Developing a way of improving the prescribing of many drugs for older people who live in their own home and are cared for by general practitioners
| ISRCTN | ISRCTN18176245 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18176245 |
| Secondary identifying numbers | 2 |
- Submission date
- 18/01/2016
- Registration date
- 22/01/2016
- Last edited
- 16/02/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
In the last century, advances in medicine have led to people living much longer as previously fatal diseases are now treatable. Many people, particularly those over the age of 60, are living with two or more long-term medical conditions (multimorbidity). These patients often need to take a range of different medications to control their conditions (polypharmacy). In some cases, the prescribing of medications may not be appropriate and patients are given too much or too little of what they actually need. Many studies have tried to improve this and ensure that patients are prescribed all the medicines they actually need, however many have been unsuccessful. This may be because studies have not considered the views and opinions of patients or the way that health professionals make decisions about which medicines are needed. The aim of this study is to try to design a programme in order to improve polypharmacy prescribing practices of GP’s for older people.
Who can participate?
GP practices in Northern Ireland willing to take part in the study, the GPs who work there and adult patients over the age of 65 who take at least 4 different medications.
What does the study involve?
GPs who work at participating practices that consent to take part in the study are given access to an online video which shows how to best prescribe multiple medications to older patients in a normal consultation. The video also contains feedback about why this approach works well. Appropriate patients are then invited to come in to see their GP for an appointment to review their medications. After each consultation, both the GPs and the patients complete anonymous feedback questionnaires to provide their opinions about the consultations. The results of these questionnaires are then reviewed to find out how acceptable the approach is. There are no specific follow-up appointments, but for the patients taking part, their medical records are reviewed 4 weeks later in order to see if there has been any change to their medication following the consultation.
What are the possible benefits and risks of participating?
There are no direct benefits or risks to participants taking part in the study.
Where is the study run from?
The study is run from Queen’s University Belfast and takes place in two GP practices in Northern Ireland (UK)
When is the study starting and how long is it expected to run for?
April 2015 to September 2015
Who is funding the study?
Dunhill Medical Trust (UK)
Who is the main contact?
Prof. Carmel Hughes
Contact information
Scientific
Queen's University Belfast
School of Pharmacy
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom
Study information
| Study design | Single-centre feasibility study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Development of an intervention to improve appropriate polypharmacy for older people in primary care |
| Study objectives | The overall aim of this project is to develop and feasibility test an intervention to improve the prescribing of appropriate polypharmacy for older people in primary care, focusing on healthcare professionals’ (HCPs’) encounters with patients in daily practice. |
| Ethics approval(s) | Health and Social Care Research Ethics Committee A, 29/05/2015, ref: 15/NI/0104 |
| Health condition(s) or problem(s) studied | Polypharmacy in older people |
| Intervention | A feasibility study is conducted in order to assess the usability and acceptability of an intervention to improve the prescribing of appropriate polypharmacy for older patients in primary care. The intervention consists of a video demonstration of how general practitioners (GPs) can prescribe appropriate polypharmacy during a typical consultation with older patients and will be delivered as an online video. The video also includes feedback emphasising the positive outcomes of this type of approach. During the recruitment phase of the study, a meeting is held between the researcher and GPs within each practice. During this meeting GPs are provided with an overview of the feasibility study protocol and intervention. Following the provision of written informed consent, GPs are provided with access to the online video, before information letters are issued by the practice to patients meeting inclusion criteria, inviting them to attend a scheduled consultation with their GP about their medicines. Baseline assessments are conducted on the date that each practice chooses to invite patients for scheduled consultations with recruited GPs. These assessments involve the collection of data from three sources: GPs, patients and recruited patients’ medical records. GPs complete a feedback questionnaire after they perform medication reviews during scheduled consultations with recruited patients. Recruited patients are also asked to complete a feedback questionnaire after the scheduled consultations with their GPs. There is no direct follow-up with GP or patient participants after the scheduled consultations are completed. Data is also extracted from recruited patients’ medical records at baseline and follow-up (one month after the scheduled consultation). The extracted data includes details of patient demographics (i.e. age, gender), clinical conditions and prescribed medications (both acute list items and repeat list items). |
| Intervention type | Behavioural |
| Primary outcome measure | 1. The usability and acceptability of the intervention for GPs is determined using a feedback questionnaire which recruited GPs complete at baseline (after medication reviews during scheduled consultations) 2. The usability and acceptability of the intervention for patients is determined using a feedback questionnaire which recruited patients complete at baseline (after medication reviews during scheduled consultations) |
| Secondary outcome measures | 1. Feasibility of recruitment procedures is assessed by determining whether recruitment targets have been met at the end of the study 2. Feasibility of the data collection procedures is determined by applying validated assessments of prescribing appropriateness (i.e. STOPP/START criteria, Medication Appropriateness Index) and prescribing regimen complexity (i.e. Medication Regimen Complexity Index) to clinical data extracted from recruited patients’ medical records at baseline and follow-up (four weeks after date of scheduled consultations) |
| Overall study start date | 01/04/2015 |
| Completion date | 30/09/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 10 |
| Key inclusion criteria | General practice inclusion criteria: 1. Located in Northern Ireland 2. The practice was willing to implement the study 3. Individual general practitioners (GPs) willing to provide written informed consent. Patient inclusion criteria: 1. Over the age of 65 2. Receiving four or more regular medicines 3. Not cognitively impaired 4. Resident in the community |
| Key exclusion criteria | 1. Not meeting the inclusion criteria 2. Not proving written informed consent |
| Date of first enrolment | 01/06/2015 |
| Date of final enrolment | 31/08/2015 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom
Sponsor information
University/education
Research and Enterprise Office
University Road
Belfast
BT7 iNN
Northern Ireland
United Kingdom
"ROR" |
https://ror.org/00hswnk62 |
|---|
Funders
Funder type
Hospital/treatment centre
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- The Dunhill Medical Trust, DMT
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/09/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned submission of a feasibility study paper to a peer-reviewed journal. |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 20/07/2017 | Yes | No | |
| Other publications | Development of intervention | 16/11/2016 | 16/02/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
16/02/2023: Publication reference added.
24/07/2017: Publication reference added.
