Randomised controlled non-inferiority trial of primary care based facilitated access to an alcohol reduction website (EFAR-FVG) - pilot study findings

Transcription

1 INEBRIA, Rome, September 19 th -20 th 2013 Randomised controlled non-inferiority trial of primary care based facilitated access to an alcohol reduction website (EFAR-FVG) - pilot study findings Piero Struzzo, Roberto Della Vedova, Costanza Tersar, Lisa Verbano, Harris Lygidakis, Richard MacGregor, Nick Freemantle, Emanuele Scafato, Paul Wallace

2 SBI in primary care - the know / do gap Good evidence about effectiveness of screening and brief intervention in primary care, but only small minority receive help In primary care, <10% at risk drinkers identified, and < 5% receive brief intervention A combination of factors are thought to be responsible for this know / do gap

3 The know / do gap - barriers to implementation Lack of confidence in dealing with screening and brief interventions for alcohol Lack of contractual / financial incentives Lack of training and support Fear of offending patients Time constraints Face-to-face brief intervention can add up to 15 minutes to consultation

4 Rationale for the EFAR trial Providing facilitated access to an alcohol reduction website could be a promising alternative to the face-to-face brief intervention. There is growing access to the necessary technology Evidence regarding the effectiveness of such a solution is limited.

5 What is facilitated access? Facilitated access involves health professionals actively encouraging their patients to use a digitally mediated health intervention such as a website. In the UK it is familiar to primary care and mental health professionals through the established model of providing facilitated access to computerised cognitive behavioural therapy programmes such as Beating the Blues and Fear Fighter.* * Department of Health. Improving Access to Psychological Therapies Implementation Plan: National guidelines for regional delivery. London: Department of Health; 2008.

6 Aim of the study Overall: To evaluate whether online facilitated access to an alcohol reduction website for at-risk drinkers is as effective as face-to-face brief intervention conducted by GPs Pilot: To test the feasibility of the trial design

7 DESIGN OF THE TRIAL

8 The EFAR FGV trial key features Non-inferiority randomised controlled trial Participating GPs are all in the Italian Region of Friuli Venezia Giulia (FVG) GPs role is to actively promote the use of the alcohol screening component of the health website Ti Vuoi Bene? On-line consent, assessment, randomisation and follow-up Comparison is between face to face and online intervention for risky drinkers Effect size to be excluded: 5% difference Required sample size patients per country

9 GP selection GP practices in the FVG region invited by and letter to participate in study Offer of training and modest financial incentives relating to trial activity Preference given to practices with at least 1000 registered patients 12 practices selected for pilot study

10 Trial website Italian language online facility developed from Includes modules for screening, consent, assessment randomisation and follow-up Incorporates the online facilitated access website ( alcol e salute for patients in the experimental group

11 GP on-line personalisation facility Includes ability for GPs to personalise feedback text and upload their photo and signature

12 GP on-line personalisation facility: There are several GP personalisation sections

13 On-line GP facilitation: Patient is welcomed online by their GP

14 On-line GP facilitation: Patient is given online personalised feedback on their AUDIT score by their GP

15 On-line GP facilitation: Patients randomised to facilitated access to the alcohol reduction website Alcol e Salute get online encouragement to register from their GP

16 The online intervention Alcol e Salute was developed and adapted from Down Your Drink *

17 Training GPs required to attend a 1 day event. Presentation of overview of EFAR FVG trial Training on face to face brief intervention Participants encouraged to familiarise themselves with the trial website Opportunity to use menu-driven facility to create own tailored patient messages

18 GP facilitated online recruitment via the Ti Vuoi Bene? brochure and website Active distribution by GPs of brochure with personalised log-in code Code provides access to with screening module using the AUDIT-C Cut point of 5 used to identify risky drinkers Those scoring at or above cut point invited to take part in study

19 Patient eligibilty to receive brochure All patients aged 18 and over who attend practice Exclusion criteria: Aged 80+ Severe psychiatric disorder, visual impairment or terminal illness Inadequate command of Italian language

20 Consent and baseline assessment Screen positive patients asked to complete online consent form Assessment includes: Demographics questionnaire 10 question AUDIT validated Italian version EQ5D validated Italian version

21 Randomisation and offer of control / experimental interventions Completion of questionnaires results in online randomisation Patients randomised to control (face to face) intervention receive a message inviting them to make an appointment to see GP. Patients randomised to experimental (online facilitated access) are invited by GP online to register and use the online intervention for at least 15 minutes.

