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Computerized Alcohol Misuse Intervention System for Health Care (CAMI)

Primary Purpose

Alcoholism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computerized Alcohol Misuse Intervention
Attention Control (AC)
Sponsored by
Research Circle Associates, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Alcoholism focused on measuring technology, information science, health care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Sites / Locations

  • Family Health Centers of Baltimore

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Computerized Alcohol Misuse Intervention

Attention Control (AC)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
February 1, 2015
Last Updated
May 8, 2017
Sponsor
Research Circle Associates, LLC
Collaborators
University of Maryland, Baltimore County, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT02368899
Brief Title
Computerized Alcohol Misuse Intervention System for Health Care
Acronym
CAMI
Official Title
Micro-targeted Computerized Alcohol Misuse Intervention System for Health Care
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
April 17, 2017 (Actual)
Study Completion Date
April 17, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Research Circle Associates, LLC
Collaborators
University of Maryland, Baltimore County, National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
technology, information science, health care

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Computerized Alcohol Misuse Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control (AC)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Computerized Alcohol Misuse Intervention
Other Intervention Name(s)
Interventionaire©
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Attention Control (AC)
Other Intervention Name(s)
RoboMemo, Luminosity, etc.
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in drinking behavior as measured by self-reported alcohol use after completing the computerized alcohol misuse intervention (CAMI)
Description
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.
Time Frame
Month 1 and Month 2
Secondary Outcome Measure Information:
Title
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)
Description
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.
Time Frame
Month 1 and Month 2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diana H Caldwell, PhD
Organizational Affiliation
Research Circle Associates
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arti P Varanasi, PhD, MPH
Organizational Affiliation
Advancing Synergy
Official's Role
Study Director
Facility Information:
Facility Name
Family Health Centers of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21225
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15279527
Citation
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.
Results Reference
background

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Computerized Alcohol Misuse Intervention System for Health Care

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