AlcoholismCAMINCT02368899
Computerized Alcohol Misuse Intervention System for Health Care
A study testing Computerized Alcohol Misuse Intervention in people with Alcoholism, run by Research Circle Associates, LLC at 1 site in United States.
Trial summary
This project expands upon the proof-of-concept work done under the pilot project in order to get Interventionaire© poised for more widespread use. Interventionaire© is designed to deploy a computerized interactive questionnaire to patients in a physician waiting room. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcoholism
- What is being tested?
- Computerized Alcohol Misuse Intervention
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 17 Apr 2017
- 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
- Adult age 18 and older;
- Positive AUDIT screening score; and
- Willing to provide contact information for themselves and two friends or family members (to assist with tracking for follow-up).
Who cannot join
- Inability to give informed consent (e.g., due to cognitive impairment);
- Acute medical or psychiatric problem that precludes ability to complete the study interview or intervention;
- Inability to comprehend or read English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Family Health Centers of Baltimore
Baltimore, Maryland, 21225
About this study
Official title: Micro-targeted Computerized Alcohol Misuse Intervention System for Health Care
This project expands upon the proof-of-concept work done under the pilot project in order to get Interventionaire© poised for more widespread use. Interventionaire© is designed to deploy a computerized interactive questionnaire to patients in a physician waiting room. The information gathered is intended to be a conversation starter for primary care providers and patients (who may feel more at ease with the computer in revealing health risk behaviors, like alcohol abuse). Widespread use of Interventionaire© could result in a substantial cost savings by delivering a wide reaching and highly acceptable prevention strategy for integrating risky health behavior screening and brief intervention into mainstream medical practice.The investigators overall hypothesis is that participants receiving the computerized intervention will have greater improvement than those receiving the attention control condition.
Read the detailed description
Alcohol misuse continues to pose a major burden for public health. Screening and brief intervention for alcohol misuse in primary care settings has been recommended for decades, and the evidence base supporting it in primary care is robust. However, many primary care providers do not intervene in alcohol misuse, and those that do often fail to do so systematically or in accordance with best-evidence standards. Computerization of screening and brief intervention for alcohol misuse holds the promise of alleviating many of the barriers that have prevented its adoption into routine care, and also offers new opportunities for optimizing the effectiveness of brief interventions. This Phase 2 Small Business Technology Transfer (STTR) project follows up on Research Circle Associates' (RCA) successful proof-of-concept work done under Phase 1, which led to the development of a versatile software platform (Interventionaire©) to support computerized alcohol misuse screening and brief intervention using evidence based strategies including motivational interviewing and normative feedback. The investigators' computerized alcohol misuse intervention includes a normative feedback component that is unique in its micro-targeting of alcohol use feedback based on participant demographic characteristics (race/ethnicity, gender, and age), drawing population normative data from the National Surveys on Drug Use and Health. This represents a novel use of epidemiological data to inform clinical services. The Phase 2 project is designed to answer a number of important research questions and prepare the product for successful commercialization. Specifically, during Phase 2 the investigators intend to implement several refinements into the Interventionaire© platform that will increase its usability and streamline the creation of complex content with tailored feedback. The investigators will also upgrade the software to make it compatible with a major electronic health record system used by the investigators' clinical partner site. This will increase the reach of the product and ensure maximum readiness for deployment into the modern healthcare marketplace, a dynamic and rapidly evolving industry. The investigators will also conduct a study at the investigators' clinical partner site using qualitative key informant, focus group, and survey methodologies to investigate barriers to adopting computerized alcohol screening and brief intervention systems. A critical question is whether the computerized alcohol misuse intervention is effective in changing drinking behavior. To answer this question, the investigators will conduct a cross-over randomized controlled trial examining the short-term impact of the computerized alcohol misuse intervention with micro-targeted normative feedback and motivational messaging compared to an "attention-control" (placebo) generic health promotion message. This trial will help to establish the short-term efficacy of the intervention and set the stage for larger trials and adoption of the product in healthcare settings. Finally, the investigators will conduct a projection analysis of the economic and health impacts of the intervention under a variety of assumptions regarding intervention effect size, target population, and product penetration. Satisfying these Phase 2 objectives will leave RCA well-poised to deploy the product commercially, which will leverage the power of the market to improve clinical service delivery and promote public health.