22 Follow-up assessment Follow up at 1 month and 3 months 10 question AUDIT EQ5D Requests sent automatically by with 2 subsequent reminders at 1 week/ 2 weeks Failure to respond notified to patients GP who then contacts patient by letter/phone

23 CONDUCT OF THE TRIAL

24 Stage1: Brochure distribution, online screening, consent, assessment, randomisation

25 Stage 2: Randomisation, follow-up and analysis

26 Where are we now?

27 FINDINGS OF THE PILOT

28 Distribution of brochures, patient log-ons, AUDIT-C activity, and randomisation by practice Practice Code Brochures Patient log on AUDIT-C Risky Randomised TOTAL (%) (42%) 524 (93%) 106 (20%) 89 (84%)

29 Distribution of brochures, patient log-ons, AUDIT-C activity, randomisation by practice Practice Code Brochures Patient log on AUDIT-C Risky Randomised

30 Distribution of brochures, patient log-ons, AUDIT-C activity, and randomisation by practice Practice Code Brochures Patient log on AUDIT-C Risky Randomised

31 Distribution of brochures, patient log-ons, AUDIT-C activity, and randomisation by practice Practice Code Brochures Patient log on AUDIT-C Risky Randomised

32 Distribution of brochures, patient log-ons, AUDIT-C activity, and randomisation by practice Practice Code Brochures Patients AUDIT-C Risky Randomised

33 Distribution of brochures, patient log-ons, AUDIT-C activity, and randomisation by practice Practice Code Brochures Patient log on AUDIT-C Risky Randomised

34 Randomisation and follow-up at 1 month and 3 months Practice Code Randomised Face to face Facilitated access 1 month FU completed 3 month FU completed TOTAL % (58%) 37 (42%) 70 (79%) 67 (75%)

35 Baseline characteristics of the subjects Item Value Male (%) 57 (64.0%) Educational level Missing=4 (4.5%) 1 24 (28.2%) 2 44 (51.8%) 3 12 (14.1%) 4 5 (5.9%) Marital Status Missing=2 (2.2%) Not married 23 (26.4%) Separated 6 (6.9%) Married 53 (60.9%) Widowed 5 (5.8%) Ethnicity Missing=3 (3.4%) Non-Italian 2 (2.3%) Italian Caucasian 84 (97.7%) Familarity with computers Missing=2 (2.2%) Not familiar 21 (24.1%) Fairly familiar 23 (26.4) Familiar 22 (25.3%) Very familiar 21 (24.1%) Children Missing=5 (5.6%) 0 33 (39.3%) 1 22 (26.2%) 2 22 (26.2%) 3 7 (8.3%) Age (years) median, (interquartile range IQR) 53.8 ( ), missing = 2 (2.2%)

36 AUDIT C, AUDIT 10 and EQ5D results: all subjects - baseline, 1 month and 3 months Baseline Audit C median, (IQR) 5 (5-6) missing = 0 Audit Total median, (IQR) 6 (5-9) missing = 0 EQ5D median, (IQR) 0.84 ( ) missing = 0 One month follow-up Audit C median, (IQR) 4 (3-5) missing = 18 (20.2%) Audit Total median, (IQR) 5 (4, 9), missing = 18 (20.2%) EQ5D median, (IQR) 1.00 ( ) missing = 18 (20.2%) Three month follow up Audit C median, (IQR) 4 (3-5) missing = 21 (23.6%) Audit Total median, (IQR) 4 (4-8) missing = 21 (23.6%) EQ5D median, (IQR) 0.94 ( ) missing = 21 (23.6%)

37 Conclusions

38 Conclusions Overall performance of the trial is acceptable GP facilitated online recruitment using brochures is feasible, but variable (22-280) On-line screening via TVB website is generally effective (~20%) Most screen +ve patients go on to provide consent & complete baseline assessment (84%) Online randomisation is feasible Follow-up rates are generally good (1m ~ 80%, 3m ~75%)

39 Issues arising from pilot Variable GP brochure distribution rates (22-280) Imbalance of randomisation groups (58% vs 42%) Potential to improve the engagement of patients with the intervention website Potential to improve follow-up rates (ideally should be at least 90%)