Condition category
Signs and Symptoms
Date applied
02/10/2015
Date assigned
06/10/2015
Last edited
12/11/2015
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 65, 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). Regularly reviewing the medications that multimorbid patients are taking is a vital part of their continuing care. In many cases, time constraints can mean that medications are not reviewed as frequently as they should be. In addition, GPs are often concerned about the consequences of taking a patient off a medication as it could have a negative impact on the patient’s health or themselves, as they are fully accountable. MY COMRADE is a new technique which has been developed to help with medication reviews. It involves two GPs reviewing the medications that multimorbid patients are taking and making joint decisions about continuing treatment. The aim of this study is to find out whether the MY COMRADE technique could improve the way that medications are reviewed in multimorbid patients.

Who can participate?
GPs who work in a practice which employs at least two GPs.

What does the study involve?
Participating GPs select patients who are taking at least 10 different medications or those taking at least four medications who have a complication making them difficult to treat. For these patients, GPs use the MY COMRADE technique to make decisions on the patient’s medications either weekly or fortnightly. After one month, the GPs are interviewed about their experience of using the MY COMRADE technique, and whether it has made a different to the way that medications are reviewed.

What are the possible benefits and risks of participating?
Benefits of participating is the possibility of an improved ways of regulating medication reviews for multimorbid patients. There are no risks of participating, although there is a time commitment involved.

Where is the study run from?
University College Cork (Ireland)

When is the study starting and how long is it expected to run for?
September 2014 to October 2015

Who is funding the study?
Health Research Board (Ireland)

Who is the main contact?
Dr Carol Sinnott

Trial website

Contact information

Type

Scientific

Primary contact

Dr Carol Sinnott

ORCID ID

http://orcid.org/0000-0002-8620-7461

Contact details

Department of General Practice
School of Medicine
University College Cork
Cork
T12 XF62
Ireland

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

A feasibility study on the MultimorbiditY COllaborative Medication Review And DEcision Making (MY COMRADE) intervention in general practice

Acronym

MY COMRADE

Study hypothesis

To evaluate the feasibility and implementation of the MY COMRADE intervention by general practitioners in the management of patients with multi-morbidity in general practice.

Ethics approval

Clinical Research Ethics Committee of the Cork Teaching Hospitals, 19/11/2014, ref: ECM3

Study design

Non-randomised feasibility study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

GP practices

Trial type

Not Specified

Patient information sheet

Condition

Multi-morbidity

Intervention

Participating GPs selected patients prescribed more than 10 medications, or more than 4 medications with a complicating factor, on which to conduct a collaborative medication review. After one month GPs are interviewed to study their experience of the intervention, referring specifically to implementation outcomes stated in the WHO Implementation of Innovations in Practice framework.

MY COMRADE intervention:
1. Prompts: A checklist was provided as a guide for the medication review. The checklist was based on the NO TEARS checklist, a pragmatic and practical set of seven questions which relate to safe prescribing and can be applied to any medication. The original NO TEARS checklist was designed for use between GP and patient – we modified it for use between two GPs in order to guide and frame the medication review. The GPs were instructed to note any potential changes to medications on the checklist page, and scan it into the patient’s notes to make the next review easier and serve as a record of the medication review process. The set of prescribing questions (prescribing tool) was offered to GPs in paper or electronic format, and participating GPs chose the format most convenient for their practice.
2. Social support: The principal component of the intervention is that GPs act in a collaborative fashion, with at least 2 GPs reviewing the medications for each multi-morbid case chosen. GPs were asked to each choose 3 patients on which to do the medication review (10+ medications or 5+ medications with another complicating factor such as dementia, poor life expectancy etc.), and schedule a time to discuss these patients with another GP in their practice.
3. Change in social environment: The GPs were asked to schedule protected time for themselves in which to conduct the medication review. This would involve them moving to one consultation room to avail of medical records for the cases that were chosen.
4 .Self-incentives (CPD points) they were advised that once the activity had been completed they could claim CPD points – certificates were provided for them to record this information on.
5. Action planning (including implementation intentions). Within each practice the implementation plan was flexible: GPs were asked to conduct their collaborative medication reviews over multiple weeks rather than all in one sitting but whether they choose to do so at weekly or fortnightly intervals was left to their discretion.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Success of the intervention in achieving behavioural change (i.e. medication review by GPs) measured in evaluation interviews, one month after the start of the intervention.

Secondary outcome measures

Implementation outcome variables, measured using the WHO implementation of innovations in practice framework, one month after the start of the intervention.

Overall trial start date

01/09/2014

Overall trial end date

31/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

1. General Practitioners (GPs)
2. Working in practices with two or more GPs employed

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

20

Participant exclusion criteria

N/A

Recruitment start date

26/11/2014

Recruitment end date

01/07/2015

Locations

Countries of recruitment

Ireland

Trial participating centre

University College Cork
Department of General Practice School of Medicine Western Gateway Building
Cork
T12 XF62

Sponsor information

Organisation

Department of General Practice

Sponsor details

School of Medicine
University College Cork
Cork
T12 XF62
Ireland

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Health Research Board

Alternative name(s)

HRB

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Ireland

Results and Publications

Publication and dissemination plan

Results will be presented at local GP meetings, national medication management seminars and international meetings on quality and safety in heathcare. Results will also be published in a peer reviewed journal.

Intention to publish date

01/04/2016

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes