CTN0059: The Tobacco, Alcohol, Prescription Medication and Other Substances Tool

• Sponsor: Friends Research Institute, Inc. (Other)
• Overall Status: Completed
• CT.gov ID: NCT02110693
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), Johns Hopkins University (Other), Virginia Commonwealth University (Other), NYU Langone Health (Other), Duke University (Other)
• Enrollment: 2,057
• Locations: 4
• Arm: 1
• Duration (Months): 13
• Patients Per Site: 514.3
• Patients Per Site Per Month: 39.5

Study Details

Study Description

Brief Summary

The purpose of the study is to develop and validate a questionnaire to screen and assess adult primary care patients for tobacco, alcohol, prescription drug, and drug use and problems related to their use.

Condition or Disease	Intervention/Treatment	Phase
Substance Use Disorder	Other: Interviewer and tablet administration of the TAPS Tool	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 2057 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: This study examined the accuracy of a substance abuse screening test compared to gold standard measures Participants all received the experimental screening instrument (via self- and tablet computer administration. The order of administration was randomly selected in order to control for an order effect.This study examined the accuracy of a substance abuse screening test compared to gold standard measures Participants all received the experimental screening instrument (via self- and tablet computer administration. The order of administration was randomly selected in order to control for an order effect.
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: The TAPS Tool: Screen and Brief Assessment Tool Validation Study
• Study Start Date: Mar 1, 2014
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Other: Interviewer and tablet administration All participants were administered the TAPS Tool via interviewer and tablet computer self-administration in the same session.	Other: Interviewer and tablet administration of the TAPS Tool; All participant will self-administer substance use screening instrument (TAPS Tool) on a tablet computer and will be administered the TAPS Tool by an interviewer.

Outcome Measures

Primary Outcome Measures

1. Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview [Baseline]

   The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria

2. Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview [Baseline]

   The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria

3. Diagnostic and Statistical Manual-5 (DSM-5) Cocaine and Amphetamine (Stimulant) Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview [Baseline]

   The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria

4. Diagnostic and Statistical Manual DSM-5 Diagnosis of Heroin Use Disorder Measured by the The Modified World Mental Health Composite International Diagnostic Interview [Baseline]

   The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria

5. Diagnostic and Statistical Manual DSM-5 Diagnosis of Tobacco Use Disorder Measured by the Modified World Mental Health Composite International Diagnostic Interview [Baseline]

   The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria

Secondary Outcome Measures

1. High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) [Baseline]

   The ASSIST assess lifetime and past 3 month substance use. A score on the Tobacco Scale from 0-3 is low risk, 4-26 is medium risk, and 27 or greater is high risk.The scales range is from 0 (no problem) to 31 (most severe problem).

2. Unhealthy Cannabis Use [Baseline]

   The Time Line Follow Back Interview measures participant's self-reported number of days of cannabis use in the 30 days prior to the interview. Unhealthy cannabis use is considered 1 or more days of cannabis use in the past 30 days.The reported data represent the correlation between the TAPS Tool Cannabis Score and the Number of Days of cannabis use

3. Risky Alcohol Use [Baseline]

   Measured by the Alcohol Use Disorders Identification Test - Consumption Items. High risk on the AUDIT-C is 10 or higher. The higher the score on the AUDIT-C the greater the alcohol problem.The range of scores on the AUDIT-C is from 0 (no problem) to 12 (maximum problem).

4. Cigarette Smoking Risk [baseline]

   Measured by the Fagerstrom Test for Nicotine Dependence. The range of scores on the Fagerstrom Test if from 0 (no risk) to 10 (highest risk). High risk is considered a score of 6 or greater.

5. Smokeless Tobacco Questionnaire [baseline]

   Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk.

