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
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
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
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.
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.
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
DESIGN OF THE TRIAL
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? www.itatvb.it 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 - 1000 patients per country
GP selection GP practices in the FVG region invited by email 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
Trial website Italian language online facility developed from www.downyourdrink.org.uk Includes modules for screening, consent, assessment randomisation and follow-up www.itatvb.it Incorporates the online facilitated access website ( alcol e salute www.alcolesalute.it) for patients in the experimental group
GP on-line personalisation facility Includes ability for GPs to personalise feedback text and upload their photo and signature
GP on-line personalisation facility: There are several GP personalisation sections
On-line GP facilitation: Patient is welcomed online by their GP
On-line GP facilitation: Patient is given online personalised feedback on their AUDIT score by their GP
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
The online intervention Alcol e Salute was developed and adapted from Down Your Drink *
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
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 www.itatvb.it 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
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
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
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.
Follow-up assessment Follow up at 1 month and 3 months 10 question AUDIT EQ5D Requests sent automatically by email with 2 subsequent reminders at 1 week/ 2 weeks Failure to respond notified to patients GP who then contacts patient by letter/phone
CONDUCT OF THE TRIAL
Stage1: Brochure distribution, online screening, consent, assessment, randomisation
Stage 2: Randomisation, follow-up and analysis
Where are we now?
FINDINGS OF THE PILOT
Distribution of brochures, patient log-ons, AUDIT-C activity, and randomisation by practice Practice Code Brochures Patient log on AUDIT-C Risky Randomised 001 43 21 20 11 8 002 80 43 39 2 2 003 90 47 43 10 8 004 205 82 74 12 12 005 280 90 88 13 13 006 113 74 69 17 15 007 140 50 48 9 9 008 32 19 18 4 2 009 147 27 27 9 7 010 32 31 25 2 2 011 143 61 59 15 10 013 22 17 14 2 1 TOTAL (%) 1327 562 (42%) 524 (93%) 106 (20%) 89 (84%)
Distribution of brochures, patient log-ons, AUDIT-C activity, randomisation by practice Practice Code Brochures Patient log on AUDIT-C Risky Randomised 001 43 21 20 11 8 002 80 43 39 2 2 003 90 47 43 10 8 004 205 82 74 12 12 005 280 90 88 13 13 006 113 74 69 17 15 007 140 50 48 9 9 008 32 19 18 4 2 009 147 27 27 9 7 010 32 31 25 2 2 011 143 61 59 15 10 013 22 17 14 2 1
Distribution of brochures, patient log-ons, AUDIT-C activity, and randomisation by practice Practice Code Brochures Patient log on AUDIT-C Risky Randomised 001 43 21 20 11 8 002 80 43 39 2 2 003 90 47 43 10 8 004 205 82 74 12 12 005 280 90 88 13 13 006 113 74 69 17 15 007 140 50 48 9 9 008 32 19 18 4 2 009 147 27 27 9 7 010 32 31 25 2 2 011 143 61 59 15 10 013 22 17 14 2 1
Distribution of brochures, patient log-ons, AUDIT-C activity, and randomisation by practice Practice Code Brochures Patient log on AUDIT-C Risky Randomised 001 43 21 20 11 8 002 80 43 39 2 2 003 90 47 43 10 8 004 205 82 74 12 12 005 280 90 88 13 13 006 113 74 69 17 15 007 140 50 48 9 9 008 32 19 18 4 2 009 147 27 27 9 7 010 32 31 25 2 2 011 143 61 59 15 10 013 22 17 14 2 1
Distribution of brochures, patient log-ons, AUDIT-C activity, and randomisation by practice Practice Code Brochures Patients AUDIT-C Risky Randomised 001 43 21 20 11 8 002 80 43 39 2 2 003 90 47 43 10 8 004 205 82 74 12 12 005 280 90 88 13 13 006 113 74 69 17 15 007 140 50 48 9 9 008 32 19 18 4 2 009 147 27 27 9 7 010 32 31 25 2 2 011 143 61 59 15 10 013 22 17 14 2 1
Distribution of brochures, patient log-ons, AUDIT-C activity, and randomisation by practice Practice Code Brochures Patient log on AUDIT-C Risky Randomised 001 43 21 20 11 8 002 80 43 39 2 2 003 90 47 43 10 8 004 205 82 74 12 12 005 280 90 88 13 13 006 113 74 69 17 15 007 140 50 48 9 9 008 32 19 18 4 2 009 147 27 27 9 7 010 32 31 25 2 2 011 143 61 59 15 10 013 22 17 14 2 1
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 001 8 5 3 7 7 002 2 1 1 1 1 003 8 4 4 7 7 004 12 7 5 12 12 005 13 9 4 11 11 006 15 11 4 15 14 007 9 5 4 4 4 008 2 1 1 0 0 009 7 5 2 3 3 010 2 0 2 2 1 011 10 4 6 8 7 012 1 0 1 0 0 TOTAL % 89 52 (58%) 37 (42%) 70 (79%) 67 (75%)
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 (37.4-63.4), missing = 2 (2.2%)
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 (0.77-1.00) 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 (0.80-1.00) 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 (0.82-1.00) missing = 21 (23.6%)
Conclusions
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%)
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%)