Condition category
Surgery
Date applied
14/05/2014
Date assigned
14/08/2014
Last edited
14/08/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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?
GP’s 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

Contact information

Type

Scientific

Primary contact

Dr Rachel Evley

ORCID ID

Contact details

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

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.

More details can be found here: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=16569

Ethics approval

Medical School Research Ethics Committee, University of Nottingham, 14/02/2013, 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 measures

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

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

http://www.nottingham.ac.uk/

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes