Randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website.

BACKGROUND: Brief interventions (BIs) delivered in primary care have been shown to be effective in reducing risky drinking, but implementation is limited. Facilitated access to a digital application offers a novel alternative to face-to-face intervention, but its relative effectiveness is unknown. METHODS: Primary care-based, non-inferiority, randomised controlled trial comparing general practitioner (GP) facilitated access to an interactive alcohol reduction website (FA) with face-to-face BI for risky drinking. Patients screening positive on the short Alcohol Use Disorders Identification Test (AUDIT-C) were invited to participate in the trial. Assessment at baseline, 3 months and 12 months was carried out using AUDIT and EQ-5D-5L questionnaires. FINDINGS: 58 participating GPs approached 9080 patients of whom 4529 (49.9%) logged on, 3841 (84.8%) undertook screening, 822 (21.4%) screened positive and 763 (19·9%) were recruited. 347 (45.5%) were allocated to FA and 416 (54.5%) to BI. At 3 months, subjects in FA group with an AUDIT score of ≥8 reduced from 95 (27.5%) to 85 (26.8%) while those in BI group increased from 123 (20.6%) to 141 (37%). Differences between groups were principally due to responses to AUDIT question 10. Analysis of primary outcome indicated non-inferiority of FA compared with BI, and prespecified subgroup analysis indicated benefits for older patients and those with higher levels of computer literacy and lower baseline severity. Additional analyses undertaken to take account of bias in response to AUDIT question 10 failed to support non-inferiority within the prespecified 10% boundary. INTERPRETATION: Prespecified protocol-driven analyses of the trial indicate that FA is non-inferior to BI; however, identified bias in the outcome measure and further supportive analyses question the robustness of this finding. It is therefore not possible to draw firm conclusions from this trial, and further research is needed to determine whether the findings can be replicated using more robust outcome measures. TRIAL REGISTRATION NUMBER: NCT01638338; Results.

Randomised controlled non-inferiority trial of primary care-based facilitated access to an alcohol reduction website: cost-effectiveness analysis.

OBJECTIVES: To evaluate the 12-month costs and quality-adjusted life years (QALYs) gained to the Italian National Health Service of facilitated access to a website for hazardous drinkers compared with a standard face-to-face brief intervention (BI). DESIGN: Randomised 1:1 non-inferiority trial. SETTING: Practices of 58 general practitioners (GPs) in Italy. PARTICIPANTS: Of 9080 patients (>18 years old) approached to take part in the trial, 4529 (49·9%) logged on to the website and 3841 (84.8%) undertook online screening for hazardous drinking. 822 (21.4%) screened positive and 763 (19.9%) were recruited to the trial. INTERVENTIONS: Patients were randomised to receive either a face-to-face BI or access via a brochure from their GP to an alcohol reduction website (facilitated access). PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome is the cost per QALY gained of facilitated access compared with face-to-face. A secondary analysis includes total costs and benefits per 100 patients, including number of hazardous drinkers prevented at 12 months. RESULTS: The average time required for the face-to-face BI was 8 min (95% CI 7.5 min to 8.6 min). Given the maximum time taken for facilitated access of 5 min, face-to-face is an additional 3 min: equivalent to having time for another GP appointment for every three patients referred to the website. Complete case analysis adjusting for baseline the difference in QALYs for facilitated access is 0.002 QALYs per patient (95% CI -0.007 to 0.011). CONCLUSIONS: Facilitated access to a website to reduce hazardous drinking costs less than a face-to-face BI given by a GP with no worse outcomes. The lower cost of facilitated access, particularly in regards to investment of time, may facilitate the increase in provision of BIs for hazardous drinking. TRIAL REGISTRATION NUMBER: NCT01638338;Post-results.

[Alcohol dependence in the Italian general population: diagnostic criteria according to general practitioners and to the Composite International Diagnostic Interview (CIDI)]. / L'alcoldipendenza nella popolazione generale: i criteri di diagnosi secondo i medici di medicina generale e secondo l'intervista Composite International Diagnostic Interview (CIDI).

