Trial Outcomes & Findings for The Tobacco, Alcohol, Prescription Medication and Other Substances Tool (NCT NCT02110693)

NCT ID: NCT02110693

Last Updated: 2018-07-26

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2057 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2018-07-26

Participant Flow

Participant milestones

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

Reasons for withdrawal

Measure	Interviewer Then Tablet Administration Interviewer will administer the substance use screening instrument first then self-administration of the same instrument on a tablet computer	Tablet First Then Interviewer Administration Self-administration on tablet computer of screening instrument first, then interviewer administration of the same instrument.
Overall Study Withdrawal by Subject	6	7
Overall Study skipped assessment	15	18
Overall Study technical difficulties	6	4
Overall Study Other	1	0

Baseline Characteristics

Missing data (n=1) and refused to answer (n=1)

Baseline characteristics by cohort

Measure	Interviewer and Tablet Administration of TAPS Tool n=2 Participants All participants self-administered TAPS Tool on a computer tablet and were administered the TAPS Tool by an interviewer
Age, Continuous	46.0 years STANDARD_DEVIATION 14.7 • n=2 Participants
Sex: Female, Male Female	1124 Participants n=1 Participants • Missing data (n=1) and refused to answer (n=1)
Sex: Female, Male Male	874 Participants n=1 Participants • Missing data (n=1) and refused to answer (n=1)
Ethnicity (NIH/OMB) Hispanic or Latino	233 Participants n=2 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1761 Participants n=2 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=2 Participants
Race (NIH/OMB) American Indian or Alaska Native	12 Participants n=2 Participants • Participant chose not to answer (n=7)
Race (NIH/OMB) Asian	35 Participants n=2 Participants • Participant chose not to answer (n=7)
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=2 Participants • Participant chose not to answer (n=7)
Race (NIH/OMB) Black or African American	1112 Participants n=2 Participants • Participant chose not to answer (n=7)
Race (NIH/OMB) White	667 Participants n=2 Participants • Participant chose not to answer (n=7)
Race (NIH/OMB) More than one race	66 Participants n=2 Participants • Participant chose not to answer (n=7)
Race (NIH/OMB) Unknown or Not Reported	108 Participants n=2 Participants • Participant chose not to answer (n=7)
Region of Enrollment United States	2000 participants n=2 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Adult primary care patients

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

Outcome measures

Measure	Interviewer Administration n=2000 Participants Interviewer administration of a substance misuse screening instrument (TAPS Tool).	Tablet Administration n=2000 Participants Self-administration on tablet computer of screening instrument for substance misuse (TAPS Tool).
Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview	.70 Sensitivity Interval 0.64 to 0.75	.74 Sensitivity Interval 0.68 to 0.79

PRIMARY outcome

Timeframe: Baseline

Population: Adult primary care population

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

Outcome measures

Measure	Interviewer Administration n=2000 Participants Interviewer administration of a substance misuse screening instrument (TAPS Tool).	Tablet Administration n=2000 Participants Self-administration on tablet computer of screening instrument for substance misuse (TAPS Tool).
Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview	0.71 Sensitivity Interval 0.63 to 0.79	.70 Sensitivity Interval 0.62 to 0.77

PRIMARY outcome

Timeframe: Baseline

Population: Adult primary care patients

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

Outcome measures

Measure	Interviewer Administration n=2000 Participants Interviewer administration of a substance misuse screening instrument (TAPS Tool).	Tablet Administration n=2000 Participants Self-administration on tablet computer of screening instrument for substance misuse (TAPS Tool).
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	.57 Sensitivity Interval 0.47 to 0.67	.60 Sensitivity Interval 0.5 to 0.69

PRIMARY outcome

Timeframe: Baseline

Population: Adult primary care patients

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

Outcome measures

Measure	Interviewer Administration n=2000 Participants Interviewer administration of a substance misuse screening instrument (TAPS Tool).	Tablet Administration n=2000 Participants Self-administration on tablet computer of screening instrument for substance misuse (TAPS Tool).
Diagnostic and Statistical Manual DSM-5 Diagnosis of Heroin Use Disorder Measured by the The Modified World Mental Health Composite International Diagnostic Interview	.66 Sensitivity Interval 0.53 to 0.77	.66 Sensitivity Interval 0.53 to 0.77

