AlcoholismTMNCT00865774
The Teachable Moment: Screening and Brief Intervention for Admitted Trauma Patients
A study testing Quantity Frequency Model and Targets Subjective Drunkenness in people with Alcoholism, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The American College of Surgeons now requires screening for alcohol use in trauma centers. The purpose of this research study is to provide information about the best screening and treatment methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism
- What is being tested?
- Quantity Frequency Model and Targets Subjective Drunkenness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 333 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient on trauma service
- 18 years or older
- Speaks either English or Spanish
- One or more of the following:
- Patient answered yes to either admission screening question
- Patient has a positive BAL of less than or equal to 79 and also has a positive Audit score (men greater than or equal to 8; women greater than or equal to 4)
- Patient has a BAL of 80 or higher
- patient has no record of a BAL on file and they have a positive Audit score
Who cannot join
- Patient unable or unwilling to provide informed consent
- Patient refusal contact at six months
- Patient has a positive BAL of less than or equal to 79 and negative AUDIT score
- Patient deemed unable to complete a BI
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
The American College of Surgeons now requires screening for alcohol use in trauma centers. The purpose of this research study is to provide information about the best screening and treatment methods. The investigators hope the findings will provide information that will improve healthcare by reducing problems related to risky alcohol use. The trauma team is conducting a comparison of two different ways of talking about alcohol use. Participants will be randomized into one of the two study groups.
Read the detailed description
The goal of this study is to guide further policy development regarding effective alcohol screening by: (a) comparing the effectiveness of two new, shorter screening tools for risky drinking patterns with the longer screening tool in current use; (b) assessing the outcomes of two different brief counseling interventions (BIs) with trauma patients screened to have risky drinking behaviors; and (c) examining the impact of the implementation of this new policy in a Level I Trauma Center.
The Specific Aims will be accomplished by:
- Screening patients who are admitted to the Trauma Center, and conducting BIs for all who screen positive;
- Collecting formative qualitative data regarding participants' perceptions of benefits of drunken states, their individual risks, and perceived healthier alternatives;
- Collecting quantitative data (injury severity score and hospital length of stay) and correlating these data with patient demographics and responses on the different screening methods;
- Collecting follow-up data by telephone on self-reported alcohol use and trauma recidivism, using an interviewer-administered assessment;
- Collecting data on trauma recidivism from ED data, publicly available records, and patient self-report at 6-month telephone follow-up;
- Surveying trauma staff and physicians at three intervals regarding the process of implementing the new ACS policy, any perceived difficulties, and the perceived impact
- Conditions
- Alcoholism
- Being tested
- Quantity Frequency Model, Targets Subjective Drunkenness
- Keywords
- Trauma, Alcohol, Brief Intervention
- Medical subject headings
- Alcoholism, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantity Frequency ModelBehavioural
The quantitative intervention involves emphasis on tracking and measuring the number of drinks on a weekly basis.
Targets Subjective DrunkennessBehavioural
Explores factors leading to drunkenness and alternative coping strategies for healthier function.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Arm number 1 focuses on the traditional quantity frequency model. Receives: Behavioral: Quantity Frequency Model |
| 2 | Experimental | Arm number 2 targets subjective drunkenness. Receives: Behavioral: Targets Subjective Drunkenness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trauma recidivism after discharge as measured by a review of computerized ED records,NC Trauma database,the Forsyth County EMS registry,NC EMS registry and self-reports at a 6-month telephone follow-up of alcohol-related injuries and changes in alcohol
Measured: 6 months
Secondary outcomes (1)
Patient satisfaction ratings of the BI,the response to the BI as rated by the interviewer,reported citations for driving under the influence(to be obtained from the NC State Department of Motor Vehicles) and 3 surveys of trauma service staff
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionJun 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Responsible party
- Sponsor
- Investigators
- Mary Claire O'Brien, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865774
- Sponsor's protocol ID
- IRB00006734
- Acronym
- TM
- Status last verified
- Aug 2018
- First submitted
- 17 Mar 2009
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fitzgerald DJ, Radek KA, Chaar M, Faunce DE, DiPietro LA, Kovacs EJ. Effects of acute ethanol exposure on the early inflammatory response after excisional injury. Alcohol Clin Exp Res. 2007 Feb;31(2):317-23. doi: 10.1111/j.1530-0277.2006.00307.x.
