Plain English Summary
Background and study aims
The study will pilot the use of a patient safety guide for patients and carers to examine the acceptability of the guide. The Guide has been co-developed with patients, carers and healthcare professionals to provide patients and carers with information that they can use to make their contacts with general practice and primary care safer.
Who can participate?
Patients consulting with any healthcare professionals at a participating general practice at least four times in the previous year (or carer or a patient consulting)
What does the study involve?
The first round of this study will be to co-develop the Guide App for patients and carers. It will be developed for Apple (IOS) and Android devices for patients and carers alongside developing a support toolkit for healthcare professionals to support the use of the Guide in primary care. The support toolkit will include written and online support materials. Two workshops will be held with patients, carers and health professionals to work together to (1) develop the App to explore content, how it will work and what it is meant to achieve, and (2) develop the support toolkit for healthcare professionals to support the use of the guide.
In the second round of the study, the acceptability of the Guide package for patients and carers (including the paper version of the guide, web-based platform and apps) will be explored with patients, carers and health care professionals (including GPs, nurses and pharmacists based within the practice) and general practice staff (including practice managers and receptionists) by piloting the Guide with two general practices. An introductory workshop will include healthcare professionals and general practice staff and will explore opportunities and problem-solving (e.g. logistical challenges) that may be identified to support the rollout of the Guide within the practice. Introductory workshops will be co-facilitated with members of the patient and public involvement (PPI) group.
The third round of the study will be to test the Guide and support toolkit in a larger scale pilot of the Guide and support toolkit with six general practices. There will be a continuous cycle of evaluation during the project to ensure that the lessons learned from the range of stakeholders will guide future rollout at other sites. The evaluation will include interviewing patients, practice staff and other key stakeholders (e.g. pharmacists), to understand if and how the Guide was used, which formats of the Guide were used, feedback and improvements for the Guide and facilitators and barriers to using it. The experiences of patients, carers and healthcare professionals will examine how people have been involved in their care and safety through communication support. Throughout the study, this approach will build on the existing PPI and wider stakeholder involvement (with GPs, pharmacists and carers) in the development of the Guide by continuing to involve PPI contributors and health care professionals in co-designing the intervention, working together to plan and manage the study, co-delivering the support toolkit to the practices, and in sharing the results of the study to different audiences. Wider stakeholder involvement will be ongoing with decision-makers and commissioners and providers of healthcare to maximise improvements in patient safety.
What are the possible benefits and risks of participating?
The researchers do not expect there to be any potential adverse effects for patients or health professionals from participating in this pilot study. Patients and/or carers will be asked to complete two questionnaire packs which take around 30 minutes to complete in total and these will be done 6 months apart. At the end of the study a sample of patients, carers and also health professionals will be asked about their experience of using the guide which will last about 40-60 minutes. The researcher conducting the interviews will be sensitive to the participants’ needs and the interview can be stopped if they become upset but the researchers do not expect this to be the case.
Where is the study run from?
NIHR Greater Manchester Patient Safety Translational Research Centre (UK)
When is the study starting and how long is it expected to run for?
October 2019 to March 2021
Who is funding the study?
NIHR Greater Manchester Patient Safety Translational Research Centre (UK)
Who is the main contact?
Dr Rebecca Morris
rebecca.morris@manchester.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Rebecca Morris
ORCID ID
http://orcid.org/0000-0003-1587-0802
Contact details
NIHR Greater Manchester Patient Safety Translational Research Centre
6th Floor Williamson Building
University of Manchester
Manchester
M13 9PL
United Kingdom
+44 (0)1612750748
rebecca.morris@manchester.ac.uk
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
CPMS 44476, IRAS 261685
Study information
Scientific title
Developing and testing a co-designed patient safety guide: pilot study
Acronym
Study hypothesis
Is the primary care patient safety guide for patients and carers acceptable for patients and carers in routine practice?
Ethics approval
Approved 24/09/2019, NHS London-West London & GTAC Research ethics committee (Boardroom, Commonwealth Building, Hammersmith Hospital, London, W12 0NN, UK; Tel: +44 (0)207 104 8007; Email: NRESCommittee.London-WestLondon@nhs.net), ref: 19/LO/1289
Study design
Non-randomised feasibility study (single-arm) study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
GP practices
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
Patients and carers in routine practice
Intervention
The study will pilot the use of a patient safety guide for patients and carers which has been co-developed with patients, carers and healthcare professionals to examine the acceptability of the guide. The Guide has been developed to provide patients and carers with information that they can use to make their contacts with general practice and primary care safer.
