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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 -

SLCTR Registration Number

SLCTR/2018/011


Date of Registration

26 Mar 2018

The date of last modification

Mar 26, 2018


View original TRDS



Application Summary


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 of 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


Trial Details


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


Assignment

Parallel


Purpose

Health services research


Purpose


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.

  1. The randomization will be done using a computer generated random sequence to allocate the participants into two arms.

  2. 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

  1. Appropriateness of prescribing. Medication appropriateness index (MAI) will be used as a tool.

  2. 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


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

At the date of recruitment (baseline) and twelve months after the date of recruitment (post intervention)


Secondary outcome

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

• Novel renal injury biomarkers: 1. NGAL 2. KIM-1 3. Clusterin 4. Cystatin C 5. IL-18 6. Beta2- microglobulin.

The measurement of these biomarkers will be done using standard multiplex assays.


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

Blood investigations will be done at the date of recruitment (baseline) and twelve months after the date of recruitment (post intervention) 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

2018-03-26


Anticipated end date

2020-03-26


Recruitment status

Pending


State of ethics review approval

Approved by the Ethics Review Committee of the Faculty of Medicine, University of Kelaniya on 14.02.2018 (Ref. No. P/14/01/2018)


Funding source

National Science Foundation, Sri Lanka



Contact & Sponsor Information


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

Secondary study sponsor (If any)

None