- Conditions
- Alcoholism
- Being tested
- Computerized Alcohol Misuse Intervention, Attention Control (AC)
- Keywords
- technology, information science, health care
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Alcohol Misuse InterventionOther
Also called Interventionaire©
Interventionaire© is a computerized alcohol misuse intervention that includes a normative feedback component unique in its micro-targeting of alcohol use feedback based on participant demographic characteristics (race/ethnicity, gender, and age), drawing population normative data from the National Surveys on Drug Use and Health. This represents a novel use of epidemiological data to inform clinical services.
Attention Control (AC)Other
Also called RoboMemo, Luminosity, etc.
These products are designed for entertainment and educational purposes only. No medical claims are made for them and, the participant's interaction with them should be conceptually unrelated to alcohol use behavior.In order to avoid any carryover effect from comparing two active treatments, we have chosen to use a simple attention control condition that is not expected to exert any real intervention effect. In that way, the effect size estimate of the intervention can be readily calculated. No research data will be collected as part of the AC, beyond the amount of time spent on the program.
| Study group | Role | What they receive |
|---|---|---|
| Computerized Alcohol Misuse Intervention | Experimental | Arm 1 is a cross-over randomized controlled trial (XRCT) comparing the short-term effects of the computerized alcohol misuse intervention (CAMI) vs. a generic health education attention-control (AC) condition in reducing past 30 day: (a) days of alcohol use, (b) days of heavy episodic drinking, (c) typical number of drinks consumed on a day of drinking, and (d) alcohol use in dangerous situations; (2) investigate changes in (a) patient motivation and (b) perceived norms as mediators of intervention effectiveness. Receives: Other: Computerized Alcohol Misuse Intervention |
| Attention Control (AC) | Placebo comparator | Arm 2 is not an active intervention but an attention control condition - it is not expected to exert any real intervention effect. Hence, any observed effects for the AC condition can be attributed to natural change via regression-to-the-mean, assessment reactivity, or a placebo effect. The effect size estimate of the intervention, both from an efficacy standpoint (i.e., above and beyond what change would have normally occurred) and an effectiveness standpoint (i.e., the magnitude of behavior change that can be expected in real-world implementation), can be readily calculated. Receives: Other: Attention Control (AC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in drinking behavior as measured by self-reported alcohol use after completing the computerized alcohol misuse intervention (CAMI)
At one month, the investigators expect the attention control group (A) to reduce their alcohol use somewhat, but the intervention group (B) is expected to show a much steeper reduction. Thus, the investigators first planned contrast tests A vs. B, and can be considered similar to a parallel group trial examining 1-month outcomes for intervention vs. attention control. After the cross-over at 1 month, the magnitude of the reduction from Month 1 to Month 2 for those receiving the intervention (C) is expected to be similar to that experienced by those who received the intervention initially.
Measured: Month 1 and Month 2
Secondary outcomes (1)
Changes in participant motivation to stop or cut down alcohol use as measured by self-reported interest in reduction of alcohol use after completing the computerized alcohol misuse intervention (CAMI)
It is expected that the effect of CAMI will be carried by changes in motivation and changes in perceived norms.The investigators will use advanced modern mediation analysis techniques to investigate the mechanisms that may drive reductions in drinking.
Measured: Month 1 and Month 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2015 (estimated)
- Study startNov 2016
- Primary completion17 Apr 2017
- Study completion17 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AlcoholismStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Research Circle Associates, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, Baltimore County, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Diana H. Caldwell, Research Circle Associates, LLC
- Investigators
- Diana H Caldwell, PhD, Principal investigator, Research Circle AssociatesArti P Varanasi, PhD, MPH, Study director, Advancing Synergy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02368899
- Sponsor's protocol ID
- RCA-AA020451-R42
- Other IDs
- 2R42AA020451-02
- Acronym
- CAMI
- Status last verified
- May 2017
- First submitted
- 1 Feb 2015
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Neighbors C, Larimer ME, Lewis MA. Targeting misperceptions of descriptive drinking norms: efficacy of a computer-delivered personalized normative feedback intervention. J Consult Clin Psychol. 2004 Jun;72(3):434-47. doi: 10.1037/0022-006X.72.3.434.
