Patient education for alcohol cessation intervention at the time of acute fracture surgery: study protocol for a randomised clinical multi-centre trial on a gold standard programme (Scand-Ankle).
BACKGROUND
Patients with hazardous alcohol intake are overrepresented in emergency departments and surgical wards. These patients have an increased risk of postoperative complications with prolonged hospital stays and admissions to intensive care unit after surgery. In elective surgery, preoperative alcohol cessation interventions can reduce postoperative complications, but no studies have investigated the effect of alcohol cessation intervention at the time of acute fracture surgery. This protocol describes a randomised clinical trial that aims to evaluate the effect of a new gold standard programme for alcohol cessation intervention in the perioperative period regarding postoperative complications, alcohol intake and cost-effectiveness.


METHODS
Patients with hazardous alcohol intake undergoing ankle fracture surgery will be recruited into the trial from multiple orthopaedic wards at university hospitals in Denmark, Sweden and Norway. Included patients will be randomly allocated to either standard care or the gold standard programme aimed at complete alcohol abstinence before, during and 6 weeks after surgery. It includes a structured patient education programme and weekly interventions meetings at the orthopaedic outpatient clinic. Furthermore, patients are provided with thiamine and B-vitamins, alcohol withdrawal prophylaxis and treatment, and disulfiram to support abstinence. Alcohol intake is biochemically validated (blood, urine and breath tests) at the weekly intervention meetings and follow-up visits. Follow-up assessments will be conducted 6 weeks and 3, 6, 9 and 12 months after surgery for all patients. The effect of the gold standard programme will be assessed comparing the outcome measures between the intervention and control group at each follow-up point.


CONCLUSIONS
The study will provide new knowledge about how to prevent alcohol-related postoperative complications at the time of acute fracture surgery. If effective, the results will be a benefit for the clinical course, patients and society alike.


BACKGROUND
The protocol is registered in ClinicalTrials.gov (Id: NCT00986791 ).
WHO-CC, Clinical Health Promotion Centre, Bispebjerg/Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark. Hanne.Tonnesen@regionh.dk.|Clinical Health Promotion Centre, Department of Health Sciences, Lund University, Skåne University Hospital, Malmö, Sweden. Hanne.Tonnesen@regionh.dk.
Hanne
H
Tønnesen
WHO-CC, Clinical Health Promotion Centre, Bispebjerg/Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.|Orthopedic Department, Hospital of Southern Jutland, University of Southern Denmark, Aabenraa, Denmark.
Julie Weber
JW
Egholm
Alcohol and Drug Research Western Norway, Stavanger University Hospital, Stavanger, Norway.
Kristian
K
Oppedal
Department of Orthopaedic Surgery, Bispebjerg/Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.
Jes Bruun
JB
Lauritzen
Department of Orthopaedic Surgery, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
Bjørn Lindegård
BL
Madsen
WHO-CC, Clinical Health Promotion Centre, Bispebjerg/Frederiksberg Hospital, University of Copenhagen, Copenhagen, Denmark.|Clinical Health Promotion Centre, Department of Health Sciences, Lund University, Skåne University Hospital, Malmö, Sweden.
Bolette
B
Pedersen
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D064829:Alcohol Abstinence; D019973:Alcohol-Related Disorders / Q000150:complications / Q000191:economics / Q000628:therapy*; D064386:Ankle Fractures / Q000150:complications / Q000191:economics / Q000601:surgery*; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D005260:Female; D005500:Follow-Up Studies; D005592:Fracture Fixation; D006801:Humans; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000191:economics / Q000379:methods*; D019990:Perioperative Care / Q000191:economics / Q000379:methods*; D011183:Postoperative Complications / Q000191:economics / Q000517:prevention & control*; D016896:Treatment Outcome; D055815:Young Adult