Condition category
Not Applicable
Date applied
04/12/2017
Date assigned
15/12/2017
Last edited
05/01/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

http://www.uea.ac.uk/chipps

Contact information

Type

Scientific

Primary contact

Ms Annie Blyth

ORCID ID

Contact details

University of East Anglia
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom
+44 (0)1603 593308
a.blyth@uea.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

35846

Study information

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

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

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

Study design

Randomised; Interventional; Design type: Process of Care, Management of Care

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Specialty: Primary care, Primary sub-specialty: Ageing; UKCRC code/ Disease: Generic Health Relevance/ 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 six 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, three months and six months.

Intervention type

Other

Phase

Drug names

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 trial start date

01/06/2017

Overall trial end date

30/04/2020

Reason abandoned (if study stopped)

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 880; UK Sample Size: 880

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

United Kingdom

Trial participating centre

University of East Anglia
Norwich Research Park
Norwich
NR4 7TJ
United Kingdom

Trial participating centre

University of Aberdeen
King's College
Aberdeen
AB24 3FX
United Kingdom

Trial participating centre

Queens University Belfast
University Road
Belfast
BT7 1NN
United Kingdom

Sponsor information

Organisation

NHS South Norfolk CCG

Sponsor details

Lakeside
400 Old Chapel Way
Norfolk
Norwich
NR7 0WG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

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 statement:
The data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

05/01/2018: Internal review.