6. Cannabis Positive Oral Fluid Test [baseline]

   Positive Oral Fluid Cannabis testing.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Primary care patients

• Able to provide informed consent

Exclusion Criteria:

• inability to comprehend spoken English

• inability to self-administer the instrument on the tablet computer due to physical limitations

• previously enrolled in the study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chase Brexton Health Services	Baltimore	Maryland	United States	21201
2	Bellevue Hospital	New York	New York	United States	10016
3	MURDOCK Study	Kannapolis	North Carolina	United States	28081
4	Virginia Commonwealth University Health System Ambulatory Care Center	Richmond	Virginia	United States	23284

Sponsors and Collaborators

• Friends Research Institute, Inc.
• National Institute on Drug Abuse (NIDA)
• Johns Hopkins University
• Virginia Commonwealth University
• NYU Langone Health
• Duke University

Investigators

• Principal Investigator: Robert P Schwartz, M.D., Friends Research Institute, Inc.
• Principal Investigator: Li-Tzy Wu, Psy.D., Duke University
• Principal Investigator: Jennifer McNeely, M.D., New York University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Friends Research Institute, Inc.
• ClinicalTrials.gov Identifier: NCT02110693
• Other Study ID Numbers: CTN 0059; 2U10DA013034
• First Posted: Apr 10, 2014
• Last Update Posted: Jul 26, 2018
• Last Verified: Jun 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Friends Research Institute, Inc.: Substance Use; Substance Use Disorder; Screening; Brief Assessment
• Additional relevant MeSH terms: Substance-Related Disorders

Study Results

Participant Flow

Arm/Group Title	Interviewer Then Tablet Administration	Tablet First Then Interviewer Administration
Arm/Group Description	Interviewer will administer the substance use screening instrument first then self-administration of the same instrument on a tablet computer	Self-administration on tablet computer of screening instrument first, then interviewer administration of the same instrument.
Period Title: Overall Study
STARTED	1026	1031
COMPLETED	998	1002
NOT COMPLETED	28	29

Baseline Characteristics

Arm/Group Title	Interviewer and Tablet Administration of TAPS Tool
Arm/Group Description	All participants self-administered TAPS Tool on a computer tablet and were administered the TAPS Tool by an interviewer
Overall Participants	2,000
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.0 (14.7)
Sex: Female, Male (Count of Participants)
Female	1124 NaN
Male	874 NaN
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	233 NaN
Not Hispanic or Latino	1761 NaN
Unknown or Not Reported	6 NaN
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	12 NaN
Asian	35 NaN
Native Hawaiian or Other Pacific Islander	0 NaN
Black or African American	1112 NaN
White	667 NaN
More than one race	66 NaN
Unknown or Not Reported	108 NaN
Region of Enrollment (participants) [Number]
United States	2000 NaN

Outcome Measures

1. Primary Outcome

Title	Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview
Description	The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Adult primary care patients

Arm/Group Title	Interviewer Administration	Tablet Administration
Arm/Group Description	Interviewer administration of a substance misuse screening instrument (TAPS Tool).	Self-administration on tablet computer of screening instrument for substance misuse (TAPS Tool).
Measure Participants	2000	2000
Number (95% Confidence Interval) [Sensitivity]	.70	.74

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interviewer Administration
	Comments	Each administration approach (interviewer and tablet) was tested separately against the reference measure.
	Type of Statistical Test	Other
	Comments	Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Sensitivity
	Estimated Value	.70
	Confidence Interval	(2-Sided) 95%; .64 to .75
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tablet Administration
	Comments	Each administration approach (interviewer and tablet) was tested separately against the reference measure.
	Type of Statistical Test	Other
	Comments	Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Alcohol Use Disorder using receiver operator characteristic (ROC) curves.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Sensitivity
	Estimated Value	.74
	Confidence Interval	(2-Sided) 95%; .68 to .79
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview
Description	The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Adult primary care population

Arm/Group Title	Interviewer Administration	Tablet Administration
Arm/Group Description	Interviewer administration of a substance misuse screening instrument (TAPS Tool)	Tablet computer administration of a substance misuse screening instrument (TAPS Tool).
Measure Participants	2000	2000
Number (95% Confidence Interval) [Sensitivity]	0.71	.70

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interviewer Administration
	Comments	Each administration approach (interviewer and tablet) were separately tested against the reference measure.
	Type of Statistical Test	Other
	Comments	Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Sensitivity
	Estimated Value	.71
	Confidence Interval	(2-Sided) 95%; .63 to .79
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tablet Administration
	Comments	Each administration approach (interviewer and tablet) were separately tested against the reference measure.
	Type of Statistical Test	Other
	Comments	Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cannabis Use Disorder using receiver operator characteristic (ROC) curves.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Sensitivity
	Estimated Value	.70
	Confidence Interval	(2-Sided) 95%; .62 to .77
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Diagnostic and Statistical Manual-5 (DSM-5) Cocaine and Amphetamine (Stimulant) Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview
Description	The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Adult primary care patients

Arm/Group Title	Interviewer Administration	Tablet Administration
Arm/Group Description	Interviewer administration of a substance misuse screening instrument (TAPS Tool).	Tablet computer administration of a substance misuse screening instrument (TAPS Tool).
Measure Participants	2000	2000
Number (95% Confidence Interval) [Sensitivity]	.57	.60

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interviewer Administration
	Comments	Each administration approach (interviewer and tablet) were tested separately against the reference measure.
	Type of Statistical Test	Other
	Comments	Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Disorder using receiver operator characteristic (ROC) curves.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Sensitivity
	Estimated Value	.57
	Confidence Interval	(2-Sided) 95%; .47 to .67
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tablet Administration
	Comments	Each administration approach (interviewer and tablet) were separately tested against the reference measure.
	Type of Statistical Test	Other
	Comments	Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Cocaine and Amphetamine (Stimulant) Use Disorder using receiver operator characteristic (ROC) curves.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Sensitivity
	Estimated Value	.60
	Confidence Interval	(2-Sided) 95%; .50 to .69
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Primary Outcome

Title	Diagnostic and Statistical Manual DSM-5 Diagnosis of Heroin Use Disorder Measured by the The Modified World Mental Health Composite International Diagnostic Interview
Description	The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Adult primary care patients

Arm/Group Title	Interviewer Administration	Tablet Administration
Arm/Group Description	Interviewer administration of a substance misuse screening instrument (TAPS Tool).	Tablet computer of a substance misuse screening instrument (TAPS Tool).
Measure Participants	2000	2000
Number (95% Confidence Interval) [Sensitivity]	.66	.66

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interviewer Administration
	Comments	Each administration approach (interviewer and tablet) were tested separately against the reference measure.
	Type of Statistical Test	Other
	Comments	Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	sensivity
	Estimated Value	.66
	Confidence Interval	(2-Sided) 95%; .53 to .77
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tablet Administration
	Comments	Each administration approach (interviewer and tablet) were tested separately against the reference measure.
	Type of Statistical Test	Other
	Comments	Concurrent validity of the interviewer and self-administered versions of the TAPS Tool compared to the reference standard was assessed for Heroin Use Disorder using receiver operator characteristic (ROC) curves.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Sensivity
	Estimated Value	.66
	Confidence Interval	(2-Sided) 95%; .53 to .77
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Primary Outcome

Title	Diagnostic and Statistical Manual DSM-5 Diagnosis of Tobacco Use Disorder Measured by the Modified World Mental Health Composite International Diagnostic Interview
Description	The Modified World Mental Health Composite International Diagnostic Interview is a structured interview that assesses whether or not the participant meets DSM-5 Diagnostic Criteria
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

adult primary care patients

Arm/Group Title	Interviewer Administration	Tablet Administration
Arm/Group Description	Interviewer administration of a substance misuse screening instrument (TAPS Tool).	Tablet computer administration of a substance misuse screening instrument (TAPS Tool).
Measure Participants	2000	2000
Number (95% Confidence Interval) [Sensivity]	.74	.73

