Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
V2
Study information
Scientific title
Practice interventions for language sensitivity: a randomised controlled pilot study to inform the delivery of pharmaceutical services in Wales
Acronym
PILSen
Study hypothesis
The aim of this pilot study is to test the feasibility of a randomised controlled trial (RCT) to build the evidence base for effective healthcare communication in the delivery of pharmaceutical services in the bilingual setting. This will be achieved through the following objectives:
1. The effect of language appropriate consultations on patient outcomes will be measured through establishing a small randomised controlled trial (RCT) of language concordance in Medicines Use Reviews (MURs) conducted by two community pharmacists in North Wales
2. Corpus linguistic analysis techniques will be used to discern the processes and patterns of language use within the healthcare consultations
Ethics approval
North West Wales Local Research Ethics pending approval as of 03/02/2009
Study design
Feasibility patient preference randomised controlled trial
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 the contact details below to request a patient information sheet
Condition
Effective healthcare communication
Intervention
1. Welsh medium randomised Medicines Use Reviews
2. English medium randomised Medicines Use Reviews
Randomised according to the protocol. Patients who demonstrate a distinct language preference will be allocated to a Welsh or English medium preference MUR, according to their choice.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Medication Adherence Questionnaire to assess participants use of medication following a Medicines Use Reviews, measured at 1 day and 1 month.
Secondary outcome measures
1. Beliefs about Medicines Questionnaire
2. Satisfaction with Information about Medicines Scale
3. Language switching measures
4. Information on processes and patterns of language use
5. Process measures for assessing feasibility of larger trial
Measured at 1 day and 1 month.
Overall trial start date
01/03/2009
Overall trial end date
30/09/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Welsh speaking patients between 18 and 80 years of age, either sex
2. Patients who are referred for Medicines Use Reviews (MUR) at the specified community pharmacies
3. Patients who are able to give informed consent
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40
Participant exclusion criteria
1. Non-Welsh speaking patients
2. Patients below 18 and above 80 years of age
3. Patients who are not eligible for MURs at the specified community pharmacies
4. Patients who are unable to give informed consent
Recruitment start date
01/03/2009
Recruitment end date
30/09/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Fferyllwyr Llyn Pharmacy
Gwynedd
LL53 7PA
United Kingdom
Sponsor information
Organisation
Fferyllwyr Llyn Pharmacy (UK)
Sponsor details
c/o Mr Llyr Hughes
Community Pharmacist
Siop Tan y Maes
Nefyn
Gwynedd
LL53 7PA
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Welsh Assembly Government (UK) - Pharmacy Practice Development Scheme 2008-2009
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary