DepressionNCT00545155
Screening and Interventions in an Acute Care Setting
An observational study of Depression and Medication Administered in Error, run by University of Rochester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression, Medication Administered in Error, Cognitive Impairment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 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: Geriatric EMS patients
Who may be able to join
- age 65 or older, cared for by participating EMS providers
Who cannot join
- too ill to participate, not transported to participating hospitals
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
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.
Read the 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:
- 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.
- Evaluate the test-retest reliability and concurrent criterion validity of EMS screening for depression and cognitive impairment.
- 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.
- Medical subject headings
- Depression, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric EMS Patients | Cohort for reliability and concurrent validity testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startJun 2007
- Primary completionJun 2010
- Study completionJun 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.
- Other trials for DepressionStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Manish Shah, University of Rochester
- Investigators
- Manish N Shah, MD MPH, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545155
- Sponsor's protocol ID
- AG028942-01
- Other IDs
- K23AG028942-01
- Status last verified
- May 2015
- First submitted
- 16 Oct 2007
- Last updated
- 19 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Interventions in an Acute Care Setting
- ClinicalTrials.gov ID
- NCT00545155
- Acronym / sponsor ID
- AG028942-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jun 2007
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 17 Oct 2007 (estimated)
- Results
- Posted 28 Sep 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- Evaluate the test-retest reliability and concurrent criterion validity of EMS screening for depression and cognitive impairment.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Geriatric EMS Patients | – | –Cohort for reliability and concurrent validity testing. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Geriatric EMS patients
Key inclusion criteria (1 listed)
- age 65 or older, cared for by participating EMS providers
Key exclusion criteria (1 listed)
- too ill to participate, not transported to participating hospitals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of Subjects Cognitively Impaired in Emergency Medical Services (EMS)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 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.
Proportion of Subjects Depressed in the ED
Time frame: Within 2 hours of EMS testing
Through testing using the PHQ-9, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.
Test-Retest Reliability Testing of PHQ-2 Screening
Time frame: 2 hours
The test for depression, using the PHQ-2, with scoring yes or no.
Concurrent Criterion Validity of PHQ-2
Time frame: 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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Manish N Shah, MD MPH principal investigator
University of Rochester
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 Depression and Medication Administered in Error, run by University of Rochester 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 1 inclusion and 1 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 19 Jun 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 28 Sep 2012). 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?
Proportion of Subjects Cognitively Impaired in Emergency Medical Services (EMS) (time frame: Upon testing by EMS.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2015.