Trial Outcomes & Findings for Screening and Interventions in an Acute Care Setting (NCT NCT00545155)

NCT ID: NCT00545155

Last Updated: 2015-06-19

Results Overview

Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by EMS personnel.

• Recruitment status: COMPLETED
• Target enrollment: 187 participants
• Primary outcome timeframe: Upon testing by EMS.
• Results posted on: 2015-06-19

Participant Flow

Participant milestones

Measure	Geriatric EMS Patients Cohort for reliability and concurrent validity testing.
Overall Study STARTED	187
Overall Study COMPLETED	187
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Screening and Interventions in an Acute Care Setting

Baseline characteristics by cohort

Measure	Geriatric EMS Patients n=187 Participants Cohort for reliability and concurrent validity testing.
Age, Continuous	75.6 years STANDARD_DEVIATION 9.2 • n=5 Participants
Sex: Female, Male Female	120 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants
Region of Enrollment United States	187 participants n=5 Participants

PRIMARY outcome

Timeframe: Upon testing by EMS.

Population: All of the subjects enrolled who completed follow up and completed all aspects of the testing.

Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by EMS personnel.

Outcome measures

Measure	Geriatric EMS Patients n=186 Participants Cohort for reliability and concurrent validity testing.
Proportion of Subjects Cognitively Impaired in Emergency Medical Services (EMS)	17 percentage of subjects Interval 4.0 to 25.0

PRIMARY outcome

Timeframe: Within 2 hours of testing by EMS.

Population: All of the subjects enrolled who completed all aspects of the testing.

Through testing using the Six Item Screener, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel in the ED.

Outcome measures

Measure	Geriatric EMS Patients n=186 Participants Cohort for reliability and concurrent validity testing.
Proportion of Subjects Cognitively Impaired in the Emergency Department (ED)	16 percentage of subjects

PRIMARY outcome

Timeframe: Within 2 hours of testing by EMS

Population: All of the subjects enrolled who completed follow up and completed all aspects of the testing.

Through testing using the Mini-Cog, this measure indicates the proportion of individuals cognitively impaired when tested by study personnel.

Outcome measures

Measure	Geriatric EMS Patients n=161 Participants Cohort for reliability and concurrent validity testing.
Proportion of Subjects Cognitively Impaired in the ED	55 percentage of subjects

PRIMARY outcome

Timeframe: 2 hours

Population: All of the subjects enrolled who completed follow up and completed all aspects of the testing.

The Six Item Screener test for cognitive impairment (answer=yes or no)as performed by EMS personnel and study personnel.

Outcome measures

Measure	Geriatric EMS Patients n=186 Participants Cohort for reliability and concurrent validity testing.
Test-Retest Reliability of Six Item Screener Screening	0.52 kappa Interval 0.36 to 0.69

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Geriatric EMS Patients n=187 Participants Cohort for reliability and concurrent validity testing.
Concurrent Criterion Validity of Six Item Screener Screening	0.23 kappa Interval 0.13 to 0.34

PRIMARY outcome

Timeframe: Upon testing by EMS.

Population: All of the subjects enrolled who completed follow up and completed all aspects of the testing.

Through testing using the Patient Health Questionnaire-2 (PHQ-2), this measure indicates the proportion of individuals depressed when tested by EMS personnel

Outcome measures

Measure	Geriatric EMS Patients n=178 Participants Cohort for reliability and concurrent validity testing.
Proportion of Subjects Depressed in EMS.	48 percentage of subjects Interval 19.0 to 38.0

PRIMARY outcome

Timeframe: Within 2 hours of EMS testing.

Population: All of the subjects enrolled who completed follow up and completed all aspects of the testing.

Through testing using the PHQ-2, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.

Outcome measures

Measure	Geriatric EMS Patients n=179 Participants Cohort for reliability and concurrent validity testing.
Proportion of Subjects Depressed in the ED	40 percentage of subjects

PRIMARY outcome

Timeframe: Within 2 hours of EMS testing

Population: All of the subjects enrolled who completed follow up and completed all aspects of the testing.

Through testing using the PHQ-9, this measure indicates the proportion of individuals depressed when tested by study staff in the ED.

Outcome measures

Measure	Geriatric EMS Patients n=180 Participants Cohort for reliability and concurrent validity testing.
Proportion of Subjects Depressed in the ED	22 percentage of subjects

PRIMARY outcome

Timeframe: 2 hours

The test for depression, using the PHQ-2, with scoring yes or no.

Outcome measures

Measure	Geriatric EMS Patients n=187 Participants Cohort for reliability and concurrent validity testing.
Test-Retest Reliability Testing of PHQ-2 Screening	0.50 kappa Interval 0.37 to 0.63

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure	Geriatric EMS Patients n=187 Participants Cohort for reliability and concurrent validity testing.
Concurrent Criterion Validity of PHQ-2	0.36 kappa Interval 0.24 to 0.48

Adverse Events

Geriatric EMS Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manish N. Shah

University of Rochester

Phone: 585-463-2920

Email: manish.shah@rochester.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place