PROGETTO STILI DI VITAROBERTO DELLA VEDOVA

XXVII Congresso CSeRMEG 16-17 Ottobre 2015

•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

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

ITALY - BURDEN OF DISEASE ATTRIBUTABLE TO LEADING RISK FACTORS, 2013

LA MODIFICA DELLO STILE DI VITA È ALTAMENTE EFFICACE

MODELLO DI PROMOZIONE DELLA SALUTE (BEATTIE 1991)

Tipi di interventoAutoritarismo

Tecniche di persuasione alla salute Azione legislativa per la salute

Focu

s dell'intervento

Individuale Collettivo

Counselling personale per la salute Sviluppo della comunità orientato alla salute

Negoziazione

British Journal of General Practice, June 2000

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

A randomised controlled non-inferiority trial of primary care-based facilitated access to analcohol reduction website (EFAR-FVG) Italy:design and results

Roberto Della Vedova, MDRegional Centre for the Training in Primary Care (Ceformed)Centro Studi e Ricerche in Medicina Generale (CSeRMEG)

Research TeamPierluigi Struzzo, Emanuele Scafato, Donatella Ferrante, Nick Freemantle, Rachel Hunter, Harris Lygidakis, Richard MacGregor, Francesco Marcatto, Francesca Scafuri, Costanza Tersar and Paul Wallace

EFAR-Italy

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

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

EFAR-Italy

The websiteGPs able to personalise pages with feedback text, upload their photo and signature

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-

5DRANDOMISATION

Face to Face

intervention

Follow up at 3m and 12m

Online intervention

EFAR-Italy

Practice Code Customization Brochures Patients % AUDIT-C % Risky % Randomised % Control % Interven

tion

Total GP 0 brochures 0

Total Yes Customisation 41Total 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

invited3 m FU

completed% 1 y FU

invited1 y FU

completed% Drop outs

7729 1878 1520 707 762 698 92 762 620 81 27

EFAR-Italy

Trial Flow

Facilitated AccessN=347

Face to FaceN=416

Randomised N=763

3 MonthsN=317 1 protocol violation* 29 lost to follow up

3 MonthsN=381 1 protocol violation* 34 lost to follow up

12 MonthsN=285 1 protocol violation 61 lost to follow up

12 MonthsN=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

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)

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.

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

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.

EFAR-Italy

By products

• Randomised trials are feasible in GP• Internet and new information

technologies can be helpfull• Facilitated access is a promising

methodology

•Progetto per uno strumento integrativo dell’azione del medico

Entra

GRAZIE