To explore general practitioners' views on post-surgical outcomes utilising a consensus Delphi methodology

ISRCTN	ISRCTN89449867
DOI	https://doi.org/10.1186/ISRCTN89449867
Secondary identifying numbers	16569

Submission date: 14/05/2014
Registration date: 14/08/2014
Last edited: 20/04/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Rachel Evley
Scientific

Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom

Study information

Study design	Non-randomised; Observational; Design type: Qualitative
Primary study design	Observational
Secondary study design	Cross-section survey
Study setting(s)	GP practice
Study type	Other
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	To explore general practitioners' views on post-surgical outcomes utilising a consensus Delphi methodology: an observational qualitative study
Study objectives	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(s)	Medical School Research Ethics Committee, University of Nottingham, 14/02/2013, ref: A13122012
Health condition(s) or problem(s) studied	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
Primary outcome measure	Consensus; Timepoint(s): Degree of consensus across statements defined through semi-structured interviews
Secondary outcome measures	N/A
Overall study start date	28/04/2014
Completion date	31/10/2014

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Planned Sample Size: 20; UK Sample Size: 20
Key inclusion criteria	1. General practitioners involved in the primary care of patients who have had recent surgery 2. Male and Female
Key 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.
Date of first enrolment	28/04/2014
Date of final enrolment	31/10/2014

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Queen's Medical Centre

Nottingham
NG7 2UH
United Kingdom

Sponsor information

University of Nottingham (UK)
University/education

Queen's Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom

Phone	--
Email	sponsor@nottingham.ac.uk
Website	http://www.nottingham.ac.uk/
"ROR"	https://ror.org/01ee9ar58

Funders

Funder type

Other

Association of Anaesthetists of Great Britain and Ireland (AAGBI) (UK), Grant Codes: WKR0-2013-0071

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

20/04/2017: No publications found in PubMed, verifying study status with principal investigator. Removed dead link from hypothesis.