Plain English Summary
Background and study aims
Medication reviews are beneficial to patients by making sure that the medications they are taking and the monitoring of their condition is appropriate, the patient knows how and why they are taking their medication and the medicines are being taken appropriately. Although pharmacists have good drug knowledge and are trained to help patients to take their medicines, research has shown that to regularly provide medication reviews pharmacists need to develop their communication skills and work more closely with medical practices. We believe that pharmacy student experience of undertaking real medication reviews under close supervision in a medical practice and a later related patient consultation is an innovative model which could provide significant patient benefit at relatively small cost. The aim of this study is to identify the potential patient benefits of these medical reviews and to describe it so that its easily repeated across other schools of pharmacy in the UK.
Who can participate?
Participants with type 2 diabetes taking non-insulin antidiabetes medication
What does the study involve?
First of all, a review of previous work is done alongside focus groups with doctors, patients, pharmacists and students. Patients from four medical practices are then recruited and then randomised to one of two groups. Those in group 1 undergo a student led medication review. Those in group 2 receive usual care. Pairs of students from the University of East Anglia are allocated 4 participants from group 1 to review under supervision at the patient’s medical practice. Students discuss their findings with the participants GP. Six weeks later supervised face to face medicines related consultations with reviewed participants are carried out at the University. A questionnaire is sent to all participants from both groups six months after the interviews and the results between the two groups compared. Focus groups are then held again in order to learn from the process.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
School of Pharmacy, University of East Anglia (UK)
When is the study starting and how long is it expected to run for?
February 2011 to November 2012
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mr Rick Adams
richard.adams@uea.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
9933
Study information
Scientific title
Supervised pharmacy student led medication review of patients with diabetes in primary care:a pilot study to ascertain the potential costs and effects.
Acronym
Study hypothesis
Pilot study to identify if there are any benefits to type 2 diabetes patients in undertaking a student led medication review. In addition we will establish if there are any benefits in terms of education for the student.
Ethics approval
10/H0306/77
Study design
Randomised; Interventional; Design type: Process of Care
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Topic: Primary Care; Subtopic: Other Primary Care; Disease: All Diseases
Intervention
1. Each intervention arm patient received a medication review of their medication by a student pharmacist, using their medical records. Any potential action forwarded to the patient's GP. Each intervention arm patient then met a student pharmacist for a one to one medication review.
2. Control patients received usual care.
Follow Up Length: 3 month(s); Study Entry : Single Randomisation only
Intervention type
Other
Phase
Drug names
Primary outcome measure
HbA1c; Timepoint(s): Pre intervention and 6 months post intervention
Secondary outcome measures
1. Blood pressure; Timepoint(s): Pre intervention and 6 months post intervention
2. Lipid profile; Timepoint(s): Pre intervention and 6 months post intervention
3. Medication adherence (MARS); Timepoint(s): Pre intervention and 6 months post intervention
4. Patient beliefs about medicines (BMQ); Timepoint(s): Pre intervention and 6 months post intervention
5. Quality of life (EQ5D); Timepoint(s): Pre intervention and 6 months post intervention
6. Satisfaction with diabetes treatment (DTSQ); Timepoint(s): Pre intervention and 6 months post intervention
7. Satisfaction with information about medicines (SIMS); Timepoint(s): Pre intervention and 6 months post intervention
Overall trial start date
14/02/2011
Overall trial end date
30/11/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Prescribed non insulin medication for type 2 diabetes for at least 2 years
2. Willing to give consent
3. Registered with one of the 4 participating GP practices
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 160; UK Sample Size: 160; Description: 80 control and 80 intervention
Participant exclusion criteria
1. Deemed unsuitable for inclusion in the study for any reason by their GP
2. Enrolled in other clinical trials
3. Suffering from terminal illness
Recruitment start date
14/02/2011
Recruitment end date
30/11/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
School of Pharmacy, University of East Anglia
Earlham Road
Norwich
Norfolk
NR4 7TJ
United Kingdom
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
1. Dissemination meetings with patient participants (both groups) July 2014
2. Documentation of results to participating medical practices - July 2014
3. Copies of any publications sent to those participants requesting this at recruitment. date to be confirmed at a later date
4. Attendance at scientific conferences as appropriate. Date to be confirmed at a later date
5. Publication in appropriate journals
Intention to publish date
01/08/2015
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26537500