PARTNERS2: A cluster randomised control trial of a model of collaborative care for people with a diagnosis of bipolar, schizophrenia or other psychoses
| ISRCTN | ISRCTN95702682 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN95702682 |
| Protocol serial number | 36484 |
| Sponsor | Birmingham and Solihull Mental Health Foundation Trust |
| Funder | National Institute for Health Research |
- Submission date
- 16/10/2017
- Registration date
- 26/10/2017
- Last edited
- 21/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Schizophrenia, bipolar and other psychosis are types of severe mental illness. Mental illness is the single largest cause of disability in the UK, contributing up to 22.8% of the total burden. These conditions lead to economic costs as a result of lost productivity and service costs. Furthermore, these conditions lead to poor physical health outcomes for those affected, as a result of increased prevalence of comorbid health conditions in these populations and a severely reduced life expectancy, believed to be up to 20 years shorter than the general population. Many people with a diagnosis of schizophrenia, bipolar and other types of psychosis have minimal and poorly coordinated primary and specialist care. PARTNERS2 aims to help primary care (GPs and Practices Nurses) and community mental health services (also called CMHTs) work more closely together by developing a system of collaborative care based in GP surgeries. Although primary care provides support to people with mental health problems, the coordination with secondary care is challenging in many areas of the country. Service user feedback states that some GPs do not contain sufficient specialist knowledge to support schizophrenia, bipolar and other psychosis; practitioners report the same knowledge and skills gap in primary care. It is hoped that by introducing someone who is trained in secondary mental health care, such as a psychiatric nurse, into general practice, will help improve care of people with these conditions. The mental health specialist, known as a ‘Care Partner’, will work with other health care providers, service users, their carers, friends and family as a team. The Care Partner will use methods such as coaching, motivational strategies and work with general practice staff to address individuals’ emotional, social and physical needs in a co-ordinated way. The aim of this study is to examine if this programme will enhance primary mental and physical health care provision and deliver better outcomes for individuals and their families.
Who can participate?
Adults aged 18 and older with schizophrenia, bipolar or other types of psychosis.
What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive their usual care. Those in the second group work with a care partner who are based in their primary care centre. The Care Partner works to provide support for physical, mental and social health using a coaching goal-setting model. The Care Partner works with the participant for 12 months meeting on a regular basis. Both groups of participants will complete measures at month 0 and month 10, which seek to understand their state of wellbeing, quality of life, mental and physical health. Health economics measures will also be utilised to look at the costs of this new service. Results between the two groups will then be compared to see if the new service is beneficial and cost effective.
What are the possible benefits and risks of participating?
Participants may benefit from improvements in the planning of their care. There are no direct risks with participating.
Where is the study run from?
This study is being run by the University of Birmingham and takes place in at GP sites filtering into Birmingham and Solihull Mental Health Foundation Trust, Livewell South West, Cornwall Partnership NHS Foundation Trust, or Somerset Partnership NHS Trust. They are part of CRN West Midlands and CRN South West Peninsula.
When is the study starting and how long is it expected to run for?
