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A cluster randomised controlled trial to determine effectiveness and cost-effectiveness of a care home independent pharmacists prescribing service

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN17847169
Enrollment
880
Registered
2017-12-15
Start date
2017-12-18
Completion date
Unknown
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

No specific disease Not Applicable

Interventions

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

Sponsors

NHS South Norfolk CCG
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Falls data, collected from care home falls register or resident notes, measured at baseline, 3 months and 6 months.

Secondary

MeasureTime frame
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

Countries

England, Northern Ireland, Scotland, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 27, 2026