory made at the second evaluation.
- 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.
Read the 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 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.
- Conditions
- Dementia, Memory Disorders
- Being tested
- No intervention delivered.
- Keywords
- Sensitivity and specificity, Physician's practice patterns, Health Care costs, Quality of Health Care
- Medical subject headings
- Dementia, Memory Disorders, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention delivered.Other
No intervention delivered.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Screening | Cognitive screening Receives: Other: No intervention delivered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance Characteristics
Sensitivity and Specificity for Modified Mini-Mental Status Examination (MMSE), a measure scored 0-100 to assess cognitive impairment
Measured: Cross-sectional [at baseline; no longitudinal component]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2006 (estimated)
- Study startOct 2009
- Primary completionDec 2009
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 630 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- John W Williams, MD MHS, Principal investigator, Durham VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00289471
- Sponsor's protocol ID
- IIR 05-112
- Acronym
- GEMS
- Status last verified
- Apr 2015
- First submitted
- 8 Feb 2006
- Last updated
- 1 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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: 10.7326/0003-4819-153-3-201008030-00258. Epub 2010 Jun 14.
PubMed 20547887Holsinger 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.x. Epub 2012 May 30.
PubMed 22646750
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia in Primary Care: Setting the Stage for Quality Improvement
- ClinicalTrials.gov ID
- NCT00289471
- Acronym / sponsor ID
- GEMS / IIR 05-112
- Conditions
- Dementia, Memory Disorders
- Keywords
- Sensitivity and specificity, Physician's practice patterns, Health Care costs, Quality of Health Care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 630 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Oct 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 9 Feb 2006 (estimated)
- Results
- Posted 26 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Compare the assessment of memory made at the initial visit to assessments of memory made at the second evaluation.
- 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 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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Screening | – | Other: No intervention delivered.Cognitive screening |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (3 listed)
- Previous participant who completed GEMS-Phase 1
- Continues to be a VA clinic patient
- Identifies a key informant with phone
Key exclusion criteria (2 listed)
- Severe hearing or visual impairment
- Acute medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention delivered.No intervention delivered. | Other | Cognitive Screening |
Primary outcome
Performance Characteristics
Time frame: Cross-sectional [at baseline; no longitudinal component]
Sensitivity and Specificity for Modified Mini-Mental Status Examination (MMSE), a measure scored 0-100 to assess cognitive impairment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20547887Plassman 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: 10.7326/0003-4819-153-3-201008030-00258. Epub 2010 Jun 14.
- Results publication: PubMed 22646750Holsinger 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.x. Epub 2012 May 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W Williams, MD MHS principal investigator
Durham VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia and Memory Disorders, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance Characteristics (time frame: Cross-sectional [at baseline; no longitudinal component]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00289471, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2015.