Condition category
Nutritional, Metabolic, Endocrine
Date applied
13/08/2015
Date assigned
13/08/2015
Last edited
01/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Public

Primary contact

Mr Rick Adams

ORCID ID

Contact details

School of Pharmacy
University of East Anglia
Earlham Road
Norwich
Norfolk
NR4 7TJ
United Kingdom

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 measures

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

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

Sponsor information

Organisation

NHS South Norfolk CCG

Sponsor details

Research & Development
NHS South Norfolk Clinical Commissioning Group
Lakeside 400
Old Chapel Way
Broadland Business Park
Thorpe St Andrew
Norwich
NR7 0WG
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/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

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26537500

Publication citations

Additional files

Editorial Notes

01/09/2016: Publication reference added.