Home » Trials » SLCTR/2013/029
Impact of a ward based clinical pharmacist on improving the quality use of medicines in patients with chronic non communicable diseases, compared to standard practice in a Sri Lankan teaching hospital
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SLCTR Registration Number
SLCTR/2013/029
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Impact of a ward based clinical pharmacist on improving the quality use of medicines in patients with chronic non communicable diseases, compared to standard practice in a Sri Lankan teaching hospital
Public Title of Trial
Impact of a ward based clinical pharmacist on improving the quality use of medicines in patients with chronic non communicable diseases, compared to standard practice in a Sri Lankan teaching hospital
Disease or Health Condition(s) Studied
Chronic non communicable diseases
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P 12/01/2012 (Ethics Review Committee, Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
Does including the services of a ward based clinical pharmacist to the existing standard care improve the quality use of medicine in the Colombo North Teaching Hospital?
Type of study
Interventional
Study design
Allocation
Non-randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Available
Intervention(s) planned
A Sri Lankan trained pharmacist will provide a clinical pharmacy service to the intervention group in addition to the standard clinical management.
The pharmacist will
• obtain a detailed drug history on admission and prepare a pharmaceutical care plan based on the drug related problem classification system created by the Pharmaceutical Care Network of Europe
• be a part of the clinical team and attend daily ward round and provide recommendations for drug therapy that will ensure continuity of care after discharge, increase adherence, optimise therapy and suit the needs of the individual patient.
• discuss drug information related queries with staff, and document discussion in diarised format.
• provide education (verbally and using printed material) to patient and carer during hospital stay and at discharge in order to improve their understanding on their medicines, all changes that have occurred in hospital and increase the likelihood of adherence after discharge.
Outcomes will be compared with a parallel group in a ward without the services of a clinical pharmacist
Inclusion criteria
• Patients admitted to the professorial medical unit in CNTH
• Age over 12 years
• Able to communicate in Sinhala or English
• Diagnosed with, a non communicable chronic disease (cardiovascular diseases, diabetes mellitus, pneumonia, cirrhosis, bronchial asthma and chronic obstructive pulmonary disease, chronic kidney diseases, peptic ulcer disease).
Exclusion criteria
None
Primary outcome(s)
|
1.
The impact of clinical pharmacist’s service on the safety, efficacy and appropriateness of all prescribed medicines for individual patients [ using Medication Appropriateness Index - MAI ] |
[ During the hospital stay ] |
|
2.
The impact of clinical pharmacist’s service on patients’ adherence to the drug regimen (compliance) is assessed by using a structured questionnaire at the 6th day of discharge through over the phone |
[ 6 days post discharge ] |
|
3.
The impact of clinical pharmacist’s service on patient knowledge and understanding of their medication regimen in the post discharge period is assessed through over the phone by using a structured questionnaire |
[ 6 days post discharge ] |
Secondary outcome(s)
|
1.
Reduction in adverse drug reactions occurring during hospital stay by active surveillance and ADR reporting by the clinical pharmacist |
[ During hospital stay ] |
Target number/sample size
800
Countries of recruitment
Sri Lanka
Anticipated start date
2013-09-18
Anticipated end date
2013-12-15
Date of first enrollment
2013-09-19
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
South Asian Clinical Toxicology Research Collaboration (SACTRC)
Regulatory approvals
Status
Approved
Date of Approval
2012-10-17
Approval number
P12/01/2012
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Prof Asita de Silva
Professor in Pharmacology
Clinical Trials Unit, Faculty of Medicine, University of Kelaniya, Thalagolla Road, Ragama
112665266
112665300
asitades@gmail.com
Contact Person for Public Queries
Lelwala Guruge Thushani Shanika
Clinical Pharmacist Project Officer
SACTRC, Faculty of Medicine, University of Kelaniya, Thalagolla Road, Ragama
0714537668
thushani85@gmail.com
Primary study sponsor/organization
South Asian Clinical Toxicology Research Collaboration
SACTRC, Faculty of Medicine, University of Peradeniya, Peradeniya
0814479822
0814479822
enquiry@sactrc.org
www.sactrc.org
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
