Working with patients, carers and healthcare professionals to develop and test a guide for patients and carers in primary care

ISRCTN ISRCTN90222092
DOI https://doi.org/10.1186/ISRCTN90222092
IRAS number 261685
Secondary identifying numbers CPMS 44476, IRAS 261685
Submission date
21/10/2019
Registration date
10/02/2020
Last edited
22/01/2021
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Other
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 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 2022 (updated 23/11/2020, previously: 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

Study website

Contact information

Dr Rebecca Morris
Scientific

NIHR Greater Manchester Patient Safety Translational Research Centre
6th Floor Williamson Building
University of Manchester
Manchester
M13 9PL
United Kingdom

ORCiD logoORCID ID 0000-0003-1587-0802
Phone +44 (0)1612750748
Email rebecca.morris@manchester.ac.uk

Study information

Study designNon-randomised feasibility study (single-arm) study
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)GP practice
Study typeOther
Participant information sheet Not available in web format, please use contact details to request a participant information sheet.
Scientific titleDeveloping and testing a co-designed patient safety guide: pilot study
Study objectivesIs the primary care patient safety guide for patients and carers acceptable for patients and carers in routine practice?
Ethics approval(s)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
Health condition(s) or problem(s) studiedPatients and carers in routine practice
InterventionThe 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 typeBehavioural
Primary outcome measureRecruitment rate recorded as the number of eligible participants who consent to participate in the study by 12 months
Secondary outcome measures1. 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 study start date01/10/2019
Completion date01/03/2022

Eligibility

Participant type(s)Mixed
Age groupAdult
SexBoth
Target number of participants150
Key inclusion criteriaPatient consulting with any healthcare professionals at the practice at least 4 times in the previous year (or carer or a patient consulting)
Key exclusion criteria1. Under the age of 18
2. Has not consulted 4 times or more within the last 12 months
Date of first enrolment01/11/2019
Date of final enrolment03/10/2021

Locations

Countries of recruitment

  • England
  • United Kingdom

Study 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

University of Manchester
University/education

Oxford Road
Manchester
M13 9PL
England
United Kingdom

Phone +44 (0)161 275 5318
Email FBMHethics@manchester.ac.uk

Funders

Funder type

Government

NIHR Greater Manchester Patient Safety Translational Research Centre
Private sector organisation / Research institutes and centers
Alternative name(s)
Greater Manchester PSTRC
Location
United Kingdom

Results and Publications

Intention to publish date01/03/2023
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planThe 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 planThe 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.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 20/01/2021 22/01/2021 Yes No
HRA research summary 28/06/2023 No No

Editorial Notes

22/01/2021: Publication reference added.
23/11/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/09/2020 to 03/10/2021.
2. The overall end date was changed from 01/03/2021 to 01/03/2022.
3. The plain English summary was updated to reflect these changes.
4. The intention to publish date was changed from 30/11/2020 to 01/03/2023.
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.