Plain English Summary
Background and study aims
The White Paper Equity and Excellence: Liberating the NHS sets out the governments vision for the long-term future of the NHS with a focus on improving healthcare outcomes for everyone. Since the introduction of the Enhanced Recovery Programme in 2010, patients have been discharged from hospital after surgery and referred back to their general practitioner (GP) sooner than before. The aim of this study is to find out the most common complications patients present to their GP following surgery, what factors lead to a better healthcare outcome for these patients and what exactly a good outcome should be. It involves using a modified version of the Delphi technique, a method that collects the opinions of experts through a number of cycles of carefully designed questionnaires. The answers from each participant are summarised after each cycle to be used in the next one and a consensus eventually reached based on common opinion.
Who can participate?
GPs involved in caring for patients who have just had surgery.
What does the study involve?
The study involves collecting the opinions of GPs in order to reach a consensus as to what complications are most routinely seen in patients referred back to them after surgery and what factors lead to better healthcare outcomes. Each GP is asked to participate in a semi-structured interview and then two rounds of questionnaires.
What are the possible benefits and risks of participating?
There should be no disadvantages of taking part in this study. However, each participant will have to give up their time to attend an interview and complete two questionnaires. This takes a maximum of 70 minutes in total.
Where is the study run from?
Queens Medical Centre, University of Nottingham (UK)
When is the study starting and how long is it expected to run for?
April 2014 to October 2014
Who is funding the study?
Association of Anaesthetists of Great Britain and Ireland (UK)
Who is the main contact?
Dr Rachel Evley
Rachel.Evley@nottingham.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
16569
Study information
Scientific title
To explore general practitioners' views on post-surgical outcomes utilising a consensus Delphi methodology: an observational qualitative study
Acronym
Study hypothesis
Aims
The purpose of this study is to use consensus methodology to define the key complications presented to the general practitioner by the patient following surgery, to determine what factors lead to better outcomes in this population of patients and to define what a good outcome is.
Primary objective
1. To explore what complications/sequelae are presented to general practitioners by the post-surgical patient
2. Utilising a consensus Delphi process methodology to define what a good outcome would be for a post-surgical patient on return to primary care
Experimental protocol and methods
A consensus development method, specifically a modified Delphi technique, will be used to determine what complications are routinely seen in primary care following surgery and what factors lead to better outcomes. Through semi-structured interviews GPs will be asked to define the expected clinical outcomes of four post-operative clinical scenarios for patients on return to a primary care setting. Following on, two questionnaire rounds of the Delphi consensus process will take place. This will produce a consensus on the expected outcomes in the general post-surgical population, the key factors that lead to better outcomes and the expected outcomes for each clinical scenario presented.
Ethics approval
Medical School Research Ethics Committee, University of Nottingham, 14/02/2013, ref: A13122012
Study design
Non-randomised; Observational; Design type: Qualitative
Primary study design
Observational
Secondary study design
Cross-section survey
Trial setting
GP practices
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Topic: Primary Care; Subtopic: Not Assigned; Disease: All Diseases
Intervention
Description: In order to ensure we recruit GPs who understand the issues, have a vision and represent a substantial variety of viewpoints, sample selection in this Delphi study will be purposive. Previous studies have found that a panel size of 10 has provided a diversity of expert opinion and therefore we aim to recruit 20 general practitioners, geographically spread across Nottinghamshire and Leicestershire.
Questionnaire: Likert Scale Questionnaire x 2
Maximum time for completion 20 minutes; semi-structured interview for maximum of 30 minutes; follow-up length: 5 month(s); study entry : registration only
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
Consensus; Timepoint(s): Degree of consensus across statements defined through semi-structured interviews
Secondary outcome measures
N/A
Overall trial start date
28/04/2014
Overall trial end date
31/10/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. General practitioners involved in the primary care of patients who have had recent surgery
2. Male and Female
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 20; UK Sample Size: 20
Participant exclusion criteria
1. Potential participants who do not give informed consent
2. Potential participants who will not be able to participate in a semi-structured interview, and able to complete both questionnaire rounds of the Delphi process.
Recruitment start date
28/04/2014
Recruitment end date
31/10/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen's Medical Centre
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
--
sponsor@nottingham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Other
Funder name
Association of Anaesthetists of Great Britain and Ireland (AAGBI) (UK), Grant Codes: WKR0-2013-0071
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list