Improving medicines use in people who take multiple medicines
| ISRCTN | ISRCTN90146150 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90146150 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | University of Bristol ref. 2018-2188; 41260 |
| Sponsor | University of Bristol |
| Funder | Health Services and Delivery Research Programme |
- Submission date
- 19/03/2019
- Registration date
- 28/03/2019
- Last edited
- 21/10/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Polypharmacy (prescribing multiple medicines to one individual) is widespread and growing in the UK. About 6% of adults take over ten regular medicines. Although often clinically appropriate, polypharmacy may be problematic and lead to a range of adverse outcomes. Despite recent national guidance, there is a lack of evidence for medication optimisation interventions that improve outcomes. The aim of this study is to develop and evaluate an intervention to optimise medication use for patients with polypharmacy in a general practice setting.
Who can participate?
Adults with polypharmacy registered at participating practices who are identified by the IMPPP case finding tool (developed in Phase 1 of the study)
What does the study involve?
Participants are asked to complete study questionnaires related to their health and wellbeing, how they cope with their medicines and what treatments and other health services they use. Some participants are asked to attend a short 20-minute appointment at their general practice to talk about the medicines they are taking and how they are getting on with them. Participants who attend this appointment are asked to complete a questionnaire afterwards and will be offered a follow-up appointment 6 months later.
What are the possible benefits and risks of participating?
Participants may or may not directly benefit from taking part. The data that participants provide however could help other people in the future. There should be no disadvantages from taking part as the study follows the same NHS guidelines for prescribing and medicines use as those currently used in routine practice.
Where is the study run from?
The research is being run by the Centre of Academic Primary Care at the University of Bristol, with the Universities of Dundee and Keele (UK)
When is the study starting and how long is it expected to run for?
February 2019 to October 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Deborah McCahon
deborah.mccahon@bristol.ac.uk
Contact information
Public
University of Bristol
Bristol Medical School
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
 ORCID ID |
0000-0003-2768-293X |
|---|---|
| Phone | +44 (0)117 331 3901 |
| deborah.mccahon@bristol.ac.uk |
Scientific
University of Bristol
Bristol Medical School
Canynge Hall
39 Whatley Road
Bristol
BS8 2PS
United Kingdom
| ORCID ID |
0000-0002-5842-4645 |
|---|---|
| Phone | +44 (0)117 331 4545 |
| r.a.payne@exeter.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Two phases; comprising a pilot feasibility study followed by a multicentre cluster randomized controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Improving Medicines use in People with Polypharmacy in Primary Care (IMPPP) |
| Study acronym | IMPPP |
| Study objectives | The aim of the IMPPP study is to develop, implement and evaluate an intervention to optimise medication use for patients with polypharmacy in a general practice setting. |
| Ethics approval(s) | Provisional approval 27/03/2019 from Wales REC 6 (Fourth Floor, Institute of Life Science 2, Swansea University, Singleton Park, Swansea, SA2 8PP; Tel: +44 (0)1792 606334; Email: penny.beresford@wales.nhs.uk), IRAS ID: 238586, REC ref: 19/WA/0090 |
| Health condition(s) or problem(s) studied | Polypharmacy |
| Intervention | Details of the randomisation process Randomisation will be generated using a computer algorithm. Practices will not be informed of whether or not they will be intervention practices before agreeing to participate. As soon as invitations to potential participants have been sent in a pair of practices, the practices will be randomised, one to intervention and one to control. Practices will be randomised in blocks, so the numbers of invitees in practices recruited later will be adjusted according to response/exclusion rates in earlier practices. The IMPPP intervention will be based in general practice, and will involve GPs and practice pharmacists working together, drawing on the specific skills of each professional sensitive to the context of each practice. This is a complex intervention and will comprise two key elements: 1. A model for conducting a polypharmacy medication review (including pharmacist-GP collaboration and case finding) 2. Components seeking to enhance professional engagement (education, practice feedback, financial incentives) An informatics tool integrated into GP clinical systems will help support the medication review element as well as the practice feedback component The researchers will develop the IMPPP approach based upon what they have learnt from similar approaches their team has used in Scottish GP surgeries. Firstly, they will test the IMPPP approach in 5 Bristol-based GP surgeries. They will interview individuals in these surgeries to find out about any problems with IMPPP so they can improve it. They will then carry out a clinical trial in Bristol and the West Midlands comparing 27 surgeries using IMPPP to 27 surgeries using current, normal practice. They will check whether IMPPP results in improved medicines safety, less use of health services, and better quality of life and less burden of treatment for the patients. They will also check whether IMPPP is acceptable to patients, doctors and pharmacists and will find out the cost implications of IMPPP for the NHS. The research will provide valuable information about which people with polypharmacy might benefit most from having improvements made to their medicines, and indicate what approaches work best for improving the use of medicines in people with polypharmacy, including how GPs and pharmacists can work together most effectively to achieve this. All participants (intervention and control) will be followed up for a period of 6 months. |
