Plain English Summary
Background and study aims
Pharmacists carrying out reviews of patients medicines have shown that they can identify and resolve medication-related problems. Pharmacists also help patients find ways of taking their medicines appropriately and improve management of their conditions. Studies have shown pharmacists improve stroke patients satisfaction, retain quality of life and help reduce admissions to hospital. Our previous work investigated the beliefs and concerns of stroke patients and identified barriers to medicine taking. We have designed a care plan incorporating these findings. A pilot study was planned to explore the feasibility of undertaking a much larger trial to test if a pharmacist applying this care plan to stroke patients in their own home can make a difference to their health and reduce the risk of further stroke.
Who can participate?
Men and women, aged 53-92 years, who were being discharged from hospital in NHS Lothian following a stroke were recruited over a 4-month period from one of the three acute stroke units or three rehabilitation units or the neurovascular outpatient clinic.
What does the study involve?
Patients were randomly allocated to one of two groups: a study group or a usual care group. The study group received three visits in their own homes from a clinical pharmacist researcher at 1, 3 and 6 months after discharge from hospital. The pharmacist obtained information about the patients medicines, conditions being treated and relevant test results from the patients General Practitioner (GP) and completed a care plan for each patient. The care plan facilitated and allowed assessment of the gathered patient information against current national clinical standards and guidelines for prevention of another stroke.
Examples of what was assessed:
1. Whether the patient was on all the medicines currently recommended for prevention of another stroke
2. Whether the doses were appropriate for the patients kidney function and clinical results
3. Whether medicines were interacting
4. Whether other diseases required treatment and possible need for additional medicines
The pharmacist also gave help with practical issues around medicine taking such as physical taking of medicines and formation of medicine taking routines. Also, advice on lifestyle issues such as smoking, diet, alcohol intake and exercise was given if necessary. Following each visit, a letter was sent to the patients GP and Community Pharmacist recording medicine-related problems and recommended actions to resolve problems where appropriate with an invitation to discuss with the clinical pharmacist researcher if required.
The usual care group were discharged from hospital following standard procedures which did not involve a detailed care plan and follow up at home by the clinical pharmacist researcher. All patients in both of the groups received a questionnaire at 6 months which included sections to measure patient satisfaction, quality of life and beliefs about medicines. A memory test was also completed at time of recruitment and at 6 months.
What are the possible benefits and risks of participating?
The benefit to the study group was that they received follow up after discharge from hospital in their own homes by a clinical pharmacist researcher with experience in stroke who ensured that patients were on the correct medicines at the correct doses for prevention of another stroke and were taking them appropriately. Blood pressure, lipid (fat) levels and blood sugar test results were monitored to assess whether medicines were being taken and target measurements achieved. Any issues identified by the pharmacist were resolved and communicated to the patients GP and community pharmacist. There were no more risks than usual care and in fact there was opportunity for improved care.
Where is the study run from?
The study was run from NHS Lothian Pharmacy Service (UK) in collaboration with stroke physicians.
When is the study starting and how long is it expected to run for?
The study started in July 2009 and was completed in 2010.
Who is funding the study?
The study was funded by the Chief Scientist Office as part of the NHS Lothian Health Services Research Programme (UK).
Who is the main contact?
Moira Kinnear
moira.kinnear@nhslothian.scot.nhs.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
7874
Study information
Scientific title
A randomised exploratory trial of a pharmacist-led home based clinical medication review in people after stroke
Acronym
Study hypothesis
Feasibility study of home based pharmacist-led clinical medication review using an evidence based pharmaceutical care plan at 1 month and 3 months after discharge from hospital. Follow up at 6 months.
Ethics approval
Lothian Local Research Ethics Committee 03, 11/06/2009, ref: 09/S1103/21
Study design
Single-centre randomised interventional process of care trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Topic: Stroke Research Network; Subtopic: Primary Care; Disease: Community study
Intervention
Pharmacist home-based clinical medication review in people after stroke versus usual care. The pharmacist visits the intervention group at home and uses the pharmaceutical care plan as a structured approach to identify pharmaceutical problems, resolves the problems and communicates with relevant healthcare professionals. Visits are undertaken at 1 month and 3 months after discharge from hospital. All patients are followed up at 6 months with blood pressure measurements being undertaken by independent researchers.
Study entry: single randomisation only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Recruitment rate - eligibility and participation. Measured 6 months after recruitment (due for completion May 2010)
Secondary outcome measures
At 6 months:
1. EUROQoL
2. Beliefs about Medicines Questionnaire
3. Self-reported adherence
4. Medication adherence
Overall trial start date
21/07/2009
Overall trial end date
30/05/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with stroke due for discharge home from acute, rehabilitation or out-patient neurovascular clinic settings
2. Male and female, aged 53-92 years
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Planned sample size: 60; UK sample size: 60
Participant exclusion criteria
1. Discharge to long-term care
2. Terminal serious illness
3. Severe confusion such that the patient does not have capacity to understand or give informed consent
4. Unable to nominate a community pharmacy
5. Severe dysphasia
Recruitment start date
21/07/2009
Recruitment end date
30/05/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Western General Hospital
Edinburgh
EH4 2XU
United Kingdom
Sponsor information
Organisation
NHS Lothian (UK)
Sponsor details
Queens Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Chief Scientist Office
Alternative name(s)
CSO
Funding Body Type
government organisation
Funding Body Subtype
government non-federal
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
Publication list
2017 results in: http://ejhp.bmj.com/content/24/2/101