Effectiveness of an Intervention in Patients With Excessi... | NCT04811729

NCT04811729

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Name	Class
Maimonides Institute for Biomedical Research of Cordoba (IMIBIC)	UNKNOWN
Progress and Health Foundation	UNKNOWN
Córdoba and Guadalquivir Health District	UNKNOWN

Oversight Module

Description Module

Brief Summary

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.

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.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental Group	Experimental	Intervention based on the Motivational Interview, previously receiving a training program	Behavioral: Motivational interview
Control Group	Active Comparator	Usual care based on a health counci	Behavioral: Medical advice

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Motivational interview	Behavioral	The participants will apply an approach based on the Motivational Interview (Rollnick, 2008) in patients with excessive alcohol consumption, previously receiving a training program

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alcohol consumption	Self-reported alcohol consumption level	12 months
AUDIT	Alcohol Use Disorder Identification Test (AUDIT) questionnaire score	12 months
Alcohol Use Disorder Identification Test (AUDIT) questionnaire score	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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Jose Angel Fernández García, Doctor	Andaluz Health Service	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Distrito sanitario Córdoba y Guadalquivir		Córdoba		14011	Spain

IPD Sharing Statement Module

Condition Browse Module

ID	Term
D000428	Alcohol Drinking
D000437	Alcoholism

ID	Term
D004327	Drinking Behavior
D001519	Behavior
D019973	Alcohol-Related Disorders
D019966	Substance-Related Disorders

Intervention Browse Module

ID	Term
D037001	Directive Counseling
D003376	Counseling
D008605	Mental Health Services
D004191	Behavioral Disciplines and Activities