A cluster randomised controlled trial to determine effectiveness and cost-effectiveness of a care home independent pharmacists prescribing service
| ISRCTN | ISRCTN17847169 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17847169 |
| Secondary identifying numbers | 35846 |
- Submission date
- 04/12/2017
- Registration date
- 15/12/2017
- Last edited
- 01/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English Summary
Background and study aims
The use of medicines in care homes could be improved and as a result the health of residents should be better. Pharmacist prescribers (i.e. pharmacists specifically accredited to prescribe in a similar way to doctors), have already been shown to provide high quality care, which is safe and well received. This study tests if making pharmacist prescribers part of the care home team, working alongside general practitioners, could improve the use of medicines and the care of residents. These pharmacist prescribers would sign and order monthly prescriptions whilst carefully monitoring how each resident respond. It is believed that such a change to the management of medicines in care homes is likely to be a good use of NHS money. However, to develop and test this idea in the best way possible we need to undertake six inter-linked work packages (WP). This application is for WP6 of this programme which is a randomised controlled study (with internal pilot) following WP5 which was a feasibility study which tested the delivery of the service to 40 participants.
Who can participate?
Pharmacists prescribers, GPs, and 20 care home residents.
What does the study involve?
Groups are randomly allocated to one of two groups. Those in the first group receive treatment as usual is where GPs have responsibility for the medicines management of care home residents associated with the GP practice. Those in the second group have the pharmacist prescriber assuming responsibility for managing their medicines, overseen by the GP. This includes the pharmacists prescriber reviewing medications, assuming prescribing responsibilities, supporting systematic ordering, prescribing and administration with in the care home, providing training within the care home and liaising with relevant staff involved in residents care. At baseline, three months and six months, the researchers collect data from the residents including falls rates, NHS resource use, information on hospitalisations and deaths as well as quality of life measures. Data is compared between the residents in the intervention arm and those receiving treatment as usual.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
1. University of East Anglia (UK)
2. University of Aberdeen (UK)
3. Queens University Belfast (UK)
When is the study starting and how long is it expected to run for?
June 2017 to April 2020
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Ms Annie Blyth
a.blyth@uea.ac.uk
Contact information
Scientific
University of East Anglia
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom
| Phone | +44 (0)1603 593308 |
|---|---|
| a.blyth@uea.ac.uk |
Study information
| Study design | Randomised; Interventional; Design type: Process of Care, Management of Care |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Care home, GP practice, Pharmacy |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Care Homes Independent Pharmacist Prescribing Service (CHIPPS): A cluster randomised controlled trial to determine both its effectiveness and cost-effectiveness Work Package 6: RCT with internal pilot: a definitive randomised controlled trial |
| Study acronym | CHIPPS |
| Study hypothesis | Providing a pharmacist independent prescriber within care homes will show patient benefit (reduced resource use, reduced falls) compared with care homes with no pharmacist prescriber. |
| Ethics approval(s) | 1. English REC: East of England, Cambridge Central Research Ethics Committee, 28/11/2017, ref: 17/EE/0360 2. Scottish REC: Scotland A Research Ethics Committee, NHS Lothian, 08/11/17, ref: 17/SS/0118 |
| Condition | No specific disease |
| Intervention | This is a cluster randomised control trial, pharmacists prescribers and GPs are randomised to treatment as usual (no pharmacist independent prescriber) or to the intervention. The intervention is the provision of a pharmacist independent prescriber for 6 months. This intervention was developed in an earlier feasibility study, and involves a pharmacist independent prescriber collaborating with a care home residents GP, assuming responsibility for managing their medicines. This includes reviewing medications, assuming prescribing responsibilities, supporting systematic ordering, prescribing and administration with in the care home, providing training within the care home and PG, and liaising with the local pharmacy, PG and care home staff as well as the research team. The residents will have their data collected at baseline, 3 months and 6 months. |
| Intervention type | Other |
| Primary outcome measure | Falls data, collected from care home falls register or resident notes, measured at baseline, 3 months and 6 months. |
