Medicines and alcohol consultation programme delivery study

ISRCTN	ISRCTN87543983
DOI	https://doi.org/10.1186/ISRCTN87543983
IRAS number	320182
Secondary identifying numbers	IRAS 320182, CPMS 54839

Submission date: 17/03/2023
Registration date: 04/04/2023
Last edited: 14/03/2025

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Some people drink alcohol and take multiple prescription medications, which poses risks to their health. This study is part of an NIHR programme grant, led by the University of York, which aims to co-produce with the pharmacy profession and with patients, an intervention discussing alcohol within routine structured medication review (SMR) consultations, delivered by clinical pharmacists in primary care. The SMR specification recognises the risks of alcohol interactions with medicines and thus the potential contribution of clinical pharmacists in addressing alcohol within their clinical practice. The approach encourages practitioners and patients to consider alcohol, not as a standalone issue to be addressed separately, but rather as integral to clinical care. This is because alcohol is another drug, the impacts of which need to be considered within patient-centred discussions about treatments, adherence, particular conditions and wider health and well-being. The medicines and alcohol consultation (MAC) intervention is intended to help patients to think through whether drinking affects their medication use, conditions and health, and to enable pharmacists to skillfully engage with these issues in a person-centred manner. The aim of the study is to examine the delivery of the MAC from the perspectives of participating clinical pharmacists and patients receiving SMRs.

Who can participate?
Patients having an SMR delivered by a clinical pharmacist who has received the MAC practice development programme.

What does the study involve?
The study involves an investigation of the delivery of the MAC programme to study how clinical pharmacists engage and acquire person-centred skills in practice, including alcohol-specific and other challenges faced, and how practice changes or does not. The study will also examine how patients participate in and respond to alcohol discussions within SMRs, their experience of the SMR and wider views on discussing alcohol as a drug linked to their medicines and conditions

What are the possible benefits and risks of participating?
The information from this study will show how clinical pharmacists might be able to help people think about their alcohol consumption and medicines use. There are no known risks to taking part.

Where is the study run from?
Yorkshire and the North East of England (UK)

When is the study starting and how long is it expected to run for?
September 2022 to December 2023

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

Who is the main contact?
Prof Duncan Stewart (Programme Manager), duncan.stewart@york.ac.uk

Contact information

Prof Duncan Stewart
Public

166-220 Holloway Road
London
N7 8DB
United Kingdom

Phone	None provided
Email	d.stewart@londonmet.ac.uk

Prof Jim McCambridge
Scientific

Seebohm Rowntree Building
University of York
Heslington
York
YO10 5DD
United Kingdom

ORCID ID	0000-0002-5461-7001
Phone	+44 (0)1904 321667
Email	jim.mccambridge@york.ac.uk

