This document summarizes the results of a study called EFAR-Italy that compared the effectiveness of an online facilitated access to an alcohol reduction website versus face-to-face brief intervention conducted by general practitioners (GPs) for risky drinkers. The study found that facilitated access to the website was not inferior and may have been more effective than face-to-face intervention in reducing risky drinking levels at 3-month follow up. The results provide evidence that internet and new technologies can be helpful for health promotion and that facilitated access is a promising methodology for GP intervention.
Progetto sugli Stili di vita (Roberto Della Vedova)
1. PROGETTO STILI DI VITA
ROBERTO DELLA VEDOVA
XXVII Congresso CSeRMEG 16-17 Ottobre 2015
2. •Stili di vita: perché?
•Studio EFAR-FVG: Risultati di un’esperienza
concreta di azione sugli stili di vita
•Descrizione di uno strumento integrativo per
l’intervento efficace e integrato sugli stili di vita
3. RISCHIO DI MALATTIA CRONICA ESPRESSO IN
DALYs
www.thelancet.com Published online September 11, 2015 http://dx.doi.org/10.1016/S0140-6736(15)00128-2
4. ITALY - BURDEN OF DISEASE ATTRIBUTABLE TO
LEADING RISK FACTORS, 2013
8. MODELLO DI PROMOZIONE DELLA SALUTE (BEATTIE
1991)
Tipi di intervento
Autoritarismo
Tecniche di persuasione alla salute Azione legislativa per la salute
Focusdell'intervento
Individuale Collettivo
Counselling personale per la salute
Sviluppo della comunità orientato alla
salute
Negoziazione
10. BREAKING DOCTOR – PATIENT RELATIONSHIP
• Don‘t believe the effectiveness
• Patients lie
• Doctors drink
• Lack of time
• Not a job for GP/FM
• Lack of knowledge and self-confidence
AGPFMSEE Conference Ljubljana 4.-6.6.2015 Marko Kolšek
12. A randomised controlled non-inferiority trial of
primary care-based facilitated access to an
alcohol reduction website (EFAR-FVG) Italy:
design and results
Roberto Della Vedova, MD
Regional Centre for the Training in Primary Care (Ceformed)
Centro Studi e Ricerche in Medicina Generale (CSeRMEG)
Research Team
Pierluigi Struzzo, Emanuele Scafato, Donatella Ferrante, Nick Freemantle, Rachel
Hunter, Harris Lygidakis, Richard MacGregor, Francesco Marcatto, Francesca
Scafuri, Costanza Tersar and Paul Wallace
EFAR-Italy
13. EFAR-Italy
Aim of the study
To evaluate whether online facilitated access to an alcohol reduction
website for risky drinkers is as effective as face-to-face brief
intervention conducted by the GPs
14. EFAR-Italy
Patient eligibility to receive brochure
• All NON-selected as risky
drinkers patients aged 18 and over
who attend practice
• Exclusion criteria:
– Severe psychiatric disorder, known
AD, visual impairment or terminal
illness
– Inadequate command of Italian
language
16. EFAR-Italy
Trial structure
In practice brochure distribution (Unique log-on code)
Access the website. (Trial information and consent)
AUDIT-C (>4 female, >5 male)
Not at risk At risk (Privacy consent)
Baseline data, AUDIT-10 and EQ-5D
RANDOMISATION
Face to Face intervention
Follow up at 3m and 12m
Online intervention
17. EFAR-Italy
Practice Code
Customi
zation
Brochures Patients % AUDIT-C % Risky % Randomised % Control %
Interven
tion
Total GP 0 brochures 0
Total Yes Customisation 41
Total No Customisation 17
Total 58 9080 4529 3841 822 763 416 347
% Brochures 49,9 42,3 9,1 8,4
% Patients 84,8 18,1 16,8
% AUDIT C 21,4 19,9
% Risky 92,8
% Randomised 54,5 45,5
TRIAL ACTIVITY
User pages
wiews
TDR
submissions
TDR records TDR pages
3 m FU
invited
3 m FU
completed
%
1 y FU
invited
1 y FU
completed
% Drop outs
7729 1878 1520 707 762 698 92 762 620 81 27
18. EFAR-Italy
Trial Flow
Facilitated Access
N=347
Face to Face
N=416
Randomised N=763
3 Months
N=317
1 protocol violation*
29 lost to follow up
3 Months
N=381
1 protocol violation*
34 lost to follow up
12 Months
N=285
1 protocol violation
61 lost to follow up
12 Months
N=335
1 protocol violation
80 lost to follow up
* Note patient 00512294af was inadvertently randomised twice; once to each group, due to a software hitch
19. EFAR-Italy
Baseline Characteristics
Item Facilitated Access n=346 Face to Face n=415
Male (%) 214 (62.0%) 255 (61.9%)
Marital Status
Single (%) 95 (27.9%) 116 (28.4%)
Married (%) 208 (61.0%) 247 (60.4%)
Separated (%) 28 (8.2%) 36 (8.8%)
Widowed (%) 10 (2.9%) 10 (2.4%)
Ethnicity
Altro Caucasico (%) 8 (2.4%) 6 (1.5%)
Bengalese (%) 1 (0.3%) 1 (0.25%)
Indiano (%) 1 (0.3%) 2 (0.5%)
Italiano (%) 320 (95.8%) 385 (96.3%)
Magrebbino (%) 0 (0%) 1 (0.25%)
Meticcio (%) 1 (0.3%) 1 (0.25%)
Nero Africano (%) 3 (0.9%) 4 (1.0%)
Familiarity with IT
Not 58 (16.9%) 62 (15.2%)
Fairly 84 (24.5%) 93 (22.8%)
Familiar 91 (26.5%) 119 (29.2%)
Very 110 (32.1%) 134 (32.8%)
Qualifications
Nessuna 2 (0.6%) 2 (0.5%)
Scuola elementare/media 112 (32.9%) 126 (30.9%)
Scuole superiori 174 (51.2%) 184 (45.1%)
Università 45 (13.2%) 78 (19.1%)
Specializzazione/Master Universitario 7 (2.1%) 18 (4.4%)
Age, median (IQR) 49 (37, 59) 50 (35, 61)
Number of Children, median (IQR) 1 (0, 2) 1 (0, 2)
AUDIT 10, median (IQR) 5 (4, 8) 6 (4, 9)
Risky Drinker (Audit 10 >7) (%) 95 (27.5%) 123 (29.6%)
Health Utility – UK Weights, median (IQR) 0.84 (0.77, 1.0) 0.84 (0.77, 1.0)
20. EFAR-Italy
Primary Analysis
• The primary analysis is a comparison between the experimental
conditions of the proportion of risky drinkers as classified by
responses to the AUDIT-10 question scale at 3 months following
randomisation.
• A score of 8 or more on the AUDIT-10 will define a risky or
hazardous drinking.
21. EFAR-Italy
Odds Ratio (95% confidence interval)
Primary Outcome – Pre-specified Subgroup Analyses
0.2 0.3 0.5 1 2
Overall 0.63 (0.45, 0.89; p=0.008)
Odds Ratio (95% CI; P) P Interaction
Male 0.58 (0.39, 0.87; p=0.009)
Female 0.78 (0.36, 1.67; p=0.518)
p=0.450
Age>50 0.45 (0.27, 0.74; p=0.002)
Age ≤50 0.95 (0.59, 1.53; p=0.825)
p=0.028
High Computer Skills 0.46 (0.24, 0.89; p=0.021)
Low Computer Skills 0.75 (0.50, 1.12; p=0.163)
p=0.137
Audit10 >5 0.76 (0.48, 1.18; p=0.213)
Audit10 ≤5 0.41 (0.21, 0.79; p=0.008)
p=0.114
Benefits Facilitated Access Benefits Face to Face
22. EFAR-Italy
Comment
• EFAR Italy achieved its scientific objective;
establishing non inferiority for the facilitated
outcome group in comparison with face to face
intervention for risky drinking on the primary
outcome.
• The actual results indicated at least nominally a
significantly better performance for patients in the
facilitated intervention group.
23. EFAR-Italy
By products
• Randomised trials are feasible in GP
• Internet and new information
technologies can be helpfull
• Facilitated access is a promising
methodology
24. •Progetto per uno strumento
integrativo dell’azione del medico
Entra
The primary outcome shows statistically significant benefit for facilitated outcome compared with standard face to face therapy
There were several interactions of note; in particular that with age (older subjects having a substantial effect, while younger subjects showing no difference).