Abstract

Background Hazardous alcohol consumption is a risk factor for developing postoperative complications. Other risk factors are smoking, overweight, malnutrition and physical inactivity. Preoperative alcohol and smoking cessation programs have been found effective in reducing postoperative morbidity, but it remains unknown whether these induce a general change of lifestyle. The aim of this study was to investigate whether the gold standard alcohol intervention programme (GSP-A, which is based on the gold standard programme for smoking GSP-S) used in the Scand-Ankle study, affected the non-targeted risk factors; smoking, overweight, malnutrition and physical inactivity.

Method 64 patients with hazardous alcohol consumption who underwent ankle fracture surgery, were randomized to the GSP-A or usual care (control). The groups were compared at baseline and 6 weeks follow-up regarding lifestyle factors. An intention to treat (ITT) and per protocol analysis were performed using non-parametric statistics.

Results The ITT-analysis showed no significant differences between the GSP-A and control group regarding non-targeted risk factors. The per protocol analysis showed that alcohol cessation regardless of study group did not influence non-targeted risk factors.

Conclusion The GSP-A did not affect smoking, overweight, malnutrition and physical inactivity. Thus, a potential effect of the GSP-A on postoperative complications will likely be due to the effect on alcohol intake and not a general change in lifestyle. The findings suggest that multiple lifestyle interventions are required, e.g. combined alcohol and smoking cessation. 

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Introduction

High alcohol consumption is a major risk factor for post-operative complications, including general infections, wound complications, pulmonary complications, prolonged hospital stay and increased mortality (1). In addition to hazardous drinking it is well-known that smoking, being overweight, malnutrition and physical inactivity also constitute major risk factors for post-operative complications (2-9). Intensive preoperative alcohol and smoking cessation intervention programs have been found to be effective at reducing postoperative complications and morbidity (10;11). Further, a postoperative smoking cessation intervention has also shown a beneficial effect on postoperative complications following acute fracture surgery (12).

Alcohol consumption and smoking are known to be associated with one another, with smokers drinking more alcohol than non-smokers (13-15), and heavy drinking being associated with heavy smoking (16). However, it is still unclear to what extent alcohol interventions affect non-targeted risk factors as smoking. To our knowledge the effect of intensive alcohol intervention in a surgical setting on other non-targeted lifestyle factors has not previously been investigated. The aim of this study was therefore to investigate whether the gold standard programme for alcohol cessation (GSP-A) induced smoking cessation, and also whether or not it had an effect on overweight status, risk of malnourishment and physical inactivity. Our hypothesis was that the GSP-A, targeting alcohol consumption, would result in a healthier lifestyle in general. The GSP-A has been proven effective on alcohol cessation in the setting of this study; 58% of the patients stopped drinking for 6 weeks in the GSP-A group vs. 13% in the control group (17).

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Methods

Study design

This is a sub-study of the Scand-Ankle study, which is an ongoing randomized clinical trial (RCT) that investigates the effect of a new GSP-A on postoperative complications, alcohol intake and cost-effectiveness in hazardous drinking patients undergoing ankle fracture surgery (ClinicalTrials.gov Id: NCT00986791). Inclusion and exclusion criteria Patients were included if they during the past three months had an alcohol consumption of ≥21 units/week (one unit equals 12 g of ethanol), were undergoing ankle fracture surgery, and gave informed consent for participation within 36 hours of admission.

Patients were excluded if they were under the age of 18 or otherwise unable to give informed consent, were pregnant or breastfeeding, were allergic to disulfiram or benzodiazepines, had previously experienced delirium or alcohol withdrawal seizures, had multiple or pathological fractures, had an American Society of Anesthesiologist (ASA) score ≥4 or fulminant heart or liver insufficiency, if the surgery was cancelled or the patient received external fixation of the fracture.

Study groups

Out of 141 eligible patients, 64 patients gave informed consent to participate in the study. The patients were recruited from Bispebjerg Hospital and Hvidovre Hospital in Denmark between April 2010 and October 2013 and were allocated to GSP-A (n=32) or usual care/control (n=32). They were stratified for each center and blockrandomized in blocks of unknown sizes.

The intervention group began the 6 week GSP-A immediately before or after surgery, consisting of a structured patient education program with weekly meetings (5 in total), including a motivational conversation in the beginning with reflections on benefits and costs of continued drinking vs cessation, and teaching sessions on the damaging effects of alcohol as well as discussions of risk situations and relapse prevention. Further, the intervention group received disulfiram (200 mg x 2 per week) and B-vitamin and Thiamin. The patients in the intervention group also received benzodiazepines if they developed abstinences. The GSP-A is developed based on the gold standard programme for smoking cessation with the same structure and content adapted to alcohol cessation (18). The control group received the orthopedic department’s standard care for patients with ankle fracture and hazardous alcohol intake, which include screening all patients with hazardous alcohol intake for abstinence and treatment with benzodiazepines if needed.

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All participants were free to seek alcohol treatment outside of the GSP-A. All participants were also informed of smoking as a risk factor for postoperative complications, and recommended to quit smoking, as part of the routine, but it was not further mentioned unless the participant brought it up. Both groups were followed up at 6 weeks. All patients underwent internal fixation and anaesthesia according to the department’s routine, including thrombo-embolic and antibiotic prophylaxis.

Registration of lifestyle factors/Outcomes

The lifestyle factors were registered at baseline and at follow-up after 6 weeks and defined as; Smoking: daily smoking, Overweight: BMI> 25 kg/m2 and/or waist measurement >80 cm(W)/94 cm(M). Subjects were weighed and had their waist measured by the investigator with measuring tape. Height was self-reported. Risk of malnutrition: BMI<20,5 kg/m2 and/or weight loss during the last 3 months and/or reduced food intake during the last week and/or severe endocrine stress metabolism. Physical inactivity was self-reported as physical activity <30 min per day during the last month (19,20).

Analyses

Three of the 64 patients were excluded in this analysis. Two patients from the control group were excluded shortly after inclusion because they underwent external fixation. One patient in the GSP-A group withdrew the informed consent on the same day as inclusion, and there was therefore no data on this patient. For patients who dropped out or cancelled their 6-week follow-up, baseline data was used for analyses. The follow-up rate at 6 weeks was 88% in the GSP-A group, and 93% in the control group (see trial profile in figure 1).

Data were presented as numbers (percentages) and medians (range). The two groups were compared at baseline and follow-up regarding the individual lifestyle factors by intention to treat using non-parametric statistics; Fischer’s exact test and Pearson Chi-square. The same method was used to perform the per protocol analyses, which investigated the effect of alcohol abstinence, regardless of study group, on lifestyle risk factors. P-values < 0.05 were considered statistically significant.

A sample size calculation was performed to provide an estimate on how many study subjects would be required to find a 20% decrease in daily smoking with a risk of type 1 error on 5% and a type 2 error of 20% (n=2825). The analyses were performed in IBM SPSS v. 19 and Excel 2010.