6. Secondary Outcome

Title	High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)
Description	The ASSIST assess lifetime and past 3 month substance use. A score on the Tobacco Scale from 0-3 is low risk, 4-26 is medium risk, and 27 or greater is high risk.The scales range is from 0 (no problem) to 31 (most severe problem).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Adult primary care patients

Arm/Group Title	Interviewer Administered	Tablet Administration
Arm/Group Description	Interviewer administration of TAPS Tool. The ASSIST was interviewer administered as well.	Tablet computer administration of TAPS Tool. The ASSIST was administered in by an interview.
Measure Participants	2000	2000
Number (95% Confidence Interval) [Sensitivity]	.90	.90

7. Secondary Outcome

Title	Unhealthy Cannabis Use
Description	The Time Line Follow Back Interview measures participant's self-reported number of days of cannabis use in the 30 days prior to the interview. Unhealthy cannabis use is considered 1 or more days of cannabis use in the past 30 days.The reported data represent the correlation between the TAPS Tool Cannabis Score and the Number of Days of cannabis use
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Interviewer Administered	Tablet Administration
Arm/Group Description	Interviewer administered TAPS. The Time Line Follow Back was interviewer administered.	Tablet computer administration of TAPS Tool. The TLFB was interviewer administered.
Measure Participants	2000	2000
Number (95% Confidence Interval) [Spearman Correlation]	.85	.84

8. Secondary Outcome

Title	Risky Alcohol Use
Description	Measured by the Alcohol Use Disorders Identification Test - Consumption Items. High risk on the AUDIT-C is 10 or higher. The higher the score on the AUDIT-C the greater the alcohol problem.The range of scores on the AUDIT-C is from 0 (no problem) to 12 (maximum problem).
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

Adult Primary Care Patients

Arm/Group Title	Self-administered	Interviewer Administered
Arm/Group Description	Self-administered TAPS Tool. The AUDIT-C was interviewer administered.	Interviewer administered TAPS Tool. The AUDIT-C was interviewer administered for both group
Measure Participants	2000	2000
Number (95% Confidence Interval) [Spearman Correlation]	.63	.64

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interviewer Administration
	Comments	Each administration approach (interviewer and tablet) were tested separately against the reference measure.
	Type of Statistical Test	Other
	Comments	The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard AUDIT-C score was assessed using Spearman Correlation.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Spearman Correlation
	Estimated Value	.63
	Confidence Interval	(2-Sided) 95%; .59 to .66
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C score. A Confidence Interval rather than a dispersion value is therefore reported.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tablet Administration
	Comments	Each administration approach (interviewer and tablet) was tested separately against the reference measure.
	Type of Statistical Test	Other
	Comments	The association on the interviewer and tablet administered versions of the TAPS Tool compared to the reference standard of the AUDIT C score was assessed using Spearman Correlation.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Spearman Correlation
	Estimated Value	.64
	Confidence Interval	(2-Sided) 95%; .61 to .68
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value is a Spearman Correlation point estimate between TAPS Tool Alcohol Score and the AUDIT-C Score. A Confidence Interval rather than a dispersion value is therefore reported.

9. Secondary Outcome

Title	Cigarette Smoking Risk
Description	Measured by the Fagerstrom Test for Nicotine Dependence. The range of scores on the Fagerstrom Test if from 0 (no risk) to 10 (highest risk). High risk is considered a score of 6 or greater.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

Adult Primary Care patients

Arm/Group Title	Self-administered TAPS Tool	Interviewer Administered
Arm/Group Description	Self-administered TAPS Tool. The Fagerstrom Test for Nicotine Dependence was administered by interviewer.	Interviewer administered TAPS Tool. The Fagerstrom Test was interviewer administered.
Measure Participants	2000	2000
Number (95% Confidence Interval) [Spearman Correlation]	.73	.75

10. Secondary Outcome

Title	Smokeless Tobacco Questionnaire
Description	Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

