Improving review appointments for people with long-term conditions
| ISRCTN | ISRCTN40295449 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40295449 |
| IRAS number | 303831 |
| Secondary identifying numbers | IRAS 303831, CPMS 51700 |
- Submission date
- 22/07/2022
- Registration date
- 03/08/2022
- Last edited
- 17/02/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
General practices regularly review patients with long-term health conditions included in the Quality & Outcomes Framework (QOF) using computerised templates (checklists) for each health condition. Reviewing each disease ‘one-at-a-time’ leads to fragmented care for people with multiple long-term health conditions (MLTC) and can ignore conditions that are not included in QOF. These are sometimes the problems that bother patients most. Standardisation of care using checklists can improve safety but a priority in the NHS Plan is also to make care more personalised, and tailored to each individual.
Some practices have replaced separate disease-focused reviews with a combined annual review consultation for people with MLTC. A promising way to balance the benefits of templates with the need to personalise care is to use a ‘smart’ template focused on what matters most to patients, which supports self-management and shared decision-making. It includes links to social prescribing and pharmacist review of complicated medication and involves agreeing a care and support plan. This concept has been shown to improve personalised care in a large research trial. In this project, we will adapt a template already developed for MLTC and make it more personalised. We will make it widely available to general practices, supported with training and other tools e.g. to identify patients with multimorbidity and to use patient questionnaires to gain feedback to improve the process. Working with primary care networks in three areas of England we will support the implementation of this approach (whole-person review, template, training, tools).
To reduce health inequalities, we will start with practices in deprived areas and patients with cardiovascular diseases alongside other conditions. In three practices in deprived areas of Bristol, we will provide more in-depth support and training, as part of developing a broader system change called ‘Maxwell’. We will conduct a more detailed evaluation in this small sub-set of practices to understand whether the additional support and training is useful and what it adds to the provision of the template alone.
Who can participate?
Adults, registered with a participating GP practice, who are due to be invited to an annual review of their long-term conditions within the next 12 months. Participation is by invitation only.
What does the study involve?
Implementation will be informed by established theories that help explain how innovations are adopted into normal practice. Implementation will be evaluated using a range of methods including routinely collected activity and clinical data, questionnaires, and interviews with patients and staff. This project will provide evidence to support and inform the widespread implementation of a ‘whole-person’ review for patients with MLTC in line with the NHS Comprehensive Model for Personalised Care.
What are the possible benefits and risks of participating?
There are no direct benefits from taking part, but participants may find it useful to have the opportunity to talk about their experiences in an interview. Disadvantages of taking part include the time taken for the interview (about 35-45 minutes).
Where is the study run from?
University of Bristol (UK)
When is the study starting and how long is it expected to run for?
From October 2021 to December 2023
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Dr Andrew Turner, andrew.turner@bristol.ac.uk
Contact information
Scientific
University of Bristol
Centre for Academic Primary Care
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
| Phone | +44 (0)7739260678 |
|---|---|
| andrew.turner@bristol.ac.uk |
Principal Investigator
Centre for Academic Primary Care
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
 ORCID ID |
0000-0002-4378-3960 |
|---|---|
| Phone | +44 (0)117331453 |
| C.Salisbury@bristol.ac.uk |
Principal Investigator
Centre for Academic Primary Care
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
| ORCID ID |
0000-0003-0266-3433 |
|---|---|
| Phone | +44 (0)7971739290 |
| rachel.johnson@bristol.ac.uk |
Study information
| Study design | Non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Personalised Primary care for Patients with Multimorbidity (PP4M) – a primary care service improvement initiative |
| Study acronym | PP4M |
| Study objectives | This is a study to implement and evaluate a computerised template for clinicians to conduct combined annual reviews with patients with multiple conditions. The study seeks to explore how best to implement the template and explore the impact of implementing it. |
| Ethics approval(s) | Approved 21/01/2022, Wales REC 6 (Swansea University, Swansea, SA2 8PP; +44 (0)7920 565664, +44 (0)2920 230457; Wales.REC6@wales.nhs.uk), ref 22/WA/0018 |
| Health condition(s) or problem(s) studied | Primary care, multimorbidity |
