PriDem: best practice in primary care led dementia support
| ISRCTN | ISRCTN11677384 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11677384 |
| IRAS number | 294881 |
| Secondary identifying numbers | CPMS 50252, IRAS 294881 |
- Submission date
- 30/11/2021
- Registration date
- 08/12/2021
- Last edited
- 16/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English Summary
Background and study aims
Dementia is a syndrome (a group of related symptoms) associated with an ongoing decline of brain functioning. Research has highlighted the urgent need for good quality, accessible and equitable post-diagnostic dementia care and support in England. This need has intensified recently due to the COVID-19 pandemic. National guidance summarises evidence-based best practice for post-diagnostic dementia support, but lacks practical advice on how to implement this. The PriDem study aims to develop and deliver accessible, feasible, sustainable primary care-based, post-diagnostic dementia care and support to people with dementia and their families. The ultimate aim is to reduce geographical inequalities in dementia care. In the earlier stages of the PriDem study, previous research and national practice have been explored through a literature review, survey, interviews and in-depth case studies. The findings were then used to develop the PriDem intervention alongside key stakeholders, including people living with dementia, carers ad professionals. The PriDem intervention will be situated within primary care networks (PCNs) and includes a Clinical Dementia Expert who will collaborate with primary care teams to improve local services. The Clinical Dementia Expert will support non-specialists to deliver dementia care and support, improve systems for delivery of evidence based, post diagnostic support and provide personalised care and support plans to meet the complex needs of with people living with dementia and their informal carers.
Who can participate?
This part of the PriDem study (Workstream 4) involves recruiting people living with dementia, their carers and professionals
What does the study involve?
This part of the PriDem study (Workstream 4) investigates feasibility i.e., is the intervention feasible and acceptable, and are the research processes feasible and realistic? It also investigates the factors that might support or hinder implementing this intervention in everyday practice. The researchers will test out the intervention in practice in a small number of Primary Care Networks – two in the Southeast and two in the Northeast of England. A Clinical Dementia Expert will work within the PCN and GP practices. People living with dementia and their carers will be recruited from the practices and asked to complete questionnaires related to wellbeing at the start of the study, and at 4 and 12 months. Interviews with participants will allow researchers to gain insights into their experiences of receiving or delivering dementia care and support. There will also be an audit of care notes of people with dementia from participating GP practices, to look at whether there is an increase in personalised care plans throughout the intervention period.
What are the possible benefits and risks of participating?
Contributing to the study will help future individuals living with dementia to receive improved care. By testing this approach to care, the researchers can see how it will work in practice, how they could improve it, and if they should recommend it being more widely used.
Talking about healthcare experiences can be tiring and possibly distressing. the research team are aware of this and will regularly check with participants if they feel alright to continue, or otherwise would like to take a break (e.g., from an interview)
Where is the study run from?
University College London, in collaboration with Newcastle University (UK)
When is the study starting and how long is it expected to run for?
October 2020 to July 2023
Who is funding the study?
Alzheimer's Society (UK)
Who is the main contact?
Dr Sarah Griffiths
s.a.griffiths@ucl.ac.uk
Contact information
Scientific
Department of Primary Care and Population Health
Upper Third Floor, Royal Free Campus
University College London
London
NW3 2FP
United Kingdom
 ORCID ID |
0000-0002-2652-3163 |
|---|---|
| Phone | +44 (0)20 3108 6699 |
| s.a.griffiths@ucl.ac.uk |
Scientific
Chief Investigator
Department of Primary Care and Population Health
Upper Third Floor, Royal Free Campus
University College London
London
NW3 2FP
United Kingdom
| ORCID ID |
0000-0002-7216-7294 |
|---|---|
| Phone | +44 (0)20 7472 6878 |
| g.rait@ucl.ac.uk |
Study information
| Study design | Interventional non-randomized study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Home |
| Study type | Quality of life |
| Participant information sheet | The PIS is currently undergoing substantial amendments but will be available here when approved: https://www.ucl.ac.uk/epidemiology-health-care/research/primary-care-and-population-health/research/ageing/centre-ageing-population-studies-1 |
| Scientific title | Primary care led post-diagnostic dementia care: Feasibility and implementation study of evidence-based, person-centred sustainable models for future care |
| Study acronym | PriDem |
| Study hypothesis | This feasibility and implementation study hypothesizes that a dedicated clinical dementia expert will be able to improve the care experienced by people living with dementia and their carers within primary care, by improving care planning, upskilling professionals and mapping local services. |
| Ethics approval(s) | Approved 20/09/2021, Wales REC 4 (Address: not available; +44 (0)7976 982591, +44 (0)2920 230457; Wales.REC4@wales.nhs.uk), REC ref: 21/WA/0267 |
| Condition | Dementia |
| Intervention | In order to test the intervention, primary care networks will be provided with a Clinical Dementia Expert (employed by University College London) who will work with the local team to formalise primary care-led systems to support post-diagnostic support and care for people living with dementia and their carers. The intervention is designed to deliver tailored care through ongoing holistic review and care planning and to provide a tiered system of support, as well as building capacity and capability to ensure that non-specialist staff have the skills and knowledge to provide best practice post-diagnostic support to people with dementia and their families. This will involve working with the primary care network staff and associates, through individual or team meetings, mapping current services, reviewing current pathways of care, and integrating evidence-based care practices that will be provided as part of the intervention. During the implementation phase, a range of professionals (e.g., health care professionals and commissioners) will be invited to participate in two audio-recorded qualitative interviews (one at 4 months and one at 12 months – lasting 30-60 minutes) that will explore their experience of the intervention and potential barriers and facilitators to implementation. People living with dementia and their carers will be invited to participate to provide information on the feasibility and implementation of the new model of care. The research team have worked with the PriDem Dementia Care Community (DCC), an inclusive stakeholder group bringing together people with dementia, family members, and representatives, to decide specific timings and numbers of research meetings and ensure that research aims are met without overburdening participants. The person with dementia and carer (where consented) will be interviewed and will complete questionnaires at the start of the study (baseline). These consent and interview meetings may vary in duration depending on the participants’ needs but may take up to 90 minutes (30 minutes consent and 60 minutes questionnaires) for carers and up to 1 hour (30 minutes consent and 30 minutes questionnaires) for the person with dementia, including breaks. This may be split over more than one visit, and may take place with the person with dementia and carer separately or as a dyad, depending on participants’ preferences and abilities. Researchers will approach these visits in a flexible person-centred way. The person living with dementia and the carer will be asked to complete the measures with a researcher individually, either in person, at their home or a different neutral location, or remotely (via telephone or video call), depending on the social restrictions at the time and the preferences of the participants. The questionnaires are validated measures, specifically designed for people living with dementia and their carers, to explore their well-being and quality of life. Later on in the study, researchers will follow up people with dementia and carers again, to complete the same questionnaires, at 4 months and 12 months = three researcher visits to complete interviews/questionnaires over the course of the study. At 4 and 12 months, at the beginning and end of the implementation phase, a sample of people with dementia and carers, who indicated that they would be happy to do so when consented at baseline, will also be offered the opportunity to participate in one audio-recorded qualitative interview that will explore the provision of dementia-related care they have received and expect to receive from their primary care professionals. This interview is likely to last between 45 minutes and one hour. Data collection not involving direct participant contact: Researchers with appropriate research governance approvals will extract data from patient medical records in order to assess primary outcomes of the study (i.e., the number of people on dementia registers in participating GP practices who have personalised care plans and have received dementia reviews). This audit will take place at baseline and 12 months. |
