Supervised pharmacy student led medication review of patients with diabetes in primary care.

ISRCTN ISRCTN26445805
DOI https://doi.org/10.1186/ISRCTN26445805
Secondary identifying numbers 9933
Submission date
13/08/2015
Registration date
13/08/2015
Last edited
01/09/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Mr Rick Adams
Public

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

Study information

Study designRandomised; Interventional; Design type: Process of Care
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleSupervised pharmacy student led medication review of patients with diabetes in primary care:a pilot study to ascertain the potential costs and effects.
Study objectivesPilot 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(s)10/H0306/77
Health condition(s) or problem(s) studiedTopic: Primary Care; Subtopic: Other Primary Care; Disease: All Diseases
Intervention1. 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 typeOther
Primary outcome measureHbA1c; Timepoint(s): Pre intervention and 6 months post intervention
Secondary outcome measures1. 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 study start date14/02/2011
Completion date30/11/2012

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsPlanned Sample Size: 160; UK Sample Size: 160; Description: 80 control and 80 intervention
Key inclusion criteria1. 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
Key exclusion criteria1. Deemed unsuitable for inclusion in the study for any reason by their GP
2. Enrolled in other clinical trials
3. Suffering from terminal illness
Date of first enrolment14/02/2011
Date of final enrolment30/11/2012

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

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

Sponsor information

NHS South Norfolk CCG
Hospital/treatment centre

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

Funders

Funder type

Government

National Institute for Health Research
Government organisation / National government
Alternative name(s)
National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
Location
United Kingdom

Results and Publications

Intention to publish date01/08/2015
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination plan1. 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
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 04/11/2015 Yes No

Editorial Notes

01/09/2016: Publication reference added.