OBJECTIVES: to identify the criteria used by general practitioners (GPs) for the diagnosis of alcohol dependence (AD) and to compare them with the criteria of the Composite International Diagnostic Interview (CIDI). DESIGN: cross-sectional correlational study. SETTING AND PARTICIPANTS: the 55 GPs of Friuli Venezia Giulia Region (Northern Italy) and Tuscany Region (Central Italy) who took part in the research conducted a clinical evaluation of the first 40 patients who came for a medical examination. MAIN OUTCOME MEASURES: prevalence of AD diagnosed by GPs and CIDI and their association with sociodemographic variables, other diseases, and alcohol consumption. RESULTS: AD prevalence assessed by the GPs was 5.4%, while AD prevalence assessed by the CIDI was 4.4%, with an overlap of about 26%. Patients identified as AD by the GPs were older and more frequently suffering from liver disease and hypertension than patients identified by the CIDI. CONCLUSIONS: the limited overlap between diagnoses of AD made by GPs and the one made by the CIDI is problematic. GPs appear to identify mainly more severe forms of AD, in which excessive consumption of alcohol is associated with the presence of liver disease, while the CIDI could identify younger patients who have not yet developed diseases. GPs' recognition of AD could be increased by using their expertise along with standardised questionnaires which measure alcohol consumption.

Download Your Doctor: Implementation of a Digitally Mediated Personal Physician Presence to Enhance Patient Engagement With a Health-Promoting Internet Application.

BACKGROUND: Brief interventions delivered in primary health care are effective in reducing excessive drinking; online behavior-changing technique interventions may be helpful. Physicians may actively encourage the use of such interventions by helping patients access selected websites (a process known as "facilitated access"). Although the therapeutic working alliance plays a significant role in the achievement of positive outcomes in face-to-face psychotherapy and its development has been shown to be feasible online, little research has been done on its impact on brief interventions. Strengthening patients' perception of their physician's endorsement of a website could facilitate the development of an effective alliance between the patient and the app. OBJECTIVE: We describe the implementation of a digitally mediated personal physician presence to enhance patient engagement with an alcohol-reduction website as part of the experimental online intervention in a noninferiority randomized controlled trial. We also report the feedback of the users on the module. METHODS: The Download Your Doctor module was created to simulate the personal physician presence for an alcohol-reduction website that was developed for the EFAR-FVG trial conducted in the Italian region of Friuli-Venezia-Giulia. The module was designed to enhance therapeutic alliance and thus improve outcomes in the intervention group (facilitated access to the website). Participating general and family practitioners could customize messages and visual elements and upload a personal photo, signature, and video recordings. To assess the perceptions and attitudes of the physicians, a semistructured interview was carried out 3 months after the start of the trial. Participating patients were invited to respond to a short online questionnaire 12 months following recruitment to investigate their evaluation of their online experiences. RESULTS: Nearly three-quarters (23/32, 72%) of the physicians interviewed chose to customize the contents of the interaction with their patients using the provided features and acknowledged the ease of use of the online tools. The majority of physicians (21/32, 57%) customized at least the introductory photo and video. Barriers to usage among those who did not customize the contents were time restrictions, privacy concerns, difficulties in using the tools, and considering the approach not useful. Over half (341/620, 55.0%) of participating patients completed the optional questionnaire. Many of them (240/341, 70.4%) recalled having noticed the personalized elements of their physicians, and the majority of those (208/240, 86.7%) reacted positively, considering the personalization to be of either high or the highest importance. CONCLUSIONS: The use of a digitally mediated personal physician presence online was both feasible and welcomed by both patients and physicians. Training of the physicians seems to be a key factor in addressing perceived barriers to usage. Further research is recommended to study the mechanisms behind this approach and its impact. TRIAL REGISTRATION: Clinicaltrials.gov NCT 01638338; https://clinicaltrials.gov/ct2/show/NCT01638338 (Archived by WebCite at http://www.webcitation.org/6f0JLZMtq).

People with alcohol use disorders in specialized care in eight different European countries.

AIM: To provide a description of patients receiving alcohol treatment in eight different European countries, including the level of comorbidities and functional limitations. METHODS: Drinking behaviours, DSM-IV alcohol use disorder (AUD), mental and somatic comorbidities, disability and health services utilization of 1767 patients from various specialized treatment settings were assessed as representative for regions of eight European countries. Severity of alcohol dependence (AD) in terms of drinking level was compared with a large representative US sample. RESULTS: Patients in specialized care for AUDs showed high levels of consumption [average level of daily ethanol intake: 141.1 g, standard deviation (SD): 116.0 g], comorbidity [e.g. liver problems: 19.6%, 95% confidence interval (CI): 17.5-21.6%; depression: 43.2%, 95% CI: 40.7-45.8%; anxiety: 50.3%, 95% CI: 47.8-52.9%], disability and health services utilization (average number of nights spent in hospital(s) during the last 6 months: 8.8, SD: 19.5 nights). Severity of AD was similar to the US sample, but European men consumed on average more alcohol daily. CONCLUSIONS: High levels of consumption, somatic and mental comorbidities, disability and functional losses were found in this representative treatment sample, indicating that treatment was initiated only at severe stages of AUDs. Earlier initiation of treatment could help avoid some of the health and social burden.