Adult Primary Care patients

Arm/Group Title	Interviewer Administered	Self Administered
Arm/Group Description	Interviewer administered TAPS Tool. The Smokeless Tobacco Questionnaire was interviewer administered.	Self-administered TAPS Tool. The Smokeless Tobacco Questionnaire was interviewer administered.
Measure Participants	2000	2000
Number (95% Confidence Interval) [Spearman Correlation]	.29	.28

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interviewer Administration
	Comments	Each administration approach (interviewer and tablet computer) was tested separately against the reference measure.
	Type of Statistical Test	Other
	Comments	The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard Smokeless Tobacco Questionnaire was assessed using Spearman Correlation.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Spearman Correlation
	Estimated Value	.29
	Confidence Interval	(2-Sided) 95%; .25 to .33
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value is a Spearman Correlation point estimate between the TAPS Tool Tobacco Score and the Smokeless Tobacco Questionnare. Confidence Interval rather than a dispersion value is therefore reported.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tablet Administration
	Comments	Each administration approach (interviewer and tablet) were tested separately against the reference measure.
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Spearman Correlation
	Estimated Value	.28
	Confidence Interval	(2-Sided) 95%; .24 to .32
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value is a Spearman Correlation point estimate between TAPS Tool Tobacco Score and the score on the Smokeless Tobacco Questionnaire. A Confidence Interval rather than a dispersion value is therefore reported.

11. Secondary Outcome

Title	Cannabis Positive Oral Fluid Test
Description	Positive Oral Fluid Cannabis testing.
Time Frame	baseline

Outcome Measure Data

Analysis Population Description

Adult Primary Care Patients with oral fluid test results

Arm/Group Title	Interviewer Administered	Self-administered TAPS Tool
Arm/Group Description	Interviewer administered TAPS Tool. Oral Fluid Cannabis Test administered to the subset of participants that consented to provide an oral fluid sample. Oral fluid specimen was collected the same way in both arms.	Self administered TAPS Tool. Oral Fluid Cannabis Test administered to the subset of participants that consented to provide an oral fluid sample. Oral fluid specimen was collected the same way in both arms.
Measure Participants	1802	1802
Number [Spearman Correlation]	.42	.40

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Interviewer Administration
	Comments	Each administration approach (interviewer and tablet) were tested separately against the reference measure.
	Type of Statistical Test	Other
	Comments	The association on the interviewer and tablet computer administered versions of the TAPS Tool compared to the reference standard of the results of the oral fluid test was assessed using Spearman Correlation.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Spearman Correlation
	Estimated Value	.42
	Confidence Interval	(2-Sided) 95%; .35 to .48
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value is a Spearman Correlation point estimate between TAPS Tool Cannabis Score and the results of the Oral Fluid Test. Confidence Interval rather than a dispersion value is therefore reported.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Tablet Administration
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Spearman Correlation
	Estimated Value	.40
	Confidence Interval	(2-Sided) 95%; .33 to .46
	Parameter Dispersion	Type: Value:
	Estimation Comments	The estimated value is a point estimate of the Spearman Correlation between the TAPS Tool Cannabis Score and the Oral Fluid Cannabis Screen. A Confidence Interval rather than a dispersion value is therefore reported.

Adverse Events

Time Frame	Baseline data only gathered in this study.
Adverse Event Reporting Description	The all cause mortality and serious adverse event data refer to the total combined sample (n = 2,000). We report the total sample here because all participants received both the interviewer and self-administered versions one immediately after the other in one single session.
Arm/Group Title	All Participants
Arm/Group Description	All participants enrolled in the study (because all participants were administered both the self-administered and the interviewer administered versions of the instrument, we are reporting adverse events for the total sample)
All Cause Mortality
	All Participants
	Affected / at Risk (%)	# Events
Total	0/2000 (0%)
Serious Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	0/2000 (0%)
Other (Not Including Serious) Adverse Events
	All Participants
	Affected / at Risk (%)	# Events
Total	16/2000 (0.8%)
Injury, poisoning and procedural complications
Blood on oral swab	16/2000 (0.8%)	16

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.