October 2016 to May 2021
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Dr Humera Plappert
h.plappert@bham.ac.uk
Contact information
Scientific
Primary Care Clinical Sciences
University of Birmingham
Birmingham
B15 2TT
United Kingdom
| Phone | +44 (0)1214146947 |
|---|---|
| h.plappert@bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment, Process of Care, Psychological & Behavioural, Management of Care |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The PARTNERS2 Study: Trial of primary care based collaborative care for people with a diagnosis of schizophrenia, or bipolar or other types of psychosis |
| Study acronym | PARTNERS2 |
| Study objectives | The aim of this study is to determine the feasibility, effectiveness, safety and acceptability of a primary care based collaborative care model for adults in England with a clinical diagnosis of schizophrenia, bipolar, or other types of psychosis [diagnostic clusters 11 and 12] . |
| Ethics approval(s) | West Midlands-Edgbaston REC, 29/06/2017, ref: 14/WM/0052 |
| Health condition(s) or problem(s) studied | Schizophrenia, bipolar disorder or psychosis |
| Intervention | Current interventions as of 22/12/2020: Cluster randomisation is done at GP Practice level. Participant numbers are across four localities: Birmingham and Solihull Mental Health NHS Foundation Trust, the South-West (Cornwall Partnership NHS Foundation Trust and Livewell South West) and Somerset Partnership NHS Trust. Recruitment is phased, each participant in the intervention arm receive up to 12 months of intervention, the entire intervention phase is expected to be 24 months. Participants are allocated to either the intervention or control group. Intervention group: Those in the intervention arm work with a Care Partner (a secondary care mental health worker) who are based in primary care with the participants’ GP practice. The Care Partner work to provide collaborative physical, mental, and social health for the participant using a coaching goal-setting model. The Care Partner work with each participant for 12 months, meeting on a regular basis. As the model is individualised care, the frequency of meeting will vary. The collaborative care intervention works by structural change that supports care partners to be able to work across primary and secondary care. It also provides information and knowledge through a manual and protocols, training, supervision, structured monitoring and assessment and the context of primary care. It aims to improve the relationship between the care partner and the patient, involving ongoing development of shared understanding and coaching to help the patient be more confident and proactive about their health. Control group: Participants in the control arm of the trial continue with their usual care are managed solely by their own GP and primary care practice staff and with secondary care specialist mental health services (if required). Crucially, they do not receive any contact with the PARTNERS care partner. Follow up of participants in both arms of the trial takes place at month 10. Some participants are invited to take part in the process evaluation. The primary outcome for the randomised control trial is the change in quality of life. The secondary outcome measures are personal recovery, time use, experience of care, physical health and capability, health economics, mental wellbeing and safety variables (Admissions: number of admissions and total days in patient, Crisis care: number of episodes under home treatment team and total days under home treatment team). There is also an process evaluation. Previous interventions from 28/10/2020 to 22/12/2020: Cluster randomisation is done at GP Practice level. Participant numbers are across three sites: Birmingham and Solihull Mental Health NHS Foundation Trust, the South-West (Cornwall Partnership NHS Foundation Trust and Livewell South West) and Somerset Partnership NHS Trust. Recruitment is phased, each participant in the intervention arm receive up to 12 months of intervention, the entire intervention phase is expected to be 24 months. Participants are allocated to either the intervention or control group. Intervention group: Those in the intervention arm work with a Care Partner (a secondary care mental health worker) who are based in primary care with the participants’ GP practice. The Care Partner work to provide collaborative physical, mental, and social health for the participant using a coaching goal-setting model. The Care Partner work with each participant for 12 months, meeting on a regular basis. As the model is individualised care, the frequency of meeting will vary. The collaborative care intervention works by structural change that supports care partners to be able to work across primary and secondary care. It also provides information and knowledge through a manual and protocols, training, supervision, structured monitoring and assessment and the context of primary care. It aims to improve the relationship between the care partner and the patient, involving ongoing development of shared understanding and coaching to help the patient be more confident and proactive about their health. Control group: Participants in the control arm of the trial continue with their usual care are managed solely by their own GP and primary care practice staff and with secondary care specialist mental health services (if required). Crucially, they do not receive any contact with the PARTNERS care partner. Follow up of participants in both arms of the trial takes place at month 10. Some participants are invited to take part in the process evaluation. The primary outcome for the randomised control trial