| Intervention type | Behavioural |
| Primary outcome measure | Presence/absence of a personalised care plan: a binary measure of whether or not a recruited person with dementia has a personalised care plan in place, measured at 0 and 12 months |
| Secondary outcome measures | 1. Health-related quality of life for the person living with dementia measured by the DEMQOL, EQ5D-5L, DEMQOL-Proxy and EQ5D-5L proxy at 0, 4 and 12 months 2. Service use measured by the Client Service Use Inventory-adapted for PriDem at 0, 4 and 12 months 3. Psychopathy in the person living with dementia measured by the Neuro-Psychiatric Inventory at 0, 4 and 12 months 4. Carer anxiety and depressions measured by the Hospital Anxiety and depression scale at 0, 4 and 12 months 5. Carer quality of life measured by the C-DEMQOL and EQ5D-5L at 0, 4 and 12 months |
| Overall study start date | 01/10/2020 |
| Overall study end date | 18/07/2023 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 80; UK Sample Size: 80 |
| Total final enrolment | 60 |
| Participant inclusion criteria | People living with dementia (PLWD): 1. Age 18+ years 2. Diagnosis of dementia recorded in patient medical record 3. Registered with a participating practice 4. Community-dwelling 5. Capacity to consent to the study. Where a patient does not have capacity to content, a consultee opinion will be sought Carers: 1. Age 18+ years 2. Identified as a carer of a PLWD. A ‘carer’ is someone who gives care and support to their partner, child, friend, or another close relative. 'Care and support' can mean practical help or emotional support 3. Willing and able to provide informed consent (and acting as a consultee for the PLWD, if applicable) Professionals: 1. Age 18+ years 2. Identified as working for or with PLWD 3. Willing and able to provide informed consent |
| Participant exclusion criteria | People living with dementia (PLWD): 1. Individuals under the age of 18 years 2. Potential participants who are judged as inappropriate for the study by a member of the primary care team (e.g., due to concurrent life events such as bereavement or receiving end of life care) 3. Participants who have an advance statement recorded in their primary care records indicating that they do not wish to take part in research studies 4. People living in a care home Carers: 1. Individuals under the age of 18 years 2. Potential participants who are judged as inappropriate for the study by a member of the primary care team (e.g., due to concurrent life events such as bereavement) 3. Participants who are not fluent English speakers will be excluded since they would be unable to complete the standardised outcome measures and are likely to have difficulties in participating in a qualitative interview Professionals: 1. Health care professionals who do not provide post-diagnostic dementia support |
| Recruitment start date | 21/02/2022 |
| Recruitment end date | 31/07/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
New Barnet
London
EN4 8QZ
United Kingdom
London
N11 1EY
United Kingdom
London
N20 0DH
United Kingdom
Throckley
Newcastle upon Tyne
NE15 9PA
United Kingdom
Newcastle upon Tyne
NE1 8DQ
United Kingdom
Gosforth
Newcastle upon Tyne
NE3 1NB
United Kingdom
Jesmond
Newcastle upon Tyne
NE2 3LD
United Kingdom
Sponsor information
University/education
Joint Research Office
Gower Street
London
WC1E 6BT
England
United Kingdom
| Phone | +44 (0)2076792000 |
|---|---|
| randd@uclh.nhs.uk | |
| Website | http://www.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- alzheimerssoc
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/07/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The researchers also intend to publish the protocol. |
| IPD sharing plan | The researchers will be able to share the quantitative datasets on request but not the qualitative data, which will be pseudonymised rather than anonymised. The contact is Prof. Greta Rait (g.rait@ucl.ac.uk). Participants have consented to their quantitative data being shared with other researchers. Requests to use data will be submitted on a standard form and reviewed by a committee prior to data-sharing agreements being developed. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol article | 18/08/2023 | 21/08/2023 | Yes | No | |
| Statistical Analysis Plan | version 1.0 | 16/01/2023 | 12/09/2023 | No | No |
| Results article | 08/07/2024 | 09/07/2024 | Yes | No | |
| Results article | feasibility and acceptability findings | 13/07/2024 | 16/07/2024 | Yes | No |
Additional files
Editorial Notes
16/07/2024: Publication reference added.
09/07/2024: Publication reference added.
10/04/2024: The intention to publish date was changed from 30/04/2024 to 31/07/2024.
27/03/2024: Internal review.
15/01/2024: The intention to publish date was changed from 31/01/2024 to 30/04/2024.
12/09/2023: The following changes were made to the trial record:
1. The statistical analysis plan was uploaded as an additional file.
2. The overall end date was changed from 30/09/2023 to 18/07/2023.
21/08/2023: Publication reference added.
18/04/2023: IPD sharing statement added.
13/03/2023: The following changes were made to the trial record:
1. The overall trial end date was changed from 31/03/2023 to 30/09/2023.
2. The intention to publish date was changed from 31/03/2024 to 31/01/2024.
3. Total final enrolment added.
29/03/2022: The trial participating centres Roseworth Surgery and The Surgery-Osborne Road were added
19/01/2022: The recruitment start date was changed from 01/01/2022 to 21/02/2022.
30/11/2021: Trial's existence confirmed by the National Institute for Health Research (NIHR) (UK).
