Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 2:00 PM
Study NCT ID:
NCT04811729
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2021-03-11
Brief Title:
Effectiveness of an Intervention in Patients With Excessive Alcohol Consumption
Sponsor:
Hospital Universitario Reina Sofia de Cordoba
Organization:
Hospital Universitario Reina Sofia de Cordoba
Study Overview
Official Title:
Effectiveness of a Brief Motivational Intervention in Addressing Excessive Alcohol Consumption in Primary Care
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALCO-AP20
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
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 005 This ICC translates for a cluster size of 15 into a design effect that corresponds to a factor of 17 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 11 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
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 005 This ICC translates for a cluster size of 15 into a design effect that corresponds to a factor of 17 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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None