Community pharmacy: highlighting alcohol use in medication appointments
| ISRCTN | ISRCTN57447996 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN57447996 |
| Secondary identifying numbers | 41747 |
- Submission date
- 17/06/2019
- Registration date
- 19/06/2019
- Last edited
- 19/07/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
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
Contact information
Scientific
University of York
Department of Health Sciences
Seebohm Rowntree Building
Heslington
York
YO10 5DD
United Kingdom
| Phone | +44 (0)1904325877 |
|---|---|
| anne.vandongen@york.ac.uk |
Study information
| 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 |
| Study setting(s) | Community |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Community pharmacy: highlighting alcohol use in medication appointments (CHAMP-1) pilot study |
| Study acronym | CHAMP-1 |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 08/04/2019 |
| Completion date | 07/08/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 80; UK Sample Size: 80 |
| Total final enrolment | 51 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 24/06/2019 |
| Date of final enrolment | 07/08/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
United Kingdom
Sponsor information
University/education
c/o Michael Barber
Research & Enterprise Directorate
Heslington
York
YO10 5DD
England
United Kingdom
"ROR" |
https://ror.org/04m01e293 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/11/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Peer reviewed scientific journals 2. Conference presentation |
| IPD sharing plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 12/10/2020 | 16/10/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Using qualitative process evaluation in the development of a complex intervention to advance person-centred practice by pharmacists: The Medicines and Alcohol Consultation (MAC) | 01/12/2021 | 19/07/2023 | Yes | No |
Editorial Notes
19/07/2023: Publication reference added.
16/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
19/06/2019: Trial's existence confirmed by the NIHR.