PubMed 15279527
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-targeted Computerized Alcohol Misuse Intervention System for Health Care
- ClinicalTrials.gov ID
- NCT02368899
- Acronym / sponsor ID
- CAMI / RCA-AA020451-R42
- Conditions
- Alcoholism
- Keywords
- technology, information science, health care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Research Circle Associates, LLCUniversity, hospital or other
- Collaborators
- University of Maryland, Baltimore County, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Nov 2016
- Primary completion
- 17 Apr 2017 (actual)
- Study completion
- 17 Apr 2017 (actual)
- First posted
- 23 Feb 2015 (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.
This project expands upon the proof-of-concept work done under the pilot project in order to get Interventionaire© poised for more widespread use. Interventionaire© is designed to deploy a computerized interactive questionnaire to patients in a physician waiting room. The information gathered is intended to be a conversation starter for primary care providers and patients (who may feel more at ease with the computer in revealing health risk behaviors, like alcohol abuse). Widespread use of Interventionaire© could result in a substantial cost savings by delivering a wide reaching and highly acceptable prevention strategy for integrating risky health behavior screening and brief intervention into mainstream medical practice.The investigators overall hypothesis is that participants receiving the computerized intervention will have greater improvement than those receiving the attention control condition.
Detailed description
Alcohol misuse continues to pose a major burden for public health. Screening and brief intervention for alcohol misuse in primary care settings has been recommended for decades, and the evidence base supporting it in primary care is robust. However, many primary care providers do not intervene in alcohol misuse, and those that do often fail to do so systematically or in accordance with best-evidence standards. Computerization of screening and brief intervention for alcohol misuse holds the promise of alleviating many of the barriers that have prevented its adoption into routine care, and also offers new opportunities for optimizing the effectiveness of brief interventions. This Phase 2 Small Business Technology Transfer (STTR) project follows up on Research Circle Associates' (RCA) successful proof-of-concept work done under Phase 1, which led to the development of a versatile software platform (Interventionaire©) to support computerized alcohol misuse screening and brief intervention using evidence based strategies including motivational interviewing and normative feedback. The investigators' computerized alcohol misuse intervention includes a normative feedback component that is unique in its micro-targeting of alcohol use feedback based on participant demographic characteristics (race/ethnicity, gender, and age), drawing population normative data from the National Surveys on Drug Use and Health. This represents a novel use of epidemiological data to inform clinical services. The Phase 2 project is designed to answer a number of important research questions and prepare the product for successful commercialization. Specifically, during Phase 2 the investigators intend to implement several refinements into the Interventionaire© platform that will increase its usability and streamline the creation of complex content with tailored feedback. The investigators will also upgrade the software to make it compatible with a major electronic health record system used by the investigators' clinical partner site. This will increase the reach of the product and ensure maximum readiness for deployment into the modern healthcare marketplace, a dynamic and rapidly evolving industry. The investigators will also conduct a study at the investigators' clinical partner site using qualitative key informant, focus group, and survey methodologies to investigate barriers to adopting computerized alcohol screening and brief intervention systems. A critical question is whether the computerized alcohol misuse intervention is effective in changing drinking behavior. To answer this question, the investigators will conduct a cross-over randomized controlled trial examining the short-term impact of the computerized alcohol misuse intervention with micro-targeted normative feedback and motivational messaging compared to an "attention-control" (placebo) generic health promotion message. This trial will help to establish the short-term efficacy of the intervention and set the stage for larger trials and adoption of the product in healthcare settings. Finally, the investigators will conduct a projection analysis of the economic and health impacts of the intervention under a variety of assumptions regarding intervention effect size, target population, and product penetration. Satisfying these Phase 2 objectives will leave RCA well-poised to deploy the product commercially, which will leverage the power of the market to improve clinical service delivery and promote public health.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized Alcohol Misuse Intervention | Experimental | Other: Computerized Alcohol Misuse InterventionArm 1 is a cross-over randomized controlled trial (XRCT) comparing the short-term effects of the computerized alcohol misuse intervention (CAMI) vs. a generic health education attention-control (AC) condition in reducing past 30 day: (a) days of alcohol use, (b) days of heavy episodic drinking, (c) typical number of drinks consumed on a day of drinking, and (d) alcohol use in dangerous situations; (2) investigate changes in (a) patient motivation and (b) perceived norms as mediators of intervention effectiveness. |
| Attention Control (AC) | Placebo comparator | Other: Attention Control (AC)Arm 2 is not an active intervention but an attention control condition - it is not expected to exert any real intervention effect. Hence, any observed effects for the AC condition can be attributed to natural change via regression-to-the-mean, assessment reactivity, or a placebo effect. The effect size estimate of the intervention, both from an efficacy standpoint (i.e., above and beyond what change would have normally occurred) and an effectiveness standpoint (i.e., the magnitude of behavior change that can be expected in real-world implementation), can be readily calculated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult age 18 and older;
- Positive AUDIT screening score; and
- Willing to provide contact information for themselves and two friends or family members (to assist with tracking for follow-up).
Key exclusion criteria (3 listed)
- Inability to give informed consent (e.g., due to cognitive impairment);
- Acute medical or psychiatric problem that precludes ability to complete the study interview or intervention;
- Inability to comprehend or read English.
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 |
|---|---|---|
| Computerized Alcohol Misuse InterventionAlso: Interventionaire©Interventionaire© is a computerized alcohol misuse intervention that includes a normative feedback component unique in its micro-targeting of alcohol use feedback based on participant demographic characteristics (race/ethnicity, gender, and age), drawing population normative data from the National Surveys on Drug Use and Health. This represents a novel use of epidemiological data to inform clinical services. | Other | Computerized Alcohol Misuse Intervention |
| Attention Control (AC)Also: RoboMemo, Luminosity, etc.These products are designed for entertainment and educational purposes only. No medical claims are made for them and, the participant's interaction with them should be conceptually unrelated to alcohol use behavior.In order to avoid any carryover effect from comparing two active treatments, we have chosen to use a simple attention control condition that is not expected to exert any real intervention effect. In that way, the effect size estimate of the intervention can be readily calculated. No research data will be collected as part of the AC, beyond the amount of time spent on the program. | Other | Attention Control (AC) |
Primary outcome
Change in drinking behavior as measured by self-reported alcohol use after completing the computerized alcohol misuse intervention (CAMI)
Time frame: Month 1 and Month 2
At one month, the investigators expect the attention control group (A) to reduce their alcohol use somewhat, but the intervention group (B) is expected to show a much steeper reduction. Thus, the investigators first planned contrast tests A vs. B, and can be considered similar to a parallel group trial examining 1-month outcomes for intervention vs. attention control. After the cross-over at 1 month, the magnitude of the reduction from Month 1 to Month 2 for those receiving the intervention (C) is expected to be similar to that experienced by those who received the intervention initially.
1 secondary outcome
Changes in participant motivation to stop or cut down alcohol use as measured by self-reported interest in reduction of alcohol use after completing the computerized alcohol misuse intervention (CAMI)
Time frame: Month 1 and Month 2
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 10 May 2017.
- Background: PubMed 15279527Neighbors C, Larimer ME, Lewis MA. Targeting misperceptions of descriptive drinking norms: efficacy of a computer-delivered personalized normative feedback intervention. J Consult Clin Psychol. 2004 Jun;72(3):434-47. doi: 10.1037/0022-006X.72.3.434.
- Individual participant dataSharing planned: No
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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.
Diana H Caldwell, PhD principal investigator
Research Circle Associates
Arti P Varanasi, PhD, MPH study director
Advancing Synergy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Alcohol Misuse Intervention in people with Alcoholism, run by Research Circle Associates, LLC 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 3 inclusion and 3 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 10 May 2017. 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. Some participants in this study may receive a placebo. 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?
Change in drinking behavior as measured by self-reported alcohol use after completing the computerized alcohol misuse intervention (CAMI) (time frame: Month 1 and Month 2). 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 NCT02368899, which also lists 1 linked publication.
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 10 May 2017; AzTrials last refreshed its copy on 31 Oct 2026.