Condition category
Not Applicable
Date applied
18/01/2016
Date assigned
22/01/2016
Last edited
21/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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?
Professor Carmel Hughes

Trial website

Contact information

Type

Scientific

Primary contact

Prof Carmel Hughes

ORCID ID

Contact details

Queen's University Belfast
School of Pharmacy
97 Lisburn Road
Belfast
BT9 7BL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2

Study information

Scientific title

Development of an intervention to improve appropriate polypharmacy for older people in primary care

Acronym

Study hypothesis

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

Health and Social Care Research Ethics Committee A, 29/05/2015, ref: 15/NI/0104

Study design

Single-centre feasibility study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Other

Patient information sheet

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

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/04/2015

Overall trial end date

30/09/2015

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

10

Participant exclusion criteria

1. Not meeting the inclusion criteria
2. Not proving written informed consent

Recruitment start date

01/06/2015

Recruitment end date

31/08/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen's University Belfast
School of Pharmacy 97 Lisburn Road
Belfast
BT9 7BL
United Kingdom

Sponsor information

Organisation

Queen's University Belfast

Sponsor details

Research and Enterprise Office
University Road
Belfast
BT7 iNN
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Dunhill Medical Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned submission of a feasibility study paper to a peer reviewed journal.

Intention to publish date

30/09/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes