Home » Trials » SLCTR/2018/011
A study to evaluate the effect of Clinical pharmacists’ interventions on management outcomes in Chronic Kidney Disease of uncertain etiology patients undergoing hemodialysis in Sri Lanka: A Randomized controlled trial
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SLCTR Registration Number
SLCTR/2018/011
Date of Registration
The date of last modification
Jul 19, 2019
Scientific Title of Trial
A study to evaluate the effect of Clinical pharmacists’ interventions on management outcomes in Chronic Kidney Disease of uncertain etiology patients undergoing hemodialysis in Sri Lanka: A Randomized controlled trial
Public Title of Trial
Clinical pharmacy services to improve management outcomes of Chronic Kidney Disease of uncertain etiology patients undergoing hemodialysis
Disease or Health Condition(s) Studied
Chronic Kidney Disease of uncertain etiology
Scientific Acronym
None
Public Acronym
None
Brief title
Improving management outcomes of CKDu patients undergoing hemodialysis using clinical pharmacy services
Universal Trial Number
U1111-1209-7816
Any other number(s) assigned to the trial and issuing authority
Faculty of Medicine, Kelaniya ERC: P/14/01/2018
What is the research question being addressed?
Does the provision of clinical pharmacy services to selected Chronic Kidney Disease of uncertain etiology (CKDu) patients undergoing hemodialysis in North Central region of Sri Lanka during twelve months improve drug adherence, reduce drug related problem and improve management outcomes?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Health services research
Study Phase
Not Applicable
Intervention(s) planned
1.The study subjects will be recruited from the patients diagnosed with CKDu undergoing hemodialysis, who attend the nephrology hemodialysis units in Teaching Hospital, Anuradhapura.
The randomization will be done using a computer generated random sequence to allocate the participants into two arms.
The clinical pharmacist interventions will be done for the intervention group after recruitment to the study, patients will be followed at 2, 6, 10 and 12 months on dremographic data, patient knowledge of their medications, drug adherence and all the laboratory measures.
The trained pharmacist will perform following interventions. • Take a detailed medication history from patient • Individual review of the patients’ drug list • Assess the appropriateness of the drugs • Identify Drug Related Problems (DRPs)and communicate to prescriber or patient when necessary • Individualized medication counselling to patients on proper use of drugs. (Individualized one to one drug counselling for 30 minutes) 4. Drug related queries of the patients in intervention arm will be discussed with medical staff to reduce the (Drug Related Problems) DRPs. 5. The pharmacist at each follow up visit will identify any unplanned changes in medications and other management plan with medical officers.
The clinical pharmacist interventions will be done for the intervention group at the date of patient recruitment, and at each visit to the dialysis units.
Drug related queries of the patients in intervention arm will be discussed with medical staff to reduce the DRPs. The pharmacist at each follow up visit will identify any unplanned changes in planned medications and other management plan.
Inclusion criteria
All consenting CKDu patients, both male and female, undergoing hemodialysis who attend the nephrology hemodialysis units 18 years old or above. Chronic Kidney Disease of Uncertain etiology diagnosed clinically and biochemically by medical officers in the nephrology units of study hospitals
Exclusion criteria
Patients with a history of renal transplantation
Primary outcome(s)
1.
Drug adherence. A Brief Medication questionnaire will be used to measure the drug adherence of the patients. Ref. Svarstad, B.L., Chewning, B.A., Sleath, B.L., Claesson, C. (1999) The brief medication questionnaire: A tool for screening patient adherence and barriers to adherence. Patient Education and Counselling, (37):113-124 |
[ At the date of recruitment (baseline) and twelve months after the date of recruitment (post intervention) ] |
2.
Appropriateness of prescribing. Medication appropriateness index (MAI) will be used as a tool. |
[ At the date of recruitment (baseline) and twelve months after the date of recruitment (post intervention) ] |
3.
Medication related problems. Drug related problem classification system created by the Pharmaceutical Care Network of Europe, the latest version of Australian Medicines Handbook (AMH) and the British National Formulary (BNF) will be used as a reference. to identify, classify and prevent the medication related problems |
[ At the date of recruitment (baseline) and twelve months after the date of recruitment (post intervention) ] |
Secondary outcome(s)
1.
The disease management outcome will be assessed based on laboratory parameters. 1. Serum calcium 2. Serum phosphate 3. Blood urea nitrogen-BUN 4. URR 5. Hemoglobin 6. Lipid profile. Relative changes in these parameters will be assessed compared to each baseline values. |
[ Blood investigations will be done at the date of recruitment (baseline) and twelve months after the date of recruitment (post intervention) ] |
2.
Novel renal injury biomarkers:
The measurement of these biomarkers will be done using standard multiplex assays. |
[ Panel of novel renal injury biomarkers will be measured in the urine samples collected at each visit (at baseline, 2, 6, 10 and 12 months post-recruitment in the intervention group and at baseline and at 12 months in the control group) ] |
Target number/sample size
270 patients (135 patients in each arm)
Countries of recruitment
Sri Lanka
Anticipated start date
2018-06-04
Anticipated end date
2020-06-04
Date of first enrollment
Date of study completion
Recruitment status
Recruiting
Funding source
National Science Foundation, Sri Lanka
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-02-14
Approval number
P/14/01/2018
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
Dr. Shaluka Jayamanne
Consultant Physician, Senior Lecturer in Medicine Department of Medicine
Faculty of Medicine, University of Kelaniya, Thalagolla Road, Ragama
0112961119
0773014722
0112958337
shalukajaya@yahoo.com
Contact Person for Public Queries
Aluth Gedara Sumedha Kalpani
Researcher
Faculty of Medicine, University of Kelaniya, Thalagolla Road, Ragama
0112961119
0771770158
0112958337
agsk1200@gmail.com
Primary study sponsor/organization
National Science Foundation
47/5, Maitland Place, Colombo 07, Sri Lanka
0112694170
0112694754
dg@nsf.ac.lk
www.nsf.ac.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
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