PubMed 17250625Zambell KL, Phelan H, Vande Stouwe C, Zhang P, Shellito JE, Molina PE. Acute alcohol intoxication during hemorrhagic shock: impact on host defense from infection. Alcohol Clin Exp Res. 2004 Apr;28(4):635-42. doi: 10.1097/01.alc.0000122104.85971.55.
PubMed 15100616Cunningham RM, Maio RF, Hill EM, Zink BJ. The effects of alcohol on head injury in the motor vehicle crash victim. Alcohol Alcohol. 2002 May-Jun;37(3):236-40. doi: 10.1093/alcalc/37.3.236.
PubMed 12003910Saitz R. Clinical practice. Unhealthy alcohol use. N Engl J Med. 2005 Feb 10;352(6):596-607. doi: 10.1056/NEJMcp042262. No abstract available.
PubMed 15703424National Highway Safety Traffic Administration. National Communications Plan 2006. http://www.nhtsa.dot.gov/people/injury/NewmediaForum Web/images/NHTS-1689%20Comm%20Plan.pdf Accessed March 18, 2008.
Schermer CR, Moyers TB, Miller WR, Bloomfield LA. Trauma center brief interventions for alcohol disorders decrease subsequent driving under the influence arrests. J Trauma. 2006 Jan;60(1):29-34. doi: 10.1097/01.ta.0000199420.12322.5d.
PubMed 16456433Crawford MJ, Patton R, Touquet R, Drummond C, Byford S, Barrett B, Reece B, Brown A, Henry JA. Screening and referral for brief intervention of alcohol-misusing patients in an emergency department: a pragmatic randomised controlled trial. Lancet. 2004 Oct 9-15;364(9442):1334-9. doi: 10.1016/S0140-6736(04)17190-0.
PubMed 15474136Gentilello LM, Rivara FP, Donovan DM, Jurkovich GJ, Daranciang E, Dunn CW, Villaveces A, Copass M, Ries RR. Alcohol interventions in a trauma center as a means of reducing the risk of injury recurrence. Ann Surg. 1999 Oct;230(4):473-80; discussion 480-3. doi: 10.1097/00000658-199910000-00003.
PubMed 10522717Anderson JA, Coscia RL, Cryer HG, et al. Injury does not occur by accident. Resources for the optimal care of the injured patient 2006. Chicago, IL: 2006. p. 115-20.
McDonald AJ 3rd, Wang N, Camargo CA Jr. US emergency department visits for alcohol-related diseases and injuries between 1992 and 2000. Arch Intern Med. 2004 Mar 8;164(5):531-7. doi: 10.1001/archinte.164.5.531.
PubMed 15006830Gentilello LM, Ebel BE, Wickizer TM, Salkever DS, Rivara FP. Alcohol interventions for trauma patients treated in emergency departments and hospitals: a cost benefit analysis. Ann Surg. 2005 Apr;241(4):541-50. doi: 10.1097/01.sla.0000157133.80396.1c.
PubMed 15798453Wechsler H, Davenport A, Dowdall G, Moeykens B, Castillo S. Health and behavioral consequences of binge drinking in college. A national survey of students at 140 campuses. JAMA. 1994 Dec 7;272(21):1672-7.
PubMed 7966895Dunn C, Ostafin B. Brief interventions for hospitalized trauma patients. J Trauma. 2005 Sep;59(3 Suppl):S88-93; discussion S94-100. doi: 10.1097/01.ta.0000174682.13138.a3.
PubMed 16355072Schermer CR. Feasibility of alcohol screening and brief intervention. J Trauma. 2005 Sep;59(3 Suppl):S119-23; discussion S124-33. doi: 10.1097/01.ta.0000174679.12567.7c.
