Plain English Summary
Background and study aims
Complications such as wound infections, chest infections and heart problems are common after major surgery. Up to half of all patients having a major operation experience complications and even though the vast majority of those patients get better and subsequently go home, their quality of life and ability to function as well as they did before their operation can be seriously affected. Hospital based preoperative assessment clinics allow healthcare professionals to detect chronic health conditions such as heart disease and diabetes, which, if not managed properly, can lead to increased death and complication rates. It is now well established that, like these chronic health conditions, certain lifestyles make complications after surgery more likely. These behaviours include: being less active and having poor physical fitness, being underweight or severely obese, smoking and drinking too much alcohol. It is common for patients to have more than one of these factors (e.g. smoking and alcohol excess) with the impact on risk of complications following surgery frequently underestimated by the medical profession. For example, patients who drink even a small amount more than the Government recommended alcohol limit have a 50% increase in the chance of suffering a complication after surgery. Despite this knowledge patients are rarely told to cut down their alcohol consumption before their operation. The prospect of surgery itself provides healthcare professionals a unique opportunity to discuss, and counsel patients about, these adverse behaviours at a time when they are likely to be focused on their health. It may be possible to use this increased focus on health, and frequent contact with healthcare professionals around this time, to help patients make lifestyle behaviour changes that will benefit not only their short-term surgical outcome, but also their long-term health. This research project aims to investigate the attitudes, beliefs and motivations of patients about to undergo major surgery with regards to making changes to their lifestyle before surgery.
Who can participate?
Adult patients (aged at least 18) attending the pre-operative assessment clinic prior to undergoing any operative procedure.
What does the study involve?
Patients are given a questionnaire exploring views about behaviour change prior to major surgery. The questionnaire investigates patient's ratings of motivation, confidence and perceptions on short and long-term behavioural changes and perceptions about multiple behaviour change. The questionnaire also asks the patient their views about the acceptability of different weight loss/gain, physical activity, alcohol reduction and smoking cessation interventions (programs or treatments).
What are the possible benefits and risks of participating?
There are no immediate benefits or risks to participants. However, information gleaned from the study may influence preoperative practice in the future and benefit future patients undergoing surgery.
Where is the study run from?
The questionnaire is run in the pre-operative assessment clinic across 3 different NHS Hospital sites (James Cook University Hospital, York Teaching Hospitals NHS Foundation Trust and Leeds General Infirmary).
When is the study starting and how long is it expected to run for?
August 2015 to March 2016
Who is funding the study?
South Tees Hospitals NHS Foundation Trust (UK)
Who is the main contact?
Dr Elke Kothmann
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.0
Study information
Scientific title
Changing health behaviours prior to surgery: an observational study
Acronym
Study hypothesis
The aim of this study is to explore attitudes, barriers and facilitators to implementing evidence based behaviour change to optimise patients health before major elective surgery.
Ethics approval
The proportionate review sub-committee of the Wales, 08/07/2015, ref: REC 7. 15-WA-0255
Study design
Observational study
Primary study design
Observational
Secondary study design
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Improving patient fitness prior to major elective surgery (prehabilitation).
Intervention
A nurse administered patient questionnaire to explore attitudes, barriers and facilitators to implementing evidence based behavioural change to optimise patients health before major surgery. Responses to questions will be rated on a visual analogue scale.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Visual analogue scale score in response to the questions asked exploring the attitudes, barriers and facilitators to implementing evidence based behavioural and non-behavioural interventions before surgery. It will be to determine patient opinion about behavioural change prior to surgery.
Secondary outcome measures
Descriptive analysis of subgroups of interest e.g. type of surgery, age, socio-economic status and baseline behaviours to look at moderators of response to individual questions.
Overall trial start date
03/08/2015
Overall trial end date
01/03/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
All adult patients (minimum 18 years of age) attending the preoperative assessment clinic prior to undergoing any operative procedure.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
100-150
Participant exclusion criteria
1. Patients aged 18 years and under
2. Patients lacking capacity to consent and complete questionnaires
Recruitment start date
03/08/2015
Recruitment end date
01/03/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Trial participating centre
York Teaching Hospitals NHS Foundation Trust
Wigginton Road
York
YO31 8HE
United Kingdom
Trial participating centre
Leeds General Infirmary
Great George Street
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
South Tees Hospitals NHS Foundation Trust
Sponsor details
James Cook University Hospital
Middlesbrough
TS4 3BW
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
South Tees Hospitals NHS Foundation Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We anticipate that we will publish our findings in an appropriate peer reviewed journal and present our findings at a national presentation. We expect to achieve this in the summer/autumn 2016.
Intention to publish date
01/07/2016
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list