Study information

Study design	Observational study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	GP practice, Internet/virtual, Telephone
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details to request a participant information sheet
Scientific title	Medicines and alcohol consultation (MAC) programme delivery study
Study acronym	CHAMP-1
Study objectives	The aim is to examine the delivery of the MAC intervention from the perspectives of participating clinical pharmacists and patients receiving structured medication reviews (SMRs) in primary care.
Ethics approval(s)	Approved 16/01/2023, North East - Newcastle & North Tyneside 2 Research Ethics Committee (Meeting held by video-conference via Zoom; +44 (0)2071048086, (0)2071048140; newcastlenorthtyneside2.rec@hra.nhs.uk), ref: 22/NE/0237
Health condition(s) or problem(s) studied	Primary care
Intervention	This is an observational study of intervention delivery, looking at the MAC intervention delivered by clinical pharmacists in general practices in Yorkshire & Humber and North East & Cumbria regions. The study involves the delivery of the 10-week practice development programme comprising two in-person consultation skills workshops, and weekly practice development coaching phone/video calls with the research team that focuses on pharmacists’ progress with integrating the MAC approach into structured medication reviews (SMRs). Information on alcohol and medications is also provided. We will recruit 15 clinical pharmacists whose practice closely resembles the SMR specification guidance (appointments booked in advance, face-to-face, 30 minutes or longer). The pharmacists will receive 10 weeks of practice development training, including workshops, individual coaching, supplementary materials and peer support activities. During the delivery of the MAC programme, we will closely monitor engagement and practice development for each pharmacist. This will enable in-depth investigations of SMRs as they are delivered, whilst also illuminating the mechanisms by which practice development may or may not change at the level of individual pharmacists. Audio-recorded interviews will be conducted immediately pre- and post-programme on pharmacists’ views on their own alcohol-specific and wider SMR practice within their particular GP practice and PCN context. Before the programme, we will investigate how these pharmacists perceive gaps in their alcohol knowledge and skills and their expectations of the programme. Shortly afterwards, they will be asked about the extent to which they are making changes to practice, the reasons for this, and whether they are feeling more confident in discussing alcohol as a drug with their patients. We will also explore how they think the programme complements or advances previous consultation practice training. Engagement during the programme will be investigated through analysis of observation data on pharmacists at practice development workshops and data kept by coaches to track changes in individual pharmacist practice. Audio recordings of consultations made during the programme will also be used to provide a different strand of evidence on impacts on practice. Pharmacists will be asked to choose two SMR consultation audio recordings from this dataset, which they judge as demonstrating good and less good consultation practice, for discussion at an exit interview. The MAC programme uses the audio recordings of SMR consultations (with full patient consent) as the key mechanism for self-assessment of developing practice, supported by reviews with coaches. The participating pharmacists will be encouraged to continue this self-assessment practice after completion of the MAC programme. At 3 months, maintenance of changes in SMR practice will be assessed by asking the MAC pharmacists to select another two examples using the same criteria to discuss at a final interview. This interview will investigate views on changing alcohol practice and calibrating consultation competence, as well as the experience of taking on a new role in the system.
Intervention type	Behavioural
Primary outcome measure	Patient experiences of the programme measured qualitatively using audio-recorded interviews with a purposive sample (at least one patient per pharmacist) after their SMR to explore the experience of discussing alcohol during the consultation, and their wider views on discussing alcohol as a drug linked to their medicines and conditions.
Secondary outcome measures	Pharmacist experiences of the programme measured qualitatively using audio-recorded interviews pre- and post-programme on pharmacists’ views on their own alcohol-specific and wider SMR practice within their particular GP practice and PCN context.
Overall study start date	01/09/2022
Completion date	31/12/2023

Eligibility

Participant type(s)	Patient, Health professional
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	10-12 clinical pharmacists and at least 10 SMR patients per pharmacist
Total final enrolment	28
Key inclusion criteria	1. Clinical pharmacists conducting structured medication reviews (SMRs) selected to participate in the MAC programme 2. SMR patients (18+ years) who drink alcohol at least twice per week
Key exclusion criteria	1. Clinical pharmacist not conducting SMRs in person 2. Clinical pharmacist not able to conduct sufficient numbers of SMRs 3. Clinical pharmacists not able to attend practice development workshops 4. SMR patients who drink alcohol less than twice per week
Date of first enrolment	20/03/2023
Date of final enrolment	30/06/2023

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Humber & North Yorkshire Health & Care Partnership Integrated Care System

https://humberandnorthyorkshire.org.uk
N/A
United Kingdom

North East and North Cumbria Integrated Care System

https://northeastnorthcumbria.nhs.uk
N/A
United Kingdom

Sponsor information

University of York
University/education

Research and Enterprise Directorate
Heslington
York
YO10 5GE
England
United Kingdom

Phone	+44 (0)1904328693
Email	michael.barber@york.ac.uk
Website	http://www.york.ac.uk/
"ROR"	https://ror.org/04m01e293

Funders

Funder type

Government

National Institute for Health and Care Research
Government organisation / National government

Alternative name(s): National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location: United Kingdom

Results and Publications

Intention to publish date	30/12/2025
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from the PI: Jim.McCambridge@york.ac.uk

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			20/09/2023	No	No

Editorial Notes

14/03/2025: The intention to publish date was changed from 30/09/2024 to 30/12/2025.
19/06/2024: The intention to publish date was changed from 30/06/2024 to 30/09/2024.
27/03/2024: The intention to publish date was changed from 31/03/2024 to 30/06/2024.
18/12/2023: Total final enrolment added. The intention to publish date was changed from 31/12/2024 to 31/03/2024.
20/09/2023: A link to the HRA research summary was added.
23/03/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).