PubMed 16355047Reboussin BA, Song EY, Shrestha A, Lohman KK, Wolfson M. A latent class analysis of underage problem drinking: evidence from a community sample of 16-20 year olds. Drug Alcohol Depend. 2006 Jul 27;83(3):199-209. doi: 10.1016/j.drugalcdep.2005.11.013. Epub 2005 Dec 15.
PubMed 16359829
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Teachable Moment: Screening and Brief Intervention for Admitted Trauma Patients
- ClinicalTrials.gov ID
- NCT00865774
- Acronym / sponsor ID
- TM / IRB00006734
- Conditions
- Alcoholism
- Keywords
- Trauma, Alcohol, Brief Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 333 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Robert Wood Johnson Foundation
- Study start
- Jan 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 19 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The American College of Surgeons now requires screening for alcohol use in trauma centers. The purpose of this research study is to provide information about the best screening and treatment methods. The investigators hope the findings will provide information that will improve healthcare by reducing problems related to risky alcohol use. The trauma team is conducting a comparison of two different ways of talking about alcohol use. Participants will be randomized into one of the two study groups.
Detailed description
The goal of this study is to guide further policy development regarding effective alcohol screening by: (a) comparing the effectiveness of two new, shorter screening tools for risky drinking patterns with the longer screening tool in current use; (b) assessing the outcomes of two different brief counseling interventions (BIs) with trauma patients screened to have risky drinking behaviors; and (c) examining the impact of the implementation of this new policy in a Level I Trauma Center.
The Specific Aims will be accomplished by:
- Screening patients who are admitted to the Trauma Center, and conducting BIs for all who screen positive;
- Collecting formative qualitative data regarding participants' perceptions of benefits of drunken states, their individual risks, and perceived healthier alternatives;
- Collecting quantitative data (injury severity score and hospital length of stay) and correlating these data with patient demographics and responses on the different screening methods;
- Collecting follow-up data by telephone on self-reported alcohol use and trauma recidivism, using an interviewer-administered assessment;
- Collecting data on trauma recidivism from ED data, publicly available records, and patient self-report at 6-month telephone follow-up;
- Surveying trauma staff and physicians at three intervals regarding the process of implementing the new ACS policy, any perceived difficulties, and the perceived impact
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Quantity Frequency ModelArm number 1 focuses on the traditional quantity frequency model. |
| 2 | Experimental | Behavioral: Targets Subjective DrunkennessArm number 2 targets subjective drunkenness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Inpatient on trauma service
- 18 years or older
- Speaks either English or Spanish
- Patient answered yes to either admission screening question
- Patient has a positive BAL of less than or equal to 79 and also has a positive Audit score (men greater than or equal to 8; women greater than or equal to 4)
Key exclusion criteria (4 listed)
- Patient unable or unwilling to provide informed consent
- Patient refusal contact at six months
- Patient has a positive BAL of less than or equal to 79 and negative AUDIT score
- Patient deemed unable to complete a BI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantity Frequency ModelThe quantitative intervention involves emphasis on tracking and measuring the number of drinks on a weekly basis. | Behavioural | 1 |
| Targets Subjective DrunkennessExplores factors leading to drunkenness and alternative coping strategies for healthier function. | Behavioural | 2 |
Primary outcome
Trauma recidivism after discharge as measured by a review of computerized ED records,NC Trauma database,the Forsyth County EMS registry,NC EMS registry and self-reports at a 6-month telephone follow-up of alcohol-related injuries and changes in alcohol
Time frame: 6 months
1 secondary outcome
Patient satisfaction ratings of the BI,the response to the BI as rated by the interviewer,reported citations for driving under the influence(to be obtained from the NC State Department of Motor Vehicles) and 3 surveys of trauma service staff
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Background: PubMed 17250625Fitzgerald DJ, Radek KA, Chaar M, Faunce DE, DiPietro LA, Kovacs EJ. Effects of acute ethanol exposure on the early inflammatory response after excisional injury. Alcohol Clin Exp Res. 2007 Feb;31(2):317-23. doi: 10.1111/j.1530-0277.2006.00307.x.
