Effectiveness of an Intervention in Patients With Excessive Alcohol Consumption (ALCO-AP20)

February 2, 2024 updated by: Luis A Perula, Hospital Universitario Reina Sofia de Cordoba

Effectiveness of a Brief Motivational Intervention in Addressing Excessive Alcohol Consumption in Primary Care

  • Main objective: to verify the effectiveness of a brief intervention, based on the motivational interview (MI), in patients with excessive alcohol consumption assisted in Primary Care (PC).
  • Design: a multicenter, randomized, cluster-controlled clinical trial with two parallel arms. PC professionals will be randomized to one of the two study groups: 1) Experimental Group (EG): MI-based approach; 2) Control group (CG): usual care. At least 50 family doctors, residents and nurses will participate, recruiting PC patients (n = 394). GE intervention: Training program to acquire specific skills on approaching risky alcohol consumption. It will consist of a workshop, with two video recordings of consultations with simulated standardized patients, before and after it, with each participant receiving formative feedback at the end. -Intervention GC: medical advice that is usually performed in these patients. To measure the knowledge and attitude of professionals in dealing with patients with alcohol consumption, they will fill out a validated questionnaire. In addition, expert evaluators, after viewing the video recordings, will fill out a check-list to check the attitude of each professional, using the EVEM Scale. -Study population: patients ≥14 years of age with risky consumption, detected by the professional in health centers in the province of Córdoba (Spain). Sample size: Assuming a loss rate of 5%, and the "cluster design effect", the number of subjects to be recruited is estimated at 394 (197 / group). Intervention control mechanism: each participant will be audio-recorded with a real patient in a randomly chosen visit, evaluating her skills with the EVEM scale. The follow-up period for each patient will be 12 months, with 4 visits (initial, per month, 3 months, and 6 months) and 4 interleaved telephone contacts. The main outcome variable will be the level of self-reported alcohol consumption and the AUDIT questionnaire score. -Statistical analysis by intention to treat. Descriptive analysis and initial comparability of the groups will be carried out, and the effect of the intervention (dependent variable: abstinence or consumption reduction and AUDIT score) will be evaluated through bivariate and multivariate analysis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • Design: controlled, cluster-randomized, open-label, two-parallel-arm, multicenter clinical trial. Primary Care professionals will be randomized to one of the two study groups: 1) Experimental Group (EG): they will apply an approach based on Motivational interview (MI), previously receiving a training program. 2) Control group (CG): usual care. They will receive an instructional program in order to avoid the "contamination" effect of the motivational approach. At least 50 professionals (family doctors, residents and nurses) will participate, each of whom will recruit (through opportunistic search) 9-10 PC patients.
  • GE intervention: they will receive a 20-hour training program to acquire specific skills on the approach to patients with risky consumption, which will consist of a workshop, with two video recordings of consultations with simulated standardized patients, one before and others after the same, each participant receiving at the end a personalized training feedback.
  • CG intervention: they will not receive the training program in MI, instructing them to carry out the medical advice that they usually carry out in these patients (informative model); They will also be videotaped, in order to verify that the approach they carry out is not motivational. On the other hand, both groups will receive an 8-hour workshop on detection, management and approach to the patient with excessive alcohol consumption, based on the recommendations and the action algorithm postulated by the PAPPS. To measure the knowledge and attitude of the professionals of both groups in relation to the approach of the patient with alcohol consumption, they will fill out a questionnaire validated by our group. In addition, expert evaluators, after viewing the video recordings, will fill out a check-list to check the attitude of each professional, using the EVEM Scale, which has been validated by members of our group.
  • Material and / or techniques to be used: The information of the participants will be obtained from tools already validated to assess risk alcohol consumption [Alcohol Use Disorder Identification Test (AUDIT), the motivational interview (EVEM questionnaire)] and satisfaction of the doctor-patient (PDRQ-9). In addition, the MCRS scale (Medical Condition Regard Scale) will be used to evaluate the attitude of health workers in the approach to alcohol, which has not been validated in Spanish to date. The Spanish validation process will be carried out by this research group. -Alcohol Use Disorder Identification Test (AUDIT). Tool designed to identify risky alcohol consumption and comprises 10 questions divided into 3 conceptual domains. The first domain assesses recent alcohol consumption and contains 3 questions (frequency of consumption, typical amount and frequency of heavy consumption). The second domain assesses symptoms of dependence through 3 items (loss of control over consumption, increased relevance of consumption and morning consumption) and finally the third domain assesses harmful alcohol consumption through 4 questions (Feeling of guilt after consumption , memory gaps, alcohol-related injuries and environmental concern about consumption). A result equal to or greater than 8 is considered indicative of risky and harmful consumption, as well as a possible dependence on alcohol. -Evaluation Scale of the Motivational Interview (EVEM). 14-item scale with a score of 0 to 4, created and validated by members of our group, to assess encounters between professionals and patients in which MS is used. This scale analyzes: 1) empathy; 2) facilitation for the patient to position himself; 3) works in accordance with the patient; 4) use open questions; 5) perform reflective listening; 6) performs summaries; 7) validate the patient; 8) agreement of change objectives; 9) promotes the design of action / plan with the patient; 10) avoid discord with the patient; 11) develop a maintenance plan with the patient; 12) global spirit: evocation, collaboration, autonomy, understanding.
  • Patient-Doctor Relationship Questionnaire (PDRQ-9). 9-question scale that assesses the doctor-patient relationship in clinical practice. Likert-type scale with 5 categories: 1 ("not at all appropriate"), 2 ("somewhat appropriate"), 3 ("appropriate"), 4 ("quite appropriate") and 5 ("very appropriate"). This scale has been validated in Spanish and will allow knowing the satisfaction of the patient in the alcohol approach developed by the health worker. -Medical Condition Regard Scale (MCRS). 11-question scale that assesses the attitude of health workers in the clinical approach. It is a Likert-type scale with 6 categories (1 = totally disagree, 6 = totally agree). It will be validated in Spanish by our research team.
  • Location: Health Centers of the Andalus Health Service of the province of Córdoba (Spain).
  • Study population: patients aged 14 or over with risky alcohol consumption (28 Standard Drink Units -SDU- / week in men and 17 SDU / week in women) users of PC services.
  • Sample size: the main evaluation criterion will be the self-reported consumption by the patient. Based on a previous study carried out by members of our team, and to detect a difference of 20% between the percentage of patients in abstinence (partial or total) between the EG (37%) and the CG (20%); for an alpha error of 5%, a statistical power of 80%, the size would be 220 subjects (110 / group). Assuming a 5% loss rate and being a cluster randomization system, we will take into account the "design effect". Estimates of the intra-cluster correlation coefficient (ICC) in CCT by cluster in PC show that they are generally less than 0.05. This ICC translates, for a cluster size of 15, into a design effect that corresponds to a factor of 1.7. Assuming this value, the size would be 394 subjects to be recruited (197 in each group).
  • Randomization: The randomization unit will be the healthcare professional and the intervention unit will be the patient. Professionals will be assigned randomly and equally (1:1) to one of the two study groups. -Mechanism of control of the interventions: each participant will also be videotaped with a real patient in a visit chosen at random, also evaluating her skills with the EVEM scale.
  • The follow-up period for each patient will be 6 months, with 4 visits (initial, per month, at 3 months, and at 6 months), in addition to four interleaved telephone contacts. -Study variables: The main outcome variable will be the level of self-reported alcohol consumption (UBEs) and the score of the Alcohol Use Disorder Identification Test (AUDIT) questionnaire.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
268