| Intervention | This is a study to implement and evaluate a computerised template for clinicians to conduct combined annual reviews with patients with multiple conditions. The study seeks to explore how best to implement the template and explore the impact of implementing it. There are three stages to the study development of the intervention, implementation and evaluation. Development of the intervention: The development of the template has already been completed. This involved the research team refining an existing template to make it more patient-centred. The development process drew on the research team's experience and insights developing a similar template for a previous trial, which was informed by extensive patient and public involvement. Implementation of the template: Implementing the template involves using the new template instead of the existing templates that clinicians currently use for conducting annual reviews with patients. The use of templates is already well-integrated into practices' computer systems, meaning this study is not about the technical task of getting the template into practice. Instead, implementation is focused on service improvement, generating buy-in from practice staff for the new template, examining how the template can best fit their needs, and exploring what further refinements may be needed. Implementation will be informed by established theories that help explain how innovations are adopted into normal practice. This will help tailor our implementation strategies to the needs of those using the template. Evaluation of the template: We will use complementary quantitative and qualitative methods in parallel to evaluate the template: this is known as a 'concurrent mixed-method' design. Standard care for annual reviews involves patients being invited and then attending one or more review consultations (which are guided by separate templates for each of their health conditions). This process is streamlined in this study, by doing one ‘whole-person’ review which covers all the patient’s health problems and includes attention to the individual’s priorities and needs. This is all made possible by the new ‘person-centred’ and interactive template. All eligible patients (those with two or more different long-term health conditions) will have anonymous routine data collected about their characteristics and about the health care they receive before and after the use of the template. Up to 200 patients per practice will be asked to complete a questionnaire before and after their review consultation. A small number of patients (about 55 overall, across 24 practices) will additionally be invited to take part in an interview about their experience of the review consultation and/or be invited to have their review consultation observed and recorded by a researcher. General practice staff participants will be invited to complete a questionnaire about how well the template has been implemented (about 7 members of staff per practice) and a smaller number of practice staff (about 55 overall) will be invited to take part in an interview about their experience using the template in practice, and/or be invited to have a review consultation observed and recorded by a researcher. More specific details about the design and methods of each of the evaluation components are given below. Quantitative methods: 1. Collection of anonymous general practice and hospital data from all eligible patients about their general characteristics (e.g. age, sex, ethnicity, health status), about their annual reviews (e.g. attendance, how much was completed), and about outpatient or inpatient care in hospitals. This will be used to explore the uptake of the multimorbidity template, and the costs of and changes in the process of care. 2. Two questionnaire surveys for up to 200 eligible patients per practice: one sent with their invitation to attend a review, and a second sent 2 months after their review. We view this as part of the intervention rather than as a research tool since patient experience surveys are increasingly promoted as a useful part of normal care. The surveys will use an established questionnaire to collect information about how person-centred their experience of care is, along with basic information. This will be used to explore whether and how the template leads to benefits for patients. 3. One questionnaire survey for approximately 7 practice staff (clinical and non-clinical) per practice. The survey will collect information about how well they perceive the template to be implemented, again using a well-established questionnaire designed for this purpose. This will be used to explore how the template leads to benefits for staff and how well it has been integrated into normal care. Qualitative methods: 1. Observation of about 39 review consultations across the study (about 4 consultations in about 6 practices, plus an additional 15 interviews in the three Maxwell practices subject to more in-depth support and evaluation). Observations will focus on the dynamics of the review conversation and the impact of the template on the structure of the conversation. This will be used to explore the different ways the template is used, what benefits it has for patients and clinicians, and how it may be improved. 2. Interviews with about 55 patients overall (about 31 patients altogether from about 9 practices, plus an additional 24 in the three Maxwell practices), after the review consultation has been completed. Some of these interviews may be with patients who have had their consultation observed. Patient interviews will focus on whether the template altered their consultation, whether it increased their sense of personalisation, choice, and control in their care, and whether it will lead to any change in how they manage their health. This will be used to explore how the template leads to benefits for patients. 3. Interviews with about 55 members of practice staff overall (about 31 staff altogether from about 9 practices, plus an additional 24 in the three Maxwell practices). Some of these interviews may be with staff who have had their consultation observed. Staff interviews will focus on the usability and usefulness of the template, as well as ways in which it could be improved. This will be used to explore how the template leads to benefits for staff. There will be a cross-site evaluation of projects funded by the funding stream that supports this (and other) projects. As part of this cross-site evaluation of projects, we will ask practice managers if we can pass on their contact details to the relevant research team. However any recruitment or interviews done for that cross-site evaluation are the responsibility of that external research team and outside the scope of our application for ethics application. |
| Intervention type | Other |
