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| ID | Type | Description | Link |
|---|---|---|---|
| K23AG028942-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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The purpose of this study is to: 1) evaluate the reliability and validity of EMS screening for depression and cognitive impairment and 2) to develop a pilot ED intervention program to address the needs of older adults found to be at risk for depression and cognitive impairment.
Many older adults (age over 64) have undetected health problems and lack basic prevention measures. Failure to identify and treat these conditions can lead to unnecessary morbidity and mortality and a decreased quality of life. Traditional screening and intervention programs, usually based in primary care providers' offices, have been insufficient, particularly in medically underserved populations. Alternate sites for screening and intervention have begun to receive attention and may hold promise.
The emergency medical services (EMS) system is a unique, community-wide system that can be used to perform in-home evaluations to uniformly screen large numbers of vulnerable older adults during emergency responses. The emergency department (ED) is the entry point for access to medical and social services for many patients. Recent programs have used the EMS system to screen patients or the ED to screen and intervene with mixed results, but little has been done to rigorously evaluate an integrated program of EMS screening that leads to focused ED interventions that promote the health of older adults. This proposed project builds upon the principal investigator's preliminary work and unique resources in Rochester, NY to develop and evaluate a program of EMS screening and ED interventions to help community-dwelling older adults with unmet needs. Specifically, this study aims to:
Upon completion, this study will have demonstrated the reliability and validity of EMS screening for these conditions and will have proposed an EMS and ED based intervention program template that can be applied to these and a wider range of geriatric disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Geriatric EMS Patients | Cohort for reliability and concurrent validity testing. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Cognitively Impaired in Emergency Medical Services (EMS) | Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by EMS personnel. | Upon testing by EMS. |
| Proportion of Subjects Cognitively Impaired in the Emergency Department (ED) | Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel in the ED. | Within 2 hours of testing by EMS. |
| Proportion of Subjects Cognitively Impaired in the ED | Through testing using the Mini-Cog, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel. | Within 2 hours of testing by EMS |
| Test-Retest Reliability of Six Item Screener Screening | The Six Item Screener test for cognitive impairment (answer=yes or no)as performed by EMS personnel and study personnel. | 2 hours |
| Concurrent Criterion Validity of Six Item Screener Screening | This is the Six Item Screener test for cognitive impairment (scoring=yes or no), as compared to performing the Mini-Cog for cognitive impairment (scoring=yes or no) on patients immediately afterwards. This is concurrent criterion testing (two different instruments, neither being a gold standard) rather than the previous test-retest reliability testing (testing the same instrument twice). | 2 hours |
| Proportion of Subjects Depressed in EMS. | Through testing using the Patient Health Questionnaire-2 (PHQ-2), this measure indicates the proportion of individuals depressed when tested by EMS personnel |
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Inclusion Criteria:
Exclusion Criteria:
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Geriatric EMS patients
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| Name | Affiliation | Role |
|---|---|---|
| Manish N Shah, MD MPH | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Geriatric EMS Patients | Cohort for reliability and concurrent validity testing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Geriatric EMS Patients | Cohort for reliability and concurrent validity testing. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Subjects Cognitively Impaired in Emergency Medical Services (EMS) | Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by EMS personnel. | All of the subjects enrolled who completed follow up and completed all aspects of the testing. | Posted | Number | percentage of subjects | Upon testing by EMS. |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Geriatric EMS Patients | Cohort for reliability and concurrent validity testing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manish N. Shah | University of Rochester | 585-463-2920 | manish.shah@rochester.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
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| Upon testing by EMS. |
| Proportion of Subjects Depressed in the ED | Through testing using the PHQ-2, this measure indicates the proportion of individuals depressed when tested by study staff in the ED. | Within 2 hours of EMS testing. |
| Proportion of Subjects Depressed in the ED | Through testing using the PHQ-9, this measure indicates the proportion of individuals depressed when tested by study staff in the ED. | Within 2 hours of EMS testing |
| Test-Retest Reliability Testing of PHQ-2 Screening | The test for depression, using the PHQ-2, with scoring yes or no. | 2 hours |
| Concurrent Criterion Validity of PHQ-2 | This is the PHQ-2, a test for depression (scoring=yes or no) as compared to the PHQ-9, a test for depression (scoring=yes or no), looking at the presence of depression. This is concurrent criterion testing (two different instruments, neither being a gold standard) rather than the previous test-retest reliability testing (testing the same instrument twice). | 2 hours |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Proportion of Subjects Cognitively Impaired in the Emergency Department (ED) | Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel in the ED. | All of the subjects enrolled who completed all aspects of the testing. | Posted | Number | percentage of subjects | Within 2 hours of testing by EMS. |
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| Primary | Proportion of Subjects Cognitively Impaired in the ED | Through testing using the Mini-Cog, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel. | All of the subjects enrolled who completed follow up and completed all aspects of the testing. | Posted | Number | percentage of subjects | Within 2 hours of testing by EMS |
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| Primary | Test-Retest Reliability of Six Item Screener Screening | The Six Item Screener test for cognitive impairment (answer=yes or no)as performed by EMS personnel and study personnel. | All of the subjects enrolled who completed follow up and completed all aspects of the testing. | Posted | Number | 95% Confidence Interval | kappa | 2 hours |
|
|
|
| Primary | Concurrent Criterion Validity of Six Item Screener Screening | This is the Six Item Screener test for cognitive impairment (scoring=yes or no), as compared to performing the Mini-Cog for cognitive impairment (scoring=yes or no) on patients immediately afterwards. This is concurrent criterion testing (two different instruments, neither being a gold standard) rather than the previous test-retest reliability testing (testing the same instrument twice). | Posted | Number | 95% Confidence Interval | kappa | 2 hours |
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| Primary | Proportion of Subjects Depressed in EMS. | Through testing using the Patient Health Questionnaire-2 (PHQ-2), this measure indicates the proportion of individuals depressed when tested by EMS personnel | All of the subjects enrolled who completed follow up and completed all aspects of the testing. | Posted | Number | percentage of subjects | Upon testing by EMS. |
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| Primary | Proportion of Subjects Depressed in the ED | Through testing using the PHQ-2, this measure indicates the proportion of individuals depressed when tested by study staff in the ED. | All of the subjects enrolled who completed follow up and completed all aspects of the testing. | Posted | Number | percentage of subjects | Within 2 hours of EMS testing. |
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| Primary | Proportion of Subjects Depressed in the ED | Through testing using the PHQ-9, this measure indicates the proportion of individuals depressed when tested by study staff in the ED. | All of the subjects enrolled who completed follow up and completed all aspects of the testing. | Posted | Number | percentage of subjects | Within 2 hours of EMS testing |
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| Primary | Test-Retest Reliability Testing of PHQ-2 Screening | The test for depression, using the PHQ-2, with scoring yes or no. | Posted | Number | 95% Confidence Interval | kappa | 2 hours |
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| Primary | Concurrent Criterion Validity of PHQ-2 | This is the PHQ-2, a test for depression (scoring=yes or no) as compared to the PHQ-9, a test for depression (scoring=yes or no), looking at the presence of depression. This is concurrent criterion testing (two different instruments, neither being a gold standard) rather than the previous test-retest reliability testing (testing the same instrument twice). | Posted | Number | 95% Confidence Interval | kappa | 2 hours |
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| 0 |
| 187 |
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| 187 |
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| D001523 |
| Mental Disorders |