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Córdoba, Spain, 14011
        • Distrito sanitario Córdoba y Guadalquivir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

  1. -Inclusion criteria: 1.1.-Present risk alcohol consumption (28 Standard Drink Units -SDU- / week in men and 17 SDU / week in women 1.2.-Present 14 years or more; 3) consent to participate in the clinical trial.
  2. -Exclusion criteria: 2.1.Present health problems that prevent the intervention or its follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
Intervention based on the Motivational Interview, previously receiving a training program
Behavioral: Motivational interview
The participants will apply an approach based on the Motivational Interview (Rollnick, 2008) in patients with excessive alcohol consumption, previously receiving a training program
Active Comparator: Control Group
Usual care based on a health counci
Behavioral: Medical advice
Usual care

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Alcohol consumption
Time Frame: 12 months
Self-reported alcohol consumption level
12 months
AUDIT
Time Frame: 12 months
Alcohol Use Disorder Identification Test (AUDIT) questionnaire score
12 months
Alcohol Use Disorder Identification Test (AUDIT) questionnaire score
Time Frame: 12 months
Tool designed to identify risky alcohol consumption and comprises 10 questions divided into 3 conceptual domains. The first domain assesses recent alcohol consumption and contains 3 questions (frequency of consumption, typical amount and frequency of heavy consumption). The second domain assesses symptoms of dependence through 3 items (loss of control over consumption, increased relevance of consumption and morning consumption) and finally the third domain assesses harmful alcohol consumption through 4 questions (Feeling of guilt after consumption , memory gaps, alcohol-related injuries and environmental concern about consumption). A result equal to or greater than 8 is considered indicative of risky and harmful consumption, as well as a possible dependence on alcohol.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Universitario Reina Sofia de Cordoba

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Maimonides Institute for Biomedical Research of Cordoba (IMIBIC)
Progress and Health Foundation
Córdoba and Guadalquivir Health District

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jose Angel Fernández García, Doctor, Andaluz Health Service

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 18, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 23, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ALCO-AP20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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