| Primary outcome measure | There is no single primary outcome. The study will use a range of qualitative and quantitative measures to evaluate the implementation of the intervention. Primary quantitative outcome: 1. The number of people who have received a personalised care and support plan as a result of their annual review consultation measured using anonymous general practice and hospital data collected at a single timpoint |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/10/2021 |
| Completion date | 31/12/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 954; UK Sample Size: 954 |
| Total final enrolment | 70 |
| Key inclusion criteria | Practices: 1. Use the EMIS practice computer system 2. Have a subscription to Ardens templates. This applies to most practices within the regions involved in this study. 3. List size of ≥5000 patients Staff: 1. Have used the intervention to conduct reviews with patients, or will soon be doing so 2. Have been involved in the implementation of the intervention within the practice Patients: 1. Registered with a practice that agrees to take part in the evaluation 2. Aged ≥18 years 3. Due to be invited by their practice for an annual review (face-to-face or remote) of their long-term conditions at the practice within the next 12 months 4. Fall under at least two of the following 11 groups of long-term health conditions, including at least one of the conditions asterisked: 4.1. Cardiovascular disease: Coronary heart disease*, hypertension*, heart failure*, peripheral arterial disease, or chronic kidney disease (stage 3 to 5) 4.2. Stroke/TIA* or Atrial fibrillation* 4.3. Diabetes* 4.4. Chronic Obstructive Pulmonary Disease* or Asthma* 4.5. Epilepsy 4.6. Depression or Severe mental health problems (schizophrenia or psychotic illness)* 4.7. Dementia* 4.8. Learning disability 4.9. Rheumatoid arthritis* 4.10. Frailty (severe) The chronic conditions listed above are included because they are common and they benefit from regular review in general practice. The conditions asterisked already lead to annual review consultations in most general practices, to meet the requirements of the QOF. Some conditions (e.g. the first group listed above) are grouped so that two or more diagnoses within the group just count as one for the purpose of defining multimorbidity. Frailty is included because although it is not a single diagnosis, patients with severe frailty are normally reviewed annually so it makes sense to do this as part of the annual multimorbidity review, rather than calling the patient back again. |
| Key exclusion criteria | Practices: 1. Not a subscriber to Ardens clinical templates 2. Does not use EMIS clinical software 3. <5000 registered patients Staff: 1. Not likely to be involved in the implementation or use of the intervention Patients: 1. On a palliative care register 2. Would be excluded from an annual review for individual reasons. For example, for some patients who are housebound or in a nursing home it may not be possible to conduct the same type of ‘template-based’ review away from the surgery. In many cases, community nurses undertake a review without a template, so these reviews would not be relevant to this study of implementation of a template. In some cases, practices offer ‘virtual’ reviews for these patients, and in such cases the practice will be encouraged to use the multimorbidity template. The usefulness of a virtual review will depend on the patient’s combination of conditions and this will be left to the discretion of the practice and clinician. 3. Have declined a review OR have been contacted multiple times unsuccessfully |
| Date of first enrolment | 01/04/2022 |
| Date of final enrolment | 06/10/2023 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
Lewins Mead
Bristol
BS1 2NT
United Kingdom
Newport Road
Albrighton
Wolverhampton
WV7 3FA
United Kingdom
Tollbar Way
Hedge End
Southampton
SO30 2UN
United Kingdom
Sponsor information
University/education
1 Cathedral Square
Bristol
BS1 5DD
England
United Kingdom
| Phone | +44 (0)1174283065 |
|---|---|
| research-governance@bristol.ac.uk | |
| Website | http://bristol.ac.uk/ |
"ROR" |
https://ror.org/0524sp257 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | 30/11/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication of study protocol. Planned publication of results in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Rachel Johnson (rachel.johnson@bristol.ac.uk). In accordance with the University of Bristol’s "Guidance on the retention of research records and data", electronic audio recordings will be held until the study is finished. After this period, electronic audio recordings will be deleted. Anonymised interview transcripts and anonymised analysed data and summaries of data will be held for 10 years after the study is finished unless consent has been provided to permit sharing this data with bona fide researchers, in which case this data will be held for a minimum of 20 years |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3.0 | 25/08/2022 | 13/04/2023 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 3.1 | 14/03/2023 | 17/08/2023 | No | No |
| Statistical Analysis Plan | version 0.4 | 21/11/2023 | 21/11/2023 | No | No |
| Basic results | 17/02/2025 | 17/02/2025 | No | No |
Additional files
Editorial Notes
17/02/2025: Basic results added.
03/12/2024: The intention to publish date was changed from 30/11/2024 to 30/11/2025.
21/11/2023: The statistical analysis plan was uploaded as an additional file.
20/11/2023: The overall end date was changed from 30/11/2023 to 31/12/2023.
13/10/2023: The following changes were made:
1. The recruitment end date was changed from 30/09/2023 to 06/10/2023.
2. The total final enrolment was added.
17/08/2023: The recruitment end date was changed from 31/07/2023 to 30/09/2023. Protocol uploaded (not peer reviewed).
13/04/2023: Protocol uploaded (not peer reviewed).
16/03/2023: The recruitment end date was changed from 31/03/2023 to 31/07/2023.
22/07/2022: Trial’s existence confirmed by the National Institute for Health and Care Research.
