Condition category
Not Applicable
Date applied
21/10/2019
Date assigned
10/02/2020
Last edited
20/04/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Suspended

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

www.patientsafety.manchester.ac.uk/

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

Publication citations

Additional files

Editorial Notes

20/04/2020: Due to current public health guidance, recruitment for this study has been paused. 10/02/2020: Trial's existence confirmed by the NIHR.