| Secondary outcome measures | 1. Quality of life is meaured using the proxy EQ-5D-5L at baseline, 3 months and 6 months 2. Face to face self-reported EQ-5D-5L (only applicable for participants with capacity), measured at baseline, 3 months and 6 months 3. Mortality and hospitalisations, collected from Primary Care (GP) records and from Care Home records, measured at baseline, 3 months and 6months. 4. Proxy Barthel Index (physical functioning measure), collected at baseline and 6 months 5. Health-service utilisation (and associated costs), collected from Primary Care (GP) records, collected at baseline and 6 months |
| Overall study start date | 01/06/2017 |
| Overall study end date | 30/04/2020 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | Planned Sample Size: 880; UK Sample Size: 880 |
| Total final enrolment | 880 |
| Participant inclusion criteria | Pharmacist inclusion criteria: 1. Registered as a pharmacist independent prescriber 2. Following training can demonstrate to their mentor and independent GP assessor competence to deliver service specification 3. Ability to work flexibly and commit a minimum of 16 hours a month to deliver the service for six months GP inclusion criteria: GP practice must manage sufficient care home residents to enable invitation of a minimum of 35 eligible care home residents in one or more care homes. Care home resident inclusion criteria: 1.65 years and over 2. Under the care of the recruited GP practice 3.65 years or over 4. Currently prescribed at least one regular medication 5. Able to provide informed consent/assent, or have a consultee (England and Northern Ireland) or Welfare Power of Attorney (WPoA) (Scotland) able to provide informed consent 6. Permanently resident in care home (not registered for respite care/temporary resident) |
| Participant exclusion criteria | Independent Prescribing Pharmacist (PIP) exclusion criteria: 1. Substantive employment with the community pharmacy (branch/store) which supplies medicines to the care home with which the PIP would work, to protect against conflict of interest 2. Already providing an intensive service to the care home GP exclusion criteria: GP practice managing less than 35 care home residents across > 1 care home Care Home exclusion criteria: 1. Care homes which receive regular (e.g. a monthly visit or more frequently, from a pharmacist) and provision of intensive medication focussed services 2. Care homes which are currently under formal investigation with Care Quality Commission (CQC) in England, Care Inspectorate in Scotland or Regulation or Quality Improvement in Northern Ireland 3. Care homes that are participating in any other study likely to affect the outcome of the CHIPPS trial (e.g. Falls intervention study, Rehydration study, e.t.c) Resident exclusion criteria: 1. Residents who are currently receiving end of life care, [equivalent to yellow (stage C) of the Gold Standards Framework prognostic indicator] 2. Resident with additional limitations on their residence (e.g. held securely) 3. Participating in another intervention research study |
| Recruitment start date | 18/12/2017 |
| Recruitment end date | 31/10/2019 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
Study participating centres
Norwich
NR4 7TJ
United Kingdom
Aberdeen
AB24 3FX
United Kingdom
Belfast
BT7 1NN
United Kingdom
Sponsor information
Hospital/treatment centre
Lakeside
400 Old Chapel Way
Norfolk
Norwich
NR7 0WG
England
United Kingdom
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
Results and Publications
| Intention to publish date | 01/12/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The intention is to publish and disseminate trial results in a high-impact peer reviewed journal in 2021. The Study protocol will be available on the programme website: https://www.uea.ac.uk/chipps/summary |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/01/2020 | 23/01/2020 | Yes | No |
| Other publications | Process evaluation | 02/10/2021 | 04/10/2021 | Yes | No |
| Protocol article | Protocol for the process evaluation | 29/05/2020 | 18/01/2023 | Yes | No |
| Results article | Primary and secondary outcome results | 14/02/2023 | 15/02/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| HRA research summary | 26/07/2023 | No | No | ||
| Other publications | secondary analysis of interview data collected as part of the process evaluation undertaken in CHIPPS | 31/10/2023 | 01/11/2023 | Yes | No |
Editorial Notes
01/11/2023: Publication reference added.
15/02/2023: Publication reference added.
24/01/2023: The study setting has been changed from ‘Hospital’ to 'Care home', 'GP practice' and 'Pharmacy'.
18/01/2023: Publication reference added.
04/10/2021: Publication reference added.
23/01/2020: Publication reference added.
18/11/2019: Total final enrolment number added.
29/03/2019: The condition has been changed from "Specialty: Primary care, Primary sub-specialty: Ageing; UKCRC code/ Disease: Generic Health Relevance/ No specific disease" to "No specific disease" following a request from the NIHR.
05/01/2018: Internal review.