- Background: PubMed 15100616Zambell KL, Phelan H, Vande Stouwe C, Zhang P, Shellito JE, Molina PE. Acute alcohol intoxication during hemorrhagic shock: impact on host defense from infection. Alcohol Clin Exp Res. 2004 Apr;28(4):635-42. doi: 10.1097/01.alc.0000122104.85971.55.
- Background: PubMed 12003910Cunningham RM, Maio RF, Hill EM, Zink BJ. The effects of alcohol on head injury in the motor vehicle crash victim. Alcohol Alcohol. 2002 May-Jun;37(3):236-40. doi: 10.1093/alcalc/37.3.236.
- Background: PubMed 15703424Saitz R. Clinical practice. Unhealthy alcohol use. N Engl J Med. 2005 Feb 10;352(6):596-607. doi: 10.1056/NEJMcp042262. No abstract available.
- BackgroundNational Highway Safety Traffic Administration. National Communications Plan 2006. http://www.nhtsa.dot.gov/people/injury/NewmediaForum Web/images/NHTS-1689%20Comm%20Plan.pdf Accessed March 18, 2008.
- Background: PubMed 16456433Schermer CR, Moyers TB, Miller WR, Bloomfield LA. Trauma center brief interventions for alcohol disorders decrease subsequent driving under the influence arrests. J Trauma. 2006 Jan;60(1):29-34. doi: 10.1097/01.ta.0000199420.12322.5d.
- Background: PubMed 15474136Crawford MJ, Patton R, Touquet R, Drummond C, Byford S, Barrett B, Reece B, Brown A, Henry JA. Screening and referral for brief intervention of alcohol-misusing patients in an emergency department: a pragmatic randomised controlled trial. Lancet. 2004 Oct 9-15;364(9442):1334-9. doi: 10.1016/S0140-6736(04)17190-0.
- Background: PubMed 10522717Gentilello LM, Rivara FP, Donovan DM, Jurkovich GJ, Daranciang E, Dunn CW, Villaveces A, Copass M, Ries RR. Alcohol interventions in a trauma center as a means of reducing the risk of injury recurrence. Ann Surg. 1999 Oct;230(4):473-80; discussion 480-3. doi: 10.1097/00000658-199910000-00003.
- BackgroundAnderson JA, Coscia RL, Cryer HG, et al. Injury does not occur by accident. Resources for the optimal care of the injured patient 2006. Chicago, IL: 2006. p. 115-20.
- Background: PubMed 15006830McDonald AJ 3rd, Wang N, Camargo CA Jr. US emergency department visits for alcohol-related diseases and injuries between 1992 and 2000. Arch Intern Med. 2004 Mar 8;164(5):531-7. doi: 10.1001/archinte.164.5.531.
- Background: PubMed 15798453Gentilello LM, Ebel BE, Wickizer TM, Salkever DS, Rivara FP. Alcohol interventions for trauma patients treated in emergency departments and hospitals: a cost benefit analysis. Ann Surg. 2005 Apr;241(4):541-50. doi: 10.1097/01.sla.0000157133.80396.1c.
- Background: PubMed 7966895Wechsler H, Davenport A, Dowdall G, Moeykens B, Castillo S. Health and behavioral consequences of binge drinking in college. A national survey of students at 140 campuses. JAMA. 1994 Dec 7;272(21):1672-7.
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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.
Mary Claire O'Brien, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantity Frequency Model and Targets Subjective Drunkenness in people with Alcoholism, run by Wake Forest University Health Sciences 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 8 inclusion and 4 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 9 Aug 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Trauma recidivism after discharge as measured by a review of computerized ED records,NC Trauma database,the Forsyth County EMS registry,NC EMS registry and self-reports at a 6-month telephone follow-up of alcohol-related injuries and changes in alcohol (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00865774, which also lists 25 linked publications.
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 9 Aug 2018.