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
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 880
Study Overview
Brief Summary
2020 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31964398 protocol (added 23/01/2020) 2021 Other publications in https://pubmed.ncbi.nlm.nih.gov/34600542/ Process evaluation (added 04/10/2021) 2020 Protocol article in https://pubmed.ncbi.nlm.nih.gov/32471514/ Protocol for the process evaluation (added 18/01/2023) 2023 Results article in https://pubmed.ncbi.nlm.nih.gov/36787910/ Primary and secondary outcome results (added 15/02/2023) 2023 Other publications in https://pubmed.ncbi.nlm.nih.gov/37907299/ secondary analysis of interview data collected as part of the process evaluation undertaken in CHIPPS (added 01/11/2023)
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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)
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
