Condition category
Surgery
Date applied
24/07/2015
Date assigned
19/10/2015
Last edited
19/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Dr Elke Kothmann

ORCID ID

Contact details

Department of Academic Anaesthesia
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

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 measures

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

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

southtees.nhs.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes