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 -

SLCTR Registration Number

SLCTR/2013/029


Date of Registration

17 Sep 2013

The date of last modification

Nov 20, 2017


Trial Status



Application Summary


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 of 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)


Trial Details


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


Assignment

Parallel


Purpose

Health services research


Purpose


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 ]
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
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


Primary outcome(s) - Time of assessment(s)

  1. During the hospital stay
  2. 6 days post discharge
  3. 6 days post discharge

Secondary outcome

Reduction in adverse drug reactions occurring during hospital stay by active surveillance and ADR reporting by the clinical pharmacist


Secondary outcome(s) - Time of assessment(s)

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


Recruitment status

Complete


State of ethics review approval

Approved by the Ethics Review Committee, Faculty of Medicine, University of Kelaniya (Ref. No. P 12/01/2012)


Funding source

South Asian Clinical Toxicology Research Collaboration (SACTRC)



Contact & Sponsor Information


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

Secondary study sponsor (If any)

None