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| ID | Type | Description | Link |
|---|---|---|---|
| 2U10DA013034 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Johns Hopkins University | OTHER |
| Virginia Commonwealth University | OTHER |
| NYU Langone Health |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interviewer and tablet administration | Other | All participants were administered the TAPS Tool via interviewer and tablet computer self-administration in the same session. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interviewer and tablet administration of the TAPS Tool | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview | 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 | Baseline |
| Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview | 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 | Baseline |
| 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 | 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 | Baseline |
| Diagnostic and Statistical Manual DSM-5 Diagnosis of Heroin Use Disorder Measured by the The Modified World Mental Health Composite International Diagnostic Interview | 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 | Baseline |
| Diagnostic and Statistical Manual DSM-5 Diagnosis of Tobacco Use Disorder Measured by the Modified World Mental Health Composite International Diagnostic Interview | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | 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). | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chase Brexton Health Services | Baltimore | Maryland | 21201 | United States | ||
| Bellevue Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27595276 | Derived | McNeely J, Wu LT, Subramaniam G, Sharma G, Cathers LA, Svikis D, Sleiter L, Russell L, Nordeck C, Sharma A, O'Grady KE, Bouk LB, Cushing C, King J, Wahle A, Schwartz RP. Performance of the Tobacco, Alcohol, Prescription Medication, and Other Substance Use (TAPS) Tool for Substance Use Screening in Primary Care Patients. Ann Intern Med. 2016 Nov 15;165(10):690-699. doi: 10.7326/M16-0317. Epub 2016 Sep 6. | |
| 27444426 | Derived | Wu LT, McNeely J, Subramaniam GA, Sharma G, VanVeldhuisen P, Schwartz RP. Design of the NIDA clinical trials network validation study of tobacco, alcohol, prescription medications, and substance use/misuse (TAPS) tool. Contemp Clin Trials. 2016 Sep;50:90-7. doi: 10.1016/j.cct.2016.07.013. Epub 2016 Jul 19. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interviewer Then Tablet Administration | Interviewer will administer the substance use screening instrument first then self-administration of the same instrument on a tablet computer |
| FG001 | Tablet First Then Interviewer Administration | Self-administration on tablet computer of screening instrument first, then interviewer administration of the same instrument. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Interviewer and Tablet Administration of TAPS Tool | All participants self-administered TAPS Tool on a computer tablet and were administered the TAPS Tool by an interviewer |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Diagnostic and Statistical Manual-5 (DSM-5) Alcohol Use Disorder Diagnosis Measured by the Modified World Mental Health Composite International Diagnostic Interview | 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 | Adult primary care patients | Posted | Number | 95% Confidence Interval | Sensitivity | Baseline |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood on oral swab | Injury, poisoning and procedural complications | Systematic Assessment | Traces of blood were seen on oral swab |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Schwartz | Friends Research Institute | 410-837-3977 | 276 | rschwartz@friendsresearch.org |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| OTHER |
| Duke University | OTHER |
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.
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| Baseline |
| Unhealthy Cannabis Use | 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 | Baseline |
| Risky Alcohol Use | 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). | Baseline |
| Cigarette Smoking Risk | 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. | baseline |
| Smokeless Tobacco Questionnaire | Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk. | baseline |
| Cannabis Positive Oral Fluid Test | Positive Oral Fluid Cannabis testing. | baseline |
| New York |
| New York |
| 10016 |
| United States |
| MURDOCK Study | Kannapolis | North Carolina | 28081 | United States |
| Virginia Commonwealth University Health System Ambulatory Care Center | Richmond | Virginia | 23284 | United States |
| technical difficulties |
|
| Other |
|
| years |
|
| Sex: Female, Male | Missing data (n=1) and refused to answer (n=1) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Participant chose not to answer (n=7) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| Primary | Diagnostic and Statistical Manual-5 (DSM-5) Cannabis Use Disorder Diagnosis Measured With Modified World Mental Health Composite International Diagnostic Interview | 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 | Adult primary care population | Posted | Number | 95% Confidence Interval | Sensitivity | Baseline |
|
|
|
|
| Primary | 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 | 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 | Adult primary care patients | Posted | Number | 95% Confidence Interval | Sensitivity | Baseline |
|
|
|
|
| Primary | Diagnostic and Statistical Manual DSM-5 Diagnosis of Heroin Use Disorder Measured by the The Modified World Mental Health Composite International Diagnostic Interview | 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 | Adult primary care patients | Posted | Number | 95% Confidence Interval | Sensitivity | Baseline |
|
|
|
|
| Primary | Diagnostic and Statistical Manual DSM-5 Diagnosis of Tobacco Use Disorder Measured by the Modified World Mental Health Composite International Diagnostic Interview | 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 | adult primary care patients | Posted | Number | 95% Confidence Interval | Sensivity | Baseline |
|
|
|
| Secondary | High Risk Tobacco Use Measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) | 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). | Adult primary care patients | Posted | Number | 95% Confidence Interval | Sensitivity | Baseline |
|
|
|
| Secondary | Unhealthy Cannabis Use | 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 | Posted | Number | 95% Confidence Interval | Spearman Correlation | Baseline |
|
|
|
| Secondary | Risky Alcohol Use | 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). | Adult Primary Care Patients | Posted | Number | 95% Confidence Interval | Spearman Correlation | Baseline |
|
|
|
|
| Secondary | Cigarette Smoking Risk | 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. | Adult Primary Care patients | Posted | Number | 95% Confidence Interval | Spearman Correlation | baseline |
|
|
|
| Secondary | Smokeless Tobacco Questionnaire | Any yes response to smokeless tobacco use reported on the smokeless tobacco questionnaire is considered high risk. | Adult Primary Care patients | Posted | Number | 95% Confidence Interval | Spearman Correlation | baseline |
|
|
|
|
| Secondary | Cannabis Positive Oral Fluid Test | Positive Oral Fluid Cannabis testing. | Adult Primary Care Patients with oral fluid test results | Posted | Number | Spearman Correlation | baseline |
|
|
|
|
| 0 |
| 2,000 |
| 0 |
| 2,000 |
| 16 |
| 2,000 |
|
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
Each administration approach (interviewer and tablet) were separately tested against the reference measure. |
| Sensitivity |
| .70 |
| 2-Sided |
| 95 |
| .62 |
| .77 |
| Other |
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. |
Each administration approach (interviewer and tablet) were separately tested against the reference measure. |
| Sensitivity |
| .60 |
| 2-Sided |
| 95 |
| .50 |
| .69 |
| Other |
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. |
Each administration approach (interviewer and tablet) were tested separately against the reference measure. |
| Sensivity |
| .66 |
| 2-Sided |
| 95 |
| .53 |
| .77 |
| Other |
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. |
| Each administration approach (interviewer and tablet) was tested separately against the reference measure. | Spearman Correlation | .64 | 2-Sided | 95 | .61 | .68 | 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. | Other | 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. |
| Each administration approach (interviewer and tablet) were tested separately against the reference measure. | Spearman Correlation | .28 | 2-Sided | 95 | .24 | .32 | 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. | Other |
| Spearman Correlation | .40 | 2-Sided | 95 | .33 | .46 | 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. | Other |