Condition category
Infections and Infestations
Date applied
10/03/2016
Date assigned
25/04/2016
Last edited
25/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
There have been concerns about the level of prescribing of antimicrobials (antibiotic, antifungal and antiviral medicines) in care homes for older people. The Chief Medical Officer (CMO) of England has highlighted that high use of antimicrobials can lead to resistance, meaning that these drugs may no longer be effective. The CMO’s report also suggested that older people, especially those living in care homes, may be at higher risk of infection. The report noted that education and training of doctors and nurses about infections and antimicrobials was very important to ensure that antimicrobials are used properly. A Canadian study found that education and training was useful in reducing the use of antimicrobials in Canadian care homes. We have based our study on this work.

Who can participate?
We will recruit 6 care homes to the study: 3 in Northern Ireland and 3 in the West Midlands.

What does the study involve?
Using the most up-to-date scientific research on how to manage infections in care home residents, we are developing training material and a training programme for care home staff and general practitioners (GPs). The Canadian approach is discussed with staff, GPs and family members of residents, and adapted for use in the UK. Care home staff and GPs are trained in using this new approach. The new approach is then tested in the 6 care homes to ensure that it is practical and feasible. Members of the research team interview the staff and GPs to explore how they found the new approach, if they had any particular difficulties, and if they have any suggestions for improvements. We also test how we will collect information about residents from care homes, community pharmacies and large databases.

What are the possible benefits and risks of participating?
For care home staff and GPs who take part in this study, the possible benefits are greater knowledge of infections in care home residents and contributing to a possible new way of improving prescribing of antimicrobials. The possible risk is the time spent undertaking training and recording activities during the study. However, we would hope that this will be out-weighed by the possible benefits.

Where is the study run from?
Queen's University Belfast (UK)

When is the study starting and how long is it expected to run for?
April 2016 to January 2018

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Prof. Carmel Hughes

Trial website

Contact information

Type

Scientific

Primary contact

Prof Carmel Hughes

ORCID ID

Contact details

School of Pharmacy
Queen's University Belfast
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2

Study information

Scientific title

An evaluation of a multifaceted intervention to reduce antimicrobial prescribing in care home residents [REducing Antimicrobials in Care Homes (REACH)]: a non-randomised feasibility study and process evaluation

Acronym

REACH (REducing Antimicrobials in Care Homes)

Study hypothesis

The aim is to evaluate the feasibility and acceptability of a multifaceted intervention on rational prescribing for infections in a non-randomised feasibility study in care homes for older people. The intervention will consist of an educational and management approach, supported by discussion on resident cases.

Ethics approval

Health and Social Care Research Ethics Committee B, 28/01/2016, ref: 16/NI/0003

Study design

Multicentre non-randomised feasibility study with an embedded process evaluation

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Other

Patient information sheet

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

Condition

Infections in care home residents and antimicrobial prescribing

Intervention

A feasibility study will be conducted in six care homes for older people (three care homes in Northern Ireland and three care homes in the Warwick/Coventry area). At this stage, the exact content of the intervention has not yet been confirmed as it requires further adaptation and development. This will be done by undertaking interviews and focus groups with care home staff, general practitioners and family members of those resident in a care home. The intervention will be based on one that was tested in Canadian care homes, but it would not be appropriate to simply apply the same intervention in the United Kingdom setting. Furthermore, the Canadian intervention only focused on urinary tract infections. This current study will examine prescribing in other conditions such as respiratory and soft tissue infections. The proposed intervention will consist of education and training of care home staff and the GPs caring for the residents, on appropriate management of common infections and appropriate use of antimicrobials. This will be achieved via visits by research staff to the participating care homes and general practices which serve these care homes. During these visits, the research staff will deliver training on common infections in care homes and how they should be best treated. The research staff will introduce the care home staff and general practitioners to algorithms (flow charts) which will help guide decision-making about prescribing of antimicrobials. Care home staff will be asked to use these algorithms over the duration of the feasibility study (6 months) when caring for residents who may have infections. This training approach will be undertaken in all 6 homes with separate sessions being provided for qualified nursing staff and care assistants who are not formally qualified. We will also offer training to general practices associated with the participating care homes. Training will be delivered on one occasion only in each setting, but we will produce a DVD of the care home training which can be viewed by staff who are unable to attend designated session.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Because this is a feasibility study, we are unable to judge effectiveness. The outcomes that we are interested in for this feasibility study are predominantly process-related and outlined as follows:
1. Acceptability of the intervention in terms of recruitment and delivery of training as assessed by collecting data on recruitment of care homes (3 months from the start of the project, based on the number of homes approached and the number recruited) and attendance at training events (after the training events have taken place during months 9-12)
2. The feasibility of measuring appropriateness of prescribing and collecting dispensing data from community pharmacies (12 months pre-baseline and 6 months from baseline)
3. Comprehensive overview of the implementation of the intervention as measured through process evaluation (observation, interviews and focus groups) over the course of the study (over 6 months).

Secondary outcome measures

There will be two main secondary outcomes for this feasibility study:
1. The costs of implementing the intervention which will be recording resource used associated with labour, training, intervention materials, equipment and space. These data will be collected over the course of the study through the use of documentation that will be prepared for the study.
2. The likelihood of being able to recruit to a larger definitive study will be assessed by distributing a short questionnaire (providing details about a proposed definitive study) to care homes in selected geographic areas (month 21)

Overall trial start date

01/04/2016

Overall trial end date

31/01/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Care homes:
1. Care homes (some with/without nursing care), principally providing 24 hour care for older residents
2. A minimum of 20 (permanent) residents
3. Associated with a small number of general practices (up to four per home providing care for a minimum of 80% of residents within a home)
4. An exclusive arrangement with one pharmacy for dispensing medications

Care home staff:
1. Working in the participating care homes
2. Willing to participate in focus group discussions

General Practitioners:
1. Working with the participating care homes
2. Willing to participate in interviews

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

Six care homes; up to 50 participants for the qualitative aspects of the process evaluation (care home staff and GPs)

Participant exclusion criteria

1. Not meeting the inclusion criteria
2. Not providing written informed consent

Recruitment start date

01/05/2016

Recruitment end date

31/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen's University Belfast
School of Pharmacy 97 Lisburn Road
Belfast
BT9 7BL
United Kingdom

Trial participating centre

Warwick Clinical Trials Unit, The University of Warwick
Gibbet Hill Road
Coventry
CV4 7AL
United Kingdom

Sponsor information

Organisation

Queen's University Belfast (UK)

Sponsor details

Research and Enterprise Office
University Road
Belfast
BT7 iNN
United Kingdom

Sponsor type

University/education

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

We plan to publish the protocol for the study by April 2017. Further papers will be produced once results become available after April 2018. We will also present the findings at appropriate conferences.

Intention to publish date

01/04/2018

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes