Condition category
Not Applicable
Date applied
17/06/2019
Date assigned
19/06/2019
Last edited
19/06/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
This application is for the pilot trial phase of a five-year research programme, funded by the National Institute for Health Research. The researchers want to find a way of discussing alcohol consumption in local pharmacies, and specifically to see if this works for NHS patients who use existing medicine review services. This research will allow them to consider how this should be rolled out across the country if it works, and what should happen if it doesn’t. In the first phase of the programme, the researchers co-produced the intervention with community pharmacists and patients. This study will examine the feasibility of implementing the intervention, called the Medicines and Alcohol Consultation (MAC), and recruiting patients to a trial.

Who can participate?
Patients aged 18 or older who receive medicine review services and are drinking more than is healthy

What does the study involve?
Participating pharmacies are randomly allocated to the intervention group or the control group. For patients in intervention group pharmacies the MAC intervention is incorporated into routine consultations. Pharmacies allocated to the control group continue to provide services as usual. 1. Participants’ total weekly alcohol consumption and medications management are measured after 2 months.

What are the possible benefits and risks of participating?
The information from this study will show how 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?
Community pharmacies in Yorkshire (UK)

When is the study starting and how long is it expected to run for?
April 2019 to August 2019

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

Who is the main contact?
Dr Anne van Dongen
anne.vandongen@york.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anne van Dongen

ORCID ID

Contact details

University of York
Department of Health Sciences
Seebohm Rowntree Building
Heslington
York
YO10 5DD
United Kingdom
+44 (0)1904325877
anne.vandongen@york.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

41747

Study information

Scientific title

Community pharmacy: highlighting alcohol use in medication appointments (CHAMP-1) pilot study

Acronym

CHAMP-1

Study hypothesis

The researchers want to find a way of discussing alcohol consumption in local pharmacies, and specifically to see if this works for NHS patients who use existing medicine review services. This research will allow them to consider how this should be rolled out across the country if it works, and what should happen if it doesn’t. In the first phase of the programme, they co-produced the intervention with community pharmacists and patients. The pilot trial will examine the feasibility of implementing the intervention, called the Medicines and Alcohol Consultation (MAC), and recruiting patients to a trial.

Ethics approval

Approved 12/06/2019, South West - Frenchay Research Ethics Committee (Level 3, Block B, Whitefriars, Lewins Mead, Bristol BS1 2NT; Tel: +44 (0)207 1048 045; Email: nrescommittee.southwest-frenchay@nhs.net), ref: 19/SW/0082

Study design

Randomised; Both; Design type: Process of Care, Education or Self-Management, Complex Intervention, Management of Care, Qualitative

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Community

Trial type

Treatment

Patient information sheet

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

Condition

Unhealthy drinking

Intervention

Pilot Trial
The pilot trial will compare two groups of patients: those who will have the MAC, and those who will have medicines reviews as they are now. A computer will decide into which group a patient goes. The study will be run in 8-12 community pharmacists in Yorkshire, with half selected to use the MAC (also decided by a computer). Pharmacists using the MAC will receive weeks of training and support. This will include audio recording consultations, if the patient agrees, so we can help pharmacists develop their practice. All pharmacists will be trained to do the research before patients are recruited to the study (the aim is to recruit at least 80). Two months after study entry, the researchers will telephone both groups of patients to ask about their drinking, medicine use and health, and because of the way the study is done, any differences between the groups should be due to the MAC. With permission, the researchers will audio-record some medicines reviews and speak to some patients and pharmacists to help understand how the MAC worked, and how it could be improved for the main study. The researchers will investigate what patient information is held in pharmacies, and if patients agree, access information on medicines and use of health services to assess if this information could be used in the main trial.

Qualitative Study
The researchers will also investigate pharmacists’ and patients’ engagement with the MAC. This will involve observation of pharmacists training days; three interviews with two pharmacists as they progress through the training; post-training audio recording of at least one consultation from each pharmacist to explore skills development; telephone interviews conducted within one week of these consultations with 1 patient from each intervention site (n=6); interviews with all pharmacists at the end of the study period.

SWAT Sub-Study
The researchers are also proposing to undertake a Study With a Trial (SWAT). A computer will decide if participants who provide a mobile telephone number will be sent a text message about the follow-up interview early (one week prior), late (72 hours prior), with personalisation which includes the recipient’s name, or with no personalisation. The researchers will evaluate what difference this makes to the follow-up rate.

Intervention type

Other

Phase

Drug names

Primary outcome measure

1. Total weekly alcohol consumption, measured using a retrospective diary in the 7 days prior to follow-up at 2 months
2. Medications management, measured using PROMIS Self-Efficacy for Managing Medications and Treatment - 8a at 2 months

Secondary outcome measures

1. Heavy drinking and drinking within recommended weekly guidelines, derived from primary alcohol measure at 2 months
2. Adherence measured by ProMAS at 2 months
3. Anxiety (GAD-7) and depression (PHQ-8) measured at 2 months
4. Quality of life measured by the EQ-5D-5L at 2 months

Overall trial start date

08/04/2019

Overall trial end date

07/08/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients:
1. Aged 18 years or older
2. Screen positive for unhealthy drinking on a single item alcohol screening question (AUDIT question 1, for frequency of drinking)
3. Using pharmacy medication review services

Any participant in the CHAMP-1 pilot trial who provides a mobile number and agrees on the consent form to receive text messages will be eligible for the text message SWAT.

Pharmacies:
1. Conducting Medicines Use Reviews during the study period
2. Agree to audio record consultations (with patient consent)
3. Agree to participate in training as required, including GCP and informed consent training delivered by Yorkshire and Humber CRN

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 80; UK Sample Size: 80

Participant exclusion criteria

1. Patients in receipt of alcohol treatment in the previous 12 months
2. Participants who do not provide a mobile number or consent to receive texts will be excluded from the text message SWAT

Recruitment start date

24/06/2019

Recruitment end date

07/08/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NIHR CRN: Yorkshire and Humber
S10 2SB
United Kingdom

Sponsor information

Organisation

University of York

Sponsor details

c/o Michael Barber
Research & Enterprise Directorate
Heslington
York
YO10 5DD
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Central Commissioning Facility (CCF); Grant Codes: RP-PG-0216-20002

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Peer reviewed scientific journals
2. Conference presentation

IPD sharing statement
This is a pilot trial to inform main trial progression. The datasets generated during and/or analysed during the current study are not expected to be made available.

Intention to publish date

01/11/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

19/06/2019: Trial's existence confirmed by the NIHR.