Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04811729 |
| Other study ID # |
ALCO-AP20 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 18, 2022 |
| Est. completion date |
July 30, 2023 |
Study information
| Verified date |
February 2024 |
| Source |
Hospital Universitario Reina Sofia de Cordoba |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