| Intervention type | Other |
| Primary outcome measure(s) |
Potentially inappropriate prescribing captured via patient notes pre-randomisation (T1), immediately pre-intervention delivery (T2), immediately post-intervention delivery (T3) and follow-up at 6 months (T4) |
| Key secondary outcome measure(s) |
1. Patient experience: |
| Completion date | 03/10/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 1975 |
| Total final enrolment | 1983 |
| Key inclusion criteria | Persons experiencing potentially problematic polypharmacy in primary care and community settings. This will specifically include “hard to reach” groups, including nursing home residents, housebound individuals, and those who lack capacity to consent (e.g. dementia). The exact patient population will be defined as part of the case finding approach to be determined by the development phase (Phase 1) of the project. It is anticipated the case finding tool will identify older people (≥60 years) who are receiving 10 or more medications regularly on prescription. This is because people in this group are more likely than younger people on fewer medications to trigger at least one of the prescribing quality indicators (being defined within Phase 1) which will underpin the case finding approach. |
| Key exclusion criteria | 1. Individuals receiving end-of-life care 2. Patients judged by their GP to have chaotic medication use (e.g. history of drug or alcohol misuse) 3. The GP deems contact to be inappropriate; for example, due to severe mental health problems, terminal illness, recent bereavement 4. Participant is unable to complete the study questionnaires or medication review appointment (either themselves or with the help of carers) 5. Individuals planning to move GP practice within the 6-month follow-up period |
| Date of first enrolment | 01/06/2019 |
| Date of final enrolment | 26/09/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
BS1 2NT
United Kingdom
United Kingdom
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in non-publicly available repository |
| IPD sharing plan | Participant consent for sharing of anonymised research data will be sought as part of the consent process. Sharing of anonymised data is optional. Anonymous research data will be stored securely at the University of Bristol (the data.bris Research Data Repository, https://data.bris.ac.uk/data/) and kept for future open access. At the end of the study, members of the trial management group will develop a data sharing policy consistent with UoB policy. Requests for access to data must be via written confidentiality and data sharing agreements (DSA) with the CI (or his appointed nominee). A protocol describing the purpose and methods intended must be provided. Requests for data release outside of the planned analyses will be considered by the trial steering committee. As data will be anonymised and identifiers destroyed, future linkage will not be possible. The DSA will cover limitations of use, transfer to 3rd parties, data storage and acknowledgements. The person applying for use of the data will be scrutinized for appropriate eligibility by members of the research team. All requests will require their own separate REC approval prior to data being released. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 16/10/2025 | 21/10/2025 | Yes | No | |
| Protocol article | 08/11/2022 | 06/06/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | Qualitative study results | 01/07/2024 | 09/09/2024 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
21/10/2025: Publication reference added.
09/09/2024: Publication reference added. Publication and dissemination plan updated. The intention to publish date was changed from 31/03/2024 to 30/11/2024.
26/10/2023: Publication reference added.
02/10/2023: The intention to publish date was changed from 01/03/2024 to 31/03/2024.
06/06/2023: The following changes were made to the study record:
1. Publication reference and total final enrolment added.
2. The recruitment end date was changed from 01/06/2022 to 26/09/2022.
3. The overall study end date was changed from 30/05/2023 to 03/10/2023.
4. The intention to publish date was changed from 01/07/2023 to 01/03/2024.
5. The target number of participants was changed from 'The pilot feasibility study (phase 2) aims to recruit 125 participants. The cluster randomised controlled trial aims to recruit 2700 participants (1350 in each of the trial arms)' to 'The pilot feasibility study (phase 2) aims to recruit 125 participants. The cluster randomised controlled trial aims to recruit 1850 participants across 37 general practices.'.
22/05/2023: A contact email was updated.
29/04/2022: The following changes have been made:
1. The recruitment end date has been changed from 30/08/2019 to 01/06/2022.
2. The overall trial end date has been changed from 30/04/2022 to 30/05/2023 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been changed from 01/03/2022 to 01/07/2023.
4. The participant information sheet has been added.
5. The trial participating centre “NIHR CRN: South West Peninsula” has been added.
6. The publication and dissemination plan has been updated.
25/03/2019: Trial's existence confirmed by the NIHR.