is the change in quality of life. The secondary outcome measures are personal recovery, time use, experience of care, physical health and capability, health economics, mental wellbeing and safety variables (Admissions: number of admissions and total days in patient, Crisis care: number of episodes under home treatment team and total days under home treatment team). There is also an process evaluation. Previous interventions: Cluster randomisation is done at GP Practice level. Participant numbers are across three sites: Birmingham and Solihull Mental Health NHS Foundation Trust, Blackburn with Darwin (Lancashire Care NHS Foundation Trust) and the South-West (Cornwall Partnership NHS Foundation Trust and Livewell South West). Recruitment is phased, each participant in the intervention arm receive up to 12 months of intervention, the entire intervention phase is expected to be 24 months. Participants are allocated to either the intervention or control group. Intervention group: Those in the intervention arm work with a Care Partner (a secondary care mental health worker) who are based in primary care with the participants’ GP practice. The Care Partner work to provide collaborative physical, mental, and social health for the participant using a coaching goal- setting model. The Care Partner work with each participant for 12 months, meeting on a regular basis. As the model is individualised care, the frequency of meeting will vary. The collaborative care intervention works by structural change that supports care partners to be able to work across primary and secondary care. It also provides information and knowledge through a manual and protocols, training, supervision, structured monitoring and assessment and the context of primary care. It aims to improve the relationship between the care partner and the patient, involving ongoing development of shared understanding and coaching to help the patient be more confident and proactive about their health. Control group: Participants in the control arm of the trial continue with their usual care care are managed solely by their own GP and primary care practice staff and with secondary care specialist mental health services (if required). Crucially, they do not receive any contact with the PARTNERS care partner. Follow up of participants in both arms of the trial takes place at month 10. Some participants are invited to take part in the process evaluation. The primary outcome for the randomised control trial is the change in quality of life. The secondary outcome measures are personal recovery, time use, experience of care, physical health and capability, health economics, mental wellbeing and safety variables (Admissions: number of admissions and total days in patient, Crisis care: number of episodes under home treatment team and total days under home treatment team). There is also an process evaluation. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
1. Feasibility of the study is measured using practice recruitment rates, patient eligibility rates (via screening logs), patient recruitment rates, patient retention rates |
| Key secondary outcome measure(s) |
1. Time Use is measured using modified ONS Time Use Survey (TUS) at baseline and 10 months |
| Completion date | 01/05/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 204 |
| Total final enrolment | 198 |
| Key inclusion criteria | 1. Registered with a participating GP practice 2. Aged 18 years and over 3. A clinical diagnosis of schizophrenia, bipolar, or other types of psychosis schizoaffective disorder (including lifetime and current) or has evidence of chronic psychoses [care clusters 11 and 12] |
| Key exclusion criteria | 1. Inability to understand and complete questionnaires 2. Inability to understand English (or access to translation services) 3. Inability to give informed consent 4. Currently receiving crisis care or care in a secure setting |
| Date of first enrolment | 07/11/2017 |
| Date of final enrolment | 28/02/2020 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
B15 2TT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Prof. Richard Byng (Richard.byng@plymouth.ac.uk). Details about the data and access criteria will be made available later. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | epidemiological medical records review | 15/02/2021 | 21/11/2023 | Yes | No |
| Results article | outcome measures | 20/04/2023 | 21/11/2023 | Yes | No |
| Protocol article | 30/06/2021 | 27/10/2022 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | qualitative formative evaluation | 07/01/2019 | 20/11/2019 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/11/2023: Publication reference and total final enrolment added.
27/10/2022: Publication reference added.
22/12/2020: The interventions were updated.
02/11/2020: The plain English summary was updated to reflect the changes below.
28/10/2020: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/05/2019 to 28/02/2020.
2. The target number of participants was changed from 336 to 204.
3. IPD sharing statement added.
4. The interventions were updated.
11/06/2020: The overall end date was changed from 07/05/2020 to 01/05/2021.
20/11/2019: Publication reference added.
25/04/2019: The condition has been changed from "Specialty: Mental Health, Primary sub-specialty: Psychosis; UKCRC code/ Disease: Mental Health/ Organic, including symptomatic, mental disorders" to "Schizophrenia, bipolar disorder or psychosis" following a request from the NIHR.
25/03/2019: The recruitment end date has been changed from 28/02/2019 to 31/05/2019.
11/01/2019: The recruitment end date was changed from 07/11/2018 to 28/02/2019. Contact details updated.