PRIMARY outcome

Timeframe: Baseline

Population: adult primary care patients

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

Outcome measures

Measure	Interviewer Administration n=2000 Participants Interviewer administration of a substance misuse screening instrument (TAPS Tool).	Tablet Administration n=2000 Participants Self-administration on tablet computer of screening instrument for substance misuse (TAPS Tool).
Diagnostic and Statistical Manual DSM-5 Diagnosis of Tobacco Use Disorder Measured by the Modified World Mental Health Composite International Diagnostic Interview	.74 Sensivity Interval 0.69 to 0.77	.73 Sensivity Interval 0.69 to 0.77

SECONDARY outcome

Timeframe: Baseline

Population: Adult primary care patients

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).

Outcome measures

Measure	Interviewer Administration n=2000 Participants Interviewer administration of a substance misuse screening instrument (TAPS Tool).	Tablet Administration n=2000 Participants Self-administration on tablet computer of screening instrument for substance misuse (TAPS Tool).
High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST)	.90 Sensitivity Interval 0.83 to 0.94	.90 Sensitivity Interval 0.83 to 0.94

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Interviewer Administration n=2000 Participants Interviewer administration of a substance misuse screening instrument (TAPS Tool).	Tablet Administration n=2000 Participants Self-administration on tablet computer of screening instrument for substance misuse (TAPS Tool).
Unhealthy Cannabis Use	.85 Spearman Correlation Interval 0.82 to 0.88	.84 Spearman Correlation Interval 0.81 to 0.88

SECONDARY outcome

Timeframe: Baseline

Population: Adult Primary Care Patients

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).

Outcome measures

Measure	Interviewer Administration n=2000 Participants Interviewer administration of a substance misuse screening instrument (TAPS Tool).	Tablet Administration n=2000 Participants Self-administration on tablet computer of screening instrument for substance misuse (TAPS Tool).
Risky Alcohol Use	.63 Spearman Correlation Interval 0.59 to 0.66	.64 Spearman Correlation Interval 0.61 to 0.68

SECONDARY outcome

Timeframe: baseline

Population: Adult Primary Care patients

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.

Outcome measures

Measure	Interviewer Administration n=2000 Participants Interviewer administration of a substance misuse screening instrument (TAPS Tool).	Tablet Administration n=2000 Participants Self-administration on tablet computer of screening instrument for substance misuse (TAPS Tool).
Cigarette Smoking Risk	.73 Spearman Correlation Interval 0.7 to 0.76	.75 Spearman Correlation Interval 0.73 to 0.77

SECONDARY outcome

Timeframe: baseline

Population: Adult Primary Care patients

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

Outcome measures

Measure	Interviewer Administration n=2000 Participants Interviewer administration of a substance misuse screening instrument (TAPS Tool).	Tablet Administration n=2000 Participants Self-administration on tablet computer of screening instrument for substance misuse (TAPS Tool).
Smokeless Tobacco Questionnaire	.29 Spearman Correlation Interval 0.25 to 0.33	.28 Spearman Correlation Interval 0.24 to 0.32

SECONDARY outcome

Timeframe: baseline

Population: Adult Primary Care Patients with oral fluid test results

Positive Oral Fluid Cannabis testing.

Outcome measures

Measure	Interviewer Administration n=1802 Participants Interviewer administration of a substance misuse screening instrument (TAPS Tool).	Tablet Administration n=1802 Participants Self-administration on tablet computer of screening instrument for substance misuse (TAPS Tool).
Cannabis Positive Oral Fluid Test	.42 Spearman Correlation	.40 Spearman Correlation

Adverse Events

All Participants

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	All Participants n=2000 participants at risk 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)
Injury, poisoning and procedural complications Blood on oral swab	0.80% 16/2000 • Number of events 16 • Baseline data only gathered in this study. 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.

Additional Information

Robert Schwartz

Friends Research Institute

Phone: 410-837-3977

Email: rschwartz@friendsresearch.org

Results disclosure agreements

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