Cognitive Impairment, Depression, Medication Administered in Error
Conditions
Brief summary
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.
Detailed description
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: 1. Implement an EMS screening program to identify community-dwelling older adults' unmet needs during emergency responses, identifying patients with needs related to depression and dementia. 2. Evaluate the test-retest reliability and concurrent criterion validity of EMS screening for depression and cognitive impairment. 3. Develop and refine an EMS and ED intervention program that addresses the needs of older adults found by EMS to be at risk for depression and cognitive impairment. 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.
Interventions
None listed
Sponsors
National Institute on Aging (NIA)
University of Rochester
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age 65 or older, cared for by participating EMS providers
Exclusion criteria
* too ill to participate, not transported to participating hospitals
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Cognitively Impaired in Emergency Medical Services (EMS) | Upon testing by EMS. | Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by EMS personnel. |
| Proportion of Subjects Cognitively Impaired in the Emergency Department (ED) | Within 2 hours of testing by EMS. | Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel in the ED. |
| Proportion of Subjects Cognitively Impaired in the ED | Within 2 hours of testing by EMS | Through testing using the Mini-Cog, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel. |
| Test-Retest Reliability of Six Item Screener Screening | 2 hours | The Six Item Screener test for cognitive impairment (answer=yes or no)as performed by EMS personnel and study personnel. |
| Concurrent Criterion Validity of Six Item Screener Screening | 2 hours | 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). |
| Proportion of Subjects Depressed in EMS. | Upon testing by EMS. | Through testing using the Patient Health Questionnaire-2 (PHQ-2), this measure indicates the proportion of individuals depressed when tested by EMS personnel |
| Proportion of Subjects Depressed in the ED | Within 2 hours of EMS testing. | Through testing using the PHQ-2, this measure indicates the proportion of individuals depressed when tested by study staff in the ED. |
| Test-Retest Reliability Testing of PHQ-2 Screening | 2 hours | The test for depression, using the PHQ-2, with scoring yes or no. |
| Concurrent Criterion Validity of PHQ-2 | 2 hours | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Geriatric EMS Patients Cohort for reliability and concurrent validity testing. | 187 |
| Total | 187 |
Baseline characteristics
| Characteristic | Geriatric EMS Patients |
|---|---|
| Age, Continuous | 75.6 years STANDARD_DEVIATION 9.2 |
| Region of Enrollment United States | 187 participants |
| Sex: Female, Male Female | 120 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 187 |
| serious Total, serious adverse events | 0 / 187 |
Outcome results
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).
Time frame: 2 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Geriatric EMS Patients | Concurrent Criterion Validity of PHQ-2 | 0.36 kappa |
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).
Time frame: 2 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Geriatric EMS Patients | Concurrent Criterion Validity of Six Item Screener Screening | 0.23 kappa |
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.
Time frame: Upon testing by EMS.
Population: All of the subjects enrolled who completed follow up and completed all aspects of the testing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Geriatric EMS Patients | Proportion of Subjects Cognitively Impaired in Emergency Medical Services (EMS) | 17 percentage of subjects |
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.
Time frame: Within 2 hours of testing by EMS
Population: All of the subjects enrolled who completed follow up and completed all aspects of the testing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Geriatric EMS Patients | Proportion of Subjects Cognitively Impaired in the ED | 55 percentage of subjects |
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.
Time frame: Within 2 hours of testing by EMS.
Population: All of the subjects enrolled who completed all aspects of the testing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Geriatric EMS Patients | Proportion of Subjects Cognitively Impaired in the Emergency Department (ED) | 16 percentage of subjects |
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
Time frame: Upon testing by EMS.
Population: All of the subjects enrolled who completed follow up and completed all aspects of the testing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Geriatric EMS Patients | Proportion of Subjects Depressed in EMS. | 48 percentage of subjects |
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.
Time frame: Within 2 hours of EMS testing.
Population: All of the subjects enrolled who completed follow up and completed all aspects of the testing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Geriatric EMS Patients | Proportion of Subjects Depressed in the ED | 40 percentage of subjects |
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.
Time frame: Within 2 hours of EMS testing
Population: All of the subjects enrolled who completed follow up and completed all aspects of the testing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Geriatric EMS Patients | Proportion of Subjects Depressed in the ED | 22 percentage of subjects |
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.
Time frame: 2 hours
Population: All of the subjects enrolled who completed follow up and completed all aspects of the testing.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Geriatric EMS Patients | Test-Retest Reliability of Six Item Screener Screening | 0.52 kappa |
Primary
Test-Retest Reliability Testing of PHQ-2 Screening
The test for depression, using the PHQ-2, with scoring yes or no.
Time frame: 2 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Geriatric EMS Patients | Test-Retest Reliability Testing of PHQ-2 Screening | 0.50 kappa |