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A randomised control trial to evaluate the impact of a clinical pharmacist on optimizing the quality use of medicines according to the Acute Coronary Syndrome (ACS) secondary prevention guidelines and medication adherence following discharge in patients with ACS

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SLCTR Registration Number

SLCTR/2019/039


Date of Registration

10 Nov 2019

The date of last modification

Nov 11, 2019



Application Summary


Scientific Title of Trial

A randomised control trial to evaluate the impact of a clinical pharmacist on optimizing the quality use of medicines according to the Acute Coronary Syndrome (ACS) secondary prevention guidelines and medication adherence following discharge in patients with ACS


Public Title of Trial

Assessment of the impact of a clinical pharmacist compared to standard care in improving quality use of medicines, patient adherence and reducing hospital readmissions in patients diagnosed with acute coronary syndrome


Disease or Health Condition(s) Studied

Acute Coronary Syndrome


Scientific Acronym

None


Public Acronym

None


Brief title

Impact of a clinical pharmacist in improving quality use of medicines, patient adherence and reducing hospital readmissions in patients diagnosed with ACS


Universal Trial Number

U1111-1241-1907


Any other number(s) assigned to the trial and issuing authority

2019/EC/26


Trial Details


What is the research question being addressed?

Does the intervention of a clinical pharmacist in patients with ACS improve quality use medicines, patient adherence and reduce hospital readmissions?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Masking not used


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Other


Study Phase

Not Applicable


Intervention(s) planned

The study will be conducted at the Medical wards of Teaching hospital Peradeniya. The patients will be randomized into control and intervention groups by block randomization method. There are four sections (A, B, C, D) in the medical wards at TH Peradeniya. Patients in the section A, B will be considered as the control group and patients in section C, D will be considered as the intervention group for the first three months of data collection. The sections will be swapped for the next three months. This method is planned to minimize the contamination of control groups by having intervention patients within the same section. The intervention will be delivered by the principle investigator, and a qualified pharmacist will assist the process. Interventions planned • Medication history will be recorded by the clinical pharmacist at the time of recruitment and it will be reconciled against the inward medication plan. • Patients medication adherence will be assessed at the time of recruitment by using a validated adherence assessment tool (Brief Medication Questionnaire). • Continuous medication review by the clinical pharmacist daily during the patients stay at the ward and discharge medication review at the time of discharge. BNF, AMH and ACS therapeutic guidelines will be used for the review. • Identification and resolution of medication related problems (Wrong drug choice, wrong dose, drug interactions etc.), • Discharge medication counselling with written information and labelled medicine by the clinical pharmacist. • Follow up after discharge at 1 month, 3 months and 6 months intervals by the clinical pharmacist at the medical clinic. • Hospital readmissions, changes to medications, adverse drug reactions will be checked during the respective period at each follow up and medication related issues will be resolved at the follow-ups. • At the end of the study period (6 months after follow up) patients medication adherence will be reassessed using the same tool to check the improvement.


Inclusion criteria

Male and female patients above 18 years of age who are diagnosed and managed as ACS by the medical team will be considered as the study population in this study


Exclusion criteria

Patients who refuse to participate Patients who are diagnosed with psychological disorders Patients who are younger than 18 years Patients who are pregnant



Primary outcome(s)

1.

1) Number of hospital readmissions due to acute coronary syndrome related issues during the study period

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At the end of the followup period (six months after discharge)

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2.

2) Changes in medication adherence. (Patients medication adherence will be compared between the time of recruitment and end of study at six months after discharge using a validated tool (Brief Medication Questionnaire)

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Secondary outcome(s)

1.

Number of Drug related problems

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At the end of the followup period (six months after discharge)

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Number of adverse drug reactions during the study period

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At the end of the followup period (six months after discharge)

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Cost effectiveness of clinical pharmacist intervention

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At the end of the followup period (six months after discharge)

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Target number/sample size

340 patients in the control arm and 340 patients in the intervention arm


Countries of recruitment

Sri Lanka


Anticipated start date

2019-11-12


Anticipated end date

2021-03-10


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Self funded


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2019-07-05


Approval number

2019/EC/26


Details of Ethics Review Committee

Name: Ethics Review Committee of the Faculty of Medicine, University of Peradeniya
Institutional Address:Faculty of Medicine, University of Peradeniya, Peradeniya
Telephone:0812396361
Email: chairpersonierc@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

N. M. Y. Bagyawantha
Lecturer (Probationary)
Department of Pharmacy, Faculty of Allied Health Sciences, University of Peradeniya, Peradeniya
0812065792
0712179296

bagyawanthanmy@gmail.com

Contact Person for Public Queries

Dr A C M Fahim
Head
Department of Pharmacy, Faculty of Allied Health Sciences, University of Peradeniya, Peradeniya
0814479822
0777664285

fahim.cader@gmail.com


Primary study sponsor/organization



Teaching hospital Peradeniya



Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

No


IPD sharing plan description


Study protocol available

No


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