Condition category
Circulatory System
Date applied
12/05/2010
Date assigned
12/05/2010
Last edited
06/09/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Pharmacists carrying out reviews of patient’s 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 patient’s medicines, conditions being treated and relevant test results from the patient’s 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 patient’s 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 patient’s 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 patient’s 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

Contact information

Type

Scientific

Primary contact

Ms Moira Kinnear

ORCID ID

Contact details

Crewe Road South
Edinburgh
EH4 2XU
United Kingdom

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 below 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 measures

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

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

Crewe Road South
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

http://www.nhslothian.scot.nhs.uk/

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

Results - basic reporting

Publication summary

2016 results in: http://ejhp.bmj.com/content/early/2016/08/08/ejhpharm-2016-000918.abstract

Publication citations

Additional files

Editorial Notes

06/09/2016: Publication reference added. 11/09/2013: The overall trial end date was changed from 06/11/2009 to 30/05/2010.