The first round of this study will be to co-develop the Guide App for patients and carers. It will be developed for Apple (IOS) and Android devices for patients and carers alongside developing a support toolkit for healthcare professionals to support the use of the Guide in primary care. The support toolkit will include written and online support materials. Two workshops will be held with patients, carers and health professionals to work together to (1) develop the App to explore content, how it will work and what it is meant to achieve, and (2) develop the support toolkit for healthcare professionals to support the use of the guide.
In the second round of the study, the acceptability of the Guide package for patients and carers (including the paper version of the guide, web-based platform and apps) will be explored with patients, carers and health care professionals (including GPs, nurses and pharmacists based within the practice) and general practice staff (including practice managers and receptionists) by piloting the Guide with two general practices. An introductory workshop will include healthcare professionals and general practice staff and will explore opportunities and problem solving (e.g. logistical challenges) that may be identified to support the rollout of the Guide within the practice. Introductory workshops will be co-facilitated with members of the patient and public involvement (PPI) group.
The third round of the study will be to test the Guide and support toolkit in a larger scale pilot of the Guide and support toolkit with six general practices. There will be a continuous cycle of evaluation informed by Normalisation Process Theory that will be undertaken during the project to ensure that the lessons learned from the range of stakeholders will guide future rollout at other sites. The evaluation will include interviewing patients, practice staff and other key stakeholders (e.g. pharmacists), to understand if and how the Guide was used, which formats of the Guide were used, feedback and improvements for the Guide and facilitators and barriers to using it. The experiences of patients, carers and healthcare professionals will examine how people have been involved in their care and safety through communication support. Throughout the study, this approach will build on the existing PPI and wider stakeholder involvement (with GPs, pharmacists and carers) in the development of the Guide by continuing to involve PPI contributors and health care professionals in co-designing the intervention, working together to plan and manage the study, co-delivering the support toolkit to the practices, and in sharing the results of the study to different audiences. Wider stakeholder involvement will be ongoing with decision-makers and commissioners and providers of healthcare to maximise improvements in patient safety.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 12 months
Secondary outcome measures
1. Patients’ perceptions of patient safety measured using PC-PMOS at baseline and 6 months
2. Health service utilisation measured using the Client Service Receipt Inventory (CSRI) at baseline and 6 months
3. Patients’ health status measured using the 5-level EQ-5D (EQ-5D-5L) at baseline and 6 months
4. Patient empowerment measured using the Empowerment Scale at baseline and 6 months
5. The acceptability of the Patient Safety Guide measured using free text evaluation questions in the 6-month follow-up questionnaire, and semi-structured interviews with patients, carers and healthcare professionals at 6 months
Overall trial start date
01/10/2019
Overall trial end date
01/03/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patient consulting with any healthcare professionals at the practice at least 4 times in the previous year (or carer or a patient consulting)
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Under the age of 18
2. Has not consulted 4 times or more within the last 12 months
Recruitment start date
01/11/2019
Recruitment end date
01/09/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
NIHR Greater Manchester Patient Safety Translational Research Centre
University of Manchester
6th Floor Williamson Building
Oxford Road
Manchester
M13 9PL
United Kingdom
Sponsor information
Organisation
University of Manchester
Sponsor details
Oxford Road
Manchester
M13 9PL
United Kingdom
+44 (0)161 275 5318
FBMHethics@manchester.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR Greater Manchester Patient Safety Translational Research Centre
Alternative name(s)
Greater Manchester PSTRC
Funding Body Type
private sector organisation
Funding Body Subtype
Research institutes and centers
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The protocol will be published. The results of the study will be published in open-access journals as well as in plain English formats through the researchers' website and presented at national and international conferences as well as stakeholder events. As this feasibility study which is not powered for a statistical test, only descriptive statistics will be reported at the final publication.
IPD sharing statement
The data will not be made available as it may contain sensitive information. It will be held by the research team at the University of Manchester.
Intention to publish date
30/11/2020
Participant level data
Not expected to be available
Basic results (scientific)
Publication list