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

Not Applicable

Completed

• Conditions: Not Applicable; o specific disease

• Registration Number: ISRCTN17847169
• Lead Sponsor: HS South Norfolk CCG

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)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-12-15
• Study Completion: 2020-04-30
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 880

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Quality of life is meaured using the proxy EQ-5D-5L at baseline, 3 months and 6 months<br>2. Face to face self-reported EQ-5D-5L (only applicable for participants with capacity), measured at baseline, 3 months and 6 months<br>3. Mortality and hospitalisations, collected from Primary Care (GP) records and from Care Home records, measured at baseline, 3 months and 6months.<br>4. Proxy Barthel Index (physical functioning measure), collected at baseline and 6 months<br>5. Health-service utilisation (and associated costs), collected from Primary Care (GP